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12:00 AM
 | 
Jun 04, 2012
 |  BioCentury  |  Product Development

Mixed messages in MTC

Exelixis: Cabozantinib will vie with AstraZeneca's Caprelsa in thyroid cancer

Updated Phase III data for Exelixis Inc.'s cabozantinib showed the compound did not improve survival in patients with medullary thyroid cancer, but the biotech says the data are not mature and that PFS and safety data suggest its compound could be competitive with AstraZeneca plc's Caprelsa vandetanib.

About 2,000 patients are diagnosed with MTC in the U.S. each year. The initial treatment is removal of the thyroid, after which some patients may have relatively indolent disease and others will experience highly progressive metastatic disease over the course of months. The exact proportion of patients with highly progressive disease is unknown.

In the latter case, treatment options include continued surgical removal of cancerous tissue and eventual systemic therapy when surgery is no longer an option.

In the latter instance, AZ's Caprelsa is the only approved therapy. The EGFR and VEGF receptor kinase inhibitor is approved for symptomatic or progressive MTC patients with unresectable locally advanced or metastatic disease.

Cabozantinib is a spectrum-selective kinase inhibitor of VEGF receptor 2 (KDR/Flk-1) and c-Met receptor tyrosine kinase.

According to an abstract released ahead of this week's American Society for Clinical Oncology (ASCO) meeting, there was no difference between cabozantinib and placebo on the secondary endpoint of overall survival (OS) at an interim analysis in the Phase III EXAM trial in 330 patients with MTC.

Only 41% of the 217 required events had occurred at the interim analysis. The trial was designed to have 80% power to detect a 50% increase in OS.

EVP and CMO Gisela Schwab told...

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