Detailed results from phase III COSMIC-311 trial of cabozantinib in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer presented at conference
New data, which served as basis for supplemental New Drug Application to FDA, show progression-free survival benefit in intent-to-treat population was also consistent across subgroups (age≤65 vs.>65; prior treatment with/without lenvatinib; 1 vs 2 prior VEGFR-targeting therapies)
Source:
Biospace Inc.
SPS commentary:
As previously announced, at a planned interim analysis, cabozantinib demonstrated a significant reduction in the risk of disease progression or death of 78% versus placebo (HR 0.22; 96% CI: 0.13-0.36; p<0.0001) in the intent-to-treat population. At a median follow-up of 6.2 months, median progression-free survival was not reached (96% CI: 5.7 months – not estimable) with cabozantinib vs. 1.9 months (1.8-3.6 months) for placebo.
The supplemental New Drug Application is for an expanded indication for use in patients aged 12 years and older with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).