Chinese Firm's New Cancer Drug Boosts Survival Rate by 34%

A China-originated cancer drug entered one of global oncology's most prominent stages this weekend, as Akeso's ivonescimab showed a significant survival benefit in a late-stage lung cancer trial presented at the American Society of Clinical Oncology annual meeting in Chicago, Illinois.

The Phase III HARMONi-6 study found that ivonescimab, a PD-1/VEGF bispecific antibody, plus chemotherapy reduced the risk of death by 34 percent compared with tislelizumab, a PD-1 inhibitor from BeOne Medicines, plus chemotherapy in first-line advanced squamous non-small cell lung cancer.

Median overall survival was 27.9 months in the ivonescimab arm, compared with 23.7 months in the control group. The data were presented at ASCO's Plenary Session and simultaneously published in The Lancet.

This presentation marked the first time a China-originated oncology drug had been selected for an ASCO Plenary Session in the society's 61-year history, a milestone for China's biotech industry as it seeks to move beyond fast-follow development.

The trial enrolled 532 patients with previously untreated advanced squamous non-small cell lung cancer. Ivonescimab also improved progression-free survival, with median progression-free survival of 11.1 months versus 6.9 months in the control arm.

"HARMONi-6 is the first global Phase III study in lung cancer to show statistically significant improvements in both overall survival and PFS compared with PD-1 plus chemotherapy. It is also the first in sq-NSCLC to achieve dual OS and progression-free survival success through a pre-specified hypothesis test," said Professor Shun Lu, principal investigator of HARMONi-6, director of the Lung Cancer Center at Shanghai Chest Hospital and a tenured professor.

The results add to growing industry interest in next-generation cancer immunotherapies designed to improve on first-generation PD-1 drugs such as MSD's (Merck) blockbuster Keytruda.

Ivonescimab is currently being evaluated in more than 30 clinical settings across multiple tumor types, including 15 Phase III trials, according to Hong Kong-listed Akeso.

"Today, we are thrilled to announce that ivonescimab plus chemotherapy has successfully challenged PD-1 plus chemotherapy, achieving both clinically meaningful and statistically significant improvements in overall survival (OS) and progression-free survival (PFS)," said Dr Yu Xia, founder, chairwoman, president and CEO of Akeso.

"Chinese patients with advanced sq-NSCLC are the first to benefit from this innovative, safe and highly effective global therapy."