Announcement under Item 8.01 of Form 8-K
On May 24, 2024, the National Medical Products Administration (NMPA), 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 (EGFR) mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI).
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 (IRRC) 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 treatment emergent adverse events (TEAEs) occurred in 61.5% patients receiving ivonescimab plus chemotherapy as compared to 49.1% patients receiving chemotherapy; the most common grade ≥3 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.
The abstract can be found here (Abstract 8508): https://meetings.asco.org/2024-asco-annual-meeting/15779?presentation=232409#232409
Ivonescimab is not approved by any regulatory authority in Summit’s license territories, which includes the United States, as well as, Canada, Europe, and Japan.
The approval in China by the NMPA does not change Summit’s current clinical development plan. Summit continues to enroll patients in its two multi-regional Phase III clinical trials in the following indications:
- ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (“HARMONi”); and
- ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”).
The approval by the NMPA approval does not affect our ongoing development of the HARMONi and HARMONi-3 trials, nor does it change the timing or requirements of the trial process, or likelihood of approval, for ivonescimab in the United States, or Summit’s other license territories.
About Summit Therapeutics
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.
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Menlo Park, California, and Oxford, UK.
For more information, please visit https://www.smmttx.com and follow us on X (formerly Twitter) @summitplc.
Contact Summit Therapeutics:
Dave Gancarz
Chief Business & Strategy Officer
Nathan LiaBraaten
Senior Director, Investor Relations
Summit Forward-looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, potential acquisitions, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, and global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that the Company makes with the Securities and Exchange Commission. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward- looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The
Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
