|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Additional data from the CheckMate 649 trial provide further support for nivolumab plus chemotherapy as a standard first-line treatment for advanced gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC).1
Markus H. Moehler, MD, PhD, of Johannes-Gutenberg University Clinic in Mainz, Germany, presented the data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
Dr. Moehler said CheckMate 649 (ClinicalTrials.gov Identifier: NCT02872116) is the largest randomized, global, phase 3 study of first-line PD-1 inhibitor–based therapy in GC, GEJC, and EAC.
Previous results from the trial demonstrated that first-line nivolumab plus chemotherapy induced superior overall survival (OS) and progression-free survival (PFS) compared with chemotherapy alone.2
The trial enrolled patients with previously untreated, unresectable advanced or metastatic GC, GEJC, or EAC. The patients were randomized 1:1:1 to the following treatments:
Dr Moehler presented results in 1581 patients — 789 who received nivolumab plus chemotherapy and 792 who received chemotherapy alone.
At a minimum follow-up of 12 months, nivolumab plus chemotherapy had a statistically significant OS benefit over chemotherapy alone. The median OS was 13.8 months and 11.6 months, respectively (hazard ratio [HR], 0.80; 95% CI, 0.68-0.94; P =.0002).
Dr Moehler noted that the OS “clearly favored” nivolumab plus chemotherapy across multiple prespecified subgroups.
A PFS benefit was also seen with nivolumab plus chemotherapy over chemotherapy alone. The median PFS was 7.7 months and 6.9 months, respectively (HR, 0.77; 95% CI, 0.68-0.87).
Response rates favored nivolumab plus chemotherapy, regardless of PD-L1 expression. The overall response rate was 58% in the nivolumab-chemotherapy arm and 46% in the chemotherapy-alone arm. The median duration of response was 8.5 months and 6.9 months, respectively.
Treatment-related adverse events (TRAEs) with potential immunologic etiology that occurred in the nivolumab-chemotherapy arm included endocrine (14%), gastrointestinal (34%), hepatic (26%), pulmonary (5%), renal (3%), and skin (27%) TRAEs. Most of these events were grade 1-2 and were resolved with the use of established management algorithms.
Tolerability, as measured by the FACT-Ga GP5 questionnaire, was similar between the treatment arms.
Patients in the nivolumab-chemotherapy arm had a 23% reduction in the risk of symptom worsening compared with patients in the chemotherapy arm.
“Nivolumab plus chemotherapy demonstrated superior overall survival versus chemotherapy alone, with clinically meaningful PFS benefit and improved, durable responses in previously untreated patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma,” Dr Moehler said. “These data clearly support nivo plus chemo as a new first-line standard treatment for patients in this indication.”
Disclosures: This research was supported by Bristol Myers Squibb. Study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
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- Moehler MH, Shitara K, Garrido M, et al. First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) versus chemo in advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): Expanded efficacy and safety data from CheckMate 649. J Clin Oncol. 2021;39:(suppl 15; abstr 4002). doi:10.1200/JCO.2021.39.15_suppl.4002
- Moehler M, Shitara K, Garrido M, et al. Nivolumab (nivo) plus chemotherapy (chemo) versus chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC)/esophageal adenocarcinoma (EAC): First results of the CheckMate 649 study. [ESMO Congress abstract LBA6]. Ann Oncol. 2020; 31(suppl)4. doi:https://doi.org/10.1016/j.annonc.2020.08.2296