Summit Therapeutics to Submit BLA for Ivonescimab

By Philip Seaworth • Monday, October 20 15:40 • Permanent Link

Summit Therapeutics Inc. has reported its financial results and operational progress for the third quarter and nine months ended September 30, 2025. The company plans to submit a Biologics License Application (BLA) in the fourth quarter of 2025 for Ivonescimab based on the results of the Harmoni global Phase III study. This follows the positive results of the multiregional Phase III study, including consistent data across regions.

Since in-licensing Ivonescimab from Akeso Inc. in January 2023, over 3,000 patients have been treated with Ivonescimab in clinical studies globally. The company has rights to develop and commercialize Ivonescimab in several regions, including the United States, Canada, Europe, Japan, Latin America, the Middle East, and Africa.

The company also announced the expansion of its Phase III clinical development program into colorectal cancer (CRC) with the planned initiation of the global Phase III Harmoni-GI3 trial. The trial will evaluate Ivonescimab plus chemotherapy compared to bevacizumab plus chemotherapy as first-line therapy in patients with unresectable metastatic CRC.

Summit has amended the protocol for the Harmoni-3 study in order to separate the statistical analysis of the primary endpoints by histology. The primary endpoints for this study are progression-free survival (PFS) and overall survival (OS).

In the Harmoni-6 study conducted in China, Ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in the primary endpoint, PFS, compared to tislelizumab in combination with chemotherapy. The overall response rate and duration of response were higher in patients treated with Ivonescimab plus chemotherapy.

The company also announced an update to its Harmoni-3 Phase III clinical trial, where it plans to separate the statistical analysis of the primary endpoints by histology and evaluate Ivonescimab plus chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous and non-squamous non-small cell lung cancer (NSCLC).

Following these announcements, the company's shares moved -4.46%, and are now trading at a price of $20.99. If you want to know more, read the company's complete 8-K report here.

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