2024-05-08 13:30:06 ET
Summary
- NPMA decision on whether to approve Summit Therapeutics Inc.'s ivonescimab for the treatment of patients with EGFR-mutant metastatic non-squamous NSCLC following TKI progression is expected in Q2 of 2024.
- Interim analysis from phase 2 AK112-303 study, using ivonescimab for the treatment of NSCLC patients with TPS >1%, expected in Q2 of 2024.
- The global non-small cell lung cancer market is expected to reach $20 billion by 2033.
- Two ongoing phase 3 studies, known as HARMONi and HARMONi-3 are evaluating use of ivonescimab for the treatment of patients with NSCLC; The purpose of this is to eventually receive U.S. marketing approval of this drug for these patients.
Summit Therapeutics Inc. ( SMMT ) is gearing up for several catalysts for investors to look forward to in Q2 of 2024. One of them is the fact that its partner Akeso, Inc. (AKESF) is expecting a decision from regulators in China on potential approval of ivonescimab for the treatment of patients with EGFR-mutant metastatic non-squamous non-small cell lung cancer [NSCLC] who have progressed following treatment with a tyrosine kinase inhibitor [TKI]. This is not only important because it would bring about regulatory approval for the company, but also since this patient population is the same as what is being advanced in the phase 3 HARMONi trial. This is being done to eventually obtain U.S. marketing approval of ivonescimab for these EGFR-mutant metastatic NSCLC patients. Speaking of this phase 3 U.S. study, it is expected that enrollment for it will be completed in the second half of 2024....
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Summit: A Few Catalysts In Q2 Of 2024 To Carry The Tide