G1 Therapeutics Initiates PRESERVE 3, A Randomized Phase 2 Study of COSELA™ (trilaciclib) in Bladder Cancer

RESEARCH TRIANGLE PARK, N.C., June 14, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that the Company has initiated PRESERVE 3, a Phase 2, randomized, open-label study of COSELA™ (trilaciclib) administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor avelumab maintenance therapy in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC). Myeloprotection and anti-tumor efficacy endpoints are being assessed in this study. Initial results of this study are expected in the second half of 2022.

“Bladder cancer is unfortunately common and the five-year survival rate for metastatic urothelial carcinoma has not changed in the last 25 years, highlighting the need for new and well tolerated therapies specifically tailored for immune sensitive tumors like this,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics. “While chemotherapy followed by avelumab maintenance therapy has proven to be a meaningful step forward for the 1L treatment of patients with mUC, patients may not receive the maximal benefit for a variety of reasons. These Phase 2 data will be instructional and important to evaluate the benefit of adding COSELA to this regimen, and if positive, would be quickly followed by a Phase 3 registrational trial.”

Patient recruitment in Preserve 3 is now underway. The study will enroll approximately 90 patients, who will be randomly assigned (1:1) to one of two treatment arms (A or B). Arm A will receive gemcitabine/platinum chemotherapy followed by avelumab maintenance therapy. Arm B will receive COSELA prior to gemcitabine/platinum chemotherapy followed by COSELA plus avelumab maintenance therapy. Standard of care gemcitabine/platinum chemotherapy (with or without the addition of COSELA) will be administered intravenously in 21-day cycles and standard of care avelumab maintenance therapy (with or without the addition of COSELA) will be administered intravenously in 14-day cycles. There will be two stratification factors for randomization: presence of visceral metastasis (yes or no), and initial platinum-based chemotherapy to be administered (cisplatin or carboplatin).

Patients enrolled in the study will be eligible to receive 4 to 6 cycles of platinum-based chemotherapy. Patients without progressive disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines (i.e., with an ongoing complete response, partial response, or stable disease) after platinum-based chemotherapy will be eligible to receive avelumab maintenance therapy (with or without COSELA) until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision, or the end of the trial, whichever occurs first.

The primary endpoint is to evaluate the anti-tumor efficacy of COSELA when combined with platinum-based chemotherapy and the checkpoint inhibitor avelumab maintenance therapy as measured by progression-free survival (PFS) during the overall study. Key secondary endpoints include:

• evaluation of the anti-tumor efficacy of COSELA as measured by the objective response rate (ORR);
• disease control rate;
• duration of objective response (DOR);
• PFS in the maintenance period;
• overall survival (OS) and probability of survival (POS) at Month 16;
• evaluation of the myeloprotective effects of COSELA on chemotherapy-induced myelosuppression; and
• assessment of the safety and tolerability of COSELA in patients receiving platinum-based chemotherapy followed by avelumab maintenance therapy.
  

G1 announced in February 2021 that it had entered into a clinical trial collaboration with the alliance between Merck KGaA, Darmstadt, Germany and Pfizer whereby the alliance will contribute clinical supply of the checkpoint inhibitor avelumab to this first-line treatment of mUC trial.

About Bladder Cancer
Bladder cancer is the most common malignancy involving the urinary system and is the sixth most common cancer in the United States. The American Cancer Society estimates that approximately 84,000 new cases of bladder cancer will be diagnosed in the U.S. in 2021. Approximately 2.4% of the US population will be diagnosed with bladder cancer at some point during their lifetime; the average age at diagnosis is 73 years and it is rarely diagnosed in people less than 40 years of age. Urothelial carcinoma, also known as transitional cell carcinoma (TCC), urothelial bladder cancer, or urothelial cell carcinoma (UCC) of the urinary tract, is the most common type of bladder cancer in the U.S. and Europe, where it accounts for 90% of all bladder cancers.  It also accounts for up to 15% of kidney cancers diagnosed in adults. The overall 5-year survival rate for metastatic urothelial carcinoma is approximately 5.5%, which has remained unchanged over the past 25 years.

About G1 Therapeutics
G1 Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of next generation therapies that improve the lives of those affected by cancer, including the Company’s first commercial product, COSELA™ (trilaciclib). G1 has a deep clinical pipeline and is executing a tumor-agnostic development plan evaluating COSELA in a variety of solid tumors, including colorectal, breast, lung, and bladder cancers. G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

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," "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 press release include, but are not limited to, COSELA’s (trilaciclib) possibility to improve patient outcomes in this Phase 2 trial of COSELA in bladder cancer, the stated primary and secondary endpoints may not achieve statistical significance, delays in the enrollment of patients in this trial of COSELA may delay or prevent our plans, COSELA may fail to achieve the degree of market acceptance for commercial success, and are based on the company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. 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 the company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company’s dependence on the commercial success of COSELA; the development and commercialization of new drug products is highly competitive; the company’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company’s 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 development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Will Roberts
G1 Therapeutics, Inc.
Vice President
Investor Relations and Corporate Communications
(919) 907-1944
wroberts@g1therapeutics.com