The phase III study CheckMate -078, evaluating nivolumab versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC), was stopped early because the independent Data Monitoring Committee (DMC) concluded that the study met its primary endpoint, demonstrating superior overall survival (OS) in patients receiving nivolumab compared with the control arm.
The safety profile of nivolumab was consistent with previously reported studies in solid tumours.
CheckMate -078 is a Phase 3, multinational, randomized study comparing nivolumab with docetaxel in the treatment of patients with Stage IIIb/IV non-small cell lung cancer (NSCLC) whose disease has progressed after platinum-based doublet chemotherapy.
The study was conducted primarily in China, with additional study sites in Hong Kong, Russia and Singapore.
The trial randomized 504 patients with both squamous and non-squamous NSCLC (451 from China, 45 from Russia, 8 from Singapore) to receive either nivolumab 3mg/kg intravenously every two weeks or docetaxel 75 mg/m2 every three weeks intravenously until documented disease progression or unacceptable toxicity.
The primary endpoint is overall survival (OS).
Secondary endpoints include objective response rate (ORR), progression-free survival (PFS), time to treatment failure (TTF), efficacy across subgroups, rates of treatment-related adverse events (AEs) and rate of disease-related symptom deterioration measured by the lung cancer symptom scale (LCSS).
Bristol-Myers Squibb submitted a Biologics License Application (BLA) for Opdivo to the China Food and Drug Administration (CFDA) for the proposed indication of previously treated NSCLC, which has been accepted by the CFDA.
Prof. Yi-Long Wu, a tenured professor of the Guangdong Lung Cancer Institute and the Guangdong General Hospital, chair of the Chinese Thoracic Oncology Group (CTONG) and the principal investigator of CheckMate -078, commented, “It is exciting to see that the Phase 3 CheckMate -078 study met its primary endpoint early, which confirmed, for the first time, a superior overall survival benefit with a PD-1 inhibitor, nivolumab, in Chinese patients, compared with the standard treatment, docetaxel. Based on the topline results, nivolumab has the potential to become the first Immuno-Oncology (I-O) treatment approved for previously treated lung cancer patients in China, and I hope that Chinese patients with NSCLC can benefit from this groundbreaking I-O treatment as early as possible.”