The global overall intermediary analysis requested from Chinese health authorities shows a clinically significant positive trend favoring Ivonescimab compared to Pembrolizumab in the PD-L1 NSCLC advanced from the Harmoni-2 study by AKESO in China
The provisional analysis of Harmoni-2 shows an overall risk report of survival of 0.777 favoring Ivonescimab at 39% of data maturity, which implies a potential digital reduction of 22% of the death risk compared to pembrolizumababe
Ivonescimab monotherapy approved by NMPA in China for the first line PD-L1 NSCLC advanced positive
Miami, April 25, 2025-(Business Wire)-Summit Therapeutics Inc. (Nasdaq: Smmt) (“Summit,” “We,” or the “Company”) TODAY NOTED THAT AKESO, Inc. (AKESO, HKEX CODE: 9926.HK) Announced that Ivonescimab was approved by the Chinese Health The National Medical Products Administration (NMPA), for a second indication based on the results of the phase III clinical trial, Harmoni-2 or AK112-303. Harmoni-2 has evaluated the Ivonescimab of monotherapy against pembrolizumab in monotherapy in patients with non-small advanced or metastatic lung cancer locally advanced or metastatic (NSCLC) whose tumors have a positive expression of PD-L1. Harmoni-2 is a unique, multicenter, phase III study conducted in China sponsored by Akeso with all the relevant data generated, managed and analyzed by Akeso.
As part of the examination of the additional marketing request submitted by AKESO to request an expansion of label of Ivonescimab in China, the NMPA asked that Keso performs a provisional analysis of global survival (OS).
AKESO announced that the results of this provisional survival overall analysis included a clinically significant risk ratio of 0.777. The analysis was carried out 39% of data maturity, with a nominal Alpha level of 0.0001.
Last September, for the primary analysis of Harmoni-2, Ivonescimab monotherapy demonstrated a statistically significant improvement in the trial evaluation criterion, progression-free survival (PFS) by the independent (IRRC) radiological examination committee (in relation to Pembrolizumab monotherapy, reaching a risk ratio (RR) of 0.51 (95% of CI: 0.38 0.69;
“We are delighted to see that a test which was designed to test progression-free survival as the only main evaluation criterion demonstrates a clinically significant global trend at only 39% of data maturity,” added Robert W. Duggan, president and Co-Chef chief and Dr. MAKY ZANGANEH, executive officer of co-tour and president of Summit. “The clinically significant global trend underlines the opportunity for Ivonescimab to represent potential to be the next generation in Immunotherapy led by PD-1, and potentially make a significant difference in the lives of patients with lung cancer and other tumors.”
Summit currently registers patients in the Harmoni-7 study. Harmoni-7 is a multi-regional phase III clinical trial sponsored by Summit which assesses Ivonescimab monotherapy against pembrolizumab monotherapy in patients with locally advanced or metastatic NSCLC whose tumors have a positive expression of PD-L1. Harmoni-7 is currently scoring patients around the world and is carried out with the intention of the United States register and other regions in the license territories of the summit.
About Ivonescimab
Ivonescimab, known as SMT112 in the Summit license territories, in North America, South America, Europe, the Middle East, Africa and Japan, and as anK112 in China and Australia, is a new, first-rate potential in class, which combines the effects of immunotherapy via a PD-1 with the anti-angiogenesis effects associated with the fight against the VEGF Moldo. Ivonescimab displays a single cooperative link to each of its targets provided with a higher multiple affinity with PD-1 in the presence of VEGF.
This could differentiate the Ivonescimab because there is a potentially higher expression (presence) of PD-1 and VEGF in tumor tissue and tumor microenvironnement (MAT) compared to the normal fabric in the body. The tetravalent structure of Ivonescimab (four connection sites) allows higher greed (accumulated resistance of multiple bonding interactions) in TME (Zhong, et al, Sitc, 2023). This tetravalent structure, the new intentional design of the molecule, and bringing these two targets to a single bispecific antibody with cooperative bond qualities have the potential to direct ivonescimab to the tumor tissue compared to healthy tissues. The intention of this design, as well as a half-life of 6 to 7 days after the first dose (Zhong, et al, Sitc, 2023), is to improve the previously established efficiency thresholds, in addition to the side effects and safety profiles associated with these targets.
Ivonescimab was designed by Akeso Inc. (Hkex code: 9926.HK) and is currently engaged in multiple phase III clinical trials. More than 2,300 patients were treated with Ivonescimab in clinical studies worldwide.
