Exelixis, Inc. (NASDAQ:EXEL) announced positive overall survival (OS) results from METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with advanced renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI). In a second interim analysis for OS, a secondary endpoint of the trial, the results showed a highly statistically significant and clinically meaningful increase in OS for patients randomized to cabozantinib as compared to everolimus. Ongoing study monitoring did not identify any new safety signals. Exelixis intends to present these data at a medical meeting later this year.
“With these results, cabozantinib is now the first and only therapy evaluated in a large, pivotal study in previously treated patients with advanced renal cell carcinoma to demonstrate a benefit in all three key efficacy parameters – overall survival, progression-free survival and objective response rate,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “This is an important moment for the kidney cancer community, including the patients, clinical investigators, and Exelixisteam members who made the METEOR trial possible. Exelixis will share these new results with regulators as part of ongoing review processes in the United States and European Union. Our highest priority is to bring this new option for advanced RCC to patients as quickly as possible.”
In late December 2015, Exelixis announced that it completed the submission of its rolling New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced RCC who have received one prior therapy; the U.S. Food and Drug Administration (FDA) recently granted Priority Review to the application and set a Prescription Drug User Fee Act action date of June 22, 2016. The FDA previously granted Breakthrough Therapy and Fast Track designations to cabozantinib for its potential advanced RCC indication.
On January 28, 2016, the European Medicines Agency (EMA) validated Exelixis’ Marketing Authorization Application (MAA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy. The MAA has been granted accelerated assessment, making it eligible for a 150-day review, versus the standard 210 days (excluding clock stops when information is requested by the EMA’s Committee for Medicinal Products for Human Use).
Both regulatory applications are based on the results of METEOR. In July 2015, Exelixisannounced top-line results from METEOR demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, a standard of care therapy for second line RCC, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. Median PFS for cabozantinib was 7.4 months as compared to 3.8 months with everolimus (HR=0.58, 95% CI 0.45-0.75, p < 0.001). Cabozantinib also significantly improved the objective response rate as compared to everolimus. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.
Cabozantinib is currently marketed in capsule form under the brand name COMETRIQ®in the United States for the treatment of progressive, metastatic medullary thyroid cancer (MTC), and in the European Union for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. COMETRIQ is not indicated for patients with RCC. In the METEOR trial, and all other cancer trials currently underway,Exelixis is investigating a tablet formulation of cabozantinib distinct from the COMETRIQ capsule form. The tablet formulation of cabozantinib is the subject of the NDA and MAA for advanced RCC. (Original Source)
Shares of Exelixis closed last Friday at $4.62. EXEL has a 1-year high of $6.81 and a 1-year low of $1.80. The stock’s 50-day moving average is $4.88 and its 200-day moving average is $5.54.
On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on January 19, Leerink Swann analyst Michael Schmidt upgraded EXEL to Buy, with a price target of $7, which represents a potential upside of 51.5% from where the stock is currently trading. Separately, on January 13, William Blair’s John Sonnier reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Schmidt and John Sonnier have a total average return of -1.8% and 4.3% respectively. Schmidt has a success rate of 44.2% and is ranked #2465 out of 3622 analysts, while Sonnier has a success rate of 45.5% and is ranked #739.
Exelixis Inc is a biotechnology company that develops small molecule therapies for the treatment of cancer.