G1 Therapeutics Inc (NASDAQ: GTHX) announced topline results from its pivotal Phase 3 PRESERVE 1 trial in patients with metastatic colorectal cancer.
PRESERVE 1 was designed to evaluate the efficacy and safety of trilaciclib in addition to triplet therapy with FOLFOXIRI + bevacizumab.
The trial achieved its co-primary endpoints related to severe neutropenia, showing clinically meaningful and statistically significant reductions in occurrences of severe neutropenia during induction (placebo=20% vs. trilaciclib=1%) and mean duration of severe neutropenia in Cycles 1 through 4 (1.3 days vs. 0.1 days).
In addition, patients receiving trilaciclib had a clinically meaningful reduction in the rate of chemotherapy-induced diarrhea compared to placebo.
Further, patients receiving trilaciclib experienced fewer chemotherapy dose reductions and delays.
Other secondary measures of myeloprotection also favored trilaciclib, including reductions in Febrile Neutropenia (placebo=5% vs. trilaciclib=0%) and ESA administration (7% vs. 3%).
However, early anti-tumor efficacy data favored the placebo arm versus trilaciclib, including overall response rate (ORR) and preliminary survival measures (61% and 50% ORRs, respectively).
Given the differential in these anti-tumor efficacy metrics and the low likelihood of achieving the progression-free survival (PFS) and overall survival (OS) endpoints, the company will discontinue the colorectal (CRC) trial.
Other clinical trials of trilaciclib in combination with different chemotherapies in patients with extensive-stage small-cell lung cancer and triple-negative breast cancer did not demonstrate this adverse survival signal.
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