Bristol Myers Squibb...announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

Nivolumab with platinum- and fluoropyrimidine-based chemotherapy is recommended, within its marketing authorisation, as an option for untreated HER2-negative, advanced or metastatic gastric, gastrooesophageal junction or oesophageal adenocarcinoma in adults whose tumours express PD-L1 with a combined positive score (CPS) of 5 or more.

For HER2-negative patients with esophageal or gastroesophageal junction (GEJ) AC and PD-L1 CPS ≥ 5, first-line therapy with nivolumab and CT is recommended.

Gastroesophageal Junction Adenocarcinoma: Principles of systemic therapy...Preferred regimens…HER2 overexpression negative…Fluoropyrimidine (Fluorouracil or Capecitabine) and oxaliplatin, and nivolumab (PDL1 CPS ≥ 5) for adenocarcinoma only (category 1)...Gastroesophageal Junction Adenocarcinoma: Principles of systemic therapy...Preferred regimens…HER2 overexpression negative…Fluoropyrimidine (fluorouracil or capecitabine) and Cisplatin, and nivolumab (PDL1 CPS ≥ 10) (Category 1)

Using data from CheckMate 649, we evaluated the quality-adjusted survival gain associated with NIVO + chemo...Patients with PD-L1 CPS ≥ 5 had greater quality-adjusted survival gain from NIVO + chemo with an estimated Q-TWiST gain of 2.8 (95% CI 1.5, 4.1) months, representing a relative gain of 20.6%. Subgroup analyses and sensitivity analyses with various QoL utility values yielded consistent findings in favor of NIVO + chemo compared with chemo alone. Q-TWiST gain from NIVO + chemo increased with longer duration of follow-up...NIVO + chemo was associated with a statistically significant and clinically important gain in quality-adjusted survival compared with chemo alone among previously untreated patients with advanced GC/GEJC/EAC.

Adults with previously untreated, unresectable advanced or metastatic, non-HER2-positive GC/GEJC/EAC were enrolled...The 36-mo OS rate was 31% with NIVO + chemo vs 11% with chemo in pts with PD-L1 CPS ≥ 5 and 26% vs 9% in all randomized pts, respectively. Objective response rate (ORR) (95% CI) per BICR in pts with PD-L1 CPS ≥ 5 who had measurable lesions at baseline was 68% (56-79) with NIVO + chemo and 48% (36-60) with chemo, and in all randomized patients was 66% (55-76) and 45% (35-56), respectively....After 3 years of follow-up, NIVO + chemo continued to demonstrate clinically meaningful survival benefit and durable objective responses vs chemo in Chinese pts, with an acceptable safety profile, consistent with the overall study population with advanced GC/GEJC/EAC.