Exelixis' Cabozantinib Data Shows Clinically Significant Benefit Versus Pfizer's Sutent, In A Type Of Kidney Cancer

Exelixis Inc (NASDAQ: EXEL) has reported new data from the Phase 2 (PAPMET) study evaluating CABOMETYX (cabozantinib) compared with Pfizer Inc's PFE Sutent (sunitinib) in patients with metastatic papillary renal cell carcinoma (PRCC), a form of kidney cancer.
Exelixis presented the data at the American Society of Clinical Oncology's Genitourinary Cancers Symposium. It will publish the findings simultaneously in the Lancet.
CABOMETYX demonstrated Median progression-free survival of 9.0 months (n=44) versus 5.6 months with sunitinib (n=46), trial's primary endpoint. The overall response rate was 23% for CABOMETYX versus 4% for sunitinib. Median overall survival was 20 months for cabozantinib and 16.4 months for sunitinib, which did not reach statistical significance.
Enrollment into additional arms of the study examining the use of crizotinib or savolitinib compared to sunitinib was halted early based on predefined interim futility analyses.
On the safety front, the most common severe/life-threatening adverse events with CABOMETYX were hypertension (32%), hand-foot syndrome (20%), and fatigue (13%). One death, secondary to a thromboembolic event, was reported for a patient receiving CABOMETYX.
The discontinuation rate of study medications due to treatment-related adverse events was 24% for sunitinib and 23% for CABOMETYX.
Last week, the Company reported Cabometyx combined with Bristol Myers Squibb's Opdivo doubled median progression-free survival (17.0 months vs. 8.3 months) compared to sunitinib, the trial's primary endpoint, in the first-line treatment of advanced renal cell carcinoma.
Price Action: EXEL gained 2.24% at $22.4 in premarket trading on the last check Tuesday.

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