This is important news for patients suffering from advanced thyroid cancer that does not respond to treatment with radioactive iodine and for whom, until now, there has been no standard of care. We are talking about the approval in Italy of a drug in tablets, cabozantinib, which has shown that it can reduce the risk of disease progression or death by 78% compared to placebo at a follow up (control) of approximately six months.
The drug, which had been approved at European level almost two years ago, had however been made available as early as October 2021 thanks to a law (648/2020, GU n.238 of 05-10-2021), in consideration of the important unmet clinical need and added therapeutic value.
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Thyroid cancer
In Italy in 2023, approximately 12,200 new diagnoses of thyroid cancer were estimated, with a clear prevalence in the female population (8,700 cases among women compared to 3,500 cases among men). In 90-95% of cases it is differentiated carcinoma (DTC, in papillary, follicular and Hürthle cell forms); the classification of thyroid cancer then includes two other types: medullary and anaplastic.
Differentiated thyroid carcinoma is commonly treated with surgery, followed by radioactive iodine ablation (RAI) of the residual thyroid tissue: 5-year survival is very high (92% in men and 96% in women), but remains a of cases – between 5 and 15% – resistant to treatment with RAI. In these cases, the prognosis is poor, with an average estimated survival of three to five years. Hence the need for a new treatment for these patients.
“The approval of the reimbursement of cabozantinib for the treatment of differentiated thyroid carcinoma refractory to radioactive iodine therapy and progressing during first-line systemic medical therapy is an important result for the clinical management of these patients – he commented Rossella Elisei, President of the Italian Thyroid Association (AIT) and associate professor of Endocrinology at the University of Pisa -. The true meaning is to have another therapeutic weapon available for these patients who will thus be able to gain additional months and years of life. The endocrinological scientific community, and in particular the thyroid community, already knows cabozantinib for its ability to stop the growth of medullary thyroid carcinoma: this approval will allow it to be used in an equally important context from a clinical point of view”.
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The drug
Cabozantinib is an orally administered small molecule that inhibits multiple tyrosine kinase receptors such as VEGFR, MET, RET and the TAM family (TYRO3, MER, AXL). These tyrosine kinase receptors are involved in normal and pathological cellular processes, such as oncogenesis, metastasis, tumor angiogenesis (the growth of new blood vessels that tumors need to grow), drug resistance, modulation of immune activities and maintenance of the tumor microenvironment.
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Effectiveness and safety
The efficacy data of cabozantinib compared to placebo emerge from the COSMIC-311 study: at the median follow-up of 6.2 months, half of the patients treated with cabozantinib had not yet progressed, while in the placebo group the disease-free survival median progression was 1.9 months. The safety profile has thus far been consistent with that previously observed, and adverse events have been managed with dosage modifications.
“The approval of cabozantinib as a 2nd/3rd line therapy is a fundamental step forward in the treatment of patients with radio-iodine resistant differentiated thyroid cancer progressing after a first line of treatment – he commented Laura Locati, Director of SC Oncology, Istituti Clinici Scientifici Maugeri, IRCCS (Pavia) and Associate Professor of Medical Oncology at the University of Pavia – The efficacy of cabozantinib was tested in a randomized study, where cabozantinib was shown to reduce the probability of progression of thyroid cancer by 78% compared to placebo, thus responding to a specific need for treatment for which, to date, a standard of care did not yet exist. In the COSMIC-311 study the median progression-free survival was 11 months.” “The decision of the Italian Medicines Agency represents a further step forward in differentiated thyroid carcinoma refractory to radioactive iodine therapy, ensuring a further reliable therapeutic option for all people who currently do not have standard treatments available after progression to systemic medical therapy of front line – he concluded Paola Mazzanti, Medical Director of Ipsen Italia -. With this news we are proud to confirm our thirty-year commitment to oncology, oriented towards research and development of solutions aimed at improving the quality of life of all patients.”