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
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
About Bladder Cancer
Bladder cancer is the most common malignancy involving the urinary system and is the sixth most common cancer in
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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
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