Phase III clinical trials show that Pfizer’s coronavirus vaccine is 100% effective in protecting children aged 12-15 years from infection, the company said in a news release.

The study enrolled 2,260 adolescents aged 12-15. No infections were reported in the group given the vaccine produced by Pfizer and its European partner, BioNTech, the release said. The placebo group reported 18 cases of COVID-19.

The vaccinated children showed a strong antibody response with no serious side effects.

Albert Bourla, PhD, chairman and CEO of Pfizer, said the company plans to seek Food and Drug Administration emergency use authorization, which could allow this age group to be vaccinated before the start of the next school year. Pfizer will also seek authorization from the European Medicines Agency.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Dr. Bourla said in the release.

The clinical trials showed a stronger response in children aged 12-15 than the 95% effectiveness reported in clinical trials in adults. The Pfizer vaccine is now authorized to be given to people aged 16 and up in the United States.

Health experts said the clinical trials – while not peer-reviewed – amounted to very good news.

“The sooner that we can get vaccines into as many people as possible, regardless of their age, the sooner we will be able to really feel like we’re ending this pandemic for good,” Angela Rasmussen, PhD, a virologist affiliated with Georgetown University in Washington, told The New York Times.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently said that getting children vaccinated is an important step toward achieving herd immunity.

“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape,” he said earlier in March during a hearing of the Senate Health, Education, Labor, and Pensions Committee. “We ultimately would like to get and have to get children into that mix.”

Pfizer said it started clinical trials during the week of March 23 with children aged 5-11 and will next start trials with children aged 2-5, followed by children aged 6 months to 2 years. Vaccine makers Moderna and AstraZeneca also have started clinical trials in younger children.

A version of this article first appeared on WebMD.com.

Phase III clinical trials show that Pfizer’s coronavirus vaccine is 100% effective in protecting children aged 12-15 years from infection, the company said in a news release.

The study enrolled 2,260 adolescents aged 12-15. No infections were reported in the group given the vaccine produced by Pfizer and its European partner, BioNTech, the release said. The placebo group reported 18 cases of COVID-19.

The vaccinated children showed a strong antibody response with no serious side effects.

Albert Bourla, PhD, chairman and CEO of Pfizer, said the company plans to seek Food and Drug Administration emergency use authorization, which could allow this age group to be vaccinated before the start of the next school year. Pfizer will also seek authorization from the European Medicines Agency.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Dr. Bourla said in the release.

The clinical trials showed a stronger response in children aged 12-15 than the 95% effectiveness reported in clinical trials in adults. The Pfizer vaccine is now authorized to be given to people aged 16 and up in the United States.

Health experts said the clinical trials – while not peer-reviewed – amounted to very good news.

“The sooner that we can get vaccines into as many people as possible, regardless of their age, the sooner we will be able to really feel like we’re ending this pandemic for good,” Angela Rasmussen, PhD, a virologist affiliated with Georgetown University in Washington, told The New York Times.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently said that getting children vaccinated is an important step toward achieving herd immunity.

“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape,” he said earlier in March during a hearing of the Senate Health, Education, Labor, and Pensions Committee. “We ultimately would like to get and have to get children into that mix.”

Pfizer said it started clinical trials during the week of March 23 with children aged 5-11 and will next start trials with children aged 2-5, followed by children aged 6 months to 2 years. Vaccine makers Moderna and AstraZeneca also have started clinical trials in younger children.

A version of this article first appeared on WebMD.com.

Phase III clinical trials show that Pfizer’s coronavirus vaccine is 100% effective in protecting children aged 12-15 years from infection, the company said in a news release.

The study enrolled 2,260 adolescents aged 12-15. No infections were reported in the group given the vaccine produced by Pfizer and its European partner, BioNTech, the release said. The placebo group reported 18 cases of COVID-19.

The vaccinated children showed a strong antibody response with no serious side effects.

Albert Bourla, PhD, chairman and CEO of Pfizer, said the company plans to seek Food and Drug Administration emergency use authorization, which could allow this age group to be vaccinated before the start of the next school year. Pfizer will also seek authorization from the European Medicines Agency.

“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Dr. Bourla said in the release.

The clinical trials showed a stronger response in children aged 12-15 than the 95% effectiveness reported in clinical trials in adults. The Pfizer vaccine is now authorized to be given to people aged 16 and up in the United States.

Health experts said the clinical trials – while not peer-reviewed – amounted to very good news.

“The sooner that we can get vaccines into as many people as possible, regardless of their age, the sooner we will be able to really feel like we’re ending this pandemic for good,” Angela Rasmussen, PhD, a virologist affiliated with Georgetown University in Washington, told The New York Times.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently said that getting children vaccinated is an important step toward achieving herd immunity.

“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape,” he said earlier in March during a hearing of the Senate Health, Education, Labor, and Pensions Committee. “We ultimately would like to get and have to get children into that mix.”

Pfizer said it started clinical trials during the week of March 23 with children aged 5-11 and will next start trials with children aged 2-5, followed by children aged 6 months to 2 years. Vaccine makers Moderna and AstraZeneca also have started clinical trials in younger children.

A version of this article first appeared on WebMD.com.

The Centers for Disease Control and Prevention has added several new medical conditions to its list of those that predispose adults to more severe COVID-19 illness.

Conditions that had previously been categorized as “might be” placing individuals at increased risk – but now are listed as high risk – include type 1 diabetes (in addition to type 2), moderate-to-severe asthma, liver disease, dementia or other neurologic conditions, stroke/cerebrovascular disease, HIV infection, cystic fibrosis, and overweight (in addition to obesity).

