Phase III trial supports the potential use of Cabometyx for thyroid cancer
pharmafile | June 8, 2021 | News story | Manufacturing and Production |
Ipsen and Exelixis have announced detailed results from the Phase III COSMIC-311 pivotal trial of Cabozantinib in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer.
Cabozantinib demonstrated a significant reduction in the risk of disease progression or death of 78% versus placebo in the intent-to-treat (ITT) population.
In the ITT population, a reduction in target lesion size was found in 76% of patients receiving cabozantinib versus 29% of patients receiving placebo.
The results support the potential use of Cabometyx across subgroups of people living with previously treated RAI-refractory DTC, for whom there is no established standard of care and a pressing need for innovation.
Results from COSMIC-311 Pivotal trial, which met the co-primary endpoint of significant improvement in progression-free survival (PFS) assessed by blinded independent radiology committee (BIRC), served as basis for Exelixis’ recent supplemental New Drug Application to the FDA.
Marcia S Brose, Professor of Otorhinolaryngology and Principal Investigator of COSMIC-311, said: “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.
“The significant improvement in progression-free survival and favourable trend for overall survival suggest cabozantinib could be an important new option for these patients.”
Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen, said: “The results from the COSMIC-311 Phase III trial have been highly anticipated, with the current survival time for people living with this uncommon form of differentiated thyroid cancer at just three to five years from the time metastatic lesions are detected.
“We’re delighted to share these data at ASCO together with Exelixis, highlighting our continued commitment to exploring the potential of cabozantinib across a range of hard-to-treat cancers. We look forward to working with regulatory authorities in our territories with the aim of bringing a meaningful new treatment option to a patient population in critical need.”
Approximately 44,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2021, and nearly three out of four of these cases will be in women.
The disease is more commonly diagnosed at a younger age compared to most other adult cancers.
Lilly Subbotin
