Summit Therapeutics has treated the first US patient with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the Phase III HARMONi study of ivonescimab.
Designed with registration intent, the double-blinded, randomised, multiregional study will evaluate the safety and efficacy of ivonescimab, along with pemetrexed and carboplatin chemotherapies, against a placebo plus pemetrexed and carboplatin.
It will enrol more than 400 patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic NSCLC who have progressed after receiving a third-generation EGFR tyrosine kinase inhibitor osimertinib.
Summit will enrol subjects from the US, Canada and Europe while its partner Akeso will be responsible for enrolment in China, which started earlier.
Two primary endpoints of the study are overall survival and progression-free survival.
Summit co-CEO and president Dr Maky Zanganeh said: “The combined work of all involved in launching HARMONi, from the closing of the deal with Akeso to in-license ivonescimab three-and-a-half months ago, to ensuring alignment with the US FDA regarding study design, preparing clinical study sites to enrol patients, readying ivonescimab for US clinical trials, and all of the foundational work needed to launch a clinical study, including contracts, Institutional Review Boards’ approvals, and quality reviews, is significant.”
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A novel, potential investigational bispecific antibody Ivonescimab is available as SMT112 in the US, Canada, Europe, and Japan, and as AK112 in China and Australia.
More than 750 patients received treatment with ivonescimab in multiple clinical trials in China and Australia.