Substance use disorders, which hadn’t been previously listed, are now also considered high risk.  

The new list groups together certain categories, such as chronic lung diseases (chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc) and heart conditions (heart failure, coronary artery disease, hypertension, etc).

Both diabetes types are now grouped under “diabetes.”  

The added medical conditions were posted on the CDC website’s COVID-19 page on March 29.
 

Type 1 diabetes and other conditions now priority for vaccination

The CDC refers to the medical conditions list as phase 1c in regard to COVID-19 vaccine prioritization, which means that anyone with any of these conditions can now be prioritized for vaccination, following those in groups 1a (frontline essential workers and those in long-term care facilities) and 1b (people aged 65-74 years; other essential workers; and people aged 16-64 years with underlying conditions that increase the risk of serious, life-threatening complications from COVID-19).

But in many cases, multiple states have already either fully opened up vaccine eligibility to all adults or have created their own lists of underlying high-risk medical conditions, CDC spokeswoman Kristen Nordlund told this news organization.  

No conditions have been removed from the list.

In January, the American Diabetes Association and 18 other organizations sent a letter to the CDC requesting that type 1 diabetes be prioritized along with type 2, based on data from studies showing people with both types to be at high risk for severe COVID-19 illness.

Now, ADA says, “this updated guidance will help to address the fact that in many states, millions of people with type 1 diabetes have not been prioritized equally, slowing their access to critical vaccines.”

While awaiting this latest CDC move, ADA had been urging state governors to prioritize type 1 and type 2 diabetes equally. As of now, 38 states and the District of Columbia had either done so or announced that they would.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has added several new medical conditions to its list of those that predispose adults to more severe COVID-19 illness.

Conditions that had previously been categorized as “might be” placing individuals at increased risk – but now are listed as high risk – include type 1 diabetes (in addition to type 2), moderate-to-severe asthma, liver disease, dementia or other neurologic conditions, stroke/cerebrovascular disease, HIV infection, cystic fibrosis, and overweight (in addition to obesity).

Substance use disorders, which hadn’t been previously listed, are now also considered high risk.  

The new list groups together certain categories, such as chronic lung diseases (chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc) and heart conditions (heart failure, coronary artery disease, hypertension, etc).

Both diabetes types are now grouped under “diabetes.”  

The added medical conditions were posted on the CDC website’s COVID-19 page on March 29.
 

Type 1 diabetes and other conditions now priority for vaccination

The CDC refers to the medical conditions list as phase 1c in regard to COVID-19 vaccine prioritization, which means that anyone with any of these conditions can now be prioritized for vaccination, following those in groups 1a (frontline essential workers and those in long-term care facilities) and 1b (people aged 65-74 years; other essential workers; and people aged 16-64 years with underlying conditions that increase the risk of serious, life-threatening complications from COVID-19).

But in many cases, multiple states have already either fully opened up vaccine eligibility to all adults or have created their own lists of underlying high-risk medical conditions, CDC spokeswoman Kristen Nordlund told this news organization.  

No conditions have been removed from the list.

In January, the American Diabetes Association and 18 other organizations sent a letter to the CDC requesting that type 1 diabetes be prioritized along with type 2, based on data from studies showing people with both types to be at high risk for severe COVID-19 illness.

Now, ADA says, “this updated guidance will help to address the fact that in many states, millions of people with type 1 diabetes have not been prioritized equally, slowing their access to critical vaccines.”

While awaiting this latest CDC move, ADA had been urging state governors to prioritize type 1 and type 2 diabetes equally. As of now, 38 states and the District of Columbia had either done so or announced that they would.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention has added several new medical conditions to its list of those that predispose adults to more severe COVID-19 illness.

Conditions that had previously been categorized as “might be” placing individuals at increased risk – but now are listed as high risk – include type 1 diabetes (in addition to type 2), moderate-to-severe asthma, liver disease, dementia or other neurologic conditions, stroke/cerebrovascular disease, HIV infection, cystic fibrosis, and overweight (in addition to obesity).

Substance use disorders, which hadn’t been previously listed, are now also considered high risk.  

The new list groups together certain categories, such as chronic lung diseases (chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc) and heart conditions (heart failure, coronary artery disease, hypertension, etc).

Both diabetes types are now grouped under “diabetes.”  

The added medical conditions were posted on the CDC website’s COVID-19 page on March 29.
 

Type 1 diabetes and other conditions now priority for vaccination

The CDC refers to the medical conditions list as phase 1c in regard to COVID-19 vaccine prioritization, which means that anyone with any of these conditions can now be prioritized for vaccination, following those in groups 1a (frontline essential workers and those in long-term care facilities) and 1b (people aged 65-74 years; other essential workers; and people aged 16-64 years with underlying conditions that increase the risk of serious, life-threatening complications from COVID-19).

But in many cases, multiple states have already either fully opened up vaccine eligibility to all adults or have created their own lists of underlying high-risk medical conditions, CDC spokeswoman Kristen Nordlund told this news organization.  

No conditions have been removed from the list.

In January, the American Diabetes Association and 18 other organizations sent a letter to the CDC requesting that type 1 diabetes be prioritized along with type 2, based on data from studies showing people with both types to be at high risk for severe COVID-19 illness.

Now, ADA says, “this updated guidance will help to address the fact that in many states, millions of people with type 1 diabetes have not been prioritized equally, slowing their access to critical vaccines.”

While awaiting this latest CDC move, ADA had been urging state governors to prioritize type 1 and type 2 diabetes equally. As of now, 38 states and the District of Columbia had either done so or announced that they would.

A version of this article first appeared on Medscape.com.

