Bristol Myers' Opdivo leads the pack with FDA approval for resected esophageal or GEJ cancer
In a first for immunotherapies, Bristol Myers Squibb’s PD-1 blockbuster Opdivo (nivolumab) won another FDA approval on Thursday, this time for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.
The approval is based on the results from a placebo-controlled, Phase III trial in 794 patients, demonstrating a statistically significant improvement in disease-free survival (DFS), which was defined as the time between randomization and the first recurrence date, or death, from any cause.
“The median DFS was 22.4 months (95% CI: 16.6, 34.0) versus 11 months (95% CI: 8.3, 14.3), respectively (HR 0.69; 95% CI: 0.56, 0.85; p=0.0003). The DFS benefit was observed regardless of tumor PD-L1 expression and histology,” FDA said.
Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 572,000 new cases and over 508,000 deaths in 2018, according to BMS. The company said Opdivo has now won approval for 22 indications across 11 types of cancer.
The approval comes as BMS saw disappointing sales for Opdivo in the first quarter, down 3% from the same time period last year at $1.72 billion, according to earnings from late April. But Opdivo is being studied in several late-stage trials, showing benefit in resectable patients across a range of tumor locations, including bladder cancer and melanoma. Those expanding data sets could position Opdivo well to take a leading position in resectable cancers over its other highly-touted rivals, Opdivo head of development Mark Rutstein told Endpoints News last month.
The approval was part of an international initiative, spearheaded by the FDA’s Oncology Center of Excellence, where the FDA works with Australia, Canada and Switzerland to try to speed access to new cancer drugs in those countries.
The FDA said the application reviews for Opdivo in this indication are still ongoing at the Australian Therapeutic Goods Administration (TGA), Health Canada, and Switzerland’s Swissmedic.