Bristol-Myers Squibb Cancer Therapy Prolongs Melanoma Survival

June 25, 2014

Bristol-Myers Squibb stopped a Phase III trial of its cancer drug nivolumab early, after determining it was likely to prolong survival in advanced melanoma patients, the company said Tuesday.

The 418-patient study, dubbed CheckMate-066, tested nivolumab as an initial therapy for patients with advanced melanoma who couldn’t undergo surgery and had yet to be treated, the New York-based drugmaker said.

BMS said an independent data monitor analyzed the data from the blinded trial, which showed indication of superior overall survival in patients receiving nivolumab compared to the control arm, which received the chemotherapy dacarbazine. Dacarbazine patients were unblinded and allowed to switch to nivolumab, it added.

Nivolumab belongs to a new class of medicines called PD-1 inhibitors, which display the ability to help the immune system recognize and attack cancer.

The company said it is studying nivolumab against other tumor types in more than 35 trials—either alone or as part of a combo. These include trials in non-small cell lung cancer melanoma, renal cell carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma.

An earlier Bristol-Myers nivolumab study discovered it shrank tumors in 28 percent of melanoma patients, 27 percent with kidney cancer and in 18 percent of people with advanced lung cancer, the drugmaker said.

Bristol-Myers didn’t say how much longer patients on nivolumab survived compared to those on dacarbazine.

Nivolumab received FDA Breakthrough Therapy Designation in May for the treatment of patients with Hodgkin lymphoma. — Kellen Owings

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.