Positive Initial Ph 1b Data for ELVN-001 in CML Reported
“We are excited about these initial Phase 1b data, the progress we made throughout 2025 and the year ahead. Our data continue to demonstrate that ELVN-001 has the potential to be the best-in-class active-site TKI for the treatment of CML and an important treatment option across all lines of therapy,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Momentum has been building over the last year leading to significant interest in our Phase 3 clinical trial from sites all around the world. We are preparing for upcoming regulatory interactions with the FDA to align on dose selection and support initiation of the Phase 3 trial in the second half of 2026.”
Share:
More News
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.