Exelixis, Inc. (EXEL - Free Report) announced encouraging results from a phase II investigator-sponsored trial (“IST”) of cabozantinib for the first-line treatment of metastatic radioiodine (“RAI”)-refractory differentiated thyroid carcinoma (“DTC”).
The trial is being conducted by the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania. Enrollment for the trial was completed in August 2017.
Patients who were enrolled in this single-arm, open-label trial, were administered oral cabozantinib 60 mg, once daily. The trial enrolled metastatic, RAI-refractory DTC patients.
The primary endpoint of the trial is objective response rate. Partial response was achieved by 54% of patients (n=19), and stable disease was reported in 43% of patients (n=15) per RECIST 1.1.
However, one evaluated patient experienced a decrease in tumor target lesions. Secondary endpoints of the trial include progression-free survival (“PFS”), time to progression (“TTP”), duration of response and clinical benefit rate (“CBR”) defined as the number of patients achieving an objective response or stable disease for at least six months. The CBR at six months was 80% (n=28). With a median follow up for the study of 35 weeks the median PFS has not been reached. The median TTP among those patients who progressed was 35 weeks.
Exelixis plans to initiate a pivotal phase III study on cabozantinib in patients with advanced DTC later in 2018 based on the abovementioned results and data from other studies of cabozantinib in previously treated DTC.
Exelixis’ stock has rallied 30.3% over a year against the industry’’s decline of 4.2%.
We note that Exelixis’ lead product, Cometriq, the capsule form of cabozantinib, was approved in the United States in 2012 for the treatment of progressive, metastatic medullary thyroid cancer (“MTC”).
In April 2016, a tablet formulation of cabozantinib, Cabometyx was approved in the United States for the treatment of patients with advanced renal cell carcinoma (“RCC”) who have received prior anti-angiogenic therapy. The recent FDA approval of Cabometyx for the treatment of previously untreated advanced RCC should further boost demand. The drug demonstrated statistically significant and clinically meaningful improvement in PFS versus the current standard of care, Pfizer’s (PFE - Free Report) Sutent.
Meanwhile, Exelixis is developing cabozantinib in a broad development program comprising over 45 clinical studies across multiple indications. The CELESTIAL study for advanced hepatocellular carcinoma is also ongoing. Exelixis also announced collaboration agreements with Bristol-Myers Squibb (BMY - Free Report) and Roche (RHHBY - Free Report) for the development of cabozantinib in combination with immunotherapy agents in early 2017.
Exelixis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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