Key clinical point: Bone marrow stromal cells in patients with myelodysplastic syndromes and acute myeloid leukemia showed a reduced frequency of colony forming unit-fibroblasts.

Major finding: The frequencies of positive/positive bone marrow stromal cells were significantly lower in AML patient samples compared to healthy individuals and MDS bone marrow samples. The median cell numbers of bone marrow stromal cells in diagnostic samples were 3,200 for healthy samples, 476 for MDS samples, and 70 for AML samples.

Study details: The data come from bone marrow samples in AML patients, MDS patients, and healthy donors.

Disclosures: The study was supported in part by Projekt DEAL and the Deutsche Forschungsgemeinschaft SFB 1243 for projects A09 and the FOR2033 project B3, as well as the Deutsche Jose Carreras Leukämie Stiftung. The researchers had no financial conflicts to disclose. 

Source: Weickert M-T et al. Sci Rep. 2021 Mar 15. doi: 10.1038/s41598-021-85122-8.

Key clinical point: Bone marrow stromal cells in patients with myelodysplastic syndromes and acute myeloid leukemia showed a reduced frequency of colony forming unit-fibroblasts.

Major finding: The frequencies of positive/positive bone marrow stromal cells were significantly lower in AML patient samples compared to healthy individuals and MDS bone marrow samples. The median cell numbers of bone marrow stromal cells in diagnostic samples were 3,200 for healthy samples, 476 for MDS samples, and 70 for AML samples.

Study details: The data come from bone marrow samples in AML patients, MDS patients, and healthy donors.

Disclosures: The study was supported in part by Projekt DEAL and the Deutsche Forschungsgemeinschaft SFB 1243 for projects A09 and the FOR2033 project B3, as well as the Deutsche Jose Carreras Leukämie Stiftung. The researchers had no financial conflicts to disclose. 

Source: Weickert M-T et al. Sci Rep. 2021 Mar 15. doi: 10.1038/s41598-021-85122-8.

Key clinical point: Bone marrow stromal cells in patients with myelodysplastic syndromes and acute myeloid leukemia showed a reduced frequency of colony forming unit-fibroblasts.

Major finding: The frequencies of positive/positive bone marrow stromal cells were significantly lower in AML patient samples compared to healthy individuals and MDS bone marrow samples. The median cell numbers of bone marrow stromal cells in diagnostic samples were 3,200 for healthy samples, 476 for MDS samples, and 70 for AML samples.

Study details: The data come from bone marrow samples in AML patients, MDS patients, and healthy donors.

Disclosures: The study was supported in part by Projekt DEAL and the Deutsche Forschungsgemeinschaft SFB 1243 for projects A09 and the FOR2033 project B3, as well as the Deutsche Jose Carreras Leukämie Stiftung. The researchers had no financial conflicts to disclose. 

Source: Weickert M-T et al. Sci Rep. 2021 Mar 15. doi: 10.1038/s41598-021-85122-8.

Key clinical point: Treatment with a combination of venetoclax (VEN) and hypomethylating agents (HMA) may be an option for younger AML patients, but myelosuppression was a concern, and 43.7% of treated patients were hospitalized for a treatment-related adverse event.

Major finding: In the 26 newly-diagnosed AML patients, the complete remission rate was 53.8%, but only 38.5% in the 39 relapsed/refractory patients; however, 70% remained dependent on red blood cell transfusion and 58.6% remained dependent on platelet transfusion during and after treatment.

Study details: The data come from 65 patients with acute myeloid leukemia and 7 patients with myelodysplastic syndrome who were treated with a combination of VEN and HMA.

Disclosures: The study’s corresponding author was supported by the National Institutes of Health and the National Cancer Institute. Lead author Dr. Feld had no financial conflicts to disclose. 

Source: Feld J et al. Hemasphere. 2021 Mar 9. doi: 10.1097/HS9.0000000000000549.

Key clinical point: Treatment with a combination of venetoclax (VEN) and hypomethylating agents (HMA) may be an option for younger AML patients, but myelosuppression was a concern, and 43.7% of treated patients were hospitalized for a treatment-related adverse event.

Major finding: In the 26 newly-diagnosed AML patients, the complete remission rate was 53.8%, but only 38.5% in the 39 relapsed/refractory patients; however, 70% remained dependent on red blood cell transfusion and 58.6% remained dependent on platelet transfusion during and after treatment.

Study details: The data come from 65 patients with acute myeloid leukemia and 7 patients with myelodysplastic syndrome who were treated with a combination of VEN and HMA.

Disclosures: The study’s corresponding author was supported by the National Institutes of Health and the National Cancer Institute. Lead author Dr. Feld had no financial conflicts to disclose. 

Source: Feld J et al. Hemasphere. 2021 Mar 9. doi: 10.1097/HS9.0000000000000549.

Key clinical point: Treatment with a combination of venetoclax (VEN) and hypomethylating agents (HMA) may be an option for younger AML patients, but myelosuppression was a concern, and 43.7% of treated patients were hospitalized for a treatment-related adverse event.

Major finding: In the 26 newly-diagnosed AML patients, the complete remission rate was 53.8%, but only 38.5% in the 39 relapsed/refractory patients; however, 70% remained dependent on red blood cell transfusion and 58.6% remained dependent on platelet transfusion during and after treatment.

Study details: The data come from 65 patients with acute myeloid leukemia and 7 patients with myelodysplastic syndrome who were treated with a combination of VEN and HMA.

Disclosures: The study’s corresponding author was supported by the National Institutes of Health and the National Cancer Institute. Lead author Dr. Feld had no financial conflicts to disclose. 

