G1 Therapeutics Provides Update on Phase 3 PRESERVE 2 Trial in Patients Receiving Trilaciclib Prior to First Line Chemotherapy in Metastatic Triple Negative Breast Cancer (mTNBC)
- PRESERVE 2 Did Not Achieve Statistical Significance in the Primary Endpoint of Overall Survival (OS) in the Intent-to-Treat (ITT) Population -
- The Company Will Focus its Efforts on the Global Extensive-Stage Small Cell
- G1 is Sufficiently Funded to Achieve Anticipated Company Profitability in the Second Half of 2025 -
- Management to Host Webcast and Conference Call Today at
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
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
The Company expects to generate between
Webcast and Conference Call
G1 will host a webcast and conference call at
About
G1 Therapeutics® and the
Forward-Looking Statements
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," “could”, “believe,” “goal”, “projections,” "estimate," "intend," “indicate,” “potential,” “opportunity,” “suggest,” 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 press release include, but are not limited to, expectations with respect to future performance and development and commercialization of our products, including our focus on ES-SCLC and ex-US partnering on COSELA (trilaciclib), our anticipated cash runway and profitability, and financial guidance for full year 2024. Each of these forward-looking statements involves significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. Factors that may cause the company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, our dependence on the commercial success of COSELA (trilaciclib); the development and commercialization of new drug products is highly competitive; our ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; our initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a commercial-stage company; chemotherapy shortages and market conditions. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. We caution readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Except as required by law, we assume no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
G1 Therapeutics Contacts:
Communications Officer
Vice President, Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com
Source: G1 Therapeutics