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Summit Therapeutics Announces Opening of Global Phase II Study of Ivonescimab-Based Regimens in Advanced Clear Cell Renal Cell Carcinoma

SMMT
  • Summit Therapeutics announced the initiation of SMT112-216, a randomized, open-label, multiregional Phase II study evaluating ivonescimab in previously untreated advanced clear cell renal cell carcinoma (ccRCC).
  • The trial is conducted in collaboration with Akeso Inc. at clinical sites in the U.S. and China with a target enrollment of approximately 100 patients.
  • Participants will be randomized to receive ivonescimab combined with cadonilimab, ivonescimab combined with ipilimumab, ivonescimab monotherapy, or nivolumab plus ipilimumab as a standard-of-care comparator.
  • Ivonescimab is a novel, potential first-in-class investigational bispecific antibody targeting PD-1 and VEGF, developed by Akeso Inc.
  • The study aims to assess safety and efficacy of multiple ivonescimab-based regimens in the treatment-naïve incurable ccRCC setting.
  • This trial expands Summit's development program beyond lung cancer into genitourinary malignancies, complementing a separate collaboration with Arcus Biosciences for a different ivonescimab combination in ccRCC.
  • According to the American Cancer Society, an estimated 80,450 Americans will be diagnosed with kidney cancer in 2026, with a 19% five-year survival rate for metastatic disease.
  • Over 5,000 patients have been treated with ivonescimab in global clinical studies, with over 100,000 patients treated in China's commercial setting.
  • Sixteen Phase III studies are currently announced, ongoing, or completed for ivonescimab, including five Summit-sponsored global trials.
  • The HARMONi BLA submission for NSCLC was accepted by the FDA in January 2026, with a PDUFA goal date of November 14, 2026.
  • Five Phase III ivonescimab trials have reported positive data to date across NSCLC and biliary tract cancer settings.
  • Ivonescimab received marketing authorization in China in May 2024 but remains investigational in Summit's license territories including the U.S. and Europe.
  • Summit Therapeutics is a biopharmaceutical oncology company listed on the Nasdaq Global Market under the symbol SMMT.