Exelixis Initiates Cabozantinib-Tecentriq Combination Trial

Exelixis, Inc. EXEL announced that it initiated the dose-escalation stage of a phase Ib trial of cabozantinib in combination with Roche's RHHBY Tecentriq. The drug will be evaluated in patients suffering from locally advanced or metastatic urothelial carcinoma (UC) or renal cell carcinoma (RCC).

The primary endpoint of the study is to determine the optimal dose and schedule of daily oral administration of cabozantinib when given in combination with Tecentriq for the subsequent expansion stage.

The FDA granted accelerated approval to immuno-oncology drug, Tecentriq in May 2016 for treating locally advanced or metastatic urothelial carcinoma. Initial uptake of the drug has been encouraging. In Oct 2016, Tecentriq became the first and only anti-PDL1 cancer immunotherapy to be approved by the FDA for the treatment of metastatic NSCLC.

The phase Ib open-label study is divided in two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase will enroll nine to 36 patients with inoperable, locally advanced, metastatic or recurrent UC (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy or RCC with or without prior systemic therapy.

The starting dose of cabozantinib will be 40 mg daily which can be increased to 60 mg daily or decreased to 20 mg daily. The patients enrolled will receive the standard Tecentriq dosing regimen (1200 mg infusion once every 3 weeks).

The secondary end points of the dose-escalation stage are to evaluate the plasma pharmacokinetics of daily oral administration of cabozantinib when given in combination with Tecentriq and to assess safety of the combination therapy through the evaluation of incidence and severity of adverse events, including immune-related adverse events.

Upon determination of the recommended dose and schedule, the trial will enroll four expansion cohorts, each with up to 30 patients, for a total of up to 120 patients with advanced or metastatic UC or RCC.

Exelixis is developing cabozantinib in a broad development program comprising over 45 clinical studies across multiple indications. The company received a significant boost in Apr 2016 when the FDA approved the tablet formulation of cabozantinib, (distinct from the capsule form) under the brand name Cabometyx for the treatment of RCC in patients who have received prior anti-angiogenic therapy.

Cabometyx was also approved in EU in Sep 2016 for the treatment of advanced RCC in adults who have received prior vascular endothelial growth factor (VEGF)-targeted therapy.

Exelixis' shares have moved up 32.8% year to date compared with the Zacks classified Medical - Biomedical and Genetics industry's gain of 2.3%.

Initial uptake of the drug was encouraging and is expected to propel the top line in the forthcoming quarters in 2017.

In early 2017, Exelixis inked agreements with Bristol-Myers Squibb BMY and Roche to collaborate on the development of cabozantinib in combination with immunotherapy agents. Exelixis and Bristol-Myers announced their plan to collaborate on the evaluation of cabozantinib in combination with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab) in a phase III trial in first-line RCC, and potentially in other tumor types including HCC and bladder cancer.

Zacks Rank & Key Pick

Exelixis currently carries a Zacks Rank #3 (Hold).

A top-ranked stock in the healthcare sector worth considering is VIVUS, Inc. VVUS which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

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