Conference Recap

Dr. Michael Grunwald presents highlights in the latest studies involving several types of leukemia from the ASCO 2021 Virtual Congress.

In a dose-optimization study of ponatinib, patients with chronic-phase chronic myeloid leukemia were randomized 1:1:1 to receive 45, 30, or 15 mg daily, with dose reductions occurring once patients met the primary endpoint of ≤1% BCR-ABL1. At 12 months, response rate was highest with the 45 mg to 15 mg regimen, and 73.3% of patients in this cohort maintained response.

The phase 1/2 ZUMA-3 study evaluated KTE-X19 in adults with relapsed/refractory B-cell acute lymphoblastic leukemia. The drug’s efficacy, speed of manufacture, and ease of safety management were found to be sufficient to provide long-term clinical benefit.

Another study focused on the efficacy and safety of aspacytarabine (BST-236) for patients with acute myeloid leukemia (AML) who were unfit for chemotherapy. The rate of complete remission was 39% among the AML population, and 63% of the population in complete remission had minimal residual disease.

Dr. Grunwald closes with a study of ponatinib and blinatumomab in patients with Philadelphia chromosome–positive acute lymphoblastic leukemia. The combination of both drugs was proven to be a safe and effective chemotherapy-free regimen in both newly diagnosed patients and patients with relapsed/refractory disease.
 

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Michael R. Grunwald, MD, Chief, Leukemia Division. Department of Hematologic Oncology and Blood Disorders. Levine Cancer Institute, Atrium Health. Charlotte, North Carolina.

Michael R. Grunwald, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Agios; Amgen; Astellas Pharma; Blueprint Medicines; Bristol Myers Squibb; Cardinal Health; Daiichi Sankyo; Gilead Sciences; Incyte; Karius; Pfizer; Premier Pharmaceuticals; Sierra Oncology; Stemline Therapeutics.
Received research grant from: Incyte; Janssen.
 

Dr. Michael Grunwald presents highlights in the latest studies involving several types of leukemia from the ASCO 2021 Virtual Congress.

In a dose-optimization study of ponatinib, patients with chronic-phase chronic myeloid leukemia were randomized 1:1:1 to receive 45, 30, or 15 mg daily, with dose reductions occurring once patients met the primary endpoint of ≤1% BCR-ABL1. At 12 months, response rate was highest with the 45 mg to 15 mg regimen, and 73.3% of patients in this cohort maintained response.

The phase 1/2 ZUMA-3 study evaluated KTE-X19 in adults with relapsed/refractory B-cell acute lymphoblastic leukemia. The drug’s efficacy, speed of manufacture, and ease of safety management were found to be sufficient to provide long-term clinical benefit.

Another study focused on the efficacy and safety of aspacytarabine (BST-236) for patients with acute myeloid leukemia (AML) who were unfit for chemotherapy. The rate of complete remission was 39% among the AML population, and 63% of the population in complete remission had minimal residual disease.

Dr. Grunwald closes with a study of ponatinib and blinatumomab in patients with Philadelphia chromosome–positive acute lymphoblastic leukemia. The combination of both drugs was proven to be a safe and effective chemotherapy-free regimen in both newly diagnosed patients and patients with relapsed/refractory disease.
 

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Michael R. Grunwald, MD, Chief, Leukemia Division. Department of Hematologic Oncology and Blood Disorders. Levine Cancer Institute, Atrium Health. Charlotte, North Carolina.

Michael R. Grunwald, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Agios; Amgen; Astellas Pharma; Blueprint Medicines; Bristol Myers Squibb; Cardinal Health; Daiichi Sankyo; Gilead Sciences; Incyte; Karius; Pfizer; Premier Pharmaceuticals; Sierra Oncology; Stemline Therapeutics.
Received research grant from: Incyte; Janssen.
 

Dr. Michael Grunwald presents highlights in the latest studies involving several types of leukemia from the ASCO 2021 Virtual Congress.

In a dose-optimization study of ponatinib, patients with chronic-phase chronic myeloid leukemia were randomized 1:1:1 to receive 45, 30, or 15 mg daily, with dose reductions occurring once patients met the primary endpoint of ≤1% BCR-ABL1. At 12 months, response rate was highest with the 45 mg to 15 mg regimen, and 73.3% of patients in this cohort maintained response.

The phase 1/2 ZUMA-3 study evaluated KTE-X19 in adults with relapsed/refractory B-cell acute lymphoblastic leukemia. The drug’s efficacy, speed of manufacture, and ease of safety management were found to be sufficient to provide long-term clinical benefit.

Another study focused on the efficacy and safety of aspacytarabine (BST-236) for patients with acute myeloid leukemia (AML) who were unfit for chemotherapy. The rate of complete remission was 39% among the AML population, and 63% of the population in complete remission had minimal residual disease.

Dr. Grunwald closes with a study of ponatinib and blinatumomab in patients with Philadelphia chromosome–positive acute lymphoblastic leukemia. The combination of both drugs was proven to be a safe and effective chemotherapy-free regimen in both newly diagnosed patients and patients with relapsed/refractory disease.
 

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Michael R. Grunwald, MD, Chief, Leukemia Division. Department of Hematologic Oncology and Blood Disorders. Levine Cancer Institute, Atrium Health. Charlotte, North Carolina.

Michael R. Grunwald, MD, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Agios; Amgen; Astellas Pharma; Blueprint Medicines; Bristol Myers Squibb; Cardinal Health; Daiichi Sankyo; Gilead Sciences; Incyte; Karius; Pfizer; Premier Pharmaceuticals; Sierra Oncology; Stemline Therapeutics.
Received research grant from: Incyte; Janssen.
 

Dr Mark A. Socinski, executive medical director of AdventHealth Cancer Institute in Orlando, Florida, highlights studies in advanced non–small cell lung cancer (NSCLC) presented at the 2021 annual meeting of the American Society of Clinical Oncology.
First, Dr Socinski reports on the updated results of the CheckMate 9LA study showing continued benefit of nivolumab and ipilimumab plus chemotherapy vs chemotherapy alone.

