Business
Exelixis and Ipsen Announce Detailed Results from Phase 3 COSMIC-311 Pivotal Trial of Cabozantinib in Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer Presented at ASCO 2021
– New findings demonstrate the significant progression-free survival benefit seen in the intent-to-treat population was also consistent across subgroups – –
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– New findings demonstrate the significant progression-free survival benefit seen in the intent-to-treat population was also consistent across subgroups –\n\n– Results from COSMIC-311 served as basis for Exelixis’ recent supplemental New Drug Application to U.S. Food and Drug Administration –\n\n– Data are in press to be published in The Lancet Oncology –\n\n ALAMEDA, Calif. & PARIS--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) today announced detailed results from the phase 3 COSMIC-311 pivotal trial of cabozantinib (CABOMETYX®) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC). Results from the trial, which met the co-primary endpoint of significant improvement in progression-free survival (PFS) assessed by blinded independent radiology committee (BIRC), are in press to be published in The Lancet Oncology and have been submitted to the U.S. Food and Drug Administration (FDA). The data are being presented during the Oral Abstract Session: Head and Neck Cancer at 11:45 a.m. PT on Monday, June 7 at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #6001).\n\n“Following disease progression on anti-VEGFR therapy, patients with radioactive iodine-refractory differentiated thyroid cancer currently have no standard of care available to them, making the positive results of the COSMIC-311 trial an important clinical advance for this community in need of additional treatment options,” said Marcia S. Brose, M.D., Ph.D., Full Professor of Otorhinolaryngology: Head and Neck Surgery and Director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania, and principal investigator of COSMIC-311. “The significant improvement in progression-free survival and favorable trend for overall survival suggest cabozantinib could be an important new option for these patients.”\n\nResults from COSMIC-311 served as the basis for the supplemental New Drug Application that Exelixis has submitted to the FDA, seeking an expanded indication for CABOMETYX for patients 12 and older with DTC that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).\n\nAs previously announced, at a planned interim analysis, cabozant...