Bristol-Myers Squibb (BMS) cancer drug Opdivo (nivolumab) failed to meet the primary endpoint of the phase 3 CheckMate -331 trial in small cell lung cancer patients whose condition relapsed after platinum-based chemotherapy treatment.
Opdivo could not significantly improve overall survival in the patients in comparison to current standard of care chemotherapy of topotecan or amrubicin (where approved) in the late-stage clinical trial.
However, the safety profile of the Bristol-Myers Squibb cancer drug Opdivo was on par with that recorded in monotherapy studies featuring small cell lung cancer patients.
Bristol-Myers Squibb cancer drug Opdivo has been designed to target the cellular pathway PD-1/PD-L1 proteins found in the immune cells and many cancer cells of the body. According to the US biopharma company, Opdivo helps in restoring an anti-tumor immune response to make the immune system fight cancer cells by blocking the PD-1/PD-L1 pathway.
Commenting on the CheckMate -331 trial results of cancer drug Opdivo, Sabine Maier -development lead, thoracic cancers, Bristol-Myers Squibb, 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.”
Bristol-Myers Squibb is currently investigating the combination of Opdivo plus Yervoy and Opdivo monotherapy in comparison to placebo in the frontline setting as a maintenance therapy for small cell lung cancer patients who do not progress on first-line chemotherapy.
The US biopharma company said that it has a comprehensive development program in thoracic malignancies, including small cell lung cancer, non-small cell lung cancer and malignant pleural mesothelioma.
Earlier this month, Bristol-Myers Squibb entered into a clinical collaboration with Israeli genomics-based drug and diagnostic discovery company Compugen to study the combination of Opdivo with the latter’s COM701 in advanced solid tumors.