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Bristol Myers’ Opdivo fails to meet primary endpoint in lung-cancer study

A phase 3 study of Bristol-Myers Squibb’s opdivo (nivolumab) in treatment-naïve patients with advanced non-small cell lung cancer (NSCLC) has failed to meet primary endpoint of progression-free survival in patients expressing PD-L1 ≥ 5%.

The company said it will fully assess the trial’s data and work with investigators on the future presentation of the results.

The phase 3, open-label, randomized CheckMate -026 study was designed to evaluate the benefit of Opdivo monotherapy in a broad patient population.

Apart from the 026 study trial, Bristol-Myers Squibb is undertaking CheckMate -227 study to evaluate the potential of the combination of Opdivo plus Yervoy for PDL-1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.

The company believes the combination therapy to offer a key opportunity to address the needs of every patient with first-line lung cancer.

Bristol-Myers Squibb CEO Giovanni Caforio said: “Opdivo has become a foundational treatment that is transforming cancer care across multiple tumor types.

“While we are disappointed CheckMate -026 did not meet its primary endpoint in this broad patient population, we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase 3 CheckMate -227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”

It is the first time that Opdivo has failed in a clinical trial. The setback expected to benefit Merck’s rival medicine, Keytruda.

Opdivo secured approval in March 2015 to treat patients with advanced NSCLC who had previously failed to benefit from chemotherapy.

Last October, Keytruda also won approval for a similar patient population.