He also outlines an FDA pooled analysis of randomized controlled trials showing that patients with PD-L1 scores between 1% and 49% benefit most from immunotherapy plus chemotherapy compared with immunotherapy alone.

Dr Socinski then takes us through one of his own studies showing that immune-related adverse events are actually associated with better outcomes, and reports some sobering data from two studies suggesting that biomarker testing is lagging behind in NSCLC patients, especially among African Americans. He closes by reviewing updated results of the CodeBreak 100 trial which showed encouraging response to sotorasib among patients with G12C KRAS mutations.

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Mark A. Socinski, MD, Executive Medical Director, AdventHealth Cancer Institute, Orlando, Florida.

Mark A. Socinski, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Genentech; Novartis; Guardant; AstraZeneca; Eli Lilly and Company; Blueprint
Received research grant from: Genentech; AstraZeneca; Novartis; Spectrum; Cullinan.

Dr Mark A. Socinski, executive medical director of AdventHealth Cancer Institute in Orlando, Florida, highlights studies in advanced non–small cell lung cancer (NSCLC) presented at the 2021 annual meeting of the American Society of Clinical Oncology.
First, Dr Socinski reports on the updated results of the CheckMate 9LA study showing continued benefit of nivolumab and ipilimumab plus chemotherapy vs chemotherapy alone.

He also outlines an FDA pooled analysis of randomized controlled trials showing that patients with PD-L1 scores between 1% and 49% benefit most from immunotherapy plus chemotherapy compared with immunotherapy alone.

Dr Socinski then takes us through one of his own studies showing that immune-related adverse events are actually associated with better outcomes, and reports some sobering data from two studies suggesting that biomarker testing is lagging behind in NSCLC patients, especially among African Americans. He closes by reviewing updated results of the CodeBreak 100 trial which showed encouraging response to sotorasib among patients with G12C KRAS mutations.

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Mark A. Socinski, MD, Executive Medical Director, AdventHealth Cancer Institute, Orlando, Florida.

Mark A. Socinski, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Genentech; Novartis; Guardant; AstraZeneca; Eli Lilly and Company; Blueprint
Received research grant from: Genentech; AstraZeneca; Novartis; Spectrum; Cullinan.

Dr Mark A. Socinski, executive medical director of AdventHealth Cancer Institute in Orlando, Florida, highlights studies in advanced non–small cell lung cancer (NSCLC) presented at the 2021 annual meeting of the American Society of Clinical Oncology.
First, Dr Socinski reports on the updated results of the CheckMate 9LA study showing continued benefit of nivolumab and ipilimumab plus chemotherapy vs chemotherapy alone.

He also outlines an FDA pooled analysis of randomized controlled trials showing that patients with PD-L1 scores between 1% and 49% benefit most from immunotherapy plus chemotherapy compared with immunotherapy alone.

Dr Socinski then takes us through one of his own studies showing that immune-related adverse events are actually associated with better outcomes, and reports some sobering data from two studies suggesting that biomarker testing is lagging behind in NSCLC patients, especially among African Americans. He closes by reviewing updated results of the CodeBreak 100 trial which showed encouraging response to sotorasib among patients with G12C KRAS mutations.

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Mark A. Socinski, MD, Executive Medical Director, AdventHealth Cancer Institute, Orlando, Florida.

Mark A. Socinski, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Genentech; Novartis; Guardant; AstraZeneca; Eli Lilly and Company; Blueprint
Received research grant from: Genentech; AstraZeneca; Novartis; Spectrum; Cullinan.

Dr. Lisa Carey, a breast cancer specialist from the University of North Carolina at Chapel Hill, looks at the latest data in metastatic breast cancer presented at the 2021 American Society of Clinical Oncology Annual Meeting.

First, Dr. Carey reviews an updated analysis from the PALOMA-3 trial of the CDK4/6 inhibitor palbociclib plus fulvestrant in women with HR+/HER2- advanced disease. This report showed that the observed survival benefit with the combination is maintained out to 6 years.

Next, she describes another updated survival analysis, this time from the MONALEESA-3 trial, which assessed fulvestrant plus another CDK4/6 inhibitor, ribociclib, in postmenopausal women with HR+/HER2- advanced disease. Again, the combination was associated with a survival benefit of almost 5 years, as well as a delay in subsequent chemotherapy.

Dr. Carey then reviews the Chinese sysucc-002 trial of endocrine therapy or chemotherapy added to trastuzumab in HR+/HER2+ disease. With noninferior outcomes and lower toxicity, trastuzumab plus endocrine therapy could become the preferred option and allow women to avoid chemotherapy.

She next turns to a subanalysis of the ASCENT trial, which examined sacituzumab govitecan in previously treated triple-negative disease. Even in the second-line metastatic setting, the drug showed a survival benefit.

Dr. Carey concludes by discussing a study that gathered patients’ views on treatment-related adverse effects, finding that over 90% would be willing to discuss alternative dosing options to improve their quality of life.

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Jacobs Preyer Distinguished Professor, Breast Cancer Research, University of North Carolina at Chapel Hill; Deputy Director, Clinical Sciences, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

Lisa A. Carey, MD, has disclosed the following relevant financial relationships:

Institution received research funding from: AbbVie; Immunomedics; NanoString Technologies; Novartis; Seattle Genetics; Syndax; Veracyte

Royalty-sharing agreement, investorship interest in licensed IP to startup company, Falcon Therapeutics, that is designing neural stem cell-based therapy for glioblastoma multiforme.

Other uncompensated relationships through institution: Aptitude Health; AstraZeneca/Daiichi Sankyo; Exact Sciences; G1 Therapeutics; Genentech/Roche; GlaxoSmithKline; Novartis; Sanofi.

Dr. Lisa Carey, a breast cancer specialist from the University of North Carolina at Chapel Hill, looks at the latest data in metastatic breast cancer presented at the 2021 American Society of Clinical Oncology Annual Meeting.

