Summit Therapeutics Inc. (NASDAQ: SMMT) (Summit or the Company) announced that on May 24, 2024, their partner Akeso Inc. (HKEX Code: 9926.HK) received marketing authorization in China for ivonescimab (SMT112) in combination with chemotherapy for the treatment of second-line and beyond (2L+) Epidermal Growth Factor Receptor-mutated non-small cell lung cancer (EGFRm NSCLC). This approval, granted by the National Medical Products Administration (NMPA), is based on the positive results from the HARMONi-A clinical trial.
Ivonescimab (SMT112) is an innovative therapeutic agent characterized as a first-in-class bispecific antibody. It exerts its effects through a dual mechanism by simultaneously blocking Programmed Cell Death Protein 1 (PD-1) and inhibiting angiogenesis. This dual action potentially enhances immunotherapeutic efficacy and reduces tumor vascularization.
Clinical Trial and Approval’
The HARMONi-A trial, a Phase III multi-center study conducted exclusively in China, served as the basis for the approval. Sponsored by Akeso Inc. the trial was carefully designed to evaluate the efficacy and safety of ivonescimab combined with chemotherapy in patients with EGFRm NSCLC who had progressed after first-line treatment.
The HARMONi-A study demonstrated promising results, showing a positive trend in overall survival (OS) for patients receiving the ivonescimab plus chemotherapy regimen. Although specific data and statistical significance were not detailed, the positive outcomes from this trial likely played a pivotal role in the NMPA’s approval decision.
Operational and Financial Updates’
Summit Therapeutics also announced its financial results and operational progress for the third quarter and nine months ending September 30, 2023. The Company reported advancements in its development of ivonescimab (SMT112) and continued to highlight the therapeutic’s potential given its unique mechanism of action. The bispecific nature of ivonescimab, combining PD-1 immune checkpoint blockade with anti-angiogenic effects, marks a novel approach in the treatment landscape of NSCLC.
Conclusion’
The NMPA’s approval of ivonescimab in combination with chemotherapy for 2L+ EGFRm NSCLC is a significant milestone for both Akeso Inc. and Summit Therapeutics. This decision underscores the positive clinical data from the Phase III HARMONi-A trial and showcases the potential of ivonescimab as an innovative treatment option for patients who have progressed after first-line therapy. Moving forward, the commercial launch and subsequent real-world data will be crucial in further establishing ivonescimab’s role in NSCLC management and its impact on patient outcomes.
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