Source: Feld J et al. Hemasphere. 2021 Mar 9. doi: 10.1097/HS9.0000000000000549.

Key clinical point: Mutations promoting loss of function in the histone methyltransferase EZH2 are relatively rare but may promote chemoresistance to the treatment agent cytarabine in patients with acute myeloid leukemia.

Major finding: In cell lines and in patient samples, AML patients, loss of function of EZH2 fostered resistance to cytarabine; the EZH2 mutation was present in 4% of AML patients at diagnosis; low expression of EZH2 mRNA was correlated with poor overall survival and relapse-free survival.

Study details: The data come from a combination of patient samples, in vivo and in vitro patient-derived xenografts, and haematopeoietic cell lines, and included 25 patients with an EZH2 mutation at the time of diagnosis.

Disclosures: The study was supported by Projekt DEAL. The researchers had no financial conflicts to disclose. 

Source: Kempf JM et al. Sci Rep. 2021 Mar 12. doi: 10.1038/s41598-021-84708-6.

Key clinical point: Mutations promoting loss of function in the histone methyltransferase EZH2 are relatively rare but may promote chemoresistance to the treatment agent cytarabine in patients with acute myeloid leukemia.

Major finding: In cell lines and in patient samples, AML patients, loss of function of EZH2 fostered resistance to cytarabine; the EZH2 mutation was present in 4% of AML patients at diagnosis; low expression of EZH2 mRNA was correlated with poor overall survival and relapse-free survival.

Study details: The data come from a combination of patient samples, in vivo and in vitro patient-derived xenografts, and haematopeoietic cell lines, and included 25 patients with an EZH2 mutation at the time of diagnosis.

Disclosures: The study was supported by Projekt DEAL. The researchers had no financial conflicts to disclose. 

Source: Kempf JM et al. Sci Rep. 2021 Mar 12. doi: 10.1038/s41598-021-84708-6.

Key clinical point: Mutations promoting loss of function in the histone methyltransferase EZH2 are relatively rare but may promote chemoresistance to the treatment agent cytarabine in patients with acute myeloid leukemia.

Major finding: In cell lines and in patient samples, AML patients, loss of function of EZH2 fostered resistance to cytarabine; the EZH2 mutation was present in 4% of AML patients at diagnosis; low expression of EZH2 mRNA was correlated with poor overall survival and relapse-free survival.

Study details: The data come from a combination of patient samples, in vivo and in vitro patient-derived xenografts, and haematopeoietic cell lines, and included 25 patients with an EZH2 mutation at the time of diagnosis.

Disclosures: The study was supported by Projekt DEAL. The researchers had no financial conflicts to disclose. 

Source: Kempf JM et al. Sci Rep. 2021 Mar 12. doi: 10.1038/s41598-021-84708-6.

Key clinical point: Gene set variation analysis (GSVA) showed that the PI3K-Akt-mTOR pathway was positively related to FLT3-ITD mutation.

Major finding: In patients with acute myeloid leukemia, expression of RPS6KA1 and AP2M1 were predictors of chemoresistance and overall survival.

Study details: The data come from four genetic data sets: GSE6891, GSE10358, GSE15434, and GSE61804 of patients with acute myeloid leukemia. 

Disclosures: The study was supported by the Young & Middle-aged Medical Key Talents Training Project of Wuhan. The researchers had no financial conflicts to disclose. 

Source: Yu D-H et al. Front Cell Dev Biol. 2021 Feb 26. doi: 10.3389/fcell.2021.641629.

Key clinical point: Gene set variation analysis (GSVA) showed that the PI3K-Akt-mTOR pathway was positively related to FLT3-ITD mutation.

Major finding: In patients with acute myeloid leukemia, expression of RPS6KA1 and AP2M1 were predictors of chemoresistance and overall survival.

Study details: The data come from four genetic data sets: GSE6891, GSE10358, GSE15434, and GSE61804 of patients with acute myeloid leukemia. 

Disclosures: The study was supported by the Young & Middle-aged Medical Key Talents Training Project of Wuhan. The researchers had no financial conflicts to disclose. 

Source: Yu D-H et al. Front Cell Dev Biol. 2021 Feb 26. doi: 10.3389/fcell.2021.641629.

Key clinical point: Gene set variation analysis (GSVA) showed that the PI3K-Akt-mTOR pathway was positively related to FLT3-ITD mutation.

Major finding: In patients with acute myeloid leukemia, expression of RPS6KA1 and AP2M1 were predictors of chemoresistance and overall survival.

Study details: The data come from four genetic data sets: GSE6891, GSE10358, GSE15434, and GSE61804 of patients with acute myeloid leukemia. 

Disclosures: The study was supported by the Young & Middle-aged Medical Key Talents Training Project of Wuhan. The researchers had no financial conflicts to disclose. 

Source: Yu D-H et al. Front Cell Dev Biol. 2021 Feb 26. doi: 10.3389/fcell.2021.641629.

Key clinical point: For AML patients unable to undergo intensive chemotherapy, glasdegib and venetoclax were similarly effective, each in combination with low-dose cytarabine.

Major finding: Overall response rates were higher in the venetoclax study compared to the glasdegib study (48% vs. 24%), but overall survival was similar (hazard ratio 0.75 vs. HR 0.46).

Study details: The data come an indirect comparison of studies of each treatment: the BRIGHT AML 1003 GLAS+LDAC trial, and the VIALE-C VEN+LDAC trial.

Disclosures: The study was sponsored by Pfizer. Several researchers are Pfizer employees and lead author Dr. Tremblay served as a paid consultant to Pfizer during the study.