First, Dr. Carey reviews an updated analysis from the PALOMA-3 trial of the CDK4/6 inhibitor palbociclib plus fulvestrant in women with HR+/HER2- advanced disease. This report showed that the observed survival benefit with the combination is maintained out to 6 years.

Next, she describes another updated survival analysis, this time from the MONALEESA-3 trial, which assessed fulvestrant plus another CDK4/6 inhibitor, ribociclib, in postmenopausal women with HR+/HER2- advanced disease. Again, the combination was associated with a survival benefit of almost 5 years, as well as a delay in subsequent chemotherapy.

Dr. Carey then reviews the Chinese sysucc-002 trial of endocrine therapy or chemotherapy added to trastuzumab in HR+/HER2+ disease. With noninferior outcomes and lower toxicity, trastuzumab plus endocrine therapy could become the preferred option and allow women to avoid chemotherapy.

She next turns to a subanalysis of the ASCENT trial, which examined sacituzumab govitecan in previously treated triple-negative disease. Even in the second-line metastatic setting, the drug showed a survival benefit.

Dr. Carey concludes by discussing a study that gathered patients’ views on treatment-related adverse effects, finding that over 90% would be willing to discuss alternative dosing options to improve their quality of life.

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Jacobs Preyer Distinguished Professor, Breast Cancer Research, University of North Carolina at Chapel Hill; Deputy Director, Clinical Sciences, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

Lisa A. Carey, MD, has disclosed the following relevant financial relationships:

Institution received research funding from: AbbVie; Immunomedics; NanoString Technologies; Novartis; Seattle Genetics; Syndax; Veracyte

Royalty-sharing agreement, investorship interest in licensed IP to startup company, Falcon Therapeutics, that is designing neural stem cell-based therapy for glioblastoma multiforme.

Other uncompensated relationships through institution: Aptitude Health; AstraZeneca/Daiichi Sankyo; Exact Sciences; G1 Therapeutics; Genentech/Roche; GlaxoSmithKline; Novartis; Sanofi.

Dr. Lisa Carey, a breast cancer specialist from the University of North Carolina at Chapel Hill, looks at the latest data in metastatic breast cancer presented at the 2021 American Society of Clinical Oncology Annual Meeting.

First, Dr. Carey reviews an updated analysis from the PALOMA-3 trial of the CDK4/6 inhibitor palbociclib plus fulvestrant in women with HR+/HER2- advanced disease. This report showed that the observed survival benefit with the combination is maintained out to 6 years.

Next, she describes another updated survival analysis, this time from the MONALEESA-3 trial, which assessed fulvestrant plus another CDK4/6 inhibitor, ribociclib, in postmenopausal women with HR+/HER2- advanced disease. Again, the combination was associated with a survival benefit of almost 5 years, as well as a delay in subsequent chemotherapy.

Dr. Carey then reviews the Chinese sysucc-002 trial of endocrine therapy or chemotherapy added to trastuzumab in HR+/HER2+ disease. With noninferior outcomes and lower toxicity, trastuzumab plus endocrine therapy could become the preferred option and allow women to avoid chemotherapy.

She next turns to a subanalysis of the ASCENT trial, which examined sacituzumab govitecan in previously treated triple-negative disease. Even in the second-line metastatic setting, the drug showed a survival benefit.

Dr. Carey concludes by discussing a study that gathered patients’ views on treatment-related adverse effects, finding that over 90% would be willing to discuss alternative dosing options to improve their quality of life.

--

Jacobs Preyer Distinguished Professor, Breast Cancer Research, University of North Carolina at Chapel Hill; Deputy Director, Clinical Sciences, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina

Lisa A. Carey, MD, has disclosed the following relevant financial relationships:

Institution received research funding from: AbbVie; Immunomedics; NanoString Technologies; Novartis; Seattle Genetics; Syndax; Veracyte

Royalty-sharing agreement, investorship interest in licensed IP to startup company, Falcon Therapeutics, that is designing neural stem cell-based therapy for glioblastoma multiforme.

Other uncompensated relationships through institution: Aptitude Health; AstraZeneca/Daiichi Sankyo; Exact Sciences; G1 Therapeutics; Genentech/Roche; GlaxoSmithKline; Novartis; Sanofi.

Dr. Harold Burstein, breast cancer specialist from Dana-Farber Cancer Institute, discusses practice-changing research and advances in early-stage breast cancer from the 2021 American Society of Clinical Oncology Annual Meeting.

He first reports on OlympiA, a phase 3 trial of adjuvant olaparib after neoadjuvant chemotherapy in patients with BRCA1/2 mutations and high-risk HR+/HER2- disease. The results showed a substantial invasive and distant disease-free survival benefit and underscored the need for genetic testing for BRCA mutations in patients with early-stage disease.

Next, he discusses two studies in triple-negative breast cancer. EA1131 was a phase 3 postoperative trial of platinum-based chemotherapy vs capecitabine in patients with residual disease after neoadjuvant chemotherapy. The negative results suggested that additional chemotherapy does not improve outcomes.

In contrast, adding durvalumab to neoadjuvant chemotherapy significantly improved outcomes in GeparNuevo, calling into question whether the drug is needed in the later adjuvant setting.

Next, Dr. Burstein looks at the ADAPT-HR-/HER2+ trial of de-escalated neoadjuvant pertuzumab plus trastuzumab, which suggested that patients with early pathologic complete responses may be suitable for further de-escalation.

Finally, he reports on a retrospective analysis of more than 330,000 US individuals that puts the well-known financial toxicity associated with cancer care into numbers and shows the impact on people’s lives beyond their diagnosis.

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Professor, Department of Medicine, Harvard Medical School

Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships.

Dr. Harold Burstein, breast cancer specialist from Dana-Farber Cancer Institute, discusses practice-changing research and advances in early-stage breast cancer from the 2021 American Society of Clinical Oncology Annual Meeting.

