by Dr. C.H. Weaver M.D. updated 7/2019
Longer follow-up confirms the survival benefit with the use of the PD-1 inhibitor, Opdivo® (nivolumab), compared to the chemotherapy agent, docetaxel, among patients with recurrent non-small cell lung cancer (NSCLC).
Once lung cancer has spread to distant sites in the body and has stopped responding to prior treatment with chemotherapy, current standard treatment options are aimed at improving duration of survival and maintaining quality of life.
Opdivo is a checkpoint inhibitor precision cancer medicine that helps the patient’s immune system to help fight the cancer cells. Opdivo blocks a molecule referred to as PD-1, which is involved in suppressing the immune system’s ability to fight cancer cells. By blocking the effects of PD-1, Opdivo restores the immune system’s ability to recognize and attack cancer cells.
Opdivo is approved by the United States Food and Drug Administration (FDA) for the treatment of both squamous and non-squamous NSCLC that has spread to distant sites in the body, and has stopped responding to prior therapy with certain chemotherapy agents referred to as platinum compounds.
The FDA also approved a laboratory test to detect levels of PD-1 in patients’ cancer cells prior to treatment with Opdivo, as Opdivo tends to improve survival only among those with elevated PD-1 levels.
Checkmate 057 included nearly 600 patients with advanced non-squamous NSCLC that had stopped responding to prior platinum-based chemotherapy. Patients were treated with either Opdivo or docetaxel and were directly compared.
- Median overall survival was over a year (12.2) months for patients treated with Opdivo, compared with 9.4 months for those treated with docetaxel.
- At one year, the overall survival rate was 51% among patients treated with Opdivo, compared with 39% among those treated with docetaxel.
- At 18 months, survival was 39% for patients treated with Opdivo, compared with 23% for those treated with docetaxel.
- Patients with higher levels of the PD-1 ligand demonstrated even greater improvements in outcomes with Opdivo, compared to those without elevated PD-1 ligand levels.
- Serious side effects were reported in 10% of patients treated with Opdivo, compared with 54% of those treated with docetaxel.
The authors stated, “Among patients with advanced non-squamous NSCLC that had progressed during or after platinum-based chemotherapy, overall survival was longer with Opdivo than with docetaxel.”
The CheckMate 063 clinical trial included patients with metastatic squamous cell NSCLC who had progressed after receiving a platinum-based therapy and at least one additional systemic treatment regimen. In this trial, Opdivo showed an estimated 18-month OS rate of 27%. At 18 months, confirmed objective response rate—the study’s primary endpoint—was 15%. Median OS was 8.1 months and the therapy was well tolerated.
CheckMate -017 also showed a significantly superior survival rate of 42% versus 24% for Taxotere.
Further analyses of different subsets of patients who might derive the greatest benefit from Opdivo is ongoing to determine optimal patient selection for this treatment.
- Bristol-Meyers Squibb Press Release
- Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer. New England Journal of Medicine. 2015; 373:1627-1639.