Cabozantinib extends advanced RCC overall survival

In continuation of my update on Cabozantinib

Patients with advanced or metastatic renal cell carcinoma (RCC) derive a significant overall survival (OS) benefit from second-line treatment with the multi-tyrosine kinase inhibitor (TKI) cabozantinib relative to everolimus.

These findings come from the final analysis of the phase III METEOR trial in which 330 participants were randomly assigned to receive cabozantinib 60 mg/day and 328 allocated to the mammalian target of rapamycin inhibitor everolimus at a dose of 10 mg/day. All patients had received at least one previous vascular endothelial growth factor receptor TKI.

After a median follow-up of 18.7 and 18.8 months in the cabozantinib and everolimus arms, respectively, the corresponding median OS times were 21.4 and 16.5 months, a significant difference equating to a hazard ratio for death of 0.66.

Progression-free survival was also significantly improved in the cabozantinib arm, as was the objective response rate - findings that were consistent with the previously reported results for the first 375 randomly assigned patients, report Toni Choueiri (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) and team.

They conclude in The Lancet Oncology: "Based on these results, cabozantinib should be considered as a new standard-of-care treatment option for previously treated patients with advanced renal cell carcinoma."

Licensed from medwireNews with permission from Springer Healthcare Ltd. ©Springer Healthcare Ltd. All rights reserved. Neither of these parties endorse or recommend any commercial products, services, or equipment.

Ref : http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2816%2930107-3/abstract

Exelixis reports data from cabozantinib phase 3 trial on MTC

Exelixis, Inc. reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC). The trial, known as EXAM, met its primary endpoint of improving progression-free survival (PFS), with patients in the cabozantinib (see structure) arm achieving a median PFS of 11.2 months compared with 4.0 months for patients in the placebo arm. Overall response rate (ORR), a secondary endpoint, was 28% in the cabozantinib arm and 0% in the placebo arm. Estimated PFS at one year was 47.3% with cabozantinib vs. only 7.2% with placebo. Data for overall survival (OS), another secondary endpoint, are not yet mature. Patients on the cabozantinib arm of the trial received a dose of 140 mg (free base equivalent). Adverse events were generally manageable allowing for treatment with cabozantinib for prolonged periods of time. Exelixis recently submitted a New Drug Application (NDA) for cabozantinib in MTC to the U.S. Food and Drug Administration (FDA).

More...

Exelixis reports data from cabozantinib phase 3 trial on MTC: Exelixis, Inc.  reported data from the phase 3 pivotal trial of cabozantinib in patients with progressive, unresectable, locally advanced or metastatic medullary thyroid cancer (MTC).