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Summit Therapeutics Partner Akeso Reports Positive Results from HARMONi-GI1 Study
Summit Therapeutics noted that its partner Akeso announced positive topline results from the randomized Phase III HARMONi-GI1 study (AK112-309) evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer. HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. Akeso reported that, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival compared to the durvalumab-based regimen. The study also met the key secondary endpoints of progression-free survival and objective response rate. Detailed results from this first readout of HARMONi-GI1, including safety and efficacy data, are expected to be presented at an upcoming medical congress and published in a peer-reviewed journal.
Summit Therapeutics Publishes HARMONi Trial Results
Summit Therapeutics announced the publication of primary analysis results from the global Phase III HARMONi clinical trial in The Lancet Oncology. In HARMONi, ivonescimab in combination with platinum-doublet chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to placebo plus platinum-doublet chemotherapy in patients with epidermal growth factor receptor-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer whose disease progressed following treatment with a third-generation EGFR tyrosine kinase inhibitor. The manuscript, titled "Ivonescimab plus chemotherapy versus placebo plus chemotherapy in patients with advanced EGFR-mutated non-small cell lung cancer after EGFR-TKI progression: a randomised, double-blind, multi-centre phase 3 trial," reports primary efficacy and safety results from the study conducted at 114 cancer centers and hospitals across Asia, Europe, and North America. The study was designed to evaluate whether ivonescimab plus chemotherapy could improve clinical outcomes in a setting where treatment options remain limited after progression on EGFR-directed therapy.
Summit Therapeutics Receives China Marketing Authorization for Ivonescimab in Lung Cancer
Summit Therapeutics announced receipt of marketing authorization in China from the National Medical Products Administration, or NMPA, for the use of ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer.
Summit Therapeutics Partner Akeso Receives Marketing Authorization in China
Summit Therapeutics (SMMT) noted that, on August 12, its partner Akeso (AKESF) announced receipt of marketing authorization in China from the National Medical Products Administration for the use of ivonescimab, a novel, potential first-in-class investigational bispecific antibody, in combination with chemotherapy for the first-line treatment of patients with advanced squamous non-small cell lung cancer. This marks the third NMPA-approved indication for an ivonescimab-containing regimen in China since the molecule's initial approval in May 2024. The latest NMPA approval is based on the results of the landmark HARMONi-6 trial, a single region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.
Summit Therapeutics Expands Ivonescimab Clinical Development to Bladder Cancer
Summit Therapeutics announced the expansion of its global registration-enabling clinical development program for the novel, potential first-in-class investigational bispecific antibody ivonescimab, into urothelial carcinoma, or bladder cancer, with the initiation of the global, multi-regional Phase II/III HARMONi-GU1 trial. "The initiation of HARMONi-GU1 marks another important step in the continued expansion of our global ivonescimab development program into additional tumor types where significant unmet need remains," said Dr. Maky Zanganeh, President and Co-CEO of Summit Therapeutics. "Because both angiogenesis and immune evasion are important features of urothelial carcinoma biology, we believe ivonescimab's tetravalent, intentionally-engineered PD-1 / VEGF bispecific mechanism offers a compelling scientific rationale for evaluation in bladder cancer. Despite recent progress in the treatment of locally advanced or metastatic urothelial carcinoma, many patients still face disease progression and poor long-term outcomes. We believe there remains an important opportunity to advance the standard of care with new treatment approaches that have the potential to deliver deeper, more durable responses and meaningfully extend survival."
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