Nivolumab Gains First Indication in China for NSCLC

Last week, Bristol-Myers Squibb (BMS) announced that the China National Drug Administration approved the country’s first immuno-oncology and first PD-1 therapy, nivolumab (Opdivo), for the treatment of patients with locally advanced or metastatic non—small cell lung cancer (NSCLC).

The approval was based on results from the phase 3 CheckMate-078 trial of Opdivo compared with chemotherapy among patients with previously treated NSCLC. The findings of the trial were presented at the American Association for Cancer Research Annual Meeting, and later the Center for Drug Evaluation in China granted it priority review.

CheckMate-078 study is a multinational, randomized study that compared nivolumab with docetaxel in the treatment of patients with stage IIIB/IV NSCLC whose disease progressed after platinum-based doublet chemotherapy. The trial randomized 504 patients without EGFR mutations and with both squamous and non-squamous NSCLC, across PD-L1 expression status of <1% and ≥1%, to receive either 3 mg/kg of intravenous nivolumab every 2 weeks (n = 338) or 75 mg/kg of docetaxel intravenously every 3 weeks (n = 166).

In the nivolumab arm, median overall survival (OS) was 12 months versus 9.6 months in the chemotherapy arm. Improved OS with nivolumab versus chemotherapy was demonstrated in patients with squamous and non-squamous tumors, as well as across all predefined subgroups based on tumor PD-L1 expression level.

“Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country,” said Yi-Long Wu, director of Guangdong General Hospital in a statement.

In fact, lung cancer is the most common tumor type in China, with about 733,000 new diagnoses each year as of 2015, according to a report. Comparatively, according to the American Cancer Society’s estimate for 2018, the United States only reported 234,000 new diagnoses.

“With approvals in more than 60 countries, Opdivo is a global standard of care for previously treated NSCLC, and we are proud to bring this foundational [immuno-oncology] treatment option to patients and physicians in China. We look forward to continuing to work together with the CNDA to usher in additional healthcare innovations in China, without shared commitment to working quickly to help patients,” said Murdo Gordon, executive vice president and chief commercial officer of Bristol-Myers Squibb in a statement.