Unlock stock picks and a broker-level newsfeed that powers Wall Street.

Summit Therapeutics Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2025

In This Article:

Ivonescimab in Combination with Chemotherapy Achieves Statistically Significant Superiority in PFS vs. Tislelizumab (PD-1 Inhibitor) Plus Chemotherapy in First-Line Treatment of Patients with Advanced Squamous NSCLC in HARMONi-6 Study Conducted by Akeso in China

Enrollment Continues in Global Phase III Trial HARMONi-3 in First-Line Treatment of Patients with Metastatic NSCLC

Ivonescimab Receives Approval in China as Monotherapy for First-Line Treatment for Advanced NSCLC in Tumors with Positive PD-L1 Expression: Interim Overall Survival HR = 0.777 in China for HARMONi-2 Study Conducted by Akeso

Enrollment Has Begun in HARMONi-7 Global Phase III Trial in First-Line PD-L1 High, Metastatic NSCLC

Ivonescimab Collaborations Progressing in Multiple Solid Tumor Settings: MD Anderson Collaboration Begins Enrolling Two Clinical Trials; Additional ISTs Initiated and Enrolling

Leadership Team Advanced with Appointment of Robert LaCaze as Chief Commercial Officer

MIAMI, May 01, 2025--(BUSINESS WIRE)--Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on its operational progress for the first quarter ended March 31, 2025.

Operational & Corporate Updates

Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

  • In January 2023, we closed our Collaboration and License Agreement with Akeso Inc. (Akeso, HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 2,300 patients have been treated in clinical studies globally. Summit has rights to develop and commercialize ivonescimab in the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa while Akeso retains development and commercialization rights for the rest of the world, including China.

  • Since in-licensing ivonescimab, we have begun our development for ivonescimab in non-small cell lung cancer ("NSCLC"), specifically launching Phase III clinical trials in the following proposed indications:

    • HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)

    • HARMONi-3: Ivonescimab combined with chemotherapy in first-line metastatic NSCLC patients

    • HARMONi-7: Ivonescimab monotherapy in first-line metastatic NSCLC patients with high PD-L1 expression

  • In October 2024, we completed enrollment in our HARMONi clinical trial. We expect to disclose topline results from HARMONi in mid-2025. Enrollment continues in HARMONi-3 and the initial patients have been enrolled in the US in HARMONi-7.

  • On April 23, 2025, our partner, Akeso, announced that the HARMONi-6 Phase III clinical trial met its primary endpoint of progression-free survival (PFS) at a prespecified interim analysis conducted by an Independent Data Monitoring Committee. This trial evaluated ivonescimab combined with platinum-based chemotherapy against tislelizumab, a PD-1 inhibitor, with the same chemotherapy regimen in patients with locally advanced or metastatic squamous NSCLC, regardless of PD-L1 expression. Conducted in China by our partners at Akeso, the trial showed statistically significant and clinically meaningful improvement in PFS for ivonescimab plus chemotherapy. Akeso noted that no new safety signals were identified.

    • This study is the first known Phase III trial in NSCLC to show significant improvement over a PD-(L)1 inhibitor combined with chemotherapy in a head-to-head setting. Following the success of Akeso’s HARMONi-2 study, this is the second instance where ivonescimab-based regimens have demonstrated a significant PFS benefit in front-line treatment in NSCLC. The full data set for HARMONi-6 is planned to be presented at an upcoming major medical conference later this year.

  • On April 25, 2025, Akeso announced that ivonescimab was approved in China by the National Medical Products Administration (NMPA), the Chinese Health Authority, for a second indication based on the results of the HARMONi-2 trial. HARMONi-2 evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-2 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso.

    • As a part of the review of the supplemental marketing application submitted by Akeso seeking a label expansion of ivonescimab in China, the NMPA requested that Akeso perform an interim analysis of overall survival (OS). Akeso announced that the results of this interim overall survival analysis included a clinically meaningful, strongly positive trend represented by a hazard ratio of 0.777. The analysis was conducted at 39% data maturity, with a nominal alpha level of 0.0001.

  • Ivonescimab clinical trial collaborations with leading organizations continue to progress and expand evaluating ivonescimab in solid tumor settings outside of metastatic non-small cell lung cancer.

    • As part of our strategic collaboration with MD Anderson, two clinical trials sponsored by MD Anderson began enrolling this past quarter in cutaneous squamous cell carcinoma and glioblastoma.

    • We continue to support investigator-sponsored trials (ISTs) beyond our work with MD Anderson; two ISTs have begun enrolling at the Memorial Sloan Kettering Cancer Center and the Dana Farber Cancer Institute.

    • As we announced in February, our clinical trial collaboration with Pfizer will evaluate multiple antibody drug conjugates (ADCs) in combination with ivonescimab in unique solid tumor settings. The studies combining ivonescimab with Pfizer’s vedotin ADCs are planned to begin later this year. We plan to review the data generated from these clinical trials as a part of our consideration for advancing our clinical development for ivonescimab beyond non-small cell lung cancer.

  • In March, we further strengthened our leadership team with the appointment of Robert LaCaze as Chief Commercial Officer. Prior to joining Summit, Mr. LaCaze has held senior positions at major pharmaceutical companies including Executive Vice President and Head of the Oncology Strategic Business Unit overseeing the global oncology franchise at Bayer Healthcare and Senior Vice President and Head of Global Oncology at Bristol-Myers Squibb. He is a seasoned biopharmaceutical executive with over 30 years of extensive leadership experience in commercial strategy and execution. He has a proven track record of launching multi-billion-dollar products, building and growing blockbuster drug franchises, and expanding market presence for various oncology products.