BOCOM International issued a research report maintaining a "Buy" rating on AKESO (09926) with a target price of HK$183. To date, no approved drugs have achieved statistically significant overall survival (OS) benefit in this indication, and the firm believes that ivonescimab achieving an HR of less than 0.8 with clearly separated curves is remarkable. Regardless of whether HARMONi receives approval, the latest data has once again demonstrated ivonescimab's potential to become a next-generation I/O cornerstone product. The firm maintains its prediction of ivonescimab's PoS-adjusted overseas peak sales of $16.5 billion. BOCOM International's main views are as follows:
**HARMONi Study's Latest OS Data Shows Improving Trends**
The latest data from ivonescimab's global Phase III HARMONi study (second-line EGFR) was presented at the WCLC conference: 1) After long-term follow-up, the OS HR improved to 0.78 (95% CI: 0.62-0.98) with a nominal P-value of 0.0332 (compared to the previously announced OS HR of 0.79 in May, 95% CI: 0.62-1.01, P=0.057). Survival benefit data in the North American population was particularly notable, with mOS: NR vs. 14.0 months, HR=0.70. 2) The long-term follow-up PFS HR was 0.57, essentially consistent with the 0.52 announced in May, with overall curves showing similar trends. 3) Survival benefits were similar between subjects with PD-L1<1% and PD-L1≥1% (PFS HR: 0.62 vs. 0.55), with PFS reaching statistical significance in almost all subgroups.
The company's partner Summit will submit a BLA application to the FDA for this indication, with the filing strategy expected to be determined within the coming weeks.
**Reduced but Persistent Uncertainty for HARMONi Overseas Approval, Focus on Subsequent Large Indications**
The firm believes this data shows improvement compared to previous results, with increased likelihood of U.S. approval. However, the firm believes continued attention should be paid to the following data trends and their potential impact on FDA decisions: 1) Both North American and overall Western populations showed OS benefit advantages in the treatment group after long-term follow-up (HR of 0.70/0.84 respectively), but have not yet reached statistical significance; 2) The long-term follow-up PFS HR for North America + Europe populations was 0.67 (95% CI 0.45-1.00), which is clinically meaningful but slightly different from the Asian population's 0.55 (95% CI 0.43-0.71). The firm recommends continued monitoring going forward.
Overseas clinical progress in other key indications also deserves continued attention, including: 1) HARMONi-3 (head-to-head vs. Keytruda + chemotherapy for 1L NSCLC) and HARMONi-7 (monotherapy head-to-head vs. Keytruda for 1L PD-L1 high-expressing NSCLC); 2) Summit plans to initiate Phase III studies in additional indications within the coming months, including lung cancer and non-lung cancer tumor types.