Patients with resectable early-stage NSCLC treated with nivolumab plus chemotherapy before surgery achieve higher rates of pathologic complete responses versus patients receiving chemotherapy alone.
CheckMate-816 is an ongoing phase 3 randomized open-label multicenter clinical trial that is evaluating nivolumab (Opdivo) plus chemotherapy compared with chemotherapy alone as neoadjuvant treatment in patients with resectable NSCLC.1 The study is enrolling patients aged ≥18 years with resectable stage IB, II, or IIIA NSCLC, Eastern Cooperative Oncology Group performance status 0 or 1, pulmonary function capable of tolerating lung resection, and available lung tumor tissue.1 Patients are ineligible for CheckMate-816 if they have an autoimmune disease or had received previous treatment with immune checkpoint inhibitors.1
In the primary analysis, 358 patients were randomized to receive either nivolumab (360 mg intravenous) plus histology-based platinum doublet chemotherapy every 3 weeks for up to 3 doses, or platinum doublet chemotherapy every 3 weeks for up to 3 doses, followed by surgery.2 The primary end points of the trial are pathologic complete response and event-free survival. Key secondary end points include OS, major pathologic response, and time to death or distant metastases.1
In October 2020, it was announced that the CheckMate-816 trial met one of the primary end points, pathologic complete response.2 Significantly more patients treated with nivolumab plus chemotherapy before surgery demonstrated no evidence of disease in their resected tissue compared with patients treated with chemotherapy alone.2 The safety profile of nivolumab plus chemotherapy was described as consistent with previously reported studies in NSCLC.2
Positive findings in this phase 3 trial represent the first evidence that an immune checkpoint inhibitor–based combination offers superior efficacy compared with chemotherapy in the neoadjuvant setting for patients with resectable NSCLC.2 CheckMate-816 is ongoing in order to assess the second primary end point, event-free survival, as well as key secondary end points. Investigators expect to present results of the CheckMate-816 trial at an upcoming medical conference.2
1. Felip E, Brahmer J, Broderick S, et al. CheckMate 816: a phase 3 trial of neoadjuvant nivolumab plus ipilimumab or chemotherapy vs chemotherapy in early-stage NSCLC. J Thorac Oncol. 2018;13:S831-S832.
2. Bristol-Myers Squibb. Opdivo (nivolumab) plus chemotherapy shows statistically significant improvement in pathologic complete response as neoadjuvant treatment of resectable non-small cell lung cancer in phase 3 CheckMate-816 trial. October 7, 2020. https://news.bms.com/news/corporate-financial/2020/Opdivo-nivolumab-Plus-Chemotherapy-Shows-Statistically-Significant-Improvement-in-Pathologic-Complete-Response-as-Neoadjuvant-Treatment-of-Resectable-Non-Small-Cell-Lung-Cancer-in-Phase-3-CheckMate--816-Trial/default.aspx. Accessed November 8, 2020.