Trial Initiated to Assess Efficacy of Cosela in Bladder Cancer

The PRESERVE 3 trial began this summer to determine efficacy of using Cosela with platinum-based chemotherapy in patients with metastatic bladder cancer.

A phase 2 trial has begun in hopes of creating a new treatment option for patients with locally advanced or metastatic urothelial carcinoma (mUC).

The PRESERVE 3 trial, initiated by G1 Therapeutics, Inc. in early June, will determine whether Cosela (trilaciclib) – when administered with first-line platinum-based chemotherapy and immune checkpoint inhibitor Bavencio (avelumab) maintenance therapy – has anti-tumor efficacy. The study will also assess myeloprotection, which is a novel approach of protecting bone marrow.

G1 Therapeutics, Inc. is currently recruiting patients for the trial, with a goal of 90 patients who will be randomly given either Cosela prior to Gemzar (gemcitabine)/platinum chemotherapy followed by COSELA plus Bavencio maintenance therapy or Gemzar/platinum chemotherapy followed by Bavencio maintenance therapy. They hope to have initial results toward the end 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 Dr. Raj Malik, Chief Medical Officer at G1 Therapeutics, in a release. “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.”

Patients enrolled in the study will be able to receive four to six cycles of platinum-based chemotherapy and afterwards, if they do not have progressive disease, will be eligible to receive Bavencio maintenance therapy (with or without Cosela) until their disease progresses, they have unacceptable toxicity, withdrawal of consent, end of trial or an investigator decision.

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