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Efficacy and Tolerability of Zenocutuzumab in Advanced NRG1 Fusion-Positive Biliary Tract Cancer
Zenocutuzumab, a HER2xHER3 bispecific antibody, produced responses in 7 of 19 evaluable patients with advanced NRG1 fusion-positive cholangiocarcinoma — an overall response rate of 36.8% (95% CI 16.3-61.6) in the single-arm phase 2 eNRGy trial. Median duration of response was 7.4 months and median progression-free survival was 9.2 months (95% CI 3.9-11.1). Most treatment-related adverse events wer…
Precision oncology needs precision trial design: lessons from FGFR2 -rearranged cholangiocarcinoma
The phase III FIGHT-302 trial showed that the FGFR inhibitor pemigatinib improves progression-free survival and response rates versus first-line chemotherapy in patients with advanced FGFR2-rearranged cholangiocarcinoma, but the trial accrued slowly and closed early after chemoimmunotherapy became the new standard of care. Two similarly terminated trials underscore the challenges of evaluating tar…