G1 Therapeutics Presents Updated Data at ESMO 2019 from Randomized Phase 2 Trial of Trilaciclib in Combination with Chemotherapy in Metastatic Triple-Negative Breast Cancer Demonstrating Significant Improvement in Overall Survival
-- Trial results published simultaneously in The Lancet Oncology --
-- Company also to present updated Phase 2 results demonstrating myelopreservation benefits in small cell lung cancer (SCLC) patients receiving trilaciclib and chemotherapy in combination with Tecentriq® --
-- Company to begin rolling New Drug Application (NDA) submission for SCLC in 4Q19 --
-- Company to host investor and analyst event, webcast and conference call at 12:45 p.m. ET on September 29, 2019 --
Updated data from a separate randomized Phase 2 trial of trilaciclib in small cell lung cancer (SCLC) will be presented during a poster session (1742PD) on
“Triple-negative breast cancer is the most aggressive form of breast cancer and tends to have a poorer prognosis than other breast cancers. We need new therapeutic approaches that improve outcomes for women diagnosed with triple-negative breast cancer,” said
“Trilaciclib is a first-in-class therapy that has improved outcomes for people with cancer being treated with chemotherapy in four randomized Phase 2 trials. The findings from these trials in small cell lung cancer and triple-negative breast cancer indicate that the clinical benefits of trilaciclib are meaningful and context-dependent,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “In metastatic triple-negative breast cancer, the benefit manifests as improved overall survival. In small cell lung cancer, patients experience myelopreservation benefits, including reduced rates of neutropenia, anemia and other chemotherapy-related side effects, and a corresponding decrease in the use of rescue therapies required to address those toxicities. Importantly, patient-reported outcome measures across all of our trials showed that trilaciclib improved the patient experience on chemotherapy.”
Overall survival benefit in mTNBC
The randomized, open-label Phase 2 study (NCT02978716) of trilaciclib in combination with GC, a current standard of care for TNBC, enrolled 102 patients who had received up to two prior chemotherapy regimens for locally recurrent or metastatic TNBC. In this three-arm trial, all three groups received a chemotherapy regimen of GC. Patients were randomized to receive GC only (Group 1) or GC plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2) or trilaciclib administered the day prior to and the day of chemotherapy (Group 3). Primary endpoints for the trial included myelopreservation measures; secondary endpoints included additional myelopreservation measures and anti-tumor efficacy measures of overall response rate (ORR), progression-free survival (PFS) and OS. Myelopreservation and preliminary anti-tumor efficacy results from the trial were reported at the 2018 San Antonio Breast Cancer Symposium (press release here). Topline OS findings were announced in
Updated results from the trial showed:
• The addition of trilaciclib to chemotherapy resulted in a significant increase in OS in both treatment groups compared to chemotherapy alone.
- Compared to GC alone (Group 1), OS was improved for both trilaciclib arms (Groups 2 and 3) with median OS of 12.6 months, 20.1 months and 17.8 months, respectively (Group 2: HR=0.33, p=0.0283; Group 3: HR=0.34, p=0.0023). The median OS for Groups 2 and 3 combined was 20.1 months (HR=0.36, p=0.0015). The median OS for GC alone (Group 1, 12.6 months) was consistent with historical data.
• PFS and ORR were consistent with previously reported data.
• The safety and tolerability of trilaciclib were consistent with previously reported data.
- There have been no serious adverse events attributed to treatment with trilaciclib in this trial.
• Patient-reported outcome (PRO) measures related to anemia were improved in patients receiving trilaciclib versus patients receiving chemotherapy alone.
• As previously reported, primary endpoints (myelopreservation measures) were not met.
Trilaciclib in SCLC
- Trilaciclib demonstrated myelopreservation benefits, as shown by statistically significant and clinically meaningful improvement in reduction of myelosuppression endpoints, reduction of chemotherapy side effects and reduction of rescue interventions.
- Trilaciclib was well tolerated, with fewer ≥ Grade 3 adverse events (AEs) compared to placebo.
- PRO measures related to anemia were improved in patients receiving trilaciclib versus patients receiving placebo.
- Trilaciclib did not adversely impact chemotherapy anti-tumor efficacy as measured by ORR, PFS and OS.
Additionally, data from another randomized Phase 1b/2 trial of trilaciclib in patients with SCLC receiving first-line chemotherapy were recently published in Annals of Oncology, the official journal of
Webcast and Conference Call Details
G1 Therapeutics will host a webcast and conference call of its investor and analyst event on Sunday, September 29, 2019, at 6:45 p.m. CEST (
Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, the timing for the commencement and completion of marketing applications in the U.S. and
Senior Director, Investor Relations & Corporate Communications
Source: G1 Therapeutics