China National Drug Administration (CNDA) has approved Bristol-Myers Squibb’s Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumour aberrations.

This is claimed to be China’s first and only programmed cell death (PD-1) inhibitor and is the only Immuno-Oncology (I-O) agent to show a superior survival benefit when compared with chemotherapy, based on data from the company’s  Phase 3 CheckMate -078 trial.

Guangdong General Hospital tenured director and Chinese Thoracic Oncology Group chair Professor Yi-Long Wu said:  “Lung cancer is a major public health issue in China, representing the highest incidence and mortality among all cancers in the country. With most lung cancer patients already at an advanced stage when diagnosed, prolonging survival is an important goal.

“The approval of Opdivo as the first I-O agent in China is a significant therapeutic advance and is great news for patients and clinicians alike, offering for the first time an I-O treatment option that is proven to extend survival in predominantly Chinese patients with previously treated NSCLC.”

This approval comes based on results from the Phase 3 CheckMate -078 trial of Opdivo against chemotherapy among patients with earlier treated NSCLC.

The trial was stopped last November as the independent Data Monitoring Committee concluded that Opdivo demonstrated superior overall survival compared with chemotherapy.

The application later got priority review by the Centre for Drug Evaluation in China.

“Opdivo is a global standard of care for previously treated NSCLC and we are proud to bring this foundational I-O treatment option to patients and physicians in China.”

Bristol-Myers Squibb executive vice president and chief commercial officer Murdo Gordon said: “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 I-O 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, with our shared commitment to moving quickly to help patients.”

CheckMate -078 is a Phase 3, multinational, randomised study comparing Opdivo with docetaxel to treat patients with Stage IIIb/IV NSCLC whose disease has progressed after platinum-based doublet chemotherapy.

The study was primarily conducted in China, with additional study locations in Hong Kong, Russia and Singapore.

The trial randomised 504 patients: 451 from China, 45 from Russia, eight from Singapore.