Preliminary results of the phase 2 trial assessing the safety and efficacy of Cosela with gemcitabine/platinum-based chemotherapy and Bavencio maintenance therapy for metastatic bladder cancer are expected to be released in the second half of 2022.
G1 Therapeutics recently announced it had launched a phase 2 trial to assess the safety and efficacy of Cosela (trilaciclib) in combination with first-line platinum-based chemotherapy and maintenance Bavencio (avelumab) in patients with untreated, locally advanced or metastatic urothelial carcinoma.
“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,” Dr. Raj Malik, Chief Medical Officer at G1 Therapeutics, said in a news release. “While chemotherapy followed by (Bavencio) maintenance therapy has proven to be a meaningful step forward for the (first line) treatment of patients with (metastatic urothelial carcinoma), patients may not receive the maximal benefit for a variety of reasons.”
The study is expected to consist of approximately 90 patients, according to the news release. One group of patients will then be randomly assigned to receive either gemcitabine/platinum-based chemotherapy plus maintenance therapy with Bavencio. The other group will receive Cosela prior to the start of gemcitabine/platinum-based chemotherapy followed by Cosela and maintenance therapy with Bavencio.
The release notes that patients enrolled on the study will be eligible to receive four to six cycles of platinum-based chemotherapy. For those patients whose disease does not progress after the cycles of chemotherapy, they will then be eligible to receive Bavencio maintenance therapy with or without Cosela. That additional treatment would continue until a patient’s disease progresses, unacceptable toxicity is reached, patient withdraws consent, an investigator decides to stop treatment or the end of the trial is reached.
Measuring progression-free survival (time during and after treatment when the patient lives without disease progression) among the patient population is the main goal of the study, according to the release. Other goals include evaluating the objective response rate, as well as overall survival and probability of survival at 16 months, disease control rate and safety and tolerability of the drugs.
Preliminary results of the study are expected in the second half of 2022, according to the release.
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