On June 24, 2024 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported topline results from the final OS analysis of its Phase 3 PRESERVE 2 trial evaluating the efficacy and safety of trilaciclib administered prior to chemotherapy (gemcitabine and carboplatin; GCb) in patients with metastatic TNBC (Press release, G1 Therapeutics, JUN 24, 2024, View Source [SID1234644498]).
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The study did not demonstrate a statistically significant treatment effect in the ITT population (n=187) with a hazard ratio (HR) of 0.91 (p=0.884). The median OS in the trilaciclib plus GCb arm was 17.4 months compared to 17.8 months in the control arm. Median OS numerically favored the trilaciclib arm in both PD-L1 subgroups (positive and negative), though neither achieved statistical significance. Varying effects were observed across regions and patients who received different types of subsequent therapies; these findings will be evaluated further. The safety profile of trilaciclib with GCb observed in the trial was consistent with prior studies, and no new safety signals were identified. Consistent with other trilaciclib studies, evidence of myeloprotection was observed, including a reduction in the occurrence of severe neutropenia, which occurred in 8% of patients who received trilaciclib compared to 29% of patients in the control arm. The Company will submit the results of this trial to a future medical conference.
"The unexpected results from PRESERVE 2 underscore the challenge of developing new therapies for triple negative breast cancer," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "We are disappointed that this trial did not deliver the benefit that we anticipated to people living with TNBC. We are also grateful to the patients who participated in this trial, their families, and their healthcare teams including the clinicians and their staff."
Mr. Bailey continued, "We will now further our focus on both accelerating and expanding the growth of the ES-SCLC business to achieve anticipated company profitability in the second half of 2025 and evaluating other myeloprotection uses for trilaciclib. We are also pursuing ex-US partners to expand the use of COSELA (trilaciclib) globally."
Financial Guidance
G1 today reaffirmed its full year 2024 COSELA net revenue guidance and updated its cash runway guidance. G1’s guidance is based on current expectations for continued sales growth of COSELA in the U.S. and achievement of its forecasts.
The Company expects to generate between $60 million and $70 million in COSELA net revenue in 2024. Additionally, G1 plans to wind down the Phase 3 PRESERVE 2 trial, discontinue the anticipated hiring of staff and investment for a 1L TNBC indication and make targeted headcount reductions outside of the existing commercial organization to streamline the Company. These efforts are expected to provide sufficient cash runway to achieve anticipated company profitability in the second half of 2025.
Webcast and Conference Call
G1 will host a webcast and conference call at 8:30 a.m. ET today to discuss PRESERVE 2. Please note the following process to access the call via telephone: To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended to join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the Company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.