Kang Fang Biology (09926): The contrast between Ivorian and chemotherapy, the results of the Harmoni-GI1 study on first-line treatment of advanced biliary tract cancer with Valliu combined chemotherapy were announced in 2026 ESMO

Zhitong Finance App News, Kang Fang Biotech (09926) issued an announcement. Harmoni-GI1/AK112-309 was selected as Late-Breaking Abstract (LBA) as an oral report for the 2026 ESMO Conference Chairman Forum. The report was presented by the main researcher, Academician Zhou Jian, director of Zhongshan Hospital affiliated to Fudan University.

Harmoni-GI1/AK112-309 (CTR20243164) is a randomized, controlled, double-blind, registered phase III clinical study to evaluate the contrast of evasil combined with chemotherapy for first-line treatment of advanced biliary tract cancer with Valliu combined with chemotherapy. A total of 682 subjects were enrolled. In August 2026, a pre-set mid-term analysis assessed by the Independent Data Monitoring Committee (IDMC) showed that the study reached the main end of overall survival (OS) and obtained statistically significant positive results with significant clinical benefits; the study also reached all key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR). The test results showed that:

Among the ITT crowd,

The median OS (MoS) in the Evosi group was 14.9 months, MoS in the Duvaliu group was 12.1 months, OS HR 0.75 (95% CI: 0.61 to 0.92), and the risk of death was reduced by 25% (P=0.0031)

The 12-month OS rate of the Evosi group vs Duvalier group was 59.7% vs 50.7%, respectively, and the 18-month OS rate was 44.0% vs 32.5%, respectively

The median PFS (mPFS) in the Evosi group was 8.4 months, MPFs in the Duvaliu group was 5.8 months, and the PFS HR was 0.61 (95% CI: 0.51 to 0.72), and the risk of disease progression or death was reduced by 39% (P<0.0001)

The ORR for the Ivorian group vs Duvalier group was 53.8% vs 32.5%, respectively, and the absolute difference (Delta) reached 21.3% (P<0.0001)

The overall safety of the evosil group was good, and the treatment drug exposure time was longer; the most common adverse event in all levels and grade 3/4 was hematologic toxicity, and no new safety signals were found.

Biliary tract malignancies are highly heterogeneous malignant tumors originating from the bile ducts and gallbladder, with poor prognosis. PD-1/L1 combination chemotherapy is an international first-line treatment for advanced biliary tract cancer, but overall survival benefits are still limited.

The groundbreaking data from the Harmoni-GI1 study strongly supports the potential of evosil combination chemotherapy as a new standard treatment for advanced biliary tract cancer. At the same time, as the first phase III study to obtain positive results in gastrointestinal tumors after receiving multiple phase III positive results in the field of lung cancer, this indicates that the breakthrough clinical value of Evosi is expanding from lung cancer to a wider range of solid tumors. Currently, the first-line treatment of biliary tract cancer with evossi combined with chemotherapy has been granted priority evaluation by the State Drug Administration.

In addition, Summit Therapeutics, an overseas partner of Evosi, has reached a cooperation with the US ECOG-Acrin cancer research team and has initiated a global multi-center registered phase II/III clinical EA2251 study comparing first-line chemotherapy with pabolizumab or duvalizumab combined chemotherapy in the first-line treatment of advanced biliary tract cancer.