Health
REALITIVTY-047 Study design showing mature response outcomes in melanoma
Jason Luke, M.D., Ph.D., associate professor of hematology/oncology and director of the Center for Cancer Immunotherapy at UPMC Hillman Cancer Center, unique from RELATIVITY-047 trial (NCT03470922) demonstrating efficacy of nivolumab describes the design of (Opdivo) and relatrimab (Opdualag) in patients with advanced melanoma.
A phase 2/3 global, double-blind, randomized trial of fixed-dose PD-1 and LAG-3 immunotherapy versus nivolumab alone in patients with previously untreated metastatic or unresectable melanoma. evaluated comparatively.
Ultimately, the study met its primary endpoint of progression-free survival (PFS), with a median PFS of 4.6 months (95% CI, 3.4-5.6) in patients on combination therapy versus nivolumab alone (HR, 0.75; 95% CI, 0.62-0.92, P. = .006). His PFS rate at 12 months still favored combination therapy over monotherapy at 47.7% vs. 36.0%, with major subgroups experiencing similar his PFS effects with the addition of relatlimab .
But Luke said the road to getting these data is to assess whether the Phase 2 portion of the study shows sufficient benefit to patients before moving to the Phase 3 portion, where the data will be collected to broaden the scope. was gated, which took extra time. of court. This was the first to report the main results of PFS. Luke found that more mature data showed an efficacy advantage in objective response rate (ORR) in patients receiving combination therapy, whereas overall survival (OS) It said it didn’t reach the full threshold but showed relevance.
Although the most recent data did not reach median OS, 12- and 24-month OS rates were 77.0% vs. 71.6% and 63.7% vs. 58.3%, respectively, favoring combination therapy over monotherapy. was supporting The confirmed ORR in patients receiving relatlimab plus nivolumab was 43.1% (95% CI 37.9-48.4) compared to 16.3% complete responses in the combination arm.
Transcription:
0:08 | [This was a] A very interesting study design in which the study began as a Phase 2 study looking for interval outcomes that would trigger the full occurrence of Phase 3 [study]Clearly that happened and the trial ultimately showed an improvement in PFS on the primary endpoint. However, due to the kind of unusual study design using this gated approach, the data refer to patients treated in phase 2. [portion] Read faster than Phase 3 patients [portion].
0:47 | This created the specificity that when we got the first result REALITIVTY-047, we only knew that the primary endpoint of PFS was achieved, but not the ORR or OS data. With more mature follow-up, clinical trials do not fully meet pre-defined statistical thresholds, but there is also an advantage in ORR and OS appears to be clinically relevant . So, broadly speaking, the addition of relatlimab to nivolumab, by statistical design, improves him PFS and ORR, but OS slightly falls short of target.
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