Back to top

Image: Bigstock

Exelixis (EXEL) Well Poised on Label Expansions of Caboemtyx

Read MoreHide Full Article

It has been a mixed year so far for Exelixis, Inc. (EXEL - Free Report) .

Its lead drug, Cabometyx, approved for advanced renal cell carcinoma (RCC) and previously treated hepatocellular carcinoma (HCC), maintains momentum on label expansions.

The advanced RCC treatment landscape evolved in recent times and the focus shifted to immunotherapy-VEGF TKI combinations in earlier-line treatment. Most of these combinations showed immense promise. Given their market potential, most pharma/biotech bigwigs are scurrying to grab a larger chunk of this pie.

In January 2021, the FDA approved Cabometyx in combination with immuno-oncology drug Bristol-Myers’ (BMY - Free Report) Opdivo for the first-line treatment of patients with advanced RCC.  Sales of the drug saw an increase in volume in the second quarter driven by the strong uptake for the combination therapy of Cabometyx and Opdivo.

However, shares took a significant hit in mid-2021 when the company announced disappointing data from the phase III study, COSMIC-312. The study is evaluating Cabometyx in combination with Roches (RHHBY - Free Report) Tecentriq (atezolizumab) compared to Bayer’s (BAYRY - Free Report) Nexavar (sorafenib) in patients with previously untreated advanced HCC.  Data from the study showed that it met only one of the primary endpoints, demonstrating significant improvement in progression-free survival (PFS) at the planned primary analysis. However, a prespecified interim analysis for the second primary endpoint of overall survival (OS) did not reach statistical significance. Hence, based on the preliminary OS data, Exelixis expects the probability of reaching statistical significance at the time of the final analysis to be low.

Nevertheless, the FDA recently approved Cabometyx (cabozantinib) for another indication. The drug is now approved in the United States for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy. The patients are also radioactive iodine-refractory or ineligible. Continued label expansions should drive sales further.

Additionally, Exelixis is looking to build a differentiated next-generation pipeline in oncology through strategic collaborations with candidates like XB002, XL092, among others. The successful development of additional candidates will diversify its revenue base and reduce dependence on Cabometyx.

Overall, the company has solid prospects with Cabometyx and the pipeline progress has been impressive in recent times.