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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.
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