Bristol-Myers Squibb Company said the ongoing phase III CheckMate-227 study met its co-primary endpoint of progression-free survival with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer patients whose tumors have high (≥10 mutations/megabase, mut/mb) tumor mutation burden, regardless of PD-L1 expression.
Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy.
