Summit Therapeutics discloses ivonescimab data, sees TEAEs in 61.5% of patients

In a regulatory 8-K filing earlier this morning, the company stated: “On May 24, 2024, the National Medical Products Administration, the regulatory authority in China responsible for providing marketing authorization for clinical drug candidates, has approved ivonescimab in combination with chemotherapy for use in patients with epidermal growth factor receptor mutated, locally advanced or metastatic non-squamous non-small cell lung cancer, or NSCLC, who have progressed after treatment with an EGFR tyrosine kinase inhibitor. This is the first approval for ivonescimab by any regulatory authority. The approval for ivonescimab was based on the trial called HARMONi-A (AK112-301), a single region Phase III clinical trial conducted in China comparing ivonescimab plus chemotherapy vs. placebo plus chemotherapy in the aforementioned setting. The trial was sponsored by our partner, Akeso, Inc. (Akeso). Data for this trial was generated and analyzed by Akeso. This data is planned to be released at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting during an oral presentation on Friday, May 31, 2024, scheduled for 4:57pm CT. On May 23, 2024, ASCO released abstracts for presentations to take place during the Annual Meeting. Included in these abstracts, was topline data associated with HARMONi-A. Notably, patients receiving ivonescimab plus chemotherapy experienced a median progression free survival (PFS) by independent radiology review committee of 7.06 months (95% CI: 5.85 – 8.74) as compared to 4.80 months (95% CI: 4.21 – 5.55) for those patients receiving chemotherapy alone (hazard ratio: 0.46; 95% CI: 0.34 – 0.62). Grade 3 or higher treatment emergent adverse events, or TEAEs, occurred in 61.5% patients receiving ivonescimab plus chemotherapy as compared to 49.1% patients receiving chemotherapy; the most common grade of 3 of higher in TEAEs were chemotherapy related adverse events. Additional data and context including, but not limited to, response rates, stable disease rates, progression free survival, overall survival, and safety is expected to be made available during ASCO’s Annual Meeting.” Shares of Summit Therapeutics are down 24% at $3.28 on the disclosure of grade 3 or higher treatment emergent adverse events in in 61.5% patients.