Source: Tremblay G et al. J Comp Eff Res. 2021 Mar 18. doi: 10.2217/cer-2020-0280.

Key clinical point: For AML patients unable to undergo intensive chemotherapy, glasdegib and venetoclax were similarly effective, each in combination with low-dose cytarabine.

Major finding: Overall response rates were higher in the venetoclax study compared to the glasdegib study (48% vs. 24%), but overall survival was similar (hazard ratio 0.75 vs. HR 0.46).

Study details: The data come an indirect comparison of studies of each treatment: the BRIGHT AML 1003 GLAS+LDAC trial, and the VIALE-C VEN+LDAC trial.

Disclosures: The study was sponsored by Pfizer. Several researchers are Pfizer employees and lead author Dr. Tremblay served as a paid consultant to Pfizer during the study.

Source: Tremblay G et al. J Comp Eff Res. 2021 Mar 18. doi: 10.2217/cer-2020-0280.

Key clinical point: For AML patients unable to undergo intensive chemotherapy, glasdegib and venetoclax were similarly effective, each in combination with low-dose cytarabine.

Major finding: Overall response rates were higher in the venetoclax study compared to the glasdegib study (48% vs. 24%), but overall survival was similar (hazard ratio 0.75 vs. HR 0.46).

Study details: The data come an indirect comparison of studies of each treatment: the BRIGHT AML 1003 GLAS+LDAC trial, and the VIALE-C VEN+LDAC trial.

Disclosures: The study was sponsored by Pfizer. Several researchers are Pfizer employees and lead author Dr. Tremblay served as a paid consultant to Pfizer during the study.

Source: Tremblay G et al. J Comp Eff Res. 2021 Mar 18. doi: 10.2217/cer-2020-0280.

Key clinical point: Venetoclax combination therapy was safe and effective in older adults with acute myeloid leukemia who had not been previously treated.

Major finding: A total of 12 patients achieved complete remission, and another 4 patients achieved complete remission with incomplete blood recovery, with a median response duration of 8.9 months; however, response duration dropped to 4.6 months for patients with adverse cytogenetic risk.

Study details: The data come from 19 consecutive patients with a median age of 77 years and previously untreated AML who received venetoclax combination therapy at a single center; 12 of these received a starting dose of 400 mg daily, 4 received 200 mg, and 3 patients received 100 mg.

Disclosures: The study was supported by the Ligue Nationale Contre le Cancer, and the association Laurette Fugain. The researchers had no financial conflicts to disclose. 

Source: Vazquez R et al. Blood Cancer J. 2021 Mar 19. doi: 10.1038/s41408-021-00448-w.

Key clinical point: Venetoclax combination therapy was safe and effective in older adults with acute myeloid leukemia who had not been previously treated.

Major finding: A total of 12 patients achieved complete remission, and another 4 patients achieved complete remission with incomplete blood recovery, with a median response duration of 8.9 months; however, response duration dropped to 4.6 months for patients with adverse cytogenetic risk.

Study details: The data come from 19 consecutive patients with a median age of 77 years and previously untreated AML who received venetoclax combination therapy at a single center; 12 of these received a starting dose of 400 mg daily, 4 received 200 mg, and 3 patients received 100 mg.

Disclosures: The study was supported by the Ligue Nationale Contre le Cancer, and the association Laurette Fugain. The researchers had no financial conflicts to disclose. 

Source: Vazquez R et al. Blood Cancer J. 2021 Mar 19. doi: 10.1038/s41408-021-00448-w.

Key clinical point: Venetoclax combination therapy was safe and effective in older adults with acute myeloid leukemia who had not been previously treated.

Major finding: A total of 12 patients achieved complete remission, and another 4 patients achieved complete remission with incomplete blood recovery, with a median response duration of 8.9 months; however, response duration dropped to 4.6 months for patients with adverse cytogenetic risk.

Study details: The data come from 19 consecutive patients with a median age of 77 years and previously untreated AML who received venetoclax combination therapy at a single center; 12 of these received a starting dose of 400 mg daily, 4 received 200 mg, and 3 patients received 100 mg.

Disclosures: The study was supported by the Ligue Nationale Contre le Cancer, and the association Laurette Fugain. The researchers had no financial conflicts to disclose. 

Source: Vazquez R et al. Blood Cancer J. 2021 Mar 19. doi: 10.1038/s41408-021-00448-w.

A radially adjustable stent retriever provided a high rate of substantial reperfusion and was associated with low rates of symptomatic intracranial hemorrhage and death in a new study. The novel device may increase the options for endovascular therapy, researchers say.

In this study, the Tigertriever (Rapid Medical) was noninferior to a prespecified performance goal and superior to established devices, as determined from historical rates derived from trials. The device achieved first-pass successful reperfusion in approximately 6 of 10 patients and final successful reperfusion in more than 9 of 10 patients.

“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large-vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, a vascular neurologist at Wellstar Health System Kennestone Hospital, Marietta, Ga., said during his presentation.

Results of the TIGER trial were presented at the International Stroke Conference, sponsored by the American Heart Association, and were published online March 19, 2021, in Stroke.

Endovascular therapy significantly improves outcomes of acute ischemic stroke resulting from large-vessel occlusion. However, current devices fail to achieve successful reperfusion in approximately 27% of patients, the researchers noted. In addition, the devices are associated with complications such as embolization to a new territory and symptomatic intracranial hemorrhage.

The Tigertriever is a radially adjustable, fully visible stent retriever. The operator controls the device’s radial expansion and force, enabling the operator to minimize vessel tension. The Tigertriever is available in Europe.