He first reports on OlympiA, a phase 3 trial of adjuvant olaparib after neoadjuvant chemotherapy in patients with BRCA1/2 mutations and high-risk HR+/HER2- disease. The results showed a substantial invasive and distant disease-free survival benefit and underscored the need for genetic testing for BRCA mutations in patients with early-stage disease.

Next, he discusses two studies in triple-negative breast cancer. EA1131 was a phase 3 postoperative trial of platinum-based chemotherapy vs capecitabine in patients with residual disease after neoadjuvant chemotherapy. The negative results suggested that additional chemotherapy does not improve outcomes.

In contrast, adding durvalumab to neoadjuvant chemotherapy significantly improved outcomes in GeparNuevo, calling into question whether the drug is needed in the later adjuvant setting.

Next, Dr. Burstein looks at the ADAPT-HR-/HER2+ trial of de-escalated neoadjuvant pertuzumab plus trastuzumab, which suggested that patients with early pathologic complete responses may be suitable for further de-escalation.

Finally, he reports on a retrospective analysis of more than 330,000 US individuals that puts the well-known financial toxicity associated with cancer care into numbers and shows the impact on people’s lives beyond their diagnosis.

--

Professor, Department of Medicine, Harvard Medical School

Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships.

Dr. Harold Burstein, breast cancer specialist from Dana-Farber Cancer Institute, discusses practice-changing research and advances in early-stage breast cancer from the 2021 American Society of Clinical Oncology Annual Meeting.

He first reports on OlympiA, a phase 3 trial of adjuvant olaparib after neoadjuvant chemotherapy in patients with BRCA1/2 mutations and high-risk HR+/HER2- disease. The results showed a substantial invasive and distant disease-free survival benefit and underscored the need for genetic testing for BRCA mutations in patients with early-stage disease.

Next, he discusses two studies in triple-negative breast cancer. EA1131 was a phase 3 postoperative trial of platinum-based chemotherapy vs capecitabine in patients with residual disease after neoadjuvant chemotherapy. The negative results suggested that additional chemotherapy does not improve outcomes.

In contrast, adding durvalumab to neoadjuvant chemotherapy significantly improved outcomes in GeparNuevo, calling into question whether the drug is needed in the later adjuvant setting.

Next, Dr. Burstein looks at the ADAPT-HR-/HER2+ trial of de-escalated neoadjuvant pertuzumab plus trastuzumab, which suggested that patients with early pathologic complete responses may be suitable for further de-escalation.

Finally, he reports on a retrospective analysis of more than 330,000 US individuals that puts the well-known financial toxicity associated with cancer care into numbers and shows the impact on people’s lives beyond their diagnosis.

--

Professor, Department of Medicine, Harvard Medical School

Institute Physician, Dana-Farber Cancer Institute, Boston, Massachusetts

Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships.

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

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Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Dr. Richard Furie presents highlights in systemic lupus erythematosus (SLE) and its various complications—such as lupus nephritis (LN), pulmonary involvement, and cutaneous manifestations—from the EULAR 2021 Virtual Congress.

The 6-month open-label extension of BLISS-LN assessed patients with LN after 2 years of double-blind treatment. Primary efficacy renal response and complete renal response (CRR) increased in both the belimumab-naïve and belimumab-experienced groups, with no new safety concerns.

The phase 2 TULIP-LN trial evaluated anifrolumab vs placebo alongside standard therapy in patients with active proliferative LN. Anifrolumab 900 mg for 3 doses, 300 mg thereafter was associated with improvements in CRR at week 52.

Another phase 2 study assessed BI 655064 vs placebo in patients with active proliferative LN. A high response to placebo prompted an exploratory analysis requiring confirmation of endpoint during weeks 46 and 52. Proportions of patients achieving confirmed CRR were higher in the 180- and 240-mg dosing groups vs placebo.

A single-center cohort of 300 patients assessed the frequency of pulmonary involvement; 16% had interstitial lung disease, nearly 7% had pulmonary hypertension, and 3% had shrinking lung syndrome.

The last 2 presentations are on cutaneous lupus. In one study, iberdomide had beneficial effects on cutaneous manifestations in patients with SLE, particularly those with subacute and chronic acute subtypes as well as those with high Aiolos or interferon gene expression signatures.

Lastly, a post hoc analysis of a phase 2 study evaluated the effects of BIIB059 on cutaneous lupus, and found that a greater proportion of participants achieved milder skin disease or clear/almost clear skin status in the BIIB059 groups vs placebo.

--

Professor, Department of Medicine, Zucker School of Medicine, Hofstra/Northwell, Hempstead;
Chief, Department of Medicine, Division of Rheumatology, Northwell Health
Great Neck, New York

Richard Furie, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AstraZeneca; Biogen; Boehringer Ingelheim; Bristol-Myers Squibb; GlaxoSmithKline

Received research grant from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Received income in an amount equal to or greater than $250 from: AstraZeneca; Biogen; Bristol-Myers Squibb; Boehringer Ingelheim; GlaxoSmithKline

Anthony Rossi, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, shares several updates in non-melanoma skin cancers emerging from the American Academy of Dermatology’s AAD VMX 2021 meeting.

With PD-1 inhibitors emerging as an immunotherapeutic option in this area, Dr. Rossi discusses a literature review that was conducted to compare the efficacy and safety of pembrolizumab, nivolumab, and cemiplimab in patients with advanced basal cell carcinoma or cutaneous squamous cell carcinoma.

Another review analyzed statin use as a predictor of more aggressive tumor characteristics in squamous cell carcinoma. Dr. Rossi shares that while there were no significant findings when examining the cohort as a whole, the male study population did see an elevated correlation between statin history and high-risk tumors.

Lastly, Dr. Rossi highlights an analysis of tumor burden in patients taking sonidegib 200 mg once daily as part of the 42-month BOLT study. Sonidegib demonstrated durable tumor response and substantial reduction in tumor burden, and safety and tolerability were consistent with earlier data.

