Bristol-Myers Squibb Release: Extended Follow-Up Data Evaluating Opdivo (Nivolumab) Shows Durable Response In Adult Patients With Relapsed Or Progressed Classical Hodgkin Lymphoma
Results show overall response rates of 65% or greater with median follow-up of at least 16 months, regardless of prior brentuximab vedotin therapies
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced extended follow-up data in which Opdivo (nivolumab) demonstrated responses in adult patients with relapsed or progressed classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT), irrespective of brentuximab vedotin (BV) therapy history. Results from the Phase 2 CheckMate -205 study reflect the longest follow-up data of a programmed death 1 (PD-1) inhibitor in patients with cHL. These data will be presented tomorrow in an oral session at 8:45 AM CEST during the 14th International Conference on Malignant Lymphoma in Lugano, Switzerland.
The ongoing multi-cohort CheckMate -205 study evaluated objective response rates (ORR), the primary endpoint, as well as duration of response rates (DOR) for each cohort, all of which were assessed by the Independent Radiology Review Committee. In the BV-naïve group (Cohort A: n=63), with a median follow-up of 19 months, patients had an ORR of 65%, with a complete response (CR) in 29% of patients. The median DOR was 20 months and the median progression-free survival (PFS) was 18.3 months (95% CI: 11.1 to 22.4).
In the group that had BV therapy after ASCT (Cohort B: n=80), with a median follow-up of 23 months, the ORR was 68%, with CR in 13% of patients. The median DOR was 16 months and the median PFS was 14.7 months (95% CI: 10.5 to 19.6).
In the BV-before- (n=33), -after- (n=58) or before-and-after- (n=9) ASCT group (Cohort C: n=100 total), with a median follow-up of 16 months, the ORR was 73%, with CR in 12% of patients. The median DOR was 15 months and the median PFS was 11.9 months (95% CI: 11.1 to 18.4).
“Treatment options are limited for patients with classical Hodgkin Lymphoma after ASCT has failed, which is why the high objective response rates shown across cohorts of the CheckMate -205 study are encouraging,” said Michelle Fanale, M.D., Department of Lymphoma/Myeloma, University of Texas MD Anderson Cancer Center. “The results are particularly welcome news, as patients experienced responses regardless of brentuximab vedotin treatment history or the depth of their Hodgkin lymphoma’s response to brentuximab vedotin.”
Across cohorts, the median overall survival was not reached, and 40% of patients remained on treatment. The safety profile was consistent with previously reported data in this tumor type. The most common treatment-related adverse events (AEs) were fatigue (23%), diarrhea (15%), and infusion reactions (IRs; 14%). Grade 3 or 4 AEs experienced included fatigue (1%), diarrhea (1%) and rash (1%).
“These extended results across cohorts indicate that Opdivo may offer a potential treatment option for patients with classical Hodgkin Lymphoma progressing after ASCT,” said Jonathan Leith, hematology development lead, Bristol-Myers Squibb.
The U.S. Food and Drug Administration and the European Medicines Agency first approved Opdivo for patients with relapsed or refractory (RR) cHL following ASCT and BV in 2016. In the U.S., the indication received accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.