Adults with previously untreated, unresectable advanced or metastatic GC/GEJC/EAC were enrolled...Objective response rate (ORR) in patients with PD-L1 CPS >/= 5 was 68% vs 48% and median duration of response (DOR) was 12.5 months vs 6.9 months for NIVO + chemo vs chemo, respectively; ORR in all randomized patients was 66% vs 45% and median DOR was 12.5 months vs 5.6 months, respectively....These results are consistent with those observed in the overall study population with advanced GC/GEJC/EAC from CheckMate 649.

Bristol Myers Squibb...today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

Of 2031 pts, 1581 (60% with PD-L1 CPS ≥ 5) were concurrently randomized to NIVO + chemo...NIVO + chemo continued to show improvement in OS vs chemo alone with an additional 12-mo follow-up from the primary analysis...NIVO + chemo continued to demonstrate clinically meaningful long-term survival benefit vs chemo and an acceptable safety profile with additional follow-up, further supporting its use as a new standard 1L treatment in pts with advanced GC/GEJC/EAC.

...we enrolled adults (≥18 years) with...gastric, gastro-oesophageal junction, or oesophageal adenocarcinoma...Patients were randomly assigned...to nivolumab...plus chemotherapy (capecitabine and oxaliplatin every 3 weeks or leucovorin, fluorouracil, and oxaliplatin every 2 weeks)...resulted in significant improvements in OS...and PFS (HR 0·68 [98 % CI 0·56–0·81]; p<0·0001)...in patients with a PD-L1 CPS of five or more (minimum follow-up 12·1 months). Additional results showed significant improvement in OS, along with PFS benefit, in patients with a PD-L1 CPS of one or more and all randomly assigned patients.

Dual primary endpoints for NIVO + chemo vs chemo were OS and PFS by blinded central review in PD-L1 CPS ≥ 5 pts....The addition of NIVO to chemo demonstrated improved OS and PFS benefit in all randomized pts, along with an acceptable safety profile and maintained tolerability as well as QoL, providing further support for NIVO + chemo as a standard 1L treatment for advanced GC/GEJC/EAC.

Adults with previously untreated, unresectable advanced or metastatic GC/GEJC/EAC were enrolled...Pts were randomized to receive NIVO (360 mg Q3W or 240 mg Q2W) + chemo (XELOX Q3W or FOLFOX Q2W), NIVO + ipilimumab, or chemo….At minimum follow-up of 12 months (mo), NIVO + chemo demonstrated clinically meaningful improvement in OS and PFS vs chemo in pts with PD-L1 CPS ≥ 5 (OS, HR 0.54 [95% CI 0.36-0.79]; PFS, HR 0.52 [0.34-0.77]...OS benefit was also observed in pts with PD-L1 CPS ≥ 1 and the all-randomized population...NIVO + chemo demonstrated a clinically meaningful improvement in OS and PFS...

Adults with previously untreated, unresectable advanced, or metastatic GC/GEJC/EAC were enrolled...With a minimum follow-up of 12 months (mo), NIVO + chemo showed a statistically significant improvement in OS and PFS vs chemo in pts whose tumors expressed PD-L1 CPS ≥ 5 (OS, HR 0.71 [98.4% CI 0.59–0.86; P < 0.0001] and PFS, HR 0.68 [98% CI 0.56–0.81; P < 0.0001]).

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.

...PD-L1 expression status must be determined by the study-designated central lab prior to randomization (CPS <5 versus CPS ≥ 5) for participants enrolled in Phase 2. ...

...- Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma or EAC whose tumours express PD-L1 with a CPS ≥ 5...