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Exelixis Adds & Expands Cohorts in Cabometyx-Tecentriq Study

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Exelixis, Inc. (EXEL - Free Report) announced that amendments have been made to its multicentre, open-label, phase Ib study, COSMIC-021, evaluating lead drug, Cabometyx, in combination with Roche’s (RHHBY - Free Report) Tecentriq in patients with locally advanced or metastatic solid tumors.

The study is divided into two parts — a dose-escalation phase and an expansion cohort phase. The dose-escalation phase determined the optimal dose of Cabometyx to be 40 mg daily, when administered in combination with Tecentriq (1200 mg infusion once every 3 weeks).

Two original cohorts are being expanded and four cohorts are being included in the COSMIC-021 study. The original immunotherapy-refractory non-small cell lung cancer (NSCLC) and metastatic castration-resistant prostate cancer (CRPC) cohorts are being expanded to 80 patients each, based on encouraging early efficacy and safety data. In addition, four cohorts consisting of two expansion and two exploratory cohorts are being added to the study. The two new expansion cohorts will evaluate the above-mentioned combination in patients with metastatic CRPC, who have received prior enzalutamide or abiraterone therapy, with or without prior docetaxel therapy.

Moreover, two exploratory arms, evaluating Cabometyx and single-agent Tecentriq in patients with metastatic CRPC, are being added to determine the individual contribution of each therapy.

Consequently, the trial now includes 20 expansion cohorts (for various cancers) and four exploratory cohorts. In the study, the company aims to enroll up to 1,732 patients with advanced or metastatic solid tumors such as renal cell carcinoma (RCC) and urothelial carcinoma (UC), among others. In the expansion stage, the trial aims to determine the objective response rate in each cohort.

The company’s shares have gained 8.9% in the year so far compared with the industry’s growth of 0.8%.


Notably, Cabometyx was approved in the United States for the treatment of patients with advanced RCC.  The drug is also approved for hepatocellular carcinoma (HCC) in Europe and the United States.

Cabometyx maintains momentum, as it continues to gain market share for the RCC indication. The initial traction for the HCC indication in second and third-line settings is encouraging as well. Label expansion of the drug for additional indications should further boost sales.

Exelixis is developing cabozantinib in a broad development program, comprising more than 45 clinical studies across multiple indications. We remind investors that the company signed collaboration agreements with Bristol-Myers Squibb Company (BMY - Free Report) and Roche in 2017 to evaluate cabozantinib in combination with immunotherapy agents.

Zacks Rank

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

A better-ranked stock in the same space is Acorda Therapeutics (ACOR - Free Report) , which carries a Zacks Rank #2 (Buy).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates of Acorda for 2020 have narrowed by seven cents in the past 60 days.

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