Ipsen’s Cabometyx Receives EC’s Approval as a 2L treatment for Radioactive Iodine-Refractory Differentiated Thyroid Cancer
Shots:
- The approval was based on the P-III (COSMIC-311) trial evaluating Cabometyx (60mg, qd) vs PBO in a ratio (2:1) in 258 patients with LA or metastatic DTC at 164 sites globally. The trial was sponsored by Exelixis & co-funded by Ipsen
- The trial had met its 1EPs of PFS & showed a 78% reduction in risk of disease progression or death at a median follow-up of 6.2mos. while other 1EPs showed ORR (15% vs 0%) at a median follow-up of 8.9mos. superior efficacy was maintained
- The safety profile across 2 analyses was consistent with prior observed for Cabometyx, AEs were managed with dose modifications. The results presented at ESMO 2021 showed superior m-PFS (11.0mos. vs 1.9mos.) at a median follow-up of 10.1mos.
Ref: IPSEN | Image: Businesswire
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