Recently, Summit Therapeutics, a partner of Kangfang Biopharma, announced updated data from the first global multicenter Phase III clinical HARMONi study of Ivoside at the World Lung Cancer Conference (WCLC 2025):

OS HR = 0.78 (P = 0.0332), an improvement compared to the previous analysis results in May (HR = 0.79, p = 0.057);

The OS benefit was more significant in the North American population, with OS HR=0.70.

Ivoside (AK112) is a world-first PD-1/VEGF dual antibody developed by Kangfang Biopharmaceuticals.

Previously, the China National Medical Products Administration (NMPA) approved Ivoside for the treatment of EGFR-mutated nsq-NSCLC that progressed on EGFR-TKI treatment based on the HARMONi-A study, and approved Ivoside for the first-line treatment of PDL1-positive NSCLC based on the HARMONi-2 study.

The results of the HARMONi-A study showed that Ivoside therapy achieved the OS clinical endpoint and achieved clinically meaningful and statistically significant OS benefits.

The HARMONi study was an international, multicenter, phase III study that randomized approximately 38% of patients in North America and Europe.

At this WCLC meeting, Summit updated and announced clinical research data with a longer follow-up period in September 2025.

Research data showed that the HR for OS was reduced to 0.78 (95% CI: 0.62–0.98) with a median follow-up time of 13.7 months, P=0.0332, and the OS data showed a clear trend of improvement.

In the North American population, the mOS of the Ivoside group has not yet been reached, while that of the control group was 14.0 months, with a HR of 0.70.

In addition, in the primary analysis of progression-free survival (PFS) in May 2025, the HARMONi study reached the PFS study endpoint, with PFS achieving both clinical and statistical significance, with a PFS HR of 0.52. The Ivoside group reduced the risk of disease progression or death by 48% compared with the control group, with P<0.00001.

In terms of safety, the Ivoside group had good safety and tolerability, and no new safety signals were found.

Comparing the results of the HARMONi and HARMONi-A studies, Ivoside achieved consistent excellent clinical performance in both PFS and OS, proving that Ivoside has highly consistent efficacy and safety in cross-regional/cross-ethnic global clinical trials and Chinese clinical trials, further highlighting the global market value of Ivoside.

In addition to the first indication, Kangfang Bio is also conducting clinical research on multiple indications for Ivoside, including 8 registration/Phase III clinical studies for lung cancer alone. Other tumors include biliary tract cancer, triple-negative breast cancer and other cold and hot tumors. It is expected to become a super blockbuster comparable to pembrolizumab.

Source：https://news.yaozh.com/archive/46019.html