The High Hope of Exelixis’s Cabometyx Label Expansion

Cabometyx’s label expansion

To manage the lifecycle of Cabometyx more effectively, Exelixis (EXEL) plans to explore the drug in combination with immune checkpoint inhibitors such as atezolizumab, ipilimumab, and nivolumab. For this reason, the company has already entered into collaborations with major oncology players Bristol-Myers Squibb (BMY) and Genentech, a subsidiary of Roche Holdings (RHHBY).

As both Cabometyx and immune checkpoint inhibitors have demonstrated a robust clinical profile, these combination regimens have high probabilities of showing high efficacy and safety in treating multiple types of cancers. To be sure, these initiatives could offer solid growth opportunities for Exelixis going forward.

The High Hope of Exelixis’s Cabometyx Label Expansion

In preclinical models, Cabometyx has already shown the ability to make tumor cells more prone to immune-mediated attacks. Exelixis has also released positive efficacy and safety data from its Phase 1b trial, which evaluated the potential of the drug in combination with either nivolumab alone or with nivolumab and ipilimumab together for a genitourinary cancer indication.

Exelixis has meanwhile collaborated with Bristol-Myers Squibb to study Cabometyx in combination with either nivolumab alone or nivolumab and ipilimumab in a Phase 3 trial for a first-line RCC (renal cell carcinoma) indication. The company plans to evaluate these combination regimens in other indications such as HCC (hepatocellular carcinoma) and bladder cancer.

Hepatocellular carcinoma

In addition to renal cell carcinoma, Exelixis is currently exploring the potential of Cabometyx for a second-line HCC indication in its Phase 3 Celestial trial. In this trial, patients who have already used a maximum of two systemic therapies and Pfizer’s (PFE) Sutent are being enrolled globally. The primary endpoint of this trial is overall survival. Exelixis expects to conduct the next interim data monitoring the committee review after 75% in 2017.

Notably, the iShares Russell 2000 Growth ETF (IWO) has about 0.33% of its total portfolio holdings in Exelixis.

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