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First-line treatment with brentuximab vedotin (BV) can produce a high response rate in older Hodgkin lymphoma (HL) patients who are unfit for chemotherapy, according to research published in Blood.
In this small study, single-agent BV produced an overall response rate of 92% and a complete response rate of 73%.
However, the drug also produced a high rate of peripheral sensory neuropathy (78%), which was the most common adverse event.
This phase 2 trial is the first to assess BV as front-line treatment. The study was funded by Seattle Genetics, Inc., which is developing BV in collaboration with Takeda Pharmaceutical Company.
Andres Forero-Torres, MD, of the University of Alabama at Birmingham, and his colleagues conducted the research, enrolling 27 HL patients (ages 64 to 92) in the trial.
The patients were either ineligible for conventional chemotherapy or declined treatment after receiving information about its risks.
They received 1.8 mg/kg of intravenous BV every 3 weeks for up to 16 doses. Those who benefitted from the drug could continue beyond this time period until disease progression, unacceptable toxicity, or study closure.
Patients received a median of 8 cycles, with 4 patients completing 16 cycles and 1 patient completing 23 cycles.
Peripheral neuropathy was the primary adverse event leading to dose modifications. Fourteen patients (52%) had dose delays, typically lasting a week (range, 1 to 3). But 11 patients (41%) had permanent dose reductions to 1.2 mg/kg.
Safety
All 27 patients were evaluable for safety, and all experienced at least 1 adverse event. The most commonly reported events were peripheral sensory neuropathy (n=21, 78%), fatigue (n=12, 44%), and nausea (n=12, 44%).
Treatment-emergent grade 3 adverse events included peripheral sensory neuropathy (n=7, 26%), rash (n=2, 7%), urinary tract infection (n=1, 4%), and maculopapular rash (n=1, 4%)
There were 2 grade 4 events—hyperuricemia and drug hypersensitivity to anesthesia—considered unrelated to BV.
Efficacy
Twenty-six patients were evaluable for efficacy. One patient was found to have nodular lymphocyte predominant HL and was therefore excluded.
The overall response rate was 92%. Nineteen patients had a complete response, 5 had a partial response, and 2 had stable disease.
The median duration of response was about 9.1 months (range, 2.8 to 20.9+ months).
The median progression-free survival was 10.5 months (range, 2.6+ to 22.3+ months), and the median overall survival had not been reached at the time of analysis (range, 4.6+ to 24.9+ months).
“While we observed promising responses,” Dr Forero-Torres said, “the next step is to evaluate this drug in combination with additional chemotherapy or immunotherapies that might allow us to prolong the response without relapse.” 
Photo from Business Wire
First-line treatment with brentuximab vedotin (BV) can produce a high response rate in older Hodgkin lymphoma (HL) patients who are unfit for chemotherapy, according to research published in Blood.
In this small study, single-agent BV produced an overall response rate of 92% and a complete response rate of 73%.
However, the drug also produced a high rate of peripheral sensory neuropathy (78%), which was the most common adverse event.
This phase 2 trial is the first to assess BV as front-line treatment. The study was funded by Seattle Genetics, Inc., which is developing BV in collaboration with Takeda Pharmaceutical Company.
Andres Forero-Torres, MD, of the University of Alabama at Birmingham, and his colleagues conducted the research, enrolling 27 HL patients (ages 64 to 92) in the trial.
The patients were either ineligible for conventional chemotherapy or declined treatment after receiving information about its risks.
They received 1.8 mg/kg of intravenous BV every 3 weeks for up to 16 doses. Those who benefitted from the drug could continue beyond this time period until disease progression, unacceptable toxicity, or study closure.
Patients received a median of 8 cycles, with 4 patients completing 16 cycles and 1 patient completing 23 cycles.
Peripheral neuropathy was the primary adverse event leading to dose modifications. Fourteen patients (52%) had dose delays, typically lasting a week (range, 1 to 3). But 11 patients (41%) had permanent dose reductions to 1.2 mg/kg.
