EXEL Stock Rises on Positive Data From Colorectal Cancer Study

Shares of Exelixis, Inc. EXEL gained 7.4% on June 23, after the company announced positive top-line results from the late-stage STELLAR-303 study.

This phase III study is a global, multicenter, randomized, open-label study that randomized 901 patients equally to receive either investigational tyrosine kinase inhibitor, zanzalintinib (100 mg) in combination with Tecentriq (atezolizumab) or Stivarga (regorafenib). The study includes patients with previously non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC).

Shares of the biotech company have gained 30.2% year to date against the industry’s decline of 3.4%.

More on EXEL’s STELLAR-303 Study on Zanzalintinib

Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER.

The STELLAR-303 study met one of its two dual primary endpoints, demonstrating a statistically significant improvement in overall survival (OS) for the intent-to-treat (ITT) population when treated with zanzalintinib in combination with Tecentriq compared to the current standard-of-care drug, regorafenib.

The ITT population consisted of all randomized patients, regardless of the presence of liver metastases.

Exelixis stated that the trial will continue to a final analysis of the second primary endpoint — OS in the subgroup without liver metastases (non-liver metastases, or NLM).

The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment.

Secondary endpoints of STELLAR-303 study include progression-free survival, objective response rate and duration of response in the ITT population and the NLM subgroup of patients.

The positive data from this study represents a pivotal achievement for Exelixis, increasing the likelihood of regulatory success and marking the first major milestone in the zanzalintinib development program.

EXEL’s Efforts to Diversify Portfolio

Exelixis’ lead drug, Cabometyx, maintains its status as the leading tyrosine kinase inhibitor (TKI) for the treatment of renal cell carcinoma (RCC) in both the frontline immuno-oncology (IO) +TKI market and the second-line monotherapy segment.

Cabometyx is also approved for use in combination with Bristol Myers’ BMY Opdivo in the first-line setting in RCC. Demand has been strong for this combination, boosting sales.

BMY’s Opdivo is one of the leading IO drugs, and has been approved for various oncology indications.

Cabometyx is also approved for the treatment of hepatocellular carcinoma.

The recent label expansion of cabozantinib for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic NET (pNET) and those with previously treated advanced extra-pancreatic NET should further fuel sales.

The pipeline progress has been impressive as well, as Exelixis looks to expand its oncology portfolio beyond Cabometyx.

Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer, head and neck cancer and neuroendocrine tumors.

Meanwhile, Exelixis collaborated with pharma giant Merck MRK to evaluate zanzalintinib, in combination with its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab), in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC).

Per the terms of the agreement, Merck is supplying Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1-positive recurrent or metastatic HNSCC.  

The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug, Cabometyx.

EXEL currently carries a Zacks Rank #2 (Buy).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research