Trilaciclib (by G1 Therapeutics) has been granted Fast Track designation by FDA for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC)

G1 Therapeutics announced completion of enrollment in its global multi-center Phase 3 PRESEVE 2 trial evaluating trilaciclib (CDK4/6i) in patients with mTNBC receiving chemo; the trial includes 187 patients receiving 1L trilaciclib or placebo prior to gemcitabine and carboplatin.

Trilaciclib, an IV-administered transient CDK4/6 inhibitor, is a first-in-class therapy designed to preserve bone marrow and immune system function during chemotherapy to improve patient outcomes. It is approved by the U.S. Food and Drug Administration in another indication. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to trilaciclib investigation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC).

Trilaciclib’s myeloprotective effect could increase patients’ time on chemotherapy, and potentially improve outcomes and delay progression to later line therapy.

The trial explores two cohorts; 1L mTNBC patients without prior immunotherapy (N=187), and 2L mTNBC patients with prior immunotherapy (N=~63).

The company expects interim analysis of the trial in H2 2023 which will determine if the trial is stopped, or continues.

Approval may offer another option to certain 2L mTNBC patients who are Trodelvy eligible.