Bristol-Myers Squibb’s Opdivo fails to meet key endpoint in small cell lung cancer trial

Bristol-Myers Squibb’s cancer drug Opdivo (nivolumab) has failed to meet the primary endpoint in the Phase 3 CheckMate -331 trial, designed to assess its effectiveness in small cell lung cancer (SCLC) patients whose condition had relapsed after platinum-based chemotherapy. The trial results reveal that Opdivo did not significantly enhance overall survival compared to the current standard chemotherapy treatments, which include topotecan or amrubicin, where approved.

Trial Results and Safety Profile

Despite this setback, the safety profile of Opdivo in this trial remained consistent with that observed in previous monotherapy studies involving SCLC patients. This suggests that while Opdivo did not improve survival outcomes in this context, it did not introduce new safety concerns.

Mechanism and Current Research Directions

Opdivo is designed to target the PD-1/PD-L1 cellular pathway, a mechanism employed by cancer cells to evade the immune system. By blocking this pathway, Opdivo aims to restore the immune system’s ability to recognize and attack cancer cells. However, in this late-stage trial, the drug did not demonstrate a significant benefit over existing therapies.

In response to the trial results, Sabine Maier, Development Lead for Thoracic Cancers at Bristol-Myers Squibb, emphasized the ongoing need for innovative treatments in this aggressive disease. Maier stated, “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.”

Future Directions and Collaborations

Bristol-Myers Squibb is exploring alternative strategies to enhance treatment efficacy. The company is currently investigating the combination of Opdivo with Yervoy, as well as Opdivo monotherapy, in comparison to placebo as a maintenance therapy for SCLC patients who do not progress on first-line chemotherapy.

Additionally, Bristol-Myers Squibb has initiated a clinical collaboration with Compugen, an Israeli genomics-based drug and diagnostic discovery company. This collaboration aims to study the combination of Opdivo with Compugen’s COM701 in advanced solid tumors, potentially offering new avenues for effective cancer treatment.

Bristol-Myers Squibb remains committed to its comprehensive development program in thoracic malignancies, which includes SCLC, non-small cell lung cancer (NSCLC), and malignant pleural mesothelioma.