COSMIC-311 clinical trial : Exelixis enrolls patients to study cabozantinib in phase 3 thyroid cancer trial

COSMIC-311 clinical trial : US biotech company Exelixis has enrolled the first 100 patients in a phase 3 trial called COSMIC-311 for evaluating cabozantinib (CABOMETYX) against placebo in a type of thyroid cancer.

The COSMIC-311 trial will feature patients having radioactive iodine-refractory differentiated thyroid cancer who have progressed following up to a couple of vascular endothelial growth factor (VEGF) receptor-targeted therapies.

The multicenter, randomized, double-blind, placebo-controlled late-stage clinical trial will look to enroll nearly 300 patients across 150 sites in different parts of the world.

Patients will be randomly grouped in a 2:1 ratio to receive cabozantinib 60 mg or placebo daily once.

Exelixis is likely to carry out an analysis in the first 100 patients for the co-primary endpoint of objective response rate, and an interim analysis of progression-free survival of the COSMIC-311 trial in the second half of this year. The US biotech company expects the total enrollment of 300 patients to be made in the second half as well.

Commenting on the COSMIC-311 clinical trial, Gisela Schwab – President, Product Development and Medical Affairs and Chief Medical Officer at Exelixis said: “Given the encouraging clinical activity observed for cabozantinib in phase 1 and 2 trials in differentiated thyroid cancer, and the poor prognosis for patients who have progressed after prior VEGF receptor-targeting therapy, it is exciting to reach this milestone for COSMIC-311.

“This brings us one step closer to a first analysis that will help us better understand cabozantinib’s potential in treating patients with this intractable form of thyroid cancer. We look forward to sharing those initial results later this year.”

CABOMETYX, currently does not have approval for the treatment of radioiodine-refractory differentiated thyroid cancer.

In the US, CABOMETYX has approval for the treatment of patients having advanced renal cell carcinoma and for the treatment of patients with hepatocellular carcinoma who were treated previously with sorafenib.

CABOMETYX tablets are also approved in the European Union and other countries and regions. In 2016, Exelixis gave exclusive rights to Ipsen for the commercialization and further clinical development of cabozantinib outside of the US and Japan.

In 2017, the US biotech company gave exclusive rights to Takeda Pharmaceutical for the commercialization and further clinical development of the cancer drug for all future indications in Japan.