Bristol-Myers Squibb reports positive late-stage data for Opdivo in advanced melanoma

Bristol-Myers Squibb said Monday that Opdivo (nivolumab) led to an objective response rate (ORR) of 32 percent compared to 11 percent for chemotherapy in a Phase III study of patients with advanced melanoma who were previously treated with the company's Yervoy (ipilimumab). "These data...mark the first presentation of results from a Phase III randomised study for the PD-1 immune checkpoint inhibitor class," remarked researcher Jeffrey S. Weber, who presented the results at the European Society of Medical Oncology (ESMO) congress.

The CheckMate-037 trial randomised 370 patients to receive Opdivo or investigator's choice of chemotherapy until progression or unacceptable toxicity, with subjects classified by PD-1 ligand expression, BRAF status and best response to prior treatment with Yervoy. The study's co-primary endpoints are ORR and overall survival, although Bristol-Myers Squibb noted that an interim analysis for survival had not taken place at the time of the current data.

Results showed that for the ORR, which included patients with at least six months of follow up, the majority of responses were ongoing in the Opdivo arm and the median duration of response was not reached. Meanwhile, patients given chemotherapy typically responded for 3.6 months. Weber noted that "a 32 percent response rate with the majority staying in remission past six months is probably going to turn into a very impressive level of survival."

Bristol-Myers Squibb indicated that Grade 3/4 drug-related adverse events (AEs) occurred in 9 percent of patients who received Opdivo, versus 31 percent given chemotherapy. In addition, serious Grade 3/4 drug-related AEs were reported in 5 percent and 9 percent of patients treated with Opdivo and chemotherapy, respectively. The company added that discontinuations due to drug-related AEs, of any grade, occurred in 2 percent of Opdivo-treated patients and 8 percent of patients administered chemotherapy.

Opdivo was the first PD-1 inhibitor approved globally, after Japanese regulators cleared the drug in July for the treatment of unresectable melanoma. Bristol-Myers Squibb recently said that the FDA granted priority review to a filing seeking approval of the therapy for patients with previously treated advanced melanoma, with a decision expected by the end of March next year.

For related analysis, see ViewPoints: Bristol-Myers Squibb claws back some ground in PD-1 melanoma race, but what can Merck & Co. do with its first-to-market advantage? and ViewPoints: Can BRAF/MEK combinations fend of immuno-oncology threat in melanoma?

To read more Top Story articles, click here.