Benzinga | Feb 16, 2021 09:06AM EST

Exelixis' Cabozantinib Shows Overall Objective Response Rates of 38% In Genitourinary Tumor Settings

* Exelixis Inc (NASDAQ: EXEL) announces final data from Phase 1 trial sponsored and conducted by the U.S. National Cancer Institute (NCI), including seven expansion cohorts, evaluating cabozantinib in combination with either Bristol-Myers Squibb Co's (NYSE:BMY) Opdivo (nivolumab) or nivolumab plus ipilimumab in patients with refractory metastatic genitourinary tumors.

* Exelixis presented the data at the American Society of Clinical Oncology's Genitourinary Cancers Symposium.

* In the study, cabozantinib, in combination with either nivolumab alone (n=64) or nivolumab plus ipilimumab (n=56), demonstrated an objective response rate (ORR) of 38%, with an 11.1% complete response (CR) rate.

* In 33 previously treated metastatic urothelial carcinoma patients, ORR was 42.4%, and the CR rate was 21%. The ORR in 16 previously treated metastatic renal cell carcinoma patients was 62.5%. The ORR was 20% for patients with urachal adenocarcinoma, 85.7% for squamous cell carcinoma of the bladder, and 44.4% for penile carcinoma.

* The median overall survival for the entire population was 15.9 months. Median progression-free survival was 5.5 months, and the median duration of response was 22.8 months.

* Recommended Phase 2 doses determined for the combination of cabozantinib plus nivolumab were cabozantinib 40 mg daily and 3 mg/kg of nivolumab every two weeks. The recommended phase 2 doses determined for the combination of cabozantinib plus nivolumab and ipilimumab were cabozantinib 40 mg daily, 3 mg/kg of nivolumab every two weeks, and 1 mg/kg ipilimumab every three weeks.

* Price Action: EXEL gained 1.41% at $22.22 in premarket trading on the last check Tuesday.