Phase III Trials for Bristol-Myers’ Opdivo Fail to Meet Primary Endpoints

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Opdivo did not meet primary endpoints in Phase III trials investigating the drug as a monotherapy for untreated advanced non-small cell lung cancer in patients whose tumors expressed PD-L1.

On August 5, 2016, Bristol-Myers Squibb’s (BMS) announced that its cancer drug Opdivo (nivolumab) did not meet primary endpoints in Phase III trials. The CheckMate -026 trial was investigating Opdivo as a monotherapy treatment for progression-free survival for patients with previously untreated advanced non-small cell lung cancer whose tumors expressed PD-L1.

Opdivo is FDA approved to treat patients with metastatic melanoma, classical Hodgkin Lymphoma, and those previously treated for advanced non-small cell lung cancer and advanced renal cell carcinoma. The drug was poised as a direct competitor for Merck’s Keytruda (pembrolizumab), an anti PD-L1 inhibitor, used to treat advanced melanoma and non-small cell lung cancer. The Wall Street Journal reported BMS shares fell 17% in the wake of the announcement, while Merck shares rose approximately 6.8%.

BMS released a statement early Friday saying they were disappointed in the results of the trial, but studying Opdivo as a combination therapy may be a promising outlet. The company’s CheckMate -227 trial is examining Opdivo in combination with Yervoy or in combination with chemotherapy, as a treatment for lung cancer patients. “We believe that combination therapy may provide an important opportunity to address the needs of every patient with first-line lung cancer,” BMS said in a statement.


Source: Bristol-Myers Squibb