Effective revascularization

Dr. Gupta and colleagues conducted the prospective, single-arm TIGER study to evaluate the safety and efficacy of the Tigertriever in restoring blood flow by removing clots for patients with ischemic stroke resulting from large-vessel occlusion. The investigators compared the performance of the Tigertriever with a composite performance goal criterion derived from six pivotal trials of the Solitaire and Trevo devices.

The researchers enrolled patients at 16 U.S. sites and one site in Israel. Eligible participants had acute ischemic stroke resulting from large-vessel occlusion and moderate to severe neurologic deficits within 8 hours of symptom onset.

The study’s primary efficacy endpoint was successful revascularization within three Tigertriever passes. The investigators defined successful revascularization as achieving a modified Thrombolysis in Cerebral Ischemia score of 2b-3. Secondary efficacy endpoints were first-pass successful revascularization and good clinical outcome, which was defined as a Modified Rankin Scale score of 0-2.

The primary safety endpoint was the composite of symptomatic intracranial hemorrhage at 24 hours and all-cause mortality at 3 months.

The researchers enrolled 160 patients between May 2018 and March 2020. The mean age of the patients was 65 years, and 61.5% were men. The median National Institutes of Health Stroke Scale score was 17. Approximately 66% of patients received tissue plasminogen activator, and the median time to tPA administration was 95 minutes.

Most occlusions were in the M1 segment of the middle cerebral artery (57.3%) or the M2 segment of the MCA (19.7%). Approximately 21% of occlusions were in the internal carotid artery.

Successful revascularization was achieved in 84.6% of participants within three passes of the Tigertriever device. This rate surpassed the 63.4% performance goal and the 73.4% historical rate.

Successful revascularization was achieved in 57.8% of cases on first pass. After three passes, the rate was 84.6%. The rate of good clinical outcome at 90 days was 58% with the Tigertriever and 43% with the historical control.

The rate of symptomatic intracranial hemorrhage at 24 hours and mortality at 90 days was 18.1% with the Tigertriever and 20.4% with the historical control.

The rates of symptomatic hemorrhage and of embolization to a new territory with the Tigertriever were lower than with other devices, despite the relatively infrequent use of balloon guide catheters in the study, said Dr. Gupta.

Unmeasured confounding

“I congratulate the TIGER investigators for an interesting study that looked at a novel stentriever with adjustable radial size and force,” said Adam de Havenon, MD, assistant professor of neurology at the University of Utah, Salt Lake City, who was asked to comment on the study. “This intuitive concept shows promise in comparison to historical controls, and I look forward to hearing more about this exciting technology.”

The major advantage of the use of a composite historical control in the study is that fewer patients are needed for a trial, said Dr. de Havenon. This design makes the trial more economical and enables it to be completed more quickly.

“The impact is that a real-world patient could receive a beneficial treatment even sooner if it was shown to be beneficial with this study design,” he added. “The disadvantage is that there is unmeasured confounding because the historical controls come from trials during different time periods and at different centers and countries, with unique demographics that may not match well with your cohort.”

Statistical methodology helps mitigate this unmeasured confounding, but it remains a concern in the quest for a high level of evidence, Dr. de Havenon added.

The data suggest that the Tigertriever is a viable alternative to other stent retrievers, but they do not support its preferential use. “If the goal is to have the Tigertriever be considered a viable treatment option for large-vessel occlusion stroke, then [the researchers] have accomplished that with this study, which provides the needed data for FDA approval of the device,” said Dr. de Havenon.

“However, these data introduce the possibility of superiority but do not definitely show that,” he concluded. “To do so, they would need a randomized trial with a comparator device or devices and, as a result, a larger sample size.”

The study was funded by Rapid Medical. Dr. Gupta was one of the principal investigators for this study and for studies sponsored by Stryker Neurovascular, Zoll, and Vesalio. He served on the clinical events committee of a trial sponsored by Penumbra and has acted as a consultant for Cerenovous. Dr de Havenon disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A radially adjustable stent retriever provided a high rate of substantial reperfusion and was associated with low rates of symptomatic intracranial hemorrhage and death in a new study. The novel device may increase the options for endovascular therapy, researchers say.

In this study, the Tigertriever (Rapid Medical) was noninferior to a prespecified performance goal and superior to established devices, as determined from historical rates derived from trials. The device achieved first-pass successful reperfusion in approximately 6 of 10 patients and final successful reperfusion in more than 9 of 10 patients.

“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large-vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, a vascular neurologist at Wellstar Health System Kennestone Hospital, Marietta, Ga., said during his presentation.

Results of the TIGER trial were presented at the International Stroke Conference, sponsored by the American Heart Association, and were published online March 19, 2021, in Stroke.

Endovascular therapy significantly improves outcomes of acute ischemic stroke resulting from large-vessel occlusion. However, current devices fail to achieve successful reperfusion in approximately 27% of patients, the researchers noted. In addition, the devices are associated with complications such as embolization to a new territory and symptomatic intracranial hemorrhage.

The Tigertriever is a radially adjustable, fully visible stent retriever. The operator controls the device’s radial expansion and force, enabling the operator to minimize vessel tension. The Tigertriever is available in Europe.

Effective revascularization

Dr. Gupta and colleagues conducted the prospective, single-arm TIGER study to evaluate the safety and efficacy of the Tigertriever in restoring blood flow by removing clots for patients with ischemic stroke resulting from large-vessel occlusion. The investigators compared the performance of the Tigertriever with a composite performance goal criterion derived from six pivotal trials of the Solitaire and Trevo devices.

