by Dr. C.H. Weaver M.D. updated 9/2019
The goal of treatment of recurrent non-small cell lung cancer (NSCLC) has historically been to control symptoms, improve quality of life and prolong survival.
The PD-1 inhibitor, Opdivo® (nivolumab) has been compared to the chemotherapy agent, Taxotere (docetaxel) for the treatment of patients with recurrent NSCLC in several pivotal clinical trials - each confirming that Opdivo produces superior survival duration. (1-3)
Updated pooled analyses of the CheckMate 017 and 057 clinical trials comparing Opdivo with Taxotere was presented at the International Association for the Study of Lung Cancer World Conference on Lung Cancer in September 2019 and showed that 13.4% of Opdivo treated patients survived 5 years compared with only 2.6% of patients treated with Taxotere. The benefit occurred among both squamous and non-squamous NSCLC.
The median duration of response for Opdivo was 19.9 months and 5.6 months with docetaxel. At 5 years, 32.2% of responders remained in response with Opdivo.
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 checkMate 017 clinical trial also showed a significantly superior survival rate of 42% versus 24% for Opdivo compared to Taxotere in patients with squamous NSCLC.
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.
- Gettinger S, et al. Abstract OA14.04. Presented at: International Association for the Study of Lung Cancer World Conference on Lung Cancer; Sept. 7-10, 2019; Barcelona.
- 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.