Safety
All 27 patients were evaluable for safety, and all experienced at least 1 adverse event. The most commonly reported events were peripheral sensory neuropathy (n=21, 78%), fatigue (n=12, 44%), and nausea (n=12, 44%).
Treatment-emergent grade 3 adverse events included peripheral sensory neuropathy (n=7, 26%), rash (n=2, 7%), urinary tract infection (n=1, 4%), and maculopapular rash (n=1, 4%)
There were 2 grade 4 events—hyperuricemia and drug hypersensitivity to anesthesia—considered unrelated to BV.
Efficacy
Twenty-six patients were evaluable for efficacy. One patient was found to have nodular lymphocyte predominant HL and was therefore excluded.
The overall response rate was 92%. Nineteen patients had a complete response, 5 had a partial response, and 2 had stable disease.
The median duration of response was about 9.1 months (range, 2.8 to 20.9+ months).
The median progression-free survival was 10.5 months (range, 2.6+ to 22.3+ months), and the median overall survival had not been reached at the time of analysis (range, 4.6+ to 24.9+ months).
“While we observed promising responses,” Dr Forero-Torres said, “the next step is to evaluate this drug in combination with additional chemotherapy or immunotherapies that might allow us to prolong the response without relapse.”
Photo from Business Wire
First-line treatment with brentuximab vedotin (BV) can produce a high response rate in older Hodgkin lymphoma (HL) patients who are unfit for chemotherapy, according to research published in Blood.
In this small study, single-agent BV produced an overall response rate of 92% and a complete response rate of 73%.
However, the drug also produced a high rate of peripheral sensory neuropathy (78%), which was the most common adverse event.
This phase 2 trial is the first to assess BV as front-line treatment. The study was funded by Seattle Genetics, Inc., which is developing BV in collaboration with Takeda Pharmaceutical Company.
Andres Forero-Torres, MD, of the University of Alabama at Birmingham, and his colleagues conducted the research, enrolling 27 HL patients (ages 64 to 92) in the trial.
The patients were either ineligible for conventional chemotherapy or declined treatment after receiving information about its risks.
They received 1.8 mg/kg of intravenous BV every 3 weeks for up to 16 doses. Those who benefitted from the drug could continue beyond this time period until disease progression, unacceptable toxicity, or study closure.
Patients received a median of 8 cycles, with 4 patients completing 16 cycles and 1 patient completing 23 cycles.
Peripheral neuropathy was the primary adverse event leading to dose modifications. Fourteen patients (52%) had dose delays, typically lasting a week (range, 1 to 3). But 11 patients (41%) had permanent dose reductions to 1.2 mg/kg.
Safety
All 27 patients were evaluable for safety, and all experienced at least 1 adverse event. The most commonly reported events were peripheral sensory neuropathy (n=21, 78%), fatigue (n=12, 44%), and nausea (n=12, 44%).
Treatment-emergent grade 3 adverse events included peripheral sensory neuropathy (n=7, 26%), rash (n=2, 7%), urinary tract infection (n=1, 4%), and maculopapular rash (n=1, 4%)
There were 2 grade 4 events—hyperuricemia and drug hypersensitivity to anesthesia—considered unrelated to BV.
Efficacy
Twenty-six patients were evaluable for efficacy. One patient was found to have nodular lymphocyte predominant HL and was therefore excluded.
The overall response rate was 92%. Nineteen patients had a complete response, 5 had a partial response, and 2 had stable disease.
The median duration of response was about 9.1 months (range, 2.8 to 20.9+ months).
The median progression-free survival was 10.5 months (range, 2.6+ to 22.3+ months), and the median overall survival had not been reached at the time of analysis (range, 4.6+ to 24.9+ months).
“While we observed promising responses,” Dr Forero-Torres said, “the next step is to evaluate this drug in combination with additional chemotherapy or immunotherapies that might allow us to prolong the response without relapse.”