Benzinga | Jul 30, 2021 07:01AM EDT

Bristol Myers Reports European Commission Approval For Co.'s Opdivo As Adjuvant Treatment for Esophageal or Gastroesophageal Junction Cancer Patients with Residual Pathologic Disease Following Chemoradiotherapy

Approval is based on Phase 3 results from the CheckMate -577 trial

Opdivo is now the first and only adjuvant therapy approved in this setting in the European Union

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT). The EC's decision is based on results from the Phase 3 CheckMate -577 trial, which demonstrated that treatment with Opdivo following neoadjuvant CRT and complete surgical resection doubled the primary endpoint of disease-free survival (DFS) compared to placebo in the all-randomized population. The safety profile of Opdivo was consistent with previously reported studies.

Results from CheckMate -577 were presented at the European Society for Medical Oncology (ESMO) Virtual Congress in September 2020 and at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2021.

"We have demonstrated that the use of immunotherapy in earlier stages of cancer has the potential to prevent recurrence for certain patients," said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. "BMS was the first company to bring checkpoint inhibitors into the adjuvant setting for the treatment of patients with melanoma, and we are pleased to be the first to bring adjuvant therapy to patients in the EU with esophageal or gastroesophageal junction cancers who continue to face a high unmet need."

The EC decision allows for the use of Opdivo for the adjuvant treatment of adult patients with esophageal or GEJ cancer who have residual pathologic disease following prior neoadjuvant CRT in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. Opdivo also received approval from the U.S. Food and Drug Administration (FDA) in May 2021 for the adjuvant treatment of completely resected esophageal or GEJ cancer with residual pathologic disease in patients who have received CRT.

CheckMate -577 Efficacy and Safety Results

Results from the CheckMate -577 include:

* DFS: Median DFS was 22.4 months in patients receiving Opdivo (95% Confidence Interval [CI]: 16.6 to 34.0) compared to 11.0 months in patients receiving placebo (95% CI: 8.3 to 14.3). Opdivo reduced the risk of disease recurrence or death by 31% compared to placebo (Hazard Ratio [HR] 0.69; 96.4% CI: 0.56 to 0.86; p=0.0003).

* Safety: The incidence of any treatment-related adverse events (TRAEs), including any grade and Grade 3-4, was 71% and 13% among patients treated with Opdivo compared to 46% and 6% among patients receiving placebo. Serious TRAEs of any grade and Grade 3-4 occurred in less than 10% of patients treated with Opdivo (any grade in 8%, Grade 3-4 in 6%) compared to 3% and 1% of patients receiving placebo, with a low rate of any grade treatment-related discontinuations in both arms (9% for Opdivo vs. 3% in placebo).