TARIS Bio Initiates Phase Ib Trial of Intravesical TAR-200 Combined with Systemic Opdivo (Nivolumab) in Muscle-Invasive Bladder Cancer

July 15, 2019/BioonBIOON/--TARIS Bio is a biopharmaceutical company dedicated to developing transformative therapies for debilitating urological diseases. Recently, the company announced the evaluation of TAR-200 in combination with Bristol-Myers Squibb’s PD-1TumorThe Phase Ib clinical study (NCT03518320) of the immunotherapy Opdivo (brand name: Opdivo; generic name: nivolumab) for the treatment of patients with muscle-invasive bladder cancer (MIBC) has completed dosing of the first patient.

This study was conducted as part of the clinical collaboration between TARIS and Bristol-Myers Squibb, which is also an equity investor in TARIS. The study is an open-label, multicenter, single-arm Phase Ib trial that will enroll 25 patients with muscle-invasive bladder cancer (MIBC) scheduled to undergo radical cystectomy. In the study, TAR-200 and Opdivo will be administered on Day 1 of each of four consecutive 21-day dosing cycles, for a total treatment duration of 84 days prior to radical cystectomy. The objective of the study is to evaluate the safety, tolerability, and preliminary efficacy of the combination of TAR-200 and Opdivo in patients with MIBC.

TAR-200 is TARIS’s lead candidate product, designed to continuously release the chemotherapy drug gemcitabine within the bladder for several weeks. The company believes that TAR-200 has the potential to leverage gemcitabine’s direct antitumor and immuneTumorpharmacological activity, delivering potent efficacy via local administration while avoiding systemic drug exposure and mitigating systemic side effects. In the United States,FDATAR-200 Granted Fast Track Designation for the Treatment of Patients with Muscle-Invasive Bladder Cancer (MIBC) Who Are Not Candidates for Curative Therapy

Bladder cancer affects more than 2.7 million patients worldwide and is one of the most costly cancers to treat in terms of patient lifetime costs. Muscle-invasive bladder cancer (MIBC) is an aggressive disease that is often fatal, with the potential for rapid progression and metastasis. The preferred standard of care for MIBC is radical cystectomy (surgical removal of the bladder) combined with platinum-based neoadjuvant chemotherapy. Compared with cystectomy alone, this neoadjuvant approach has been shown to provide a survival benefit for patients. Unfortunately, fewer than 15% of patients undergoing cystectomy receive this therapy, primarily due to concerns about patient frailty and potential delays in surgery. Neoadjuvant regimens such as the combination of TAR-200 and Opdivo have the potential to be used in the majority of patients who do not receive platinum-based chemotherapy, addressing a significant unmet medical need in this field.

Christopher J. Cutie, M.D., Chief Medical Officer of TARIS Biomedical, stated, “This study will be the first clinical trial to evaluate the combination of the locally administered TAR-200 system with a systemic PD-1 checkpoint inhibitor. Opdivo has previously been approved for adult patients with previously treated advanced bladder cancer. We aim to evaluate the potential anti-”Tumorand synergistic effects with the immune system.”(Bioon.com)

Original Source:TARIS Initiates Clinical Trial of TAR-200 in Combination with Opdivo (nivolumab) for Patients with Muscle-Invasive Bladder Cancer