Bristol-Myers’ Phase III lung cancer trial of Opdivo meets endpoint

19th April 2015 (Last Updated April 19th, 2015 18:30)

Bristol-Myers Squibb has stopped CheckMate -057, an open-label, randomised Phase III trial, which is evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous non small cell lung cancer (NSCLC).

Bristol-Myers Squibb has stopped CheckMate -057, an open-label, randomised Phase III trial, which is evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous non small cell lung cancer (NSCLC).

The trial was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the trial met its endpoint, showing superior overall survival in patients receiving Opdivo compared to the control arm.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, which has secured approval from the US Food and Drug Administration (FDA) as a monotherapy in two cancer indications.

"The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer."

Investigators of CheckMate -057 are being informed of the decision to stop the comparative portion of the trial.

Bristol-Myers Squibb Oncology Development senior vice-president and head Michael Giordano said: "The results of CheckMate -057 mark the second time Opdivo has demonstrated a survival advantage in lung cancer.

"Through our Opdivo clinical development programme, we seek to bring the potential for long-term survival to a broad range of patients, across lines of therapy and stages of disease."

Currently, the company is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of its commitment to providing patient access to Opdivo, and characterising long-term survival.

The company said that it will complete a full evaluation of the final CheckMate -057 data and work with investigators on the future presentation and publication of the results.

In the trial, a total of 582 patients were given either nivolumab 3mg/kg intravenously every two weeks or docetaxel 75mg/m2 intravenously every three weeks.

The primary endpoint of the trial is overall survival (OS), while secondary endpoints include objective response rate and progression free survival (PFS).

In March, Opdivo received FDA approval to treat patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy.

In the US, Opdivo is also indicated to treat patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.