FDA Grants Trilaciclib Plus Chemotherapy Fast Track Designation for Locally Advanced or Metastatic TNBC


The combination of trilaciclib plus chemotherapy has been granted a fast track designation by the FDA for the treatment of locally advanced metastatic triple-negative breast cancer.

The FDA has granted a fast track designation to trilaciclib (Cosela) in combination with chemotherapy for the treatment of patients with locally advanced or metastatic triple-negative breast cancer (TNBC), according to a press release from drug developer G1 Therapeutics.1

Trilaciclib is currently being evaluated in the pivotal, randomized, double blind, placebo-controlled phase 3 PRESERVE 2 study (NCT04799249) in patients with TNBC who have received first- or second-line gemcitabine and carboplatin–based chemotherapy.

“Fast Track designation underscores the urgent need for innovative drugs that can significantly improve TNBC patient outcomes,” Raj Malik, MD, chief medical officer at G1 Therapeutics, said in a press release. “It provides an important pathway to help expedite the development and regulatory review of Cosela in this indication. We look forward to working closely with the FDA as we advance this pivotal program in TNBC and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types.”

The trial aims to enroll an estimated 250 patients who will be randomized to receive 1000 mg/m2 of gemcitabine and carboplatin at area under the curve 2 plus either 240 mg/m2 of trilaciclib or placebo.

Patients need to be aged 18 years or older with documented TNBC to enroll. In cohort 1, patients are not eligible following prior systemic therapy in the locally advanced unresectable or metastatic setting or prior PD-1/PD-L1 inhibitors; time between completion of last curative intent treatment and first metastatic recurrence needs to be 6 months or more. In cohort 2, patients need documentation of PD-1/PD-L1 expression status and to have undergone treatment with a PD-1/PD-L1 inhibitor for a minimum of 4 months for locally advanced unresectable or metastatic disease as their most recent therapy. Additionally, an ECOG performance status of 0 or 1 and adequate organ function are required.

The primary outcome of the trial is overall survival (OS), with key secondary outcomes including quality of life, myeloproliferative effects, and progression-free survival (PFS).

Trilaciclib has previously been examined in metastatic TNBC prior to treatment with chemotherapy and was found to provide a significant survival benefit, according to the results of a phase 2 study (NCT02978716) that was presented at the 2020 San Antonio Breast Cancer Symposium.2 Data from the study indicated that treatment with trilaciclib prior to gemcitabine and carboplatin yielded an overall response rate of 44.3%. Moreover, the median PFS for all patients treated with trilaciclib was 9.0 months (95% CI, 6.4-11.3) vs 5.7 months (95% CI, 3.3-9.9) for those receiving chemotherapy alone (HR, 0.62; 95% CI, 0.36-1.10; P = .1291); the corresponding median OS was 19.8 months (95% CI, 14.0–not reached) vs 12.6 months (6.3-15.6; HR, 0.37; 95% CI, 0.21-0.63; P <.0001).


  1. G1 Therapeutics recieves fast track designation from U.S. Food and Drug Administration for Cosela (Trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer. News release. G1 Therapeutics, Inc. July 19, 2021. Accessed July 19, 2021. https://bit.ly/3z9kOKg
  2. O’Shaughnessy J, Wright GS, Thummala AR, et al. Trilaciclib improves overall survival when given with gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer: final analysis of a randomized phase 2 trial. Presented at: 2020 San Antonio Breast Cancer Symposium; December 8-12, 2020; Virtual. Abstract PD1-06.
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