Exelixis Bets on Zanza as Next Cancer Franchise as FDA Decision Nears

Key Points

• Exelixis is positioning zanzalintinib (zanza) as its next cancer-drug franchise, aiming to make it a leading tyrosine kinase inhibitor in the 2030s. Seven pivotal studies are underway or have reported results, with additional trials planned.
• The FDA extended its review of zanza in the Phase 3 STELLAR-303 colorectal cancer study and set a March 3 decision date next year, after requesting additional data. Exelixis also expects a STELLAR-304 readout in the first quarter.
• Cabometyx (CABO) volume grew 13% in the third quarter, supported by share gains in kidney cancer and growth in neuroendocrine tumors. Exelixis expects R&D spending of about $1 billion and says its debt-free position allows it to fund research, business development and share repurchases.

Exelixis NASDAQ: EXEL is working to build its next cancer drug franchise around zanzalintinib, or zanza, while continuing to grow its established CABO business, Chief Strategy Officer Andrew Peters said at a conference discussion with Guggenheim biotech analyst Michael Schmidt.

Peters described the company’s goal as making zanza a leading tyrosine kinase inhibitor, or TKI, in the 2030s, building on CABO’s position in the current decade. He said Exelixis has seven pivotal zanza studies underway or already read out in its first wave of development, with a second wave planned.

CABO Growth and Competition

Schmidt said CABO volume grew 13% in the third quarter. Peters attributed continued growth to efforts to win market share in renal cell carcinoma, or RCC, and to the launch in neuroendocrine tumors, or NETs. He said the company is targeting prescribers who use CABO less frequently and is seeing growth across the business.

Asked about potential competition from products submitted through the FDA’s 505(b)(2) pathway, Peters said such oncology products historically have not achieved broad commercial success without meaningful clinical data. He cited factors including a lack of automatic substitutability and, generally, a lack of guideline inclusion. Exelixis remains focused on patients and protecting its intellectual property, he said.

Zanza Review and Upcoming Data

Schmidt said the Phase 3 STELLAR-303 study met its overall survival outcome in the full colorectal cancer study population and that the FDA had extended its review, setting a March 3 decision date for next year. Peters said the agency requested additional data, Exelixis supplied it, and the FDA said it needed more time for review. He declined to discuss ongoing regulatory interactions further.

Peters said the company sees the potential for zanza in combination with atezolizumab as a chemotherapy-free option in colorectal cancer. Although the study’s original hypothesis about patients without liver metastases did not bear out, he said the overall data showed a consistent benefit across the population, regardless of liver metastasis status.

For STELLAR-304, Peters said Exelixis expects a readout in the first quarter as the study approaches its clinical cