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Ivonescimab in Combination with Chemotherapy Approved in China by NMPA for 2L+ EGFRm NSCLC based on HARMONi-A Clinical Trial: Positive Trend Observed in Overall Survival towards Ivonescimab Plus Chemotherapy
Separate & Distinct from HARMONi-2 Announcement, HARMONi-A Showed Clinically Meaningful and Statistically Significant Benefit: PFS Hazard Ratio of 0.46 For
About this update from Summit Therapeutics Inc.
[{"type":"text","content":"\n Separate & Distinct from HARMONi-2 Announcement, HARMONi-A Showed Clinically Meaningful and Statistically Significant Benefit: PFS Hazard Ratio of 0.46\n\n\nFor Subset of Patients Previously Receiving 3rd Generation EGFR-TKI: PFS Hazard Ratio of 0.48\n\n\n5.6% Treatment Discontinuation of Ivonescimab due to Adverse Events vs. 2.5% Treatment Discontinuation of Placebo\n\n\nHARMONi-A was Featured in Oral Presentation at ASCO 2024 on May 31, 2024\n\n\nConference Call to be Held at 8:00am ET on Monday, June 3, 2024\n\n\n MIAMI--(BUSINESS WIRE)--\nSummit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) announced that, on May 24, 2024, our partner, Akeso Inc. (Akeso, HKEX Code: 9926.HK), received marketing authorization in China from the National Medical Products Administration (NMPA). The approval is based on the positive dataset associated with HARMONi-A, a single region, multi-center, Phase III study conducted in China sponsored by Akeso with data generated and analyzed by Akeso.\n\n\nHARMONi-A evaluated ivonescimab combined with platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI) against placebo plus platinum-doublet chemotherapy. This is a clinical setting with a patient population where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials. The Phase III HARMONi-A study provides further evidence supporting the differentiated mechanism of action of ivonescimab, a PD-1 / VEGF bispecific antibody evidencing cooperative binding characteristics.\n\n\nThis data and trial are separate and distinct from the Phase III HARMONi-2 trial in locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%), which was covered in a separate announcement. For clarity, the data in this release is with respect to the HARMONi-A trial.\n\n\nClinically Meaningful Efficacy\n\n\nProgression free survival (PFS), the primary endpoint of the study, was significantly improved in the ivonescimab plus chemotherapy arm (HR 0.46; 95% CI: 0.34 – 0.62; p10% Incidence:\n\n\n\n\n\n\n \n\n\n\n\n\n\n\n\nGr 3+ WBC Count Decrease\n\n\n\n\n\n\n19.9%\n\n\n\n\n\n\n16.8%\n\n\n\...