G1 Therapeutics Reveals An Early Cut Data From Bladder Cancer Trial

• G1 Therapeutics Inc (NASDAQ: GTHX) provided an initial update on the PRESERVE 3 Phase 2 study of first-line platinum-based chemotherapy and maintenance therapy with avelumab, administered alone, or in combination with trilaciclib, in patients with untreated, locally advanced or metastatic urothelial carcinoma (mUC).

• Additional safety and efficacy data, including the primary endpoint of progression-free survival (PFS), are anticipated in the middle of 2023.

• The confirmed objective response rate (ORR) was comparable between arms; ORR was 40.0% (n=18/45) and 46.7% (n=21/45) among evaluable patients in the trilaciclib and control arms, respectively.

• Related: G1 Therapeutics Says Its Lead Candidate May Cut Adverse Events Of Gilead's Breast Cancer Drug.

• Longer-term follow-up is required to characterize additional anti-tumor endpoints, including median duration of confirmed objective response and PFS, which is the study's primary endpoint.

• Safety is reviewed by the data monitoring committee (DMC) on an ongoing basis, and the study has been recommended to continue as planned.

• Though early, the safety and tolerability profile of trilaciclib administered before chemotherapy is generally consistent.

• Price Action: GTHX shares are down 3.05% at $5.56 on the last check Wednesday.

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