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Key Highlights
- HARMONi Trial Enrollment: The trial successfully enrolled patients across North America, Europe, and China, marking a significant milestone in global clinical research.
- FDA Fast Track Designation: The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ivonescimab, expediting its review process for NSCLC treatment.
- Focus on Unmet Medical Needs: The HARMONi study addresses a patient population where existing PD-1 monoclonal antibodies have previously failed in clinical trials.
Summit Therapeutics Inc. (NASDAQ:SMMT) has announced the completion of patient enrollment in its HARMONi clinical trial, a pivotal Phase III study designed to evaluate the efficacy of ivonescimab in combination with platinum-doublet chemotherapy against a placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). This trial targets patients who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI).
Dr. Maky Zanganeh, Chief Executive Officer and President of Summit, expressed gratitude towards the investigators, site coordinators, and patients involved in the trial. He emphasized the significance of completing enrollment in what is described as the first global study for ivonescimab. The growing belief in the drug's potential to impact patient lives positively was highlighted as a motivating factor for the research team.
The HARMONi trial is particularly noteworthy as it aims to provide treatment options in a challenging clinical setting. Previous studies using PD-1 monoclonal antibodies for similar patient populations have not yielded successful outcomes. This underlines the urgent need for effective therapies for those suffering from advanced stages of NSCLC who have limited options after EGFR TKI therapy.
In a further advancement, the FDA’s Fast Track designation allows Summit to expedite the development process of ivonescimab. This designation facilitates more frequent interactions with the FDA, enabling a rolling review process for the Biologic License Application (BLA). Such provisions are designed to ensure that important new therapies reach patients more quickly, especially for conditions with unmet medical needs.
Robert W. Duggan, Chairman and Chief Executive Officer of Summit, remarked on the enrollment completion as a significant step towards their mission of providing innovative treatments for serious medical conditions. The dual primary endpoints of the HARMONi trial—progression-free survival and overall survival—indicate a comprehensive approach to evaluating ivonescimab's potential benefits for patients.
The HARMONi trial builds on findings from the earlier HARMONi-A study, which examined the same drug in a single-region trial sponsored by Akeso, Inc. The positive results from HARMONi-A contributed to Akeso receiving marketing authorization in China from the National Medical Products Administration (NMPA) in May 2024. The focus on progression-free survival as a primary endpoint in HARMONi-A, and the expansion to include overall survival in HARMONi, highlights the researchers' commitment to thorough clinical evaluation.
As Summit Therapeutics moves forward, the completion of enrollment in the HARMONi trial and the FDA’s Fast Track designation position the company favorably in the quest to improve treatment options for patients grappling with advanced NSCLC. The results of this trial may pave the way for significant advancements in the therapeutic landscape for this challenging disease.
