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). These results were recently published in the New England Journal of Medicine while simultaneously being presented at the 2015 European Cancer Congress.
Lung cancer remains the leading cause of cancer-related deaths in the United States and worldwide. The treatment of lung cancer is determined by its cellular type, the extent of spread, characteristics of the cancer cells, and the ability of patients to tolerate certain types of therapy.
Once lung cancer has spread to distant sites in the body and has stopped responding to prior therapies, current standard treatment options are aimed at improving duration of survival and maintaining quality of life.
Opdivo is an agent that stimulates 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. Through blocking the effects of PD-1, Opdivo restores the immune system’s ability to recognize and attack cancer cells.
Opdivo was recently 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.
The updated clinical trial was an international phase 3 study, referred to as the checkmate 057 trial, that 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.”
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.
Reference: 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.
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