Summit Therapeutics' Ivonescimab BLA Accepted by FDA

By Chris Stiles • Thursday, January 29 12:34 • Permanent Link

Summit Therapeutics Inc. (NASDAQ: SMMT) has announced that the U.S. Food and Drug Administration (FDA) has accepted its biologics license application (BLA) seeking approval for Ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy.

The BLA was submitted based on the overall results of the phase III Harmoni trial, which evaluated Ivonescimab plus platinum-doublet chemotherapy compared to placebo plus platinum-doublet chemotherapy in patients with EGFR-mutated, locally advanced or metastatic NSCLC who were previously treated with a 3rd generation EGFR TKI.

Ivonescimab, known as SMT112 in Summit’s license territories, is a novel potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule.

Over 4,000 patients have been treated with Ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China. Summit began its clinical development of Ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional phase III clinical trials, Harmoni and Harmoni-3. In 2025, the company began enrolling patients in Harmoni-7 and expanded its phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in Harmoni-GI3.

Additionally, Akeso Inc. (HKEX code: 9926.HK) has had positive read-outs in three single-region (China) randomized phase III clinical trials, Harmoni-A, Harmoni-2, and Harmoni-6, for Ivonescimab in NSCLC, including a statistically significant overall survival benefit in Harmoni-A with a manageable safety profile in each study.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. It was initially approved for marketing authorization in China in May 2024 and granted fast track designation by the U.S. FDA for the Harmoni clinical trial setting.

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver-, and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. The company's shares are listed on the NASDAQ Global Market (symbol "SMMT"), and it is headquartered in Miami, Florida, with additional offices in Menlo Park, California, and Oxford, UK. Today the company's shares have moved -1.33% to a price of $17.04. Check out the company's full 8-K submission here.

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