CICC: Maintaining Kangfang Biotech's (09926) “outperforming the industry” rating is expected to reshape the 1L cervical cancer treatment pattern

The Zhitong Finance App learned that CICC published a report stating that it maintained its 2024 and 2025 profit forecasts for Kangfang Biology (09926) and maintained a “outperforming industry” rating. Based on the DCF model, the bank maintained a target price of HK$90.00. According to reports, on October 16, the company announced the detailed PFS and OS double positive results of the Phase III clinical study (AK104-303/COMPASSION-16) of cardonilizumab (AK104) compared placebo plus platinum-containing chemotherapy with/without bevacizumab to treat 1L of persistent, recurrent, or metastatic cervical cancer at the same time as the 2024 Global Conference and “The Lancet”.

The main contents of the CICC research report are as follows:

The data from COMPASSION-16 is positive and is expected to reshape the 1L cervical cancer treatment pattern. According to the company announcement, a total of 445 patients were enrolled in the study, with PD-L1 CPS<1 (negative expression) accounting for 26%, which is consistent with the expression level distribution of patients in the ITT group. MPFS 12.7m vs 9.1m, HR = 0.62; MoS NR vs 22.8m, HR = 0.64; 24-month OS rate 62.6% vs 48.4%, with significant differences between PFS and OS. Furthermore, as the follow-up period was further extended (as of April 30, 2024), the mPFs for the trial group and control group were updated to 13.3 months and 8.2 months (HR 0.62), and the clinical benefits were further highlighted.

The efficacy of AK104 was stable in people with different PD-L1 expression levels. According to the company announcement, stratification was carried out according to the patient's PD-L1 expression level, and the OS HR of the negative/low expression/high expression groups stabilized at 0.68-0.77. In particular, in the PD-L1 CPS<1 subgroup, COMPASSION-16 PFS and OS HR were 0.65 and 0.77, respectively, while KEYNOTE-826 was 0.95 and 0.87, respectively, indicating that AK104 was significantly superior to KeyTruda in this group of people. Based on this data, the bank believes that AK104 significantly improves the response of PD-L1 negative/low-expression cervical cancer to I/O treatment.

AK104 has significant OS benefits regardless of whether bevacizumab is used in combination with or without bevacizumab. Without the Bevar group, PFS and OS HR in COMPASSION-16 were 0.44 and 0.50, respectively, while KEYNOTE-826 was 0.69 and 0.67, respectively, indicating that AK104 was significantly superior to KeyTruda in people intolerant to Bevar. Cervical cancer patients are often contraindicated for the use of bevacizumab due to long-term radiotherapy toxicity such as radioproctitis/cystitis. Based on this data, the bank believes that AK104 is expected to fill the clinical gap in the treatment of cervical cancer patients who are intolerant of bevacizumab.

The overall safety of cardonil is excellent, and no new safety signals have been detected. The incidence of grade 3 and above AE in this clinical trial group and control group was 85.4% and 80.4%, respectively. There was no significant difference between the two; the incidence of grade 3 and above iRAE was 9.70% and 0.90%, respectively, and the safety was manageable.