The researchers enrolled patients at 16 U.S. sites and one site in Israel. Eligible participants had acute ischemic stroke resulting from large-vessel occlusion and moderate to severe neurologic deficits within 8 hours of symptom onset.

The study’s primary efficacy endpoint was successful revascularization within three Tigertriever passes. The investigators defined successful revascularization as achieving a modified Thrombolysis in Cerebral Ischemia score of 2b-3. Secondary efficacy endpoints were first-pass successful revascularization and good clinical outcome, which was defined as a Modified Rankin Scale score of 0-2.

The primary safety endpoint was the composite of symptomatic intracranial hemorrhage at 24 hours and all-cause mortality at 3 months.

The researchers enrolled 160 patients between May 2018 and March 2020. The mean age of the patients was 65 years, and 61.5% were men. The median National Institutes of Health Stroke Scale score was 17. Approximately 66% of patients received tissue plasminogen activator, and the median time to tPA administration was 95 minutes.

Most occlusions were in the M1 segment of the middle cerebral artery (57.3%) or the M2 segment of the MCA (19.7%). Approximately 21% of occlusions were in the internal carotid artery.

Successful revascularization was achieved in 84.6% of participants within three passes of the Tigertriever device. This rate surpassed the 63.4% performance goal and the 73.4% historical rate.

Successful revascularization was achieved in 57.8% of cases on first pass. After three passes, the rate was 84.6%. The rate of good clinical outcome at 90 days was 58% with the Tigertriever and 43% with the historical control.

The rate of symptomatic intracranial hemorrhage at 24 hours and mortality at 90 days was 18.1% with the Tigertriever and 20.4% with the historical control.

The rates of symptomatic hemorrhage and of embolization to a new territory with the Tigertriever were lower than with other devices, despite the relatively infrequent use of balloon guide catheters in the study, said Dr. Gupta.

Unmeasured confounding

“I congratulate the TIGER investigators for an interesting study that looked at a novel stentriever with adjustable radial size and force,” said Adam de Havenon, MD, assistant professor of neurology at the University of Utah, Salt Lake City, who was asked to comment on the study. “This intuitive concept shows promise in comparison to historical controls, and I look forward to hearing more about this exciting technology.”

The major advantage of the use of a composite historical control in the study is that fewer patients are needed for a trial, said Dr. de Havenon. This design makes the trial more economical and enables it to be completed more quickly.

“The impact is that a real-world patient could receive a beneficial treatment even sooner if it was shown to be beneficial with this study design,” he added. “The disadvantage is that there is unmeasured confounding because the historical controls come from trials during different time periods and at different centers and countries, with unique demographics that may not match well with your cohort.”

Statistical methodology helps mitigate this unmeasured confounding, but it remains a concern in the quest for a high level of evidence, Dr. de Havenon added.

The data suggest that the Tigertriever is a viable alternative to other stent retrievers, but they do not support its preferential use. “If the goal is to have the Tigertriever be considered a viable treatment option for large-vessel occlusion stroke, then [the researchers] have accomplished that with this study, which provides the needed data for FDA approval of the device,” said Dr. de Havenon.

“However, these data introduce the possibility of superiority but do not definitely show that,” he concluded. “To do so, they would need a randomized trial with a comparator device or devices and, as a result, a larger sample size.”

The study was funded by Rapid Medical. Dr. Gupta was one of the principal investigators for this study and for studies sponsored by Stryker Neurovascular, Zoll, and Vesalio. He served on the clinical events committee of a trial sponsored by Penumbra and has acted as a consultant for Cerenovous. Dr de Havenon disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A radially adjustable stent retriever provided a high rate of substantial reperfusion and was associated with low rates of symptomatic intracranial hemorrhage and death in a new study. The novel device may increase the options for endovascular therapy, researchers say.

In this study, the Tigertriever (Rapid Medical) was noninferior to a prespecified performance goal and superior to established devices, as determined from historical rates derived from trials. The device achieved first-pass successful reperfusion in approximately 6 of 10 patients and final successful reperfusion in more than 9 of 10 patients.

“The Tigertriever is a highly effective and safe device to remove thrombus in patients with large-vessel occlusion who are eligible for mechanical thrombectomy,” Rishi Gupta, MD, a vascular neurologist at Wellstar Health System Kennestone Hospital, Marietta, Ga., said during his presentation.

Results of the TIGER trial were presented at the International Stroke Conference, sponsored by the American Heart Association, and were published online March 19, 2021, in Stroke.

Endovascular therapy significantly improves outcomes of acute ischemic stroke resulting from large-vessel occlusion. However, current devices fail to achieve successful reperfusion in approximately 27% of patients, the researchers noted. In addition, the devices are associated with complications such as embolization to a new territory and symptomatic intracranial hemorrhage.

The Tigertriever is a radially adjustable, fully visible stent retriever. The operator controls the device’s radial expansion and force, enabling the operator to minimize vessel tension. The Tigertriever is available in Europe.

Effective revascularization

Dr. Gupta and colleagues conducted the prospective, single-arm TIGER study to evaluate the safety and efficacy of the Tigertriever in restoring blood flow by removing clots for patients with ischemic stroke resulting from large-vessel occlusion. The investigators compared the performance of the Tigertriever with a composite performance goal criterion derived from six pivotal trials of the Solitaire and Trevo devices.

The researchers enrolled patients at 16 U.S. sites and one site in Israel. Eligible participants had acute ischemic stroke resulting from large-vessel occlusion and moderate to severe neurologic deficits within 8 hours of symptom onset.

