Benzinga | Feb 16, 2021 09:01AM EST

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 (NYSE: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.