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G1 Therapeutics IncGTHX 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.
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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