One of Johnson & Johnson’s high-profile pipeline drugs, TAR-200, has missed in a Phase III trial in patients with muscle-invasive bladder cancer (MIBC), but the company said the drug-device technology platform is still expected to become a $5bn+ commercial franchise.
The company announced on 8 October that the SunRISe-2 trial testing TAR-200 in combination with J&J’s proprietary PD-1 inhibitor cetrelimab in patients who are ineligible for or refuse radical cystectomy was discontinued for not showing superiority to chemoradiation. The decision was based on a pre-specified interim analysis and the recommendation of an independent data monitoring committee.
“The SunRISe-2 study in patients with muscle-invasive bladder cancer who are not receiving radical cystectomy was a bold approach to disrupt the established standard of care in chemoradiation in this difficult-to-treat population,” the company said in a statement.
J&J said it remains “highly confident” in TAR-200 as an intervention for bladder cancer, including non-muscle invasive bladder cancer (NMIBC) and MIBC. The product relies on a silicone-based device to deliver the chemotherapy gemcitabine continuously to the bladder. It’s implanted during a minimally-invasive office procedure.
A regulatory filing for TAR-200 is already being prepared for submission to the US Food and Drug Administration in early 2025 in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk NMIBC with carcinoma in situ (CIS), who are ineligible for or decline radical cystectomy, based on data from the SunRIS2-1 study.
J&J presented data from SunRISe-1 and another study, SunRISe-4, at the European Society for Medical Oncology (ESMO) meeting in September that impressed experts in the field. (Also see "ESMO 24: SunRISes On J&J’s TAR-200 In Bladder Cancer" - Scrip, 26 September, 2024.)
SunRISe-4 is a Phase II study testing TAR-200 in the neoadjuvant setting in combination with J&J’s proprietary PD-1 antibody cetrelimab versus cetrelimab alone in patients with MIBC scheduled for radical cystectomy who are ineligible for or refuse neoadjuvant platinum-based chemotherapy. The interim analysis of the trial showed neoadjuvant TAR-200 plus cetrelimab resulted in overall efficacy with a centrally confirmed pathological complete response (pCR) rate of 42% compared to 23% for patients treated with cetrelimab alone in patients with non-metastatic MIBC.
“Data from the SunRISe-4 study…show the potential of TAR-200 in MIBC and we will continue to pursue approaches to advance care in this setting,” J&J said.
J&J acquired TAR-200 in 2019 through the acquisition of TARIS Biomedical LLC for an undisclosed sum. CEO Joaquin Duato recently highlighted it as an acquisition that didn’t make big headlines at the time because of the technology’s stage of development, but as one that has big potential. (Also see "J&J Interested In ‘Differentiated’ Obesity Assets" - Scrip, 4 September, 2024.)
“We remain confident in the Taris platform having $5bn+ potential,” the company said. In addition to TAR-200, J&J is developing another product, TAR-210, relying on the technology to deliver the FGFR inhibitor erdafitinib to treat bladder cancer.
