G1 Therapeutics announces topline results from trial of trilaciclib
G1 Therapeutics announced positive topline data showing multi-lineage myelopreservation benefits in its randomized, double-blind, placebo-controlled Phase 2 trial evaluating trilaciclib in combination with topotecan as a treatment for 2nd-/3rd-line small cell lung cancer."This is the third positive Phase 2 trial of trilaciclib in small cell lung cancer showing significant reductions in the duration and occurrence of Grade 4 neutropenia, and lower rates of G-CSF administrations and red blood cell transfusions. Small cell lung cancer is difficult to treat, particularly in later lines of therapy, and trilaciclib has shown potential to improve outcomes for these patients," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. "We now have four randomized Phase 2 trials showing trilaciclib's multi-lineage myelopreservation benefits. We plan to meet with U.S. and European regulatory authorities in 2019 to discuss the totality of trilaciclib data. Data from this trial demonstrated that trilaciclib reduced clinically relevant consequences of myelosuppression versus placebo when administered in combination with topotecan. Achieved both primary endpoints after multiplicity adjustment: the trilaciclib arm demonstrated statistically significant reductions in both the duration of Grade 4 neutropenia in cycle 1. "We have observed positive, multi-lineage myelopreservation benefits across different tumor types, lines of therapy and chemotherapy regimens in four randomized Phase 2 trials," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "The totality of the data demonstrates trilaciclib's potential to become a standard of care with chemotherapy and improve patient outcomes."