Leap Therapeutics (LPTX) announced positive initial data from Part B of the DeFianCe study evaluating sirexatamab in combination with bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer, or CRC, and initial data from Part C of the DisTinGuish study evaluating sirexatamab in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction, or GEJ and gastric cancer. The DeFianCe study showed 35% objective response rate, or ORR, in second-line CRC patients treated with sirexatamab plus bevacizumab and chemotherapy, vs. 23% ORR in the control arm; DKK1 levels highly correlated with clinical activity in CRC population; ORR benefit with sirexatamab observed across multiple potential Phase 3 CRC populations; sirexatamab plus bevacizumab and chemotherapy was well-tolerated, without additive toxicity to the standard of care. Preparations will begin for a registrational Phase 3 study in second-line CRC patients. The DisTinGuish Part C study in gastric cancer demonstrated activity in biomarker populations, but not the signal necessary to advance into Phase 3.
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