Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

Nivolumab Combined with Chemotherapy Improves Survival Outcome in Patients with Advanced Gastric/Esophageal Cancers

Web Exclusives - Gastrointestinal Cancers

Gastric cancer is the fourth leading cause of cancer death globally, with adenocarcinoma being the most common type of gastric and gastroesophageal junction (GEJ) cancer.1 These cancers share similar molecular profiles and, with systemic chemotherapy, have comparable clinical outcomes.1 Standard first-line treatment for advanced or metastatic unresectable HER2-negative GEJ or gastric adenocarcinoma is fluoropyrimidine plus platinum-based chemotherapy.1 However, this therapy is associated with <1 year median overall survival.1 The phase 3 ATTRACTION-2 study demonstrated that nivolumab, a programmed death (PD)-1 inhibitor, provided significant overall survival benefit when compared with a placebo in pretreated advanced or recurrent GEJ or gastric cancer.1 First-line PD-1 inhibitors were studied in the phase 3 CheckMate 649 study in participants with previously untreated advanced gastric, GEJ, or esophageal adenocarcinoma.1 The use of nivolumab plus chemotherapy gave a superior survival advantage over use of chemotherapy alone in these patients. Based on these results, FDA approval was granted for nivolumab in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma.

At the European Society for Medical Oncology Congress 2021, Yelena Janjigian, MD, presented further follow-up information on nivolumab plus chemotherapy versus chemotherapy alone and first results on the combination of nivolumab plus ipilimumab versus chemotherapy alone. Patients were enrolled regardless of PD-ligand 1 (PD-L1) expression prior to being randomized into treatment groups, but those with known HER2-positive status were excluded from the study. The study’s primary end points were overall survival and progression-free survival.

There were 1581 patients randomized to receive nivolumab plus chemotherapy or chemotherapy alone with 60% of these patients having PD-L1 combined positive score (CPS) ≥5. Nivolumab dosing was 360 mg every 3 weeks or 240 mg every 2 weeks. Chemotherapy consisted of XELOX (capecitabine and oxaliplatin) every 3 weeks or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) every 2 weeks. The results indicated that participants showed continued improvement over the 12-month follow-up period in overall survival with nivolumab plus chemotherapy when compared with chemotherapy alone.

There were 813 patients randomized into groups receiving nivolumab plus ipilimumab or chemotherapy alone and 58% of these patients had PD-L1 CPS ≥5. Nivolumab dosing was 1 mg/kg and ipilimumab was dosed at 3 mg/kg every 3 weeks for 4 doses, followed by nivolumab at 240 mg every 2 weeks. When the 2 treatment groups’ overall survival was compared, nivolumab plus ipilimumab did not confer any significant overall survival benefit when compared with chemotherapy. There was an acceptable safety profile for nivolumab plus chemotherapy.

Source

Janjigian YY, Ajani JA, Moehler M, et al. Nivolumab (NIVO) plus chemotherapy (Chemo) or ipilimumab (IPI) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): CheckMate 649 study. Ann Oncol. 2021;32(suppl_5):S1283-S1346.

Reference

  1. Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021;398:27-40.
Related Items
Health-Related Quality-of-Life Scores Higher in Patients with Advanced Gastric Cancer, Esophageal Adenocarcinoma, or Gastroesophageal Junction Cancer Receiving Nivolumab plus Chemotherapy
Web Exclusives published on November 17, 2021 in Gastrointestinal Cancers
First-Line Pembrolizumab plus Chemotherapy Improves Overall Survival and Progression-Free Survival in Patients with Advanced Esophageal Cancer
Web Exclusives published on November 17, 2021 in Gastrointestinal Cancers
Sintilimab Therapy in Patients with Previously Treated Advanced or Metastatic Gastric Cancer Demonstrates Modest Response
Web Exclusives published on November 17, 2021 in Gastrointestinal Cancers
Bavituximab Pembrolizumab Combination Demonstrates Antitumor Activity in Patients with Pretreated Advanced Gastric or Gastroesophageal Junction Cancer
Web Exclusives published on November 17, 2021 in Gastrointestinal Cancers
First-Line Toripalimab Combined with Chemotherapy Conveys Significant Benefits in Patients with Esophageal Squamous-Cell Carcinoma
Web Exclusives published on November 17, 2021 in Gastrointestinal Cancers
Progression-Free Survival Improved in Patients with HER2-Negative Recurrent or Advanced Gastric or Gastroesophageal Junction Cancer Receiving Nivolumab plus Chemotherapy
Web Exclusives published on November 17, 2021 in Gastrointestinal Cancers
Second-Line Pembrolizumab Therapy Conveys Survival Benefit in Patients with Advanced Esophageal Cancer
Web Exclusives published on October 25, 2021 in Gastrointestinal Cancers
ASCO Clinical Practice Guidelines for Clinician Management of Patients with Advanced Esophageal Cancer
Web Exclusives published on October 25, 2021 in Gastrointestinal Cancers
CheckMate 648 Study Data Indicate Improved Overall Survival for Patients with Advanced Esophageal Squamous-Cell Carcinoma Treated with Nivolumab and Ipilimumab or Chemotherapy
Web Exclusives published on October 25, 2021 in Gastrointestinal Cancers
Immune Checkpoint Analysis in Gastric Adenocarcinoma
Web Exclusives published on October 25, 2021 in Gastrointestinal Cancers
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.