G1 Therapeutics Announces Positive Myelopreservation Data

G1 Therapeutics (Nasdaq:GTHX), a clinical-stage oncology company, today announced positive topline data from its randomized, double-blind, placebo-controlled Phase 2 trial evaluating trilaciclib in combination with chemotherapy and the checkpoint inhibitor Tecentriq (atezolizumab) as a treatment for 1L SCLC.

As quoted in the press release:

Trilaciclib’s potential to preserve immune system function during chemotherapy may enhance overall survival (OS) in this trial. OS data are immature and will be reported when available.

There was no statistical difference between the trilaciclib and placebo groups in overall response rate (ORR) (trilaciclib 56.0%, placebo 63.5%) and median duration of response (DOR) (trilaciclib 5.2 months, placebo 4.2 months). Preliminary median progression-free survival (PFS) was 5.7 months for trilaciclib versus 5.4 months for placebo (hazard ratio 0.74, p=0.3025; less than 80% of events).

“We now have positive myelopreservation results from two randomized trials of trilaciclib in first-line small cell lung cancer, and later this year will report findings from two additional trials in different indications, metastatic triple-negative breast cancer and second-/third-line small cell lung cancer,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “We plan to request meetings with U.S. and European regulatory agencies in early 2019 to discuss the totality of our clinical data and potential pathways to approval.”

Click here to read the full press release.