--

Anthony Rossi, MD, Assistant Professor, Department of Dermatology, Weill Cornell Medical College; Assistant Attending Physician, Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY

Anthony Rossi, MD, has disclosed the following relevant financial relationships:

Serve(d) as a board member, director, officer, partner, employee, advisor, consultant, or trustee for: DAR Inc; American Society for Dermatologic Surgery Association.

Received research grant from: Regeneron; Biofrontera; Memorial Sloan Kettering Society; Skin Cancer Foundation.

Have a 5% or greater equity interest in: DAR Inc.

Received income in an amount equal to or greater than $250 from: Allergan; Regeneron; Evolus; Cutera; Biofrontera; Iam; DynaMed; Canfield; Merz.

Anthony Rossi, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, shares several updates in non-melanoma skin cancers emerging from the American Academy of Dermatology’s AAD VMX 2021 meeting.

With PD-1 inhibitors emerging as an immunotherapeutic option in this area, Dr. Rossi discusses a literature review that was conducted to compare the efficacy and safety of pembrolizumab, nivolumab, and cemiplimab in patients with advanced basal cell carcinoma or cutaneous squamous cell carcinoma.

Another review analyzed statin use as a predictor of more aggressive tumor characteristics in squamous cell carcinoma. Dr. Rossi shares that while there were no significant findings when examining the cohort as a whole, the male study population did see an elevated correlation between statin history and high-risk tumors.

Lastly, Dr. Rossi highlights an analysis of tumor burden in patients taking sonidegib 200 mg once daily as part of the 42-month BOLT study. Sonidegib demonstrated durable tumor response and substantial reduction in tumor burden, and safety and tolerability were consistent with earlier data.

--

Anthony Rossi, MD, Assistant Professor, Department of Dermatology, Weill Cornell Medical College; Assistant Attending Physician, Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY

Anthony Rossi, MD, has disclosed the following relevant financial relationships:

Serve(d) as a board member, director, officer, partner, employee, advisor, consultant, or trustee for: DAR Inc; American Society for Dermatologic Surgery Association.

Received research grant from: Regeneron; Biofrontera; Memorial Sloan Kettering Society; Skin Cancer Foundation.

Have a 5% or greater equity interest in: DAR Inc.

Received income in an amount equal to or greater than $250 from: Allergan; Regeneron; Evolus; Cutera; Biofrontera; Iam; DynaMed; Canfield; Merz.

Anthony Rossi, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, shares several updates in non-melanoma skin cancers emerging from the American Academy of Dermatology’s AAD VMX 2021 meeting.

With PD-1 inhibitors emerging as an immunotherapeutic option in this area, Dr. Rossi discusses a literature review that was conducted to compare the efficacy and safety of pembrolizumab, nivolumab, and cemiplimab in patients with advanced basal cell carcinoma or cutaneous squamous cell carcinoma.

Another review analyzed statin use as a predictor of more aggressive tumor characteristics in squamous cell carcinoma. Dr. Rossi shares that while there were no significant findings when examining the cohort as a whole, the male study population did see an elevated correlation between statin history and high-risk tumors.

Lastly, Dr. Rossi highlights an analysis of tumor burden in patients taking sonidegib 200 mg once daily as part of the 42-month BOLT study. Sonidegib demonstrated durable tumor response and substantial reduction in tumor burden, and safety and tolerability were consistent with earlier data.

--

Anthony Rossi, MD, Assistant Professor, Department of Dermatology, Weill Cornell Medical College; Assistant Attending Physician, Dermatology Service, Memorial Sloan Kettering Cancer Center, New York, NY

Anthony Rossi, MD, has disclosed the following relevant financial relationships:

Serve(d) as a board member, director, officer, partner, employee, advisor, consultant, or trustee for: DAR Inc; American Society for Dermatologic Surgery Association.

Received research grant from: Regeneron; Biofrontera; Memorial Sloan Kettering Society; Skin Cancer Foundation.

Have a 5% or greater equity interest in: DAR Inc.

Received income in an amount equal to or greater than $250 from: Allergan; Regeneron; Evolus; Cutera; Biofrontera; Iam; DynaMed; Canfield; Merz.

Key studies on psoriasis presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021included data on new topical treatments and biological therapies.

Dr Steven Feldman, of Wake Forest School of Medicine, reviews trial data demonstrating the efficacy of a topical formulation of roflumilast, a phosphodiesterase type 4 (PDE-4) inhibitor previously used in oral systemic form to treat psoriasis.

He also discusses a meta-analysis of the efficacy of biologics favoring newer treatments, such as drugs targeting IL-17 and IL-23.

Dr Feldman reviews the results of two pivotal phase 3 trials presented at the meeting. The POETYK study examined deucravacitinib, a TYK2 inhibitor. In a head-to-head comparison, deucravacitinib was found to be more effective and better tolerated than apremilast in treating psoriasis. BE RADIANT, another head-to-head study, compared the IL-17 blockers bimekizumab and secukinumab. The year-long study favored bimekizumab, though it was associated with a higher risk for candidiasis.

Finally, Dr Feldman discusses the significance of a study showing that psoriasis patients have an approximately 20% higher risk for COVID-19 infection compared with a control group.

--

Steven R. Feldman, MD, PhD, Professor, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina

Steven R. Feldman, MD, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Alvotech; Advance Medical; Almirall; Arena; Bristol-Myers Squibb; Caremark; Amgen; Celgene; Galderma Laboratories; Gerson Lehrman Group; Guidepoint Global; Helsinn; Janssen; Kikaku; Leo Pharma; Eli Lilly and Company; Merck; Mylan; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sienna; Sun Pharma; Suncare Research; Xenoport
Serve(d) as a speaker for: AbbVie; Amgen; Celgene; Janssen; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sun Pharma
Receive(d) grant support from: AbbVie; Amgen; Celgene; Galderma Laboratories; Janssen; Eli Lilly and Company; Novartis; Pfizer; Regeneron; Sanofi
Receive(d) royalties from: Informa; UpToDate; Xlibris
Holds stock in: Causa Technologies; Medical Quality Enhancement Corporation
Serves as founder and chief technology officer for: Causa Technologies

Key studies on psoriasis presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021included data on new topical treatments and biological therapies.

