Global Registrational Ph 3 Study of Lisaftoclax in 1L CLL/SLL Patients Approved by the China CDE
“In earlier studies, lisaftoclax combined with acalabrutinib has already demonstrated impressive efficacy and safety, validating the combination regimen’s therapeutic potential and its promise as a patient-centric treatment strategy,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “We are very encouraged by this approval for the global registrational Phase III study of lisaftoclax combined with acalabrutinib. In terms of the dose ramp-up schedule for the Bcl-2 inhibitor and no lead-in of the BTK inhibitor, this trial adopts an innovative and optimized dosing regimen that is more convenient and allows for a faster onset of actions compared to studies of similar combinations. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will vigorously advance those clinical programs of lisaftoclax to expedite the drug’s journey to market for the benefit of more patients.”
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.