The FDA has approved nivolumab plus platinum-doublet chemotherapy for patients with non-small cell lung cancer in the neoadjuvant setting. Nivolumab is the first immune checkpoint inhibitor to get approval for resectable NSCLC. This FDA approval is supported by findings from the phase 3 CheckMate-816 clinical trial. CheckMate-816 is an international and open-label study investigating the combination of nivolumab plus platinum doublet chemotherapy versus platinum doublet chemo alone in early-stage NSCLC patients.
In this study, nivolumab plus platinum chemotherapy achieved 37% reduction in the risk of progression or death as compared to chemotherapy alone. Also, the median event-free survival was 31.6 months in comparison with 20.8 of chemotherapy alone. The interim analysis of the study shows that nivolumab plus chemotherapy showed statistically significant and clinically meaningful improvement in pathologic complete response in comparison with chemotherapy alone. 34% of those treated with experimental combination experienced grade 3/4 treatment-related adverse events when compared with 37% of chemotherapy alone. Also, a higher percentage of patients who received both has R0 resection.
Mark Awad, MD, PhD, CheckMate -816 study investigator and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, said, Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning.” “The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery. Today’s announcement reinforces the need to increase the rates of NSCLC screening and early detection, and for patients to discuss treatment options with their providers,” he added.
Nivolumab-based therapies have also shown efficacy for treatment of other cancers as well such as bladder cancer, melanoma and esophageal/gastroesophageal junction cancer etc. This new approval helps in expanding the role of Opdivo-based treatment in NSCLC so that patients may get benefit during the early course of their disease.
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