Summit began its clinical development of Ivonescimab in non-small cell lung cancer (CBNPC), starting registration in 2023 in two multi-regional phase III, Harmoni and Harmoni-3 clinical trials, and the company began to activate clinical trial sites in the United States for Harmoni-7.
Harmoni is a phase III clinical trial which intends to assess IVOSCIMAB combined with chemotherapy compared to placebo chemotherapy plus in patients with non -squamous EGFR NSCLC, locally or metastatic advanced (EG, OSIMERTINIB). The registration in Harmoni was completed in the second half of 2024, and the first line results should be announced in the middle of this year.
Harmoni-3 is a phase III clinical trial which is intended to assess the IVOSCIMAB combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with metastatic, dizzy and non-squamous first-line NSCLC.
Harmoni-7 is a phase III clinical trial which aims to assess the monotherapy of Ivonescimab monotherapy compared to monotherapy by pembrolizumab in patients with first line metastatic NSCLC whose tumors have a high expression of PD-L1.
In addition, Akeso recently had positive readings in three randomized clinical trials of phase III randomized for Ivonescimab in NSCLC: Harmoni-A, Harmoni-2 and Harmoni-6.
Harmoni-A was a phase III clinical trial which assessed IVOSCIMAB combined with chemotherapy compared to Placebo Plus chemotherapy in NSCLC non-squamous patients mutated by EGFR, locally advanced or metastatic that has progressed after treatment with a TKI EGFR.
Harmoni-2 is a phase III clinical trial evaluating Ivonescimab monotherapy against pembrolizumab in monotherapy in patients with locally advanced or metastatic NSCLC whose tumors have a positive expression of PD-L1.
Harmoni-6 is a phase III clinical trial evaluating Ivonescimab in combination with platinum-based chemotherapy compared to tislelizumab, anti-PD-1 antibodies, in combination with platinum chemotherapy in patients with a locally advanced or metastatic square or metastatic dirt.
Ivonescimab is investigation therapy that is not approved by any regulatory authority in the Summit license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab obtained the rapid designation by the US Food & Drug Administration (FDA) for the Harmoni clinical trial.
About Summit Therapeutics
Summit Therapeutics Inc. is a biopharmaceutical company in oncology focused on the discovery, development and marketing of medicinal therapies for patients, doctors, caregivers and companies intended to improve quality of life, increase potential lifespan and resolve serious medical needs not followed.
Summit was founded in 2003 and our actions are listed on the global NASDAQ market (“SMMT” symbol). We have its headquarters in Miami, Florida, and we have additional offices in Menlo Park, California and Oxford, the United Kingdom.
For more information, please visit https://www.smmttx.com and follow us on x @Smmt_tx.
Summit prospective statements
Any statements in this press release about the company’s future expectations, plans and prospects, included 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 anticipate 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 Availabibility of clinical test data, potential submission of requests for marketing approval, potential acquisitions, statements on Disclosed previously disclosed (“ATM” ATM “),” continues “” Project “,” should “,” target “,” would be “, and similar expressions constitute prospective declarations within the meaning of the 1995 law on private titles in 1995. Underlying data in connection with the development and commercialization activity for ivonescimab, the outcome of discussions Authorities, Including the Food and Drug Administration, the Ucertainties inherent in the Initiation of Future Clinical Trials, Available and Timing of Data from Nail and Future Clinical Trials, The Results of Such Trials, and Their Success, Global Public Health Crises, That May Affect Timing and Status of Operations 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, Whhet Business Development Oppands to Expand the Company’s Pipeline of Drug Candidates, include Without Limitation, Through Potential Acquisitions of, and/Or Collaborations With, Other Entities Occur, Expectations for Regulatory Approacals, Laws and Regulations Affecting Government Contracts and Funding Awards, Availabity of sufficient financing for predictable and unpredictable operating expenses and the requirements in terms of capital and other. In the “Risk factors” section of deposits that the company makes with the Securities and Exchange Commission. Any change in our current trials could lead to delays, assign our future expenses and add uncertainty to our marketing efforts, as well as to affect the probability of successful completion of the clinical development of Ivonescimab. Consequently, readers should not rely excessively with regard to prospective declarations or information. In addition, all the prospective declarations included in this press release represent the opinions of the company only on the date of this press release and must not be invoked as representing the opinions of the company from any later date. The company specifically declines any obligation to update the prospective instructions included in this press release.
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