Key Takeaways:
Ivonescimab cut the risk of death 34 percent in a Phase III trial, winning Akeso's drug a third NMPA approval for squamous lung cancer.
"By outperforming PD-1 plus chemotherapy, this regimen has rewritten the gold standard of care and represents a landmark advance in the treatment of lung cancer," Shun Lu, principal investigator of HARMONi-6 and director of oncology at Shanghai Chest Hospital, said.
China's National Medical Products Administration approved ivonescimab (依達方) plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer, Akeso said Wednesday. The decision rests on HARMONi-6, a 532-patient Phase III study in which the PD-1/VEGF bispecific antibody improved median overall survival to 27.9 months from 23.7 months with tislelizumab plus chemotherapy (hazard ratio 0.66; 95% CI 0.50-0.87; P=0.0017). Median progression-free survival reached 11.1 months versus 6.9 months (HR 0.60; P<0.0001), and the 24-month survival rate was 64.7 percent versus 48.6 percent.
The approval is the third for an ivonescimab-containing regimen in China since the molecule's initial nod in May 2024, following uses in EGFR-mutated non-squamous NSCLC after EGFR TKI failure and PD-L1-positive advanced NSCLC. It fills a treatment gap left by bevacizumab, which is not approved in squamous disease, and extends Akeso's reach in China's lung cancer market. Grade 3 or higher treatment-related adverse events occurred in 69.2 percent of ivonescimab patients versus 58.9 percent in the control arm, with comparable rates of events leading to discontinuation or death.
Shares of Akeso (HK: 9926) rose 0.2 percent. The company is running 16 registrational and Phase III trials across tumor types, while partner Summit Therapeutics (NASDAQ: SMMT) is enrolling global studies including HARMONi-3, which tests ivonescimab against pembrolizumab plus chemotherapy in first-line metastatic NSCLC. Summit's HARMONi trial in EGFR-mutated disease carries a US Food and Drug Administration decision date of Nov. 14.
The approval gives Akeso a third reimbursed lung-cancer indication and strengthens ivonescimab's case as a cornerstone immunotherapy as it moves into global markets. Investors will watch Summit's US filing for HARMONi, where a positive decision would open the drug's largest addressable market.
This article is for informational purposes only and does not constitute investment advice.
