The P-III trial (PRESERVE 1) evaluating trilaciclib + FOLFOXIRI and Avastin vs PBO in 326 patients. The trial met its co-primary EPs i.e., reduction in the occurrence of sev. neutropenia during induction (1% vs 20%) & duration of sev. neutropenia in cycles 1-4 (0.1 vs 1.3 days)
Clinical reduction in the rate of CT-induced diarrhea, incl. a 50% & 30% reduction in the rate of grade 3/4 & any grade diarrhea, respectively over PBO, patients experienced fewer CT dose reductions & delays while the secondary measures of myeloprotection also favored trilaciclib, incl. reductions in Febrile neutropenia (0% vs 5%) & ESA administration (3% vs 7%)
Early anti-tumor efficacy data, incl. ORR (50% vs 60%) & preliminary measures of survival favored the PBO, the company has decided to discontinue its research due to a lack of responses
Ref: Globenewswire | Image: G1 Therapeutics
Related News:- G1 Therapeutics and Boehringer Ingelheim Collaborate to Co-Promote Trilaciclib for Small Cell Lung Cancer in the US and Puerto Rico
