Bank of Communications International has issued a research report maintaining its 'buy' rating and HK$175 target price for AKESO.
The report highlights that the head-to-head PD-1 monotherapy for ivonescimab achieved statistically positive results in both progression-free survival (PFS) and overall survival (OS). It is poised to potentially redefine the first-line treatment gold standard for squamous non-small cell lung cancer (sq-NSCLC) and unlock a global market potential valued in the tens of billions of US dollars.
Key Points from the Report
The OS results from the HARMONi-6 trial exceeded expectations. Interim OS analysis from the Phase III HARMONi-6 study, comparing ivonescimab plus chemotherapy against tislelizumab plus chemotherapy for first-line sq-NSCLC, was presented at the ASCO conference.
The results showed an OS hazard ratio (HR) of 0.66, with a p-value of 0.0017, which is below the pre-specified alpha of 0.0049. The median OS was 27.9 months versus 23.7 months for the control group, a figure close to results from the RATIONALE-307 study.
The 12-month and 24-month OS rates were 78.9%/64.7% for the treatment group versus 72.2%/48.6% for the control group. The survival benefit for the treatment group significantly increased over time, demonstrating an excellent long tail effect.
Key subgroup analysis indicated HR values of 0.64, 0.67, and 0.64 for PD-L1 TPS <1%, 1-49%, and ≥50% subgroups, respectively. This shows survival benefit advantages across all expression levels and validates that VEGF can extend OS in patients with low expression.
Researchers noted that as subsequent data matures, the median OS is expected to extend further.
Further Considerations on the Global HARMONi-3 Study
Regarding differences between age subgroups, the OS HR was higher for patients over 65 compared to those under 65 (0.93 vs. 0.43). This trend is consistent with prior PFS results (0.88 vs. 0.40). Researchers attributed this to greater baseline inconsistencies in older patients, such as target lesion size and brain metastasis status.
Furthermore, in other Phase III studies like HARMONi, HARMONi-A, and HARMONi-2, differences between age subgroups were minimal. The median baseline age in the KEYNOTE-407 study was 65 years, which is similar to the 64-year median age in the HARMONi-6 study. Therefore, it is anticipated that the median age in the HARMONi-3 study will also be around 65 years.
Concerning subsequent therapies, post-progression treatments in the HARMONi-6 study included immuno-oncology agents, targeted therapies, and antibody-drug conjugates. The control group had a higher proportion of patients receiving innovative therapies in later lines, suggesting the actual survival benefit improvement for the treatment group might be even greater.
In summary, the report maintains a cautiously optimistic stance on the HARMONi-3 study, advising close attention to the final PFS analysis and interim OS analysis expected in the second half of 2026.
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