Johnson & Johnson (J&J) has announced positive results for TAR-200 in patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
TAR-200 is the company’s investigational targeted releasing system designed to provide extended local release of gemcitabine into the bladder.
The announcement is based on additional data from the Phase 2b SunRISe-1 study in patients with BCG-unresponsive HR-NMIBC who are ineligible for radical cystectomy.
SunRISe-1 is a randomised, open-label Phase 2 clinical study evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone, or cetrelimab.
In the study, which supported the safety and efficacy profile of TAR-200, the participants were randomised into four cohorts.
Patients in Cohort 1 received treatment with TAR-200 plus cetrelimab, Cohort 2 received TAR-200 alone, Cohort 3 received cetrelimab alone, and Cohort 4 received TAR-200 alone.
In Cohort 2, all 85 patients who received TAR-200 monotherapy showed a high, centrally confirmed, single-agent complete response (CR) rate of 83.5%.
The results showed highly durable CRs without the need for reinduction, with 82% of patients maintaining response after a median follow-up of nine months, based on the Kaplan-Meier curve.
Results from Cohort 1 showed a 67.9% CR and Cohort 3 showed a 46.4% CR.
Johnson & Johnson Innovative Medicine vice president, bladder cancer disease area leader Christopher Cutie said: “Our mission, to stay in front of cancer, drives us to innovate in ways that truly redefine treatment paradigms for patients with bladder cancer.
“The data from our SunRISe clinical programme illuminate the possibility of an innovative approach in an outpatient setting with the potential to impact patient well-being and enhance the entire treatment experience.”
In a separate development, J&J announced positive results for its investigational therapy TAR-200 in combination with cetrelimab (CET), in treating muscle-invasive bladder cancer (MIBC).
The announcement is based on interim data from the ongoing Phase 2 SunRISe-4 study.
The study evaluated the combination in patients with MIBC who are ineligible for neoadjuvant platinum-based chemotherapy and are scheduled for radical cystectomy (RC).
In the Phase 2 clinical trial, TAR-200 plus CET achieved nearly double the pathological complete response (pCR) rate compared to CET alone.
CET is an investigational PD-1 monoclonal antibody being developed for the treatment of bladder cancer, prostate cancer, melanoma, and multiple myeloma as a combination treatment.
In the interim analysis, neoadjuvant TAR-200 plus CET showed an overall efficacy with a centrally confirmed pCR rate of 42%, compared to 23% with CET alone.
The combination also showed a pathological overall response (pOR) rate of 60% compared to 36% with CET alone.
In a subgroup analysis, TAR-200 plus CET showed a 48% pCR rate in patients with organ-confined disease (cT2), compared to 23% with CET alone.
Also, 68% of patients were downstaged at the time of radical cystectomy, potentially improving surgical outcomes and reducing the risk of recurrence, said the US drugmaker.
Johnson & Johnson Innovative Medicine solid tumours clinical development vice president Kiran Patel said: “With these promising results, TAR-200 plus cetrelimab as a neoadjuvant therapy before radical cystectomy could potentially alter how bladder cancer is treated.
“This investigational innovative approach may offer a possible alternative for many patients who are not eligible for the current standard of pre-operative treatments.”