Dr Steven Feldman, of Wake Forest School of Medicine, reviews trial data demonstrating the efficacy of a topical formulation of roflumilast, a phosphodiesterase type 4 (PDE-4) inhibitor previously used in oral systemic form to treat psoriasis.

He also discusses a meta-analysis of the efficacy of biologics favoring newer treatments, such as drugs targeting IL-17 and IL-23.

Dr Feldman reviews the results of two pivotal phase 3 trials presented at the meeting. The POETYK study examined deucravacitinib, a TYK2 inhibitor. In a head-to-head comparison, deucravacitinib was found to be more effective and better tolerated than apremilast in treating psoriasis. BE RADIANT, another head-to-head study, compared the IL-17 blockers bimekizumab and secukinumab. The year-long study favored bimekizumab, though it was associated with a higher risk for candidiasis.

Finally, Dr Feldman discusses the significance of a study showing that psoriasis patients have an approximately 20% higher risk for COVID-19 infection compared with a control group.

--

Steven R. Feldman, MD, PhD, Professor, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina

Steven R. Feldman, MD, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Alvotech; Advance Medical; Almirall; Arena; Bristol-Myers Squibb; Caremark; Amgen; Celgene; Galderma Laboratories; Gerson Lehrman Group; Guidepoint Global; Helsinn; Janssen; Kikaku; Leo Pharma; Eli Lilly and Company; Merck; Mylan; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sienna; Sun Pharma; Suncare Research; Xenoport
Serve(d) as a speaker for: AbbVie; Amgen; Celgene; Janssen; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sun Pharma
Receive(d) grant support from: AbbVie; Amgen; Celgene; Galderma Laboratories; Janssen; Eli Lilly and Company; Novartis; Pfizer; Regeneron; Sanofi
Receive(d) royalties from: Informa; UpToDate; Xlibris
Holds stock in: Causa Technologies; Medical Quality Enhancement Corporation
Serves as founder and chief technology officer for: Causa Technologies

Key studies on psoriasis presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021included data on new topical treatments and biological therapies.

Dr Steven Feldman, of Wake Forest School of Medicine, reviews trial data demonstrating the efficacy of a topical formulation of roflumilast, a phosphodiesterase type 4 (PDE-4) inhibitor previously used in oral systemic form to treat psoriasis.

He also discusses a meta-analysis of the efficacy of biologics favoring newer treatments, such as drugs targeting IL-17 and IL-23.

Dr Feldman reviews the results of two pivotal phase 3 trials presented at the meeting. The POETYK study examined deucravacitinib, a TYK2 inhibitor. In a head-to-head comparison, deucravacitinib was found to be more effective and better tolerated than apremilast in treating psoriasis. BE RADIANT, another head-to-head study, compared the IL-17 blockers bimekizumab and secukinumab. The year-long study favored bimekizumab, though it was associated with a higher risk for candidiasis.

Finally, Dr Feldman discusses the significance of a study showing that psoriasis patients have an approximately 20% higher risk for COVID-19 infection compared with a control group.

--

Steven R. Feldman, MD, PhD, Professor, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, North Carolina

Steven R. Feldman, MD, PhD, has disclosed the following relevant financial relationships:
Serve(d) as a consultant for: AbbVie; Alvotech; Advance Medical; Almirall; Arena; Bristol-Myers Squibb; Caremark; Amgen; Celgene; Galderma Laboratories; Gerson Lehrman Group; Guidepoint Global; Helsinn; Janssen; Kikaku; Leo Pharma; Eli Lilly and Company; Merck; Mylan; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sienna; Sun Pharma; Suncare Research; Xenoport
Serve(d) as a speaker for: AbbVie; Amgen; Celgene; Janssen; Leo Pharma; Eli Lilly and Company; Novartis; Ortho Dermatology; Pfizer; Regeneron; Sanofi; Sun Pharma
Receive(d) grant support from: AbbVie; Amgen; Celgene; Galderma Laboratories; Janssen; Eli Lilly and Company; Novartis; Pfizer; Regeneron; Sanofi
Receive(d) royalties from: Informa; UpToDate; Xlibris
Holds stock in: Causa Technologies; Medical Quality Enhancement Corporation
Serves as founder and chief technology officer for: Causa Technologies

Mitzi Joi Williams, MD, Medical Director and CEO of Joi Life Wellness Group in Atlanta, GA, discusses treatment data and other timely updates in multiple sclerosis (MS) coming out of the American Academy of Neurology (AAN) 2021 Annual Meeting.

Dr. Williams introduces the new National African Americans with Multiple Sclerosis Registry, an important initiative aimed at expanding evidence-based knowledge of MS in African American patients, increasing clinical trial participation, and engaging in research that will benefit this community.

In a review of a long-term analysis of evobrutinib, Dr. Williams shares the positive efficacy and safety outcomes that were observed and maintained in patients receiving evobrutinib 75 mg twice daily throughout the duration of the 48-week double-blind, randomized, phase 2 trial and the 60-week open-label extension portions of the study.

Next, Dr. Williams highlights a study of patients taking disease-modifying therapies (DMTs) at the NYU MS Care Center. The analysis found factors such as public insurance status, younger age, and Hispanic ethnicity to be larger predictors of COVID-19 infection in this patient population than any of the DMTs that were studied.

Lastly, Dr. Williams discusses an analysis of racial and ethnic differences in patients receiving ofatumumab in the ASCLEPIOS I/II and APOLITOS trials. The study revealed no clinically relevant differences in annualized relapse rate, pharmacokinetics, B-cell depletion, or safety profile between the study populations.

--

Mitzi Joi Williams, MD, Medical Director, CEO; Department of Neurology, Joi Life Wellness Group, Atlanta, Georgia

Mitzi Joi Williams, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Biogen Idec; EMD Serono; Genentech; Novartis; Bristol-Myers Squibb; AbbVie; Alexion; Novartis.

