Summit二季报重复披露ivonescimab临床进展，核心HARMONi数据已提前发布

Consistent Overall Survival Observed in Western, Asian Patients in Updated Analysis from Phase III HARMONi Study in EGFRm NSCLC Post-TKI Setting for Ivonescimab Plus Chemotherapy vs. Chemotherapy

Ivonescimab Plus Chemotherapy Achieves Statistically Significant and Clinically Meaningful Overall Survival Benefit in 1L Squamous NSCLC HARMONi-6 Trial Conducted in China, the First Phase III Head-to-Head Clinical Study to Demonstrate Superiority over an Anti-PD-(L)1 Antibody-Containing Regimen

HARMONi-3 Global Phase III 1L NSCLC Study: Squamous Cohort Final PFS Analysis Events Expected to Be Reached in Second Half of 2026 with Interim OS Analyses Planned; Non-Squamous Cohort PFS Events Expected to Be Reached in the First Half of 2027

Summit Closes Second Quarter with $690.7 Million in Cash and Investments

MIAMI--(BUSINESS WIRE)--
Summit Therapeutics Inc. (NASDAQ: SMMT) today reported its financial results for the second quarter and six months ended June 30, 2026 and provided an update on clinical and operational progress.
“The clinical momentum of ivonescimab continues to build, with two recent key data readouts that significantly bolster our development progress. At ASCO, the landmark HARMONi-6 results established the first head-to-head Phase III study in any tumor type to demonstrate a meaningful overall survival advantage over anti-PD-1 inhibitors in combination with chemotherapy, representing an important milestone for cancer patients and for the broader immuno-oncology field,” said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. “This was followed by updated overall survival data from the HARMONi trial, in which western patients replicated the survival benefit seen in Asian patients and further reinforces our confidence in the regional consistency of the efficacy results of ivonescimab.”
“These new data continue to demonstrate the differentiated profile of ivonescimab,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. “In HARMONi-6, we saw an outcome that underscores the potential impact of our bispecific PD-1 / VEGF program. Equally important, the updated HARMONi overall survival analysis provided additional evidence of consistency of efficacy outcomes across patient populations. We also presented encouraging Phase II colorectal cancer data at ASCO that adds to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific antibody across tumor types. We believe these results meaningfully strengthen the overall body of evidence supporting ivonescimab and provide important validation as we advance our global development program across multiple solid tumors.”
Clinical & Operational Updates
Clinical and 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:
Summit in-licensed ivonescimab from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023. In total, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has exclusive rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China.
Summit is developing ivonescimab in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), specifically conducting multiregional 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 were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI);
HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors;
HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression; and
HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC.

HARMONi
In January 2026, the U.S. Food and Drug Administration (FDA) accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The BLA was submitted based on the overall results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
In July 2026, Summit announced results of a new updated overall survival (OS) analysis from the HARMONi study, which showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study. These encouraging results provide further evidence of the geographic translatability of ivonescimab across the globe, including western patients from North America and Europe. In this new analysis, western patients increased their time on study, reaching a median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months. A hazard ratio of 0.76 was observed for the full ITT population; the same 0.76 hazard ratio was observed in both Asian and western patient subgroups, respectively, in this analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were observed. These results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical meeting.
HARMONi-3
Enrollment in both the squamous and non-squamous NSCLC cohorts of the global HARMONi-3 study is now complete. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for overall survival independent of PFS is planned for the first half of 2027. For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027. In a similar patient population to the squamous cohort of HARMONi-3, Akeso’s HARMONi-6 study evaluated ivonescimab plus platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, plus platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-6 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso with all relevant data exclusively generated and analyzed by Akeso.
Positive OS data for HARMONi-6 was presented in May 2026 as a part of the Plenary Session at the ASCO 2026 Annual Meeting; previously, positive PFS results for the HARMONi-6 trial were presented in October 2025 as part of the Presidential Symposium at the ESMO 2025 Annual Congress. In the recently presented HARMONi-6 analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in OS when compared to tislelizumab in combination with chemotherapy, with a hazard ratio of 0.66 (95% CI: 0.50, 0.87; p=0.0017). For both PFS and OS, a clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression. The HARMONi-6 results represent the first regimen to achi