Nivolumab Trial Halted Early: Promising Phase 3 Results in Advanced Melanoma

Results indicate that nivolumab is likely to prolong survival in advanced melanoma.

A late-stage trial testing Bristol-Myers Squibb Co's cancer immunotherapy nivolumab in advanced melanoma patients was halted early after it was determined that the drug was likely to prolong survival, the company said on Tuesday. Bristol-Myers shares rose nearly 3 percent after the company announced the survival benefit finding.

The 418-patient Phase III study, called CheckMate -066, was testing nivolumab as an initial, or first line, therapy for patients with advanced melanoma, the deadliest form of skin cancer. An interim analysis performed by an independent data-monitoring committee found evidence of superior overall survival in patients receiving nivolumab compared with those who received the chemotherapy dacarbazine, Bristol said. The committee stopped the study early to allow the dacarbazine patients to switch to the Bristol drug.

Nivolumab belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer.

Analysts have forecast multibillion-dollar sales for the drugs being developed by several companies once they gain regulatory approval.


Source: Reuters