BMS' Opdivo Flounders in Phase III Trial for Small Cell Lung Cancer

Bristol Myers Squibb on rocky sign

Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo failed to meet endpoints as a treatment option for small cell lung cancer (SCLC) patients who relapsed following platinum-based chemotherapy.

This morning BMS announced Phase III results from the CheckMate -331 study that showed that Opdivo, a programmed death-1 immune checkpoint inhibitor, did not provide additional benefits in overall survivability versus chemotherapy. Opdivo’s safety profile was consistent with previous monotherapy studies, the company said.

The Checkmate-331 trial randomized patients into two groups, one receiving the company’s immuno-oncology drug and a chemotherapy arm, with patients receiving topotecan or amrubicin. The primary objective was overall survival. Secondary endpoints included progression-free survival and objective response rate. In its brief announcement this morning, BMS did not provide details on the Phase III trial, only noted that it failed to meet that primary endpoint.

For small cell lung cancer, chemotherapy has been the standard of care in the front-line setting. However, the majority of patients experience relapse within one year. Small cell lung cancer is one of two main types of lung cancer and accounts for about 10 percent to 15 percent of all lung cancers. An aggressive disease, SCLC is often not detected until it’s in the advanced stages of the disease. BMS had been hoping Opdivo, the first PD-1 immune checkpoint inhibitor to receive regulatory approval, would prove to be a strong option to benefit overall survivability. In its announcement, the company noted that the median range of survival for extensive-stage SCLC (ES-SCLC) patients is between eight and 13 months. Less than 5 percent of patients with ES-SCLC survive two years and the five-year survival rate is 1 percent to 2 percent, BMS said.

“Small cell lung cancer is a highly aggressive disease in which significant unmet need remains. We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer. We thank the patients, their families, and the physicians involved in the CheckMate -331 study,” Sabine Maier, development lead in thoracic cancers at BMS said in a statement.

While Opdivo did not fare well as a stand-alone treatment in the Checkmate-331 trial, BMS has been pairing the drug with other medications as a potential treatment for a number of cancers. Earlier this week BMS struck a collaboration deal with Compugen. The companies will pair Opdivo with Compugen’s COM701, an investigational anti-PVRIG antibody as a potential treatment against advanced solid tumors.

The two companies are aiming the combination treatment at four tumor types, non-small cell lung, ovarian, breast and endometrial cancer. Compugen will sponsor the ongoing two-part Phase I trial, the companies said.

The collaboration between BMS and Compugen is also designed to address potential future combinations of checkpoint mechanisms, such as PVRIG and TIGIT, the companies said. The clinical combination of multiple immune checkpoint inhibition is designed to test the biological rationale of the PVRIG pathway and the synergistic activity demonstrated in preclinical models, they added in the announcement.

As part of the deal, BMS made a $12 million equity investment in Compugen.

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