Serve(d) as a speaker or a member of a speakers bureau for: Biogen Idec; EMD Serono; Genentech Roche; Novartis; Bristol-Myers Squibb.

Mitzi Joi Williams, MD, Medical Director and CEO of Joi Life Wellness Group in Atlanta, GA, discusses treatment data and other timely updates in multiple sclerosis (MS) coming out of the American Academy of Neurology (AAN) 2021 Annual Meeting.

Dr. Williams introduces the new National African Americans with Multiple Sclerosis Registry, an important initiative aimed at expanding evidence-based knowledge of MS in African American patients, increasing clinical trial participation, and engaging in research that will benefit this community.

In a review of a long-term analysis of evobrutinib, Dr. Williams shares the positive efficacy and safety outcomes that were observed and maintained in patients receiving evobrutinib 75 mg twice daily throughout the duration of the 48-week double-blind, randomized, phase 2 trial and the 60-week open-label extension portions of the study.

Next, Dr. Williams highlights a study of patients taking disease-modifying therapies (DMTs) at the NYU MS Care Center. The analysis found factors such as public insurance status, younger age, and Hispanic ethnicity to be larger predictors of COVID-19 infection in this patient population than any of the DMTs that were studied.

Lastly, Dr. Williams discusses an analysis of racial and ethnic differences in patients receiving ofatumumab in the ASCLEPIOS I/II and APOLITOS trials. The study revealed no clinically relevant differences in annualized relapse rate, pharmacokinetics, B-cell depletion, or safety profile between the study populations.

--

Mitzi Joi Williams, MD, Medical Director, CEO; Department of Neurology, Joi Life Wellness Group, Atlanta, Georgia

Mitzi Joi Williams, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Biogen Idec; EMD Serono; Genentech; Novartis; Bristol-Myers Squibb; AbbVie; Alexion; Novartis.

Serve(d) as a speaker or a member of a speakers bureau for: Biogen Idec; EMD Serono; Genentech Roche; Novartis; Bristol-Myers Squibb.

Mitzi Joi Williams, MD, Medical Director and CEO of Joi Life Wellness Group in Atlanta, GA, discusses treatment data and other timely updates in multiple sclerosis (MS) coming out of the American Academy of Neurology (AAN) 2021 Annual Meeting.

Dr. Williams introduces the new National African Americans with Multiple Sclerosis Registry, an important initiative aimed at expanding evidence-based knowledge of MS in African American patients, increasing clinical trial participation, and engaging in research that will benefit this community.

In a review of a long-term analysis of evobrutinib, Dr. Williams shares the positive efficacy and safety outcomes that were observed and maintained in patients receiving evobrutinib 75 mg twice daily throughout the duration of the 48-week double-blind, randomized, phase 2 trial and the 60-week open-label extension portions of the study.

Next, Dr. Williams highlights a study of patients taking disease-modifying therapies (DMTs) at the NYU MS Care Center. The analysis found factors such as public insurance status, younger age, and Hispanic ethnicity to be larger predictors of COVID-19 infection in this patient population than any of the DMTs that were studied.

Lastly, Dr. Williams discusses an analysis of racial and ethnic differences in patients receiving ofatumumab in the ASCLEPIOS I/II and APOLITOS trials. The study revealed no clinically relevant differences in annualized relapse rate, pharmacokinetics, B-cell depletion, or safety profile between the study populations.

--

Mitzi Joi Williams, MD, Medical Director, CEO; Department of Neurology, Joi Life Wellness Group, Atlanta, Georgia

Mitzi Joi Williams, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Biogen Idec; EMD Serono; Genentech; Novartis; Bristol-Myers Squibb; AbbVie; Alexion; Novartis.

Serve(d) as a speaker or a member of a speakers bureau for: Biogen Idec; EMD Serono; Genentech Roche; Novartis; Bristol-Myers Squibb.

Dr Anju Peters, an expert in allergy and immunology from Northwestern University, discusses data on new and emerging biologics in rhinosinusitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.

Dr Peters reviews a study examining the effect of dupilumab (Dupixent) on blood eosinophil levels in patients with a range of atopic/allergic diseases; the trial found that hypereosinophilia was rare.

She then addresses two post-hoc analyses of phase 3 dupilumab trials in chronic rhinosinusitis with nasal polyps (CRSwNP). The first examined the impact of the disease on physical and mental health–related quality of life. The second assessed the effect of the drug on both objective and patient-reported subjective endpoints.

Dr Peters closes by discussing two studies that relied on data from the SYNAPSE phase 3 trial of the anti–IL-5 antibody mepolizumab (Nucala) vs placebo in adult patients with CRSwNP. The first looked at the effect of the drug on health-related quality of life, while the second focused on meaningful within-patient changes in disease outcomes.

--
Professor, Department of Medicine, Division of Allergy-Immunology, Northwestern University Feinberg School of Medicine; Director of Clinical Research, Associate Chief of Research, Education, and Clinical Affairs, Division of Allergy-Immunology, Northwestern Medicine, Chicago, Illinois.

Anju T. Peters, MD, MSci, has disclosed the following relevant financial relationships: 
Serve(d) on the advisory board for: Sanofi Regeneron; Optinose; AstraZeneca. Received research grant from: AstraZeneca; Optinose.

Dr Anju Peters, an expert in allergy and immunology from Northwestern University, discusses data on new and emerging biologics in rhinosinusitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.

Dr Peters reviews a study examining the effect of dupilumab (Dupixent) on blood eosinophil levels in patients with a range of atopic/allergic diseases; the trial found that hypereosinophilia was rare.

She then addresses two post-hoc analyses of phase 3 dupilumab trials in chronic rhinosinusitis with nasal polyps (CRSwNP). The first examined the impact of the disease on physical and mental health–related quality of life. The second assessed the effect of the drug on both objective and patient-reported subjective endpoints.

