Exelixis Nears FDA Decision, Key Kidney Cancer Data for Zanzalintinib

Key Points

• FDA decision on zanzalintinib is expected in early March for use with atezolizumab in previously treated colorectal cancer; the FDA extended its review to request additional data.
• Kidney cancer trial results are expected in the first quarter of next year. Exelixis delayed the STELLAR-304 readout because trial events accumulated more slowly than anticipated.
• Exelixis is seeking to reduce its reliance on cabozantinib by building a zanzalintinib franchise. The company says seven pivotal studies represent more than $5 billion in potential opportunity, contingent on successful development and commercialization.

Exelixis NASDAQ: EXEL is preparing for a regulatory decision on its cancer drug candidate zanzalintinib and expects results from a kidney cancer study in the first quarter of next year, Chief Strategy Officer Andrew Peters said at an investor event.

Peters described the company as approaching a transition from reliance on its existing cabozantinib, or Cabo, franchise toward a business with multiple drug franchises. The Food and Drug Administration has an early March decision date next year for zanzalintinib, also known as zanza, in combination with atezolizumab for previously treated colorectal cancer, he said.

Exelixis also plans to expand development of zanzalintinib beyond its existing pivotal studies. Peters said a second wave of trials would start shortly and would almost certainly include a study in newly diagnosed metastatic kidney cancer.

Kidney cancer data expected in first quarter

The company recently moved its expected timing for top-line results from STELLAR-304, a Phase 3 study in non-clear cell renal cancer, to the first quarter of next year. Peters said events in the trial were accumulating more slowly than anticipated, pushing the expected clinical cutoff closer to year-end.

He did not specify how much data Exelixis would disclose in its top-line announcement, saying the company’s past releases have varied in detail. Its goal is to generate a robust dataset, pursue a filing and reach patients as soon as possible, he said.

Peters cautioned against comparing the Phase 3 trial directly with smaller, single-arm studies. He said Exelixis launched STELLAR-304 to potentially establish a standard of care using evidence from a large, randomized global study. He also said it was too early to speculate about the potential scope of a label for zanzalintinib and nivolumab before seeing the data.

Asked about a 60-milligram zanzalintinib dose in the LITESPARK-034 study, lower than the 100-milligram dose used in some earlier trials, Peters said dosing would be tailored to the indication, combination and line of therapy. He said Exelixis was comfortable with the 60-milligram dose and had generated additional data to inform its decisions.

Colorectal cancer opportunity

For colorectal cancer, Exelixis is seeking approval of zanzalintinib with atezolizumab for patients who have received at least two prior lines of treatment. The FDA extended its review to accommodate a request for more data, according to the event moderator.

Peters declined to discuss specifics of regulatory conversations. He said the STELLAR-303 data showed a survival advantage against standard care and described the treatment as active across a broad range of patient subgroups, rather than having its effect driven by a single subgroup.

Exelixis estimates the relevant later-line colorectal cancer market at about $1.5 billion, based on patient numbers, treatment duration and pricing, Peters said. The company aims to gain share across existing treatment categories, rather than targeting a single regimen, he added.

Exelixis is also studying zanzalintinib alone and with pembrolizumab in STELLAR-316, a Phase 3 trial involving patients with minimal residual disease after adjuvant chemotherapy. Peters said the study is designed to test whether treatment can delay disease recurrence compared with a watch-and-wait approach. He acknowledged that tolerability and appropriate dosing are important considerations when treating patients earlier in the course of disease.

Looking beyond Cabo

Peters said the seven pivotal studies Exelixis has outlined for zanzalintinib represent more than $5 billion in total opportunity. He said the company could expand that opportunity by adding studies and using clinical collaborations to share costs. Those estimates are prospective and depend on successful development and commercialization.

As Exelixis considers the eventual loss of Cabo exclusivity, Peters said the trajectory of zanzalintinib revenue will depend on clinical results and commercial execution. The company also has a high strategic priority to establish a third franchise, potentially from its internal pipeline or an external opportunity.

Peters said Exelixis would remain selective about business development and acquisitions, weighing both biological prospects and commercial potential. For earlier-stage programs, he said the company’s decisions will center on whether the data justify a pivotal study and whether a successful product could generate meaningful revenue.

About Exelixis (NASDAQ:EXEL)

Exelixis, Inc. is a biotechnology company focused on discovering, developing and commercializing medicines for cancer. Founded in 1994 and headquartered in Alameda, California, the company has built its business around oncology treatments and continues to advance a pipeline of potential cancer therapies. Its principal marketed medicine is cabozantinib, sold in the United States as Cabometyx and Cometriq. Cabometyx is used to treat certain patients with advanced kidney, liver and thyroid cancers, while Cometriq is used for medullary thyroid cancer.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.