Seattle Genetics Announces Updated Data of ADCETRIS (Brentuximab Vedotin) in Combination with OPDIVO (Nivolumab) in Frontline and Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced updated and long-term follow-up analyses from two clinical trials evaluating ADCETRIS (brentuximab vedotin) and OPDIVO (nivolumab) in frontline Hodgkin lymphoma (HL) patients aged 60 years and older and in relapsed or refractory classical HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS and OPDIVO are not approved in combination for the treatment of HL. Results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla.
“We continue to evaluate ADCETRIS in combination with novel therapies, such as checkpoint inhibitors, with the goal of identifying new options for CD30-expressing lymphomas where there is high unmet need,” said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. “These data presentations at ASH reinforce our strong commitment to the ADCETRIS clinical development program, potentially moving into new patient populations and novel combination treatment strategies.”
Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥ 60 Years (Abstract #237, oral presentation at 2:30 p.m. ET on Saturday, December 7,
Data were presented from an updated analysis from the phase 2 clinical trial evaluating ADCETRIS in combination with OPDIVO as frontline therapy for HL patients aged 60 years and older. Data were reported from 21 patients, and the median age was 72 years. The majority of patients (76 percent) had stage III/IV disease at the time of diagnosis. These results will be highlighted in an oral presentation by Christopher A. Yasenchak, M.D., Willamette Valley Cancer Institute and Research Center/US Oncology Research, Ore., and include:
- Of 19 response-evaluable patients, 18 patients (95 percent) had an objective response, including 13 patients (68 percent) with a complete response and five patients (26 percent) with a partial response. All response-evaluable patients experienced tumor reduction (complete response + partial response + stable disease) following treatment with ADCETRIS in combination with OPDIVO. Median duration of response was not yet reached and the maximum duration of response was 22 months and ongoing (95% CI: 7.06, -).
- The most common treatment-related adverse events of any grade occurring in at least 20 percent of patients were fatigue, diarrhea, pyrexia, infusion related reaction, peripheral motor neuropathy, peripheral sensory neuropathy and increase in lipase. One treatment-related serious adverse event was pyrexia. Fifty-seven percent of patients (12/21) had at least one treatment-related adverse event greater than or equal to Grade 3, most commonly increase in lipase (24 percent, 5/21), peripheral motor neuropathy and peripheral sensory neuropathy (each 14 percent, 3/21), and fatigue and hyponatremia (each 10 percent, 2/21).
Two-Year Follow-up Results from the Phase 1-2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (Abstract #238, oral presentation at 2:45 p.m. ET on Saturday, December 7, 2019)