CICC has released a research report maintaining its earnings forecasts for AKESO (09926) for 2026 and 2027. The firm reiterates its Outperform rating and, based on a DCF model, sustains a target price of HK$184.00, implying a potential upside of 55.8%.
Key Developments and Analysis
On June 1st, the company presented overall survival data from the Phase III HARMONi-6 trial at ASCO. The trial compared AK112 combined with chemotherapy versus tislelizumab combined with chemotherapy for first-line squamous non-small cell lung cancer. The median OS was 27.9 months versus 23.7 months, with a hazard ratio of 0.66. This indicates AK112 combined with chemotherapy significantly reduces the risk of death by 34% compared to the tislelizumab regimen.
HARMONi-6 OS Data Redefines First-Line Lung Cancer Treatment
According to the company's announcement, the trial enrolled 532 patients. The patient distribution, with 63% having central squamous cell carcinoma and 33.8% with metastatic tumors, aligns with real-world demographics. At a median follow-up of 21.36 months, the median OS was 27.9m vs. 23.7m. The 12-month OS rate was 78.9% vs. 72.2%, and the 24-month OS rate was 64.7% vs. 48.6%. The separation of the OS curves began at six months and became more pronounced with longer follow-up. Across all patient subgroups, regardless of PD-L1 expression levels, the OS hazard ratio was below 0.7. In the PD-L1 TPS≥50% population, the OS HR was 0.64, showing a more significant benefit than the PFS HR of 0.71, demonstrating AK112's pronounced long-term survival tail effect.
Positive Implications for the HARMONi-3 Trial
The analysis suggests the HARMONi-6 results provide positive extrapolation data for the ongoing HARMONi-3 trial for three primary reasons. Firstly, AK112's median OS of 27.89 months notably surpasses the global median OS of 16-17 months for Keytruda (pembrolizumab) as seen in the KEYNOTE-407 study. Secondly, the strong HR of 0.66 in HARMONi-6 provides a substantial buffer, meaning HARMONi-3 would only need to achieve an OS HR below 0.8 to outperform Keytruda. Thirdly, a review of clinical data for Keytruda, tislelizumab, and osimertinib shows that while differences between global and Chinese/Asian subgroup data are common, the direction of benefit for median PFS and OS HR is generally consistent across regions.
Broad Anti-Tumor Potential Beyond NSCLC
AK112 has demonstrated promising data across multiple tumor types. In second-line small cell lung cancer combined with irinotecan, it achieved an objective response rate of 61.7% and a median PFS of 9.8 months, showing favorable comparative data. For locally advanced head and neck squamous cell carcinoma combined with chemotherapy, it achieved a 100% ORR, indicating strong tumor shrinkage and potential for conversion surgery. In first-line MSS metastatic colorectal cancer combined with mFOLFOX6, it achieved a 70.8% ORR, with a 9-month PFS rate of 76.1% in the high-dose group, supporting the potential success of a Phase III trial.
Investment Risks to Consider
Potential risks include clinical trial data falling short of expectations and delays in the progress of the research and development pipeline.
Comments