Ph 3 Trial of LAE002 (afuresertib) for Breast Cancer Met PFS Primary Endpoint
“We are proud to share that the Phase III clinical trial of LAE002 (afuresertib) for breast cancer has met its primary endpoint. The treatment has brought significant and clinically meaningful improvements to patients, with the top-line results clearly demonstrating best-in-class efficacy and safety profile.” said Dr. Chris Lu, Chairman and CEO of Laekna. “In response to the high unmet medical needs, we are pursuing collaborations with partners to accelerate patient access to this novel therapy in global markets.”
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“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.