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Exelixis Presents Phase 1 Trial Results for Cabozantinib, Nivolumab Combo in Genitourinary Tumors.

M2 PHARMA-February 22, 2017-Exelixis Presents Phase 1 Trial Results for Cabozantinib, Nivolumab Combo in Genitourinary Tumors

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- US-based biopharmaceutical company Exelixis, Inc. (NASDAQ: EXEL) has shown results from a phase 1 trial of cabozantinib in combination with either nivolumab or nivolumab plus ipilimumab in patients with refractory genitourinary tumors, the company said.

The primary endpoint of the trial is to determine the dose limiting toxicity and recommended phase 2 doses of the doublet and triplet combinations.

Between July 22, 2015 and December 31, 2016, 48 patients were accrued with previously treated metastatic urothelial carcinoma (mUC, n=19), urachal adenocarcinoma, squamous cell carcinoma of the bladder or urethra, germ cell tumor, castration-resistant prostate cancer, renal cell carcinoma, trophoblastic tumor, sertoli cell tumor or penile squamous cell carcinoma and treated in two parts.

In Part I, 30 patients were treated with the doublet combination of cabozantinib and nivolumab at four dose levels. In Part II, 18 patients were treated with the triplet combination of cabozantinib, nivolumab and ipilimumab at three dose levels.

Among the 43 patients who were evaluable for response, the objective response rate for all tumor types was 30% (38% for the doublet dosing schedule and 18% for the triplet dosing schedule), with a 7% complete response rate and a 23% partial response rate. Stable disease was reported in 56% of patients.

The ORR for patients with mUC was 38%, and 2 of 16 patients achieved a CR, while 2 patients with squamous cell carcinoma of the bladder had objective responses (1 CR and 1 PR).

In the mUC cohort, 15 of 16 patients had a CR, PR or SD as their best response.

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Publication:M2 Pharma
Date:Feb 22, 2017
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