European Society for Medical Oncology Congress

European Society for Medical Oncology Congress

Perspective from Afsaneh Barzi, MD, PhD
Source:

Janjigian YY, et al. Abstract LBA7. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 16-21, 2021.

Disclosures: Bristol Myers Squibb funded the study. Janjigian research grants or personal fees from AstraZeneca, Bayer, Bristol Myers Squibb, Eli Lilly, Genentech Roche, Merck, Pfizer and several other pharmaceutical companies or entities. Please see the abstract for all other researchers’ relevant financial disclosures.
October 06, 2021
2 min read
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2-year data confirm benefit of nivolumab regimen for advanced gastric, esophageal cancers

Perspective from Afsaneh Barzi, MD, PhD
Source:

Janjigian YY, et al. Abstract LBA7. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 16-21, 2021.

Disclosures: Bristol Myers Squibb funded the study. Janjigian research grants or personal fees from AstraZeneca, Bayer, Bristol Myers Squibb, Eli Lilly, Genentech Roche, Merck, Pfizer and several other pharmaceutical companies or entities. Please see the abstract for all other researchers’ relevant financial disclosures.
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The addition of nivolumab to chemotherapy showed durable benefit for treatment-naive patients with advanced gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, 2-year data from the CheckMate 649 study showed.

However, results of the randomized phase 3 study showed the combination of nivolumab (Opdivo, Bristol Myers Squibb) and ipilimumab (Yervoy, Bristol Myers Squibb) did not significantly improve survival compared with chemotherapy.

Addition of nivolumab to chemotherapy.
Janjigian YY, et al. Abstract LBA7. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 16-21, 2021.

“Nivolumab plus chemotherapy continues to demonstrate clinically meaningful benefit [as first-line treatment], and it is nice to have these additional 12 months of follow-up data,” Yelena Y. Janjigian, MD, oncologist and chief of the gastrointestinal oncology service at Memorial Sloan Kettering Cancer Center, said during a presidential symposium presentation at the virtual ESMO Congress. “These data have already changed practice for patients with metastatic gastric, gastroesophageal junction and esophageal adenocarcinoma.”

The CheckMate 649 study included adults with advanced or metastatic HER2-negative gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma enrolled regardless of PD-L1 expression.

Yelena Janjigian
Yelena Y. Janjigian

In one analysis, researchers randomly assigned 1,581 patients to the anti-PD-1 antibody nivolumab plus chemotherapy (n = 789) or chemotherapy alone (n = 792). Researchers dosed nivolumab at 360 mg every 3 weeks or 240 mg every 2 weeks, and chemotherapy consisted of XELOX every 3 weeks or FOLFOX every 2 weeks.

A second analysis included 813 patients. Researchers assigned 409 of them to nivolumab plus the anti-CTLA-4 antibody ipilimumab (n = 409) or chemotherapy alone (n = 404). Patients assigned the combination received 1 mg/kg nivolumab plus 3 mg/kg ipilimumab every 3 weeks for four doses, followed by 240 mg nivolumab every 2 weeks.

Previously reported data based on 12-month follow-up showed the addition of nivolumab to chemotherapy conferred significant OS and PFS benefits among patients with a combined positive score (CPS) of 5 or greater for PD-L1 tumor expression.

At ESMO, Janjigian reported data based on median follow-up of 24 months.

Results showed sustained improvement in OS with the addition of nivolumab to chemotherapy among patients with PD-L1 CPS of 5 or greater (median, 14.4 months vs. 11.1 months; HR = 0.7; 95% CI, 0.61-0.81), as well as among all randomly assigned patients (median, 13.8 months vs. 11.6 months; HR = 0.79; 95% CI, 0.71-0.88).

Researchers also reported a sustained PFS benefit among patients with PD-L1 CPS of 5 or greater (median, 8.1 months vs. 6.1 months; HR = 0.7; 95% CI, 0.6-0.81) and among all randomly assigned patients (median, 7.7 months vs. 6.9 months; HR = 0.79; 95% CI, 0.7-0.89).

Researchers observed no OS benefit with the nivolumab-ipilimumab combination compared with chemotherapy among patients with PD-L1 CPS of 5 or greater (median, 11.2 months vs. 11.6 months; HR = 0.89; 96.5% CI, 0.71-1.1) or all randomly assigned patients (median, 11.7 months vs. 11.8 months; HR = 0.91; 96.5% CI, 0.77-1.07). Results also showed no PFS benefit with nivolumab-ipilimumab vs. chemotherapy among patients with PD-L1 CPS of 5 or greater (median, 2.8 months vs. 6.3 months; HR = 1.42; 95% CI, 1.14-1.76) or all randomly assigned patients (median, 2.8 months vs. 7.1 months; HR = 1.66; 95% CI, 1.4-1.95).

Researchers reported no new safety signals with the nivolumab-chemotherapy and nivolumab-ipilimumab combinations.

“Longer follow-up data for nivolumab plus chemotherapy further support its use as a new standard first-line treatment [for these patient populations],” Janjigian said.