Exelixis Sees Success in Cancer Trial

A regimen including Exelixis’ investigational drug zanzalintinib has outperformed Bayer’s gastrointestinal cancer medication Stivarga in a phase 3 study. The overall survival advantage propels Exelixis nearer to its goal of transforming the oral tyrosine kinase inhibitor into a product that generates $5 billion annually.

Exelixis is a publicly listed biotechnology firm located in California, dedicated to the research, development, and marketing of novel cancer therapeutics. Its main emphasis is on creating small molecule treatments for challenging cancers. Exelixis is recognized for its principal product, Cabozantinib, and has a robust internal cancer research and drug development portfolio.

The firm aims to move forward with zanzalintinib as the replacement for its premier cancer drug, Cabometyx. By enhancing characteristics such as pharmacokinetic half-life, the firm has developed a molecule it anticipates will get approval for several disorders and surpass the peak sales of Cabometyx. The stage 3 colorectal cancer study served as a crucial first validation for zanzalintinib.

Researchers randomized 901 participants to get either Stivarga or zanzalintinib in conjunction with Roche’s Tecentriq. The combination substantially outlasted Stivarga in terms of overall survival in patients with high-grade metastatic colorectal cancer that had not been treated earlier and did not have microsatellite instability.

Experts at William Blair said in a communication to investors that the impact on the study’s co-primary endpoint guarantees a significant commercial possibility for the emerging brand. Analysts indicate that the patient group included by the endpoint is the most substantial economic potential for zanzalintinib, with projected risk-adjusted peak sales in the U.S. reaching $875 million.

Analysts also noted that the positive topline results from the trial likely enhance both the strategic and underlying value of the company’s stock. They suggested that zanzalintinib could potentially help sustain the company’s revenue following the expiration of cabozantinib’s exclusivity in 2030.

The analysts will examine relative and absolute risk mitigation with the release of the complete findings, since these measures could shed light on the clinical significance of the survival advantage. The favorable findings prompted investors to increase the drug’s share price by 12% to over $45 on Monday.

However, Exelixis must achieve more trial successes to realize its primary objective for zanzalintinib. The biotechnology firm anticipates that gastrointestinal cancers, particularly colorectal tumors, will provide 45% of the projected $5 billion in revenue by 2033. GI cancers constituted 10% of Cabometyx sales in 2024, rendering these indications pivotal to Exelixis’ aspirations to surpass the $1.8 billion revenue earned by its existing medicine.