AKESO (09926) opened significantly higher today, rising 9.23% to HKD 129 at the time of reporting, with a turnover of HKD 362 million. The catalyst is the release of updated results from the Phase III HARMONi-6 study for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) with its PD-1/VEGF bispecific antibody, Ivonescimab, in combination with chemotherapy. The results were presented at the ASCO Plenary Session.
Compared to the control group of tislelizumab plus chemotherapy, the Ivonescimab group demonstrated a 34% reduction in the risk of death, achieving statistically significant overall survival (OS) benefit. The two-year survival rate was 64.7% versus 48.6% in the control group.
The HARMONi-6 trial enrolled 532 patients, with central squamous cell carcinoma accounting for approximately 63% of the cohort. Patients with PD-L1 TPS <1% comprised 39%, and those with multi-site metastases, including liver and brain metastases, constituted about 33.8%.
Key data highlights: The median OS (mOS) for the Ivonescimab group reached 27.89 months, compared to 23.69 months for the control group, an extension of nearly four months. The hazard ratio (HR) was 0.66 with a p-value of 0.0017, which is significantly better than the pre-specified statistical boundary of 0.0049.
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