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

- The Primary Endpoint of PRESERVE 3 Will Assess the Anti-Tumor Efficacy of COSELA with Platinum-Based Chemotherapy Followed by COSELA in Combination with Immune Checkpoint Inhibitor Avelumab in 90 Patients with Metastatic Urothelial Carcinoma (mUC) -

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).