Home Business Bio Tech FDA Setback Hits Akeso’s...

FDA Setback Hits Akeso’s Lung Cancer Drug Approval

Bio Tech

Business Honor
02 June, 2025

Akeso’s lung cancer drug ivonescimab faces FDA setback after U.S. trial fails to show overall survival benefit.

Chinese biotech firm Akeso, hailed as a rising star in oncology, has faced a regulatory roadblock in the U.S. after its lung cancer drug ivonescimab failed to meet a critical efficacy benchmark. The development sent Akeso’s shares plunging 11.6% to HK$73.65 on Monday, while its U.S. partner Summit Therapeutics saw its Nasdaq-listed shares tumble over 30% on Friday.

Ivonescimab, an innovative PD-1/VEGF bispecific antibody, targets non-small cell lung cancer (NSCLC) patients with genetic mutations that drive abnormal tumor growth. Although the drug showed encouraging progression-free survival (PFS) data in global trials, it fell short of demonstrating a statistically significant overall survival (OS) benefit – a key requirement by the U.S. Food and Drug Administration (FDA) for marketing approval.

This casts some shadow on the drug’s approval outlook in the U.S., said Zhang Jialin, head of China healthcare research at Nomura, who described the data as largely comparable with results from Akeso’s China-based trial, but insufficient by current FDA standards.

In March, The Lancet published phase-three trial results from China showing that ivonescimab doubled the PFS compared to Merck’s Keytruda, the current global leader in cancer immunotherapy. The results had sparked widespread optimism in China, likened to the nation’s AI breakthrough by DeepSeek.

Akeso is still a major force in China's biotech industry in spite of the setback. In addition to investigating combination therapies, it is still conducting trials for other cancers, such as colorectal and squamous carcinoma. Robert Duggan, CEO of Summit, underlined that there may be a chance for future reexamination because none of the currently approved treatments have demonstrated OS significance in this subtype of NSCLC.

Under a contract worth up to US$5.5 billion, Summit owns the license for ivonescimab in the US, Europe, Canada, and Japan, while Akeso maintains rights in China and emerging markets.