FOR patients with a rare and aggressive form of thyroid cancer that is unresponsive to RAI treatment, there is currently no standard of care. But from the European Congress of Oncology (ESMO) today comes the confirmation of the efficacy of di cabozantinib. In fact, after more than 10 months of treatment, the drug continued to demonstrate a progression-free survival superior to placebo, with a 78% reduction in the risk of disease progression or death. The data are in line with what had already been presented in June at the Asco congress, and published in the Lancet Oncology. Further data from the final analysis also confirmed that increased efficacy was maintained regardless of previous vascular endothelial growth factor (VEGFR) targeted therapy.
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Thyroid cancer is the ninth most common cancer globally (more than 580,000 diagnosed in 2020) and its incidence is three times higher in women than in men: it represents one in 20 cancer diagnoses in the female population. Thyroid cancers include differentiated, medullary and anaplastic forms; differentiated thyroid tumors make up about 90-95% of cases. These include the papillary, follicular and Hürthle cell forms. Differentiated thyroid cancer (DTC) is commonly treated with surgery, followed by radioactive iodine ablation (RAI) of residual thyroid tissue, but approximately 5-15% of cases are resistant to RAI treatment. Patients with radioiodine-refractory differentiated thyroid cancer have a poor prognosis with an estimated average survival of three to five years.
Pending the extension of the indication for the drug
The efficacy and safety data from the interim analysis of the COSMIC-311 study are the basis of the request to the European Medicines Agency (EMA) for an extension of the indication of cabozantinib (already approved with other indications) also in differentiated thyroid cancer. refractory to radioiodine (RAI-R DTC). On August 14, 2021, the EMA validated the change, confirming the completeness of the request and initiating the centralized review process.
The COSMIC-311 study and the safety profile
COSMIC-311 is a multicentre, randomized, double-blind, placebo-controlled Phase III study enrolling 258 patients in 164 centers globally. Patients were randomized on a 2: 1 ratio to receive cabozantinib or placebo. The safety profile identified in the study was consistent with that previously observed for cabozantinib and adverse events were managed by adjusting the dosage. The discontinuation rate for treatment-related adverse events was 8.8% for cabozantinib versus 0% for placebo. Grade 3/4 treatment-related adverse events occurred in 62% of cabozantinib-treated patients vs. 28% for placebo, while no grade 5 events attributable to treatment were observed.
“The potential of cabozantinib continues to be confirmed as a key therapeutic option available to us against a wide range of cancers,” said Steven Hildemann, MD, Executive Vice President, Chief Medical Officer, Global Patient Safety and Patient Affairs, Ipsen: “I Final data from the COSMIC-311 study are a great example of how cabozantinib can make a real difference in patients’ lives, and we look forward to hearing about the EMA’s decision next year. We are committed to analyzing the role that cabozantinib can continue to play against difficult-to-treat cancers, while we await the results of the ongoing Phase III studies in non-small cell lung cancer and metastatic castration-resistant prostate cancer. “
In advanced prostate cancer
Other cabozantinib data presented at ESMO include new results on the combination of cabozantinib with atezolizumab (an immunotherapy) in patients with previously treated metastatic castration-resistant prostate cancer. At a minimum follow-up of 15.2 months, the objective response rate was 23%, with three patients in complete response. “As a uro-oncologist I am very encouraged by the results presented at this year’s ESMO congress,” said Gunhild von Amsberg, University Medical Center Hamburg-Eppendorf (UKE) and investigator of the CONTACT-02 study: “For patients with advanced cancer metastatic castration resistant prostate, the prognosis is often poor and the potential for new innovative therapies is of paramount importance. We look forward to the results of the ongoing Phase III CONTACT-02 “.
New data also in advanced kidney cancer
The results of further analyzes of the CheckMate -9ER study, which evaluates the combination of cabozantinib and nivolumab (another immunotherapist), which brings further data for clinical decision making in advanced renal cell carcinoma, were also presented to ESMO. The new results demonstrate improved efficacy of cabozantinib combined with nivolumab, regardless of previous nephrectomy status, and improved duration of response, compared to sunitinib. Yet another analysis shows the improvement in quality of life in favor of cabozantinib and nivolumab, compared to the combination of axitinib and pembrolizumab.
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