Akeso, Inc. (AKESF), a biopharmaceutical company, announced that its investigational oncology drug, Ivonescimab, achieved a statistically significant and clinically meaningful improvement in overall survival (OS) in the Phase III HARMONi-6 study as a first-line treatment for patients with advanced squamous non-small cell lung cancer (sq-NSCLC).
HARMONi-6
HARMONi-6 enrolled 532 patients, among whom 63% had centrally squamous tumours, 39% had programmed death-ligand 1 or PD-L1 TPS <1%, and 33.8% had multi-site metastases.
As of the data cut-off date of February 27, 2026, the median follow-up for the study was 21.36 months.
Key Highlights
As assessed by the Independent Data Monitoring Committee (IDMC), the study met its key secondary endpoint of overall survival (OS), demonstrating both a clinically meaningful and statistically significant benefit.
The study showed that Ivonescimab with chemotherapy reduced death risk by 34% in comparison to Tislelizumab with chemotherapy.
Median Overall Survival (OS) was 27.9 months in the Ivonescimab arm versus 23.7 months in the control arm.
The 12-month OS rate was 78.9% with Ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively.
In addition, Ivonescimab with chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS), with a median of 11.1 months, compared with Tislelizumab with chemotherapy, with a median of 6.9 months. In addition, Ivonescimab with chemotherapy maintained a favourable safety profile, comparable to that of tislelizumab plus chemotherapy, according to the firm.
Meanwhile, Treatment-related adverse events of grade 3 and higher occurred in 69.2% of patients in the Ivonescimab arm and 58.9% in the control arm.
In addition, the firm noted that rates of adverse events leading to treatment discontinuation or death were similar between arms.
The company featured its findings in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting held on May 31, 2026. In addition, the HARMONi-6 study results were also published in The Lancet, a leading medical journal.
Notably, Ivonescimab is currently being evaluated in more than 30 clinical settings across a wide range of tumours, including 15 Phase III trials, seven of which are head-to-head studies versus PD-1/PD-L1 therapies.
AKESF closed Friday's trade at $14.96, up 4.64% on the OTC Market.
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