Bristol-Myers Squibb says that a late-stage trial of its immunotherapy Opdivo has been stopped early after a survival benefit for patients with advanced kidney cancer was shown.
An independent data monitoring committee has put an early stop to the Phase III study after interim analysis concluded that it met its primary endpoint, showing that Opdivo (nivolumab), a PD-1 inhibitor, beat Novartis’ Afinitor (everolimus) in improving overall survival.
Michael Giordano, head of oncology development at BMS, said the latest results “mark the first time an immuno-oncology agent has shown a survival advantage in advanced renal cell carcinoma, a patient group that currently has limited treatment options”.
He added that “through our Opdivo clinical development programme, we aim to redefine treatment expectations for patients with advanced RCC by providing improved survival”. B-MS gave no other details about the data, saying that full results from the 821-patient trial will be reported at an upcoming scientific conference.
Second Europe approval in a month
As if that was not enough, B-MS also noted that the European Commission has approved Opdivo for the treatment of locally advanced or metastatic squamous non-small cell lung cancer.
The company said that the approval marks the first major treatment advance in the disease in more than a decade. The green light is based principally on a trial which showed nivolumab had a 41% reduction in the risk of death versus docetaxel, and nearly doubled overall survival at one-year versus chemotherapy (42% vs. 24%).
Opdivo got its first approval in Europe just a month ago, for the treatment of advanced melanoma in adults.