Johnson & Johnson’s Anti-PD-1 Antibody Cetrelimab in Combination with TAR-200 Granted Clinical Trial Approval in China for Bladder Cancer

▎WuXi AppTec Content Team Report

Today (October 12), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that Johnson & Johnson's Class 1 new drug...Cetrelimab InjectionAndTAR-200Two clinical trial applications for combination use have received tacit approval, respectively intended for development in patients who have not received Bacillus Calmette-Guérin (BCG) treatment.High-risk Non-muscle-invasive Bladder CancerTreatment of patients, as well as for those who have not undergone radical cystectomyMuscle-invasive Bladder Urothelial CarcinomaPatient Treatment.

Screenshot source: CDE official website

Bladder cancer is a malignant tumor originating from the urothelium of the bladder and is one of the most common malignant tumors of the urinary system. Bladder cancer can be divided into categories based on the extent of tumor invasion.Non-Muscle-Invasive Bladder Cancer (NMIBC)、Muscle-invasive Bladder CancerAndMetastatic Bladder CancerIn patients initially diagnosed with bladder cancer, about 75% are at the NMIBC disease stage. For high-risk NMIBC patients, guidelines recommend intravesical BCG instillation, but approximately 50% of patients still experience tumor recurrence within 5 years. Therefore, there is an unmet clinical need in this area.

According to the public information disclosed by Johnson & Johnson,Cetrelimab is an anti-PD-1 monoclonal antibody being developed for administration via intravenous injection as part of a combination therapy., used to treat bladder cancer, melanoma, and multiple myeloma.TAR-200 is a novel intravesical drug delivery system, a long silicone tube that releases the chemotherapy drug gemcitabine into the bladder over an extended period at a very low dose.. The study found that when cetrelimab and TAR-200 were used in combination,They may exhibit synergistic effects, thereby improving treatment outcomes for high-risk NMIBC patients who are unresponsive to intravesical BCG.。

Previously, the combination therapy consisting of cetrelimab and TAR-200 has been applied to NMIBC patients who did not respond to standard BCG treatment.Phase 2 SunRISe-1 TrialPositive results were achieved in China. In the trial, TAR-200 was administered once every 3 weeks for a total of 24 weeks, then once every 12 weeks until week 96; cetrelimab was administered prior to week 78. A total of 22 patients were in the second cohort.Patients treated with TAR-200 achieved a complete response (CR) rate of 73%; among those treated with cetrelimab, the CR rate was 38%.The number of evaluable patients in the combination therapy group (Cohort 1) was insufficient for analysis.

SunRISe-1 Study Principal Investigator Dr. Siamak Daneshmand once stated in a Johnson & Johnson press release: "As a clinician, my ultimate treatment goal is to achieve deep and durable responses in these patients. It is encouraging that,Patients treated with TAR-200 alone and cetrelimab alone showed improvement in their condition, and we look forward to reporting the results of future study cohorts evaluating these two combination therapies.。”

[2]Janssen Reports First Results from Phase 2 SunRISe-1 Study of TAR-200 and Anti- PD-1 Antibody Cetrelimab in Patients with Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer. Retrieved Apr 30, 2023 from https://www.jnj.com/janssen-reports-first-results-from-phase-2-sunrise-1-study-of-tar-200-and-anti-pd-1-antibody-cetrelimab-in-patients-with-bacillus-calmette-guerin-unresponsive-non-muscle-invasive-bladder-cancer