Akeso Inc. announced that its PD-1/VEGF bispecific antibody, ivonescimab, in combination with chemotherapy, has demonstrated strongly positive results in the Phase III clinical trial (AK112-306/HARMONi-6) for first-line treatment of advanced squamous non-small cell lung cancer or sq-NSCLC.
The Independent Data Monitoring Committee or IDMC declared that the study had met its primary endpoint of progression-free survival at the first pre-specified interim analysis. The results of HARMONi-6 study are both statistically significant and clinically meaningful, the company said in a statement.
Data from the HARMONi-6 study show that, in the intention-to-treat population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival.
The company noted that the ivonescimab combination showed clinically meaningful progression-free survival benefits in both PD-L1-positive and PD-L1-negative populations.
Ivonescimab demonstrated a favorable safety profile, with no new safety signals identified. The incidence of treatment related serious adverse events and the incidence of bleeding events of grade 3 or higher were comparable to those of the control group.
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