Ipsen Receives Positive CHMP Opinion for Cabometyx® in Radioactive Iodine-refractory Differentiated Thyroid Cancer
Ipsen announced a positive recommendation from the European Medicines Agency's CHMP for Cabometyx as a treatment for locally advanced or metastatic differentiated thyroid cancer (DTC) in adults. This recommendation is based on the COSMIC-311 Phase III trial, where Cabometyx showed a 78% reduction in disease progression or death compared to placebo. The objective response rate was 15% for Cabometyx versus 0% for placebo. This follows prior FDA approval in September 2021. Cabometyx is marketed in over 60 countries worldwide, addressing a critical need for new treatment options.
- Cabometyx demonstrated a 78% reduction in the risk of disease progression or death versus placebo in the COSMIC-311 trial.
- The objective response rate for Cabometyx was 15% compared to 0% for placebo.
- Cabometyx is now recommended by the CHMP for treating patients with refractory DTC.
- Cabometyx is approved in over 60 countries, enhancing its market presence.
- The objective response rate did not meet statistical significance, which could raise concerns about Cabometyx's overall efficacy.
- The trial's median follow-up of 6.2 months may be considered short for long-term efficacy assessment.
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Recommendation based on data from the COSMIC-311 Phase III trial, in which Cabometyx® (cabozantinib) demonstrated a
78% reduction in risk of disease progression or death versus placebo1
Disclaimer: Intended for international media and investor audiences only
The CHMP positive opinion was based on results from the pivotal COSMIC-311 Phase III trial in which, at a planned interim analysis with a median follow-up of 6.2 months, Cabometyx demonstrated a significant reduction in the risk of disease progression or death by
This positive CHMP opinion follows the
About radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC)
In 2020, over 580,000 new cases of thyroid cancer were diagnosed worldwide.3 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.3 While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid cancer (DTC) makes up about 90 to
About the COSMIC-311 trial
COSMIC-311 is a multicenter, randomized, double-blind, placebo-controlled Phase III trial that enrolled 258 patients at 164 sites globally.1,2 Patients were randomized in a 2:1 ratio to receive either Cabometyx 60 mg or placebo once-daily.1 The primary endpoints were progression-free survival in the intention-to-treat population as well as ORR in the first 100 randomly assigned patients (objective response rate intention-to-treat [OITT] population), both evaluated by a blinded independent radiology committee. Additional endpoints include safety, overall survival and quality of life.1 Exelixis is the sponsor of COSMIC-311, and Ipsen is co-funding the trial. More information about this trial is available at ClinicalTrials.gov.
About Cabometyx (cabozantinib)
In the
The detailed recommendations for the use of Cabometyx are described in the Summary of Product Characteristics (EU SmPC) and in the
Ipsen has exclusive rights for the commercialization of Cabometyx outside the
About Ipsen
Ipsen is a global mid-size biopharmaceutical company with a focus on transformative medicines in Oncology, Rare Disease and Neuroscience. Ipsen also has a well-established
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References
- Brose et al., Cabozantinib for radioiodine-refractory differentiated thyroid cancer (COSMIC-311): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncology. 2021; 22:8. DOI:https://doi.org/10.1016/S1470-2045(21)00332-6.
- Capdevila et al., ESMO 2021. Cabozantinib (C) versus placebo (P) in patients (pts) with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC) who have progressed after prior VEGFR-targeted therapy: updated results from the phase 3 COSMIC-311 trial and prespecified subgroup analyses based on prior VEGFR-targeted therapy.
- Sung. H et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal For Clinicians. doi: 10.3322/caac.21660.
- Agarwal et al., ASCO 2020. Cabozantinib in combination with atezolizumab in patients with metastatic castration-resistant prostate cancer: Results of cohort 6 of the COSMIC-021 study.
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Cancer.Net. ASCO. Thyroid Cancer: Introduction. Last accessed:
December 2021 . Available at: https://www.cancer.net/cancer-types/thyroid-cancer/introduction. - Chen D. et al. Innovative analysis of distant metastasis in differentiated thyroid cancer. Oncol Lett 19: 1985-1992, 2020. doi: 10.3892/ol.2020.11304.
- Worden F. Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer. Ther Adv Med Oncol. 6:267–279. doi: 10.1177/1758834014548188.
- Fugazzola L. et al. 2019 European Thyroid Association Guidelines for the Treatment and Follow-Up of Advanced Radioiodine-Refractory Thyroid Cancer. Eur Thyroid J. 2019;8:227–245. doi: 10.1159/000502229.
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