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Ivonescimab in Combination with Chemotherapy Demonstrates Statistically Significant and Strongly Positive Results in First-Line Treatment of Squamous Non-Small Cell Lung Cancer (sq-NSCLC) vs. Tislelizumab in Combination with Chemotherapy
Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is both pleased and honored to announce that its global first-in-class 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 (sq-NSCLC). The Independent Data Monitoring Committee (IDMC) declared that the study had met its primary endpoint of progression-fre
About this update from Akeso, Inc.
[{"type":"text","content":"HONG KONG, April 22, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is both pleased and honored to announce that its global first-in-class 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 (sq-NSCLC). The Independent Data Monitoring Committee (IDMC) declared that the study had met its primary endpoint of progression-free survival (PFS) at the first pre-specified interim analysis. The results of HARMONi-6 study are both statistically significant and clinically meaningful.","length":716,"tagName":"p"},{"type":"text","content":"Detailed results from the HARMONi-6 study will be presented at an upcoming medical conference later this year.","length":110,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Data from the HARMONi-6 study show that, in the intention-to-treat (ITT) population, ivonescimab plus chemotherapy decisively beat tislelizumab plus chemotherapy in terms of progression-free survival (PFS)","length":215,"tagName":"p"}]},{"val":[{"type":"text","content":"The ivonescimab combination showed clinically meaningful PFS benefits in both PD-L1-positive and PD-L1-negative populations","length":123,"tagName":"p"}]},{"val":[{"type":"text","content":"The trial enrolled a total of 532 patients, approximately 63% of whom had centrally located squamous cell carcinoma, a distribution consistent with real-world patient populations","length":178,"tagName":"p"}]},{"val":[{"type":"text","content":"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","length":253,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":769,"olType":false},{"type":"text","content":"The HARMONi-6 study is ivonescimab's third Phase III clinical trial with positive results in lung cancer, highlighting that treatment with ivonescimab can overcome the limitations of bevacizumab in treating squamous-NSCLC.","length":226,"tagName":"p"},{"type":"text","content":"The HARMONi-6 study is also ...