Dr Peters closes by discussing two studies that relied on data from the SYNAPSE phase 3 trial of the anti–IL-5 antibody mepolizumab (Nucala) vs placebo in adult patients with CRSwNP. The first looked at the effect of the drug on health-related quality of life, while the second focused on meaningful within-patient changes in disease outcomes.

--
Professor, Department of Medicine, Division of Allergy-Immunology, Northwestern University Feinberg School of Medicine; Director of Clinical Research, Associate Chief of Research, Education, and Clinical Affairs, Division of Allergy-Immunology, Northwestern Medicine, Chicago, Illinois.

Anju T. Peters, MD, MSci, has disclosed the following relevant financial relationships: 
Serve(d) on the advisory board for: Sanofi Regeneron; Optinose; AstraZeneca. Received research grant from: AstraZeneca; Optinose.

Dr Anju Peters, an expert in allergy and immunology from Northwestern University, discusses data on new and emerging biologics in rhinosinusitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.

Dr Peters reviews a study examining the effect of dupilumab (Dupixent) on blood eosinophil levels in patients with a range of atopic/allergic diseases; the trial found that hypereosinophilia was rare.

She then addresses two post-hoc analyses of phase 3 dupilumab trials in chronic rhinosinusitis with nasal polyps (CRSwNP). The first examined the impact of the disease on physical and mental health–related quality of life. The second assessed the effect of the drug on both objective and patient-reported subjective endpoints.

Dr Peters closes by discussing two studies that relied on data from the SYNAPSE phase 3 trial of the anti–IL-5 antibody mepolizumab (Nucala) vs placebo in adult patients with CRSwNP. The first looked at the effect of the drug on health-related quality of life, while the second focused on meaningful within-patient changes in disease outcomes.

--
Professor, Department of Medicine, Division of Allergy-Immunology, Northwestern University Feinberg School of Medicine; Director of Clinical Research, Associate Chief of Research, Education, and Clinical Affairs, Division of Allergy-Immunology, Northwestern Medicine, Chicago, Illinois.

Anju T. Peters, MD, MSci, has disclosed the following relevant financial relationships: 
Serve(d) on the advisory board for: Sanofi Regeneron; Optinose; AstraZeneca. Received research grant from: AstraZeneca; Optinose.

Key studies on severe asthma from the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) meeting include data on newer biologic treatments.

Dr Mario Castro, of the University of Kansas School of Medicine in Kansas City, discusses results from the pivotal NAVIGATOR trial. This 1-year study demonstrated that tezepelumab, a monoclonal antibody inhibitor of the activity of thymic stromal lymphopoietin (TSLP), can provide clinically meaningful exacerbation reductions inpatients with severe asthma.

Dr Castro also discusses the phase 3 PONENTE study of benralizumab, a biologic therapy that targets the IL-5 pathway to reduce eosinophilic inflammation. He reviews data showing that benralizumab can significantly reduce the use of oral corticosteroids in patients with asthma, and considers the PONENTE trial results in light of data from the prior ZONDA phase 3 clinical trial.

--

Mario Castro, MD, MPH, Professor; Chief, Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas School of Medicine, Kansas City, Kansas. 

Mario Castro, MD, MPH, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Genentech; Teva; Sanofi-Aventis; Novartis.
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Genentech; GlaxoSmithKline; Regeneron; Sanofi; Teva.
Received research grant from: AstraZeneca; GlaxoSmithKline; Pulmatrix; Sanofi-Aventis; Shirogi.

Key studies on severe asthma from the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) meeting include data on newer biologic treatments.

Dr Mario Castro, of the University of Kansas School of Medicine in Kansas City, discusses results from the pivotal NAVIGATOR trial. This 1-year study demonstrated that tezepelumab, a monoclonal antibody inhibitor of the activity of thymic stromal lymphopoietin (TSLP), can provide clinically meaningful exacerbation reductions inpatients with severe asthma.

Dr Castro also discusses the phase 3 PONENTE study of benralizumab, a biologic therapy that targets the IL-5 pathway to reduce eosinophilic inflammation. He reviews data showing that benralizumab can significantly reduce the use of oral corticosteroids in patients with asthma, and considers the PONENTE trial results in light of data from the prior ZONDA phase 3 clinical trial.

--

Mario Castro, MD, MPH, Professor; Chief, Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas School of Medicine, Kansas City, Kansas. 

Mario Castro, MD, MPH, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Genentech; Teva; Sanofi-Aventis; Novartis.
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Genentech; GlaxoSmithKline; Regeneron; Sanofi; Teva.
Received research grant from: AstraZeneca; GlaxoSmithKline; Pulmatrix; Sanofi-Aventis; Shirogi.

Key studies on severe asthma from the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) meeting include data on newer biologic treatments.

Dr Mario Castro, of the University of Kansas School of Medicine in Kansas City, discusses results from the pivotal NAVIGATOR trial. This 1-year study demonstrated that tezepelumab, a monoclonal antibody inhibitor of the activity of thymic stromal lymphopoietin (TSLP), can provide clinically meaningful exacerbation reductions inpatients with severe asthma.

Dr Castro also discusses the phase 3 PONENTE study of benralizumab, a biologic therapy that targets the IL-5 pathway to reduce eosinophilic inflammation. He reviews data showing that benralizumab can significantly reduce the use of oral corticosteroids in patients with asthma, and considers the PONENTE trial results in light of data from the prior ZONDA phase 3 clinical trial.

--

Mario Castro, MD, MPH, Professor; Chief, Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas School of Medicine, Kansas City, Kansas. 

Mario Castro, MD, MPH, has disclosed the following relevant financial relationships:
Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: Genentech; Teva; Sanofi-Aventis; Novartis.
Serve(d) as a speaker or a member of a speakers bureau for: AstraZeneca; Genentech; GlaxoSmithKline; Regeneron; Sanofi; Teva.
Received research grant from: AstraZeneca; GlaxoSmithKline; Pulmatrix; Sanofi-Aventis; Shirogi.