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)
G1 Therapeutics announced that their Phase 3 PRESERVE 2 trial for trilaciclib did not meet its primary endpoint of overall survival (OS) in metastatic triple negative breast cancer (mTNBC) patients. The trial involved 187 patients and showed a hazard ratio (HR) of 0.91 with a p-value of 0.884, indicating no significant treatment effect.
The median OS was 17.4 months for the trilaciclib plus chemotherapy arm versus 17.8 months for the control. The safety profile was consistent with prior studies, showing myeloprotection but no new safety signals. Severe neutropenia was reduced from 29% to 8% with trilaciclib.
G1 Therapeutics will focus on the global extensive-stage small cell lung cancer (ES-SCLC) market and is aiming for profitability in the second half of 2025. They anticipate COSELA net revenue of $60-70 million in 2024 and are implementing cost-cutting measures to extend their cash runway.
- G1 Therapeutics is sufficiently funded to aim for profitability in the second half of 2025.
- The safety profile of trilaciclib was consistent with prior studies, with no new safety signals.
- Severe neutropenia was significantly reduced from 29% in the control arm to 8% in the trilaciclib arm.
- G1 anticipates generating $60-70 million in COSELA net revenue in 2024.
- The Phase 3 PRESERVE 2 trial did not achieve statistical significance in the primary endpoint of overall survival.
- The median overall survival was lower in the trilaciclib arm (17.4 months) compared to the control arm (17.8 months).
- The trial results showed no statistically significant treatment effect in the intent-to-treat population.
- The company will discontinue anticipated hiring and investment for a 1L TNBC indication and make targeted headcount reductions.
Insights
The news about G1 Therapeutics not achieving statistical significance in the Phase 3 PRESERVE 2 trial for trilaciclib in metastatic triple-negative breast cancer (mTNBC) is a notable setback in oncology. This type of cancer is particularly aggressive and lacks targeted treatments, making any new potential therapy highly anticipated. However, the trial results showed no significant improvement in overall survival, which is a important endpoint in cancer research. This implies that trilaciclib may not offer the expected survival benefit in this patient population.
While the safety profile remained consistent with previous studies and some myeloprotection benefits were noted, these are not enough to justify its use specifically for mTNBC without a survival advantage. The company may need to pivot its research focus, as indicated, towards other cancer types like extensive-stage small cell lung cancer (ES-SCLC) where trilaciclib has shown more promise.
For retail investors, understanding that oncology trials are inherently high-risk and high-reward is essential. The failure to meet primary endpoints in such trials is not uncommon but does influence investor sentiment and stock performance significantly.
From a financial perspective, G1 Therapeutics’ announcement about the PRESERVE 2 trial results is critical. The failure to show a statistically significant improvement in overall survival for mTNBC patients will likely impact investor confidence. However, the company has reaffirmed its revenue guidance for 2024, expecting between
In the short term, the stock may face downward pressure due to the disappointing trial results. Long-term investors, however, might find some solace in the company’s robust financial strategy and renewed focus on the ES-SCLC market, which could stabilize or even enhance future profitability.
G1 Therapeutics’ focus shift towards the ES-SCLC market is a strategic move. This market has different dynamics compared to mTNBC, with fewer treatment options available, potentially giving trilaciclib a better competitive positioning. The company’s plan to seek ex-US partners to expand COSELA’s global reach is also a positive step to diversify revenue streams and mitigate risks associated with the U.S. market.
For retail investors, this suggests that while the immediate news on mTNBC is negative, the company's broader strategy and diversification might still hold potential for long-term growth. It’s essential to monitor how well G1 Therapeutics executes these new plans and whether they can maintain or grow their market share in the ES-SCLC space.
- 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 Lung Cancer (ES-SCLC) Market -
- G1 is Sufficiently Funded to Achieve Anticipated Company Profitability in the Second Half of 2025 -
- Management to Host Webcast and Conference Call Today at 8:30 AM ET -
RESEARCH TRIANGLE PARK, N.C., June 24, 2024 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced 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.
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
“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
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.
About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage oncology biopharmaceutical company whose mission is to develop and deliver next-generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA® (trilaciclib). G1’s goal is to provide innovative therapeutic advances for people living with cancer. G1 is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on X (formerly known as Twitter) @G1Therapeutics and LinkedIn.
G1 Therapeutics® and the G1 Therapeutics logo and COSELA® and the COSELA logo are trademarks of G1 Therapeutics, Inc.
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:
Will Roberts
Communications Officer
Vice President, Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com
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