Ph 3 SunRISe-2 trial in MIBC patients discontinued for not showing superiority versus chemoradiation
“The SunRISe-2 study in patients with muscle-invasive bladder cancer (MIBC) 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. Following an Independent Data Monitoring Committee recommendation and pre-specified interim analysis, SunRISe-2 was discontinued for not showing superiority versus chemoradiation. Based on data presented, we are highly confident in TAR-200 as a transformative therapy for bladder cancer where innovative and bladder-sparing options are urgently needed. Data from the SunRISe-4 study recently presented at the 2024 European Society for Medical Oncology Congress show the potential of TAR-200 in MIBC and we will continue to pursue approaches to advance care in this setting. We are on target for the U.S. FDA filing of TAR-200 monotherapy (SunRISe-1) in non-muscle invasive bladder cancer in early 2025 with the SunRISe-3 and SunRISe-5 studies underway.”
Share:
More News
Pnina Fishman, CSO & Chairperson of Can-Fite BioPharma, commented: “We are pleased to offer this compassionate use program with Namodenoson for eligible patient in the US to address the unmet medical needs for pancreatic cancer. Initiating this program is another milestone achieved for Namodenoson, and concurrently to our ongoing Phase
“We are deeply disappointed by these results from our Phase 1 trial. Despite continuing to demonstrate differentiated safety as a more combinable ADC, updated efficacy data suggest that treatment with EO-3021 does not meet our bar for success and is insufficient to provide patients a competitive benefit-risk profile compared to
Søren Bregenholt, CEO of Alligator, commented: “The FDA’s recognition of HLX22/AC101’s potential with Orphan Drug Designation is a notable recognition. While Alligator’s is not directly involved in the development of HLX22/AC101, we continue to follow its progress as it potentially represents future income to Alligator.”
“At Servier, we are dedicated to transforming patient care in areas with significant unmet needs. Our partnership to develop BDTX-4933 is an important opportunity in targeted cancer therapies, as we believe we can serve more people by helping the right patients find the right treatment, at the right time,” said
