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Summit Therapeutics Announces First Patient Treated in Phase III HARMONi Clinical Trial Evaluating Ivonescimab (SMT112)
Phase III Study Designed to Establish the Effect of Ivonescimab in Lung Cancer Patients Whose Tumors Progressed after EGFR-TKI Therapy MENLO PARK,
About this update from Summit Therapeutics Inc.
[{"type":"text","content":"\nPhase III Study Designed to Establish the Effect of Ivonescimab in Lung Cancer Patients Whose Tumors Progressed after EGFR-TKI Therapy\n\n\n MENLO PARK, Calif.--(BUSINESS WIRE)--\nSummit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study.\n\n\nHARMONi is a Phase III multiregional, randomized, double-blinded study. The study will evaluate the efficacy and safety of ivonescimab combined with 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 a third-generation EGFR tyrosine kinase inhibitor (TKI) such as osimertinib. Specifically, the study will compare ivonescimab combined with pemetrexed and carboplatin chemotherapies against a placebo plus pemetrexed and carboplatin. The study, designed with registration intent, has two primary endpoints: overall survival (OS) and progression-free survival (PFS).\n\n\nHARMONi, also referred to as AK112-301, will enroll patients from the United States, Canada, Europe, and China in conjunction with our high-achieving partner, Akeso Inc. (Akeso). Akeso is responsible for enrollment in China, which has previously commenced; Summit is responsible for enrollment in the United States, Canada, and Europe. Over 400 patients are planned to be enrolled in the study.\n\n\n“Advanced or metastatic non-small cell lung cancer is such a devastating diagnosis for patients,” said Ian Anderson, M.D., Medical Oncologist at Providence Medical Foundation, who treated the first patient in HARMONi. “While we are making great strides as a medical community to improve the quality and duration of patients’ lives, there remains significant room for improvement in the treatment options available for these patients. In particular, for patients with an EGFR-mutated tumor whose tumor has progressed after their initial TKI therapy, there are limited options. We are particularly excited to evaluate the potential of ivonescimab in the HARMONi study to make a meaningful impact on the lives of these patients facing this difficult disease.”\n\n\nIvonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a...