Ipsen Opts-in to Join Exelixis With Ongoing Development of Cabometyx for People Living With a Form of Thyroid Cancer, Based on Promising Interim Results

Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced it has exercised its option to collaborate with Exelixis, Inc. (Exelixis) in the pivotal COSMIC-311 Phase III trial. COSMIC-311 is evaluating Cabometyx (cabozantinib) 60 mg versus placebo in people living with radioiodine-refractory differentiated thyroid cancer (DTC) who have progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies.² Radioactive iodine (RAI) is a treatment option for DTC when patients are at high risk of disease recurrence, have incompletely resected cancer, or distant metastases.³ Patients who develop RAI-refractory DTC, whereby they are resistant to RAI treatment, typically have a poor prognosis with an estimated survival of three to five years on average.⁴

Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen, commented:
“A planned interim analysis of the COSMIC-311 Phase III trial has shown promising and clinically meaningful results in the use of Cabometyx in people living with radioiodine-refractory differentiated thyroid cancer who have progressed after prior therapy. We are delighted to build on our strong foundation and join Exelixis to further evaluate, and to work with regulatory authorities on, the potential of Cabometyx in a patient population who currently have limited treatment options.”

Results from the planned Phase III interim analysis of COSMIC-311 showed that the trial met the co-primary endpoint of demonstrating significant improvement in progression-free survival.¹ The detailed results from the analysis will be presented at the forthcoming ASCO Annual Meeting, taking place virtually from 4 to 8 June 2021.

Ipsen has an exclusive collaboration agreement with Exelixis for the commercialization of Cabometyx outside of the U.S. and Japan. Following the decision to opt-in to the COSMIC-311 trial, Ipsen gains access to the results to support potential future regulatory submissions in its territories.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Cabometyx in February 2021 as a potential treatment for people living with DTC who have progressed following prior therapy and who are RAI-refractory (if RAI is appropriate).

About radioiodine-refractory differentiated thyroid cancer

In 2020, over 580,000 new cases of thyroid cancer were diagnosed worldwide.⁵ Thyroid cancer is the ninth most commonly occurring cancer globally and incidence is three times higher in women than in men, with the disease representing one in every 20 cancers diagnosed among women.⁵ While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid tumors make up about 90 to 95% of cases.^6,7 These include papillary, follicular and Hürthle cell cancer.^6,7 DTC is typically treated with surgery, followed by ablation of the remaining thyroid tissue with RAI, but approximately 5 to 15% of cases are resistant to RAI treatment.⁸ Patients who develop RAI-refractory DTC have a poor prognosis with an estimated survival of three to five years on average.⁴