The study’s primary efficacy endpoint was successful revascularization within three Tigertriever passes. The investigators defined successful revascularization as achieving a modified Thrombolysis in Cerebral Ischemia score of 2b-3. Secondary efficacy endpoints were first-pass successful revascularization and good clinical outcome, which was defined as a Modified Rankin Scale score of 0-2.

The primary safety endpoint was the composite of symptomatic intracranial hemorrhage at 24 hours and all-cause mortality at 3 months.

The researchers enrolled 160 patients between May 2018 and March 2020. The mean age of the patients was 65 years, and 61.5% were men. The median National Institutes of Health Stroke Scale score was 17. Approximately 66% of patients received tissue plasminogen activator, and the median time to tPA administration was 95 minutes.

Most occlusions were in the M1 segment of the middle cerebral artery (57.3%) or the M2 segment of the MCA (19.7%). Approximately 21% of occlusions were in the internal carotid artery.

Successful revascularization was achieved in 84.6% of participants within three passes of the Tigertriever device. This rate surpassed the 63.4% performance goal and the 73.4% historical rate.

Successful revascularization was achieved in 57.8% of cases on first pass. After three passes, the rate was 84.6%. The rate of good clinical outcome at 90 days was 58% with the Tigertriever and 43% with the historical control.

The rate of symptomatic intracranial hemorrhage at 24 hours and mortality at 90 days was 18.1% with the Tigertriever and 20.4% with the historical control.

The rates of symptomatic hemorrhage and of embolization to a new territory with the Tigertriever were lower than with other devices, despite the relatively infrequent use of balloon guide catheters in the study, said Dr. Gupta.

Unmeasured confounding

“I congratulate the TIGER investigators for an interesting study that looked at a novel stentriever with adjustable radial size and force,” said Adam de Havenon, MD, assistant professor of neurology at the University of Utah, Salt Lake City, who was asked to comment on the study. “This intuitive concept shows promise in comparison to historical controls, and I look forward to hearing more about this exciting technology.”

The major advantage of the use of a composite historical control in the study is that fewer patients are needed for a trial, said Dr. de Havenon. This design makes the trial more economical and enables it to be completed more quickly.

“The impact is that a real-world patient could receive a beneficial treatment even sooner if it was shown to be beneficial with this study design,” he added. “The disadvantage is that there is unmeasured confounding because the historical controls come from trials during different time periods and at different centers and countries, with unique demographics that may not match well with your cohort.”

Statistical methodology helps mitigate this unmeasured confounding, but it remains a concern in the quest for a high level of evidence, Dr. de Havenon added.

The data suggest that the Tigertriever is a viable alternative to other stent retrievers, but they do not support its preferential use. “If the goal is to have the Tigertriever be considered a viable treatment option for large-vessel occlusion stroke, then [the researchers] have accomplished that with this study, which provides the needed data for FDA approval of the device,” said Dr. de Havenon.

“However, these data introduce the possibility of superiority but do not definitely show that,” he concluded. “To do so, they would need a randomized trial with a comparator device or devices and, as a result, a larger sample size.”

The study was funded by Rapid Medical. Dr. Gupta was one of the principal investigators for this study and for studies sponsored by Stryker Neurovascular, Zoll, and Vesalio. He served on the clinical events committee of a trial sponsored by Penumbra and has acted as a consultant for Cerenovous. Dr de Havenon disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Key clinical point: Green tea extract was safely tolerated and associated with improved immune modulation regardless of tumor burden in older acute myeloid leukemia patients on low-dose chemotherapy.

Major finding: After 30 days, older adults with acute myeloid leukemia who consumed green tea extract showed an increase in total and CD8⁺ T cells, perforin⁺/granzyme B⁺ natural killer cells, monocytes, and classical monocytes. 

Study details: The data come from 10 patients aged 60 years and older with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received two capsules of green tea extract for a 1,000-mg daily dose for at least 6 months.

Disclosures: The study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, the Fundação de Amparo à Pesquisa do Estado de São Paulo, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose. 

Source: Calgarotto AK et al. Integr Cancer Ther. 2021 Mar 23. doi:10.1177/15347354211002647.

Key clinical point: Green tea extract was safely tolerated and associated with improved immune modulation regardless of tumor burden in older acute myeloid leukemia patients on low-dose chemotherapy.

Major finding: After 30 days, older adults with acute myeloid leukemia who consumed green tea extract showed an increase in total and CD8⁺ T cells, perforin⁺/granzyme B⁺ natural killer cells, monocytes, and classical monocytes. 

Study details: The data come from 10 patients aged 60 years and older with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received two capsules of green tea extract for a 1,000-mg daily dose for at least 6 months.

Disclosures: The study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, the Fundação de Amparo à Pesquisa do Estado de São Paulo, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose. 

Source: Calgarotto AK et al. Integr Cancer Ther. 2021 Mar 23. doi:10.1177/15347354211002647.

Key clinical point: Green tea extract was safely tolerated and associated with improved immune modulation regardless of tumor burden in older acute myeloid leukemia patients on low-dose chemotherapy.

Major finding: After 30 days, older adults with acute myeloid leukemia who consumed green tea extract showed an increase in total and CD8⁺ T cells, perforin⁺/granzyme B⁺ natural killer cells, monocytes, and classical monocytes. 

Study details: The data come from 10 patients aged 60 years and older with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) who received two capsules of green tea extract for a 1,000-mg daily dose for at least 6 months.

Disclosures: The study was supported by Conselho Nacional de Desenvolvimento Científico e Tecnológico, the Fundação de Amparo à Pesquisa do Estado de São Paulo, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose. 

Source: Calgarotto AK et al. Integr Cancer Ther. 2021 Mar 23. doi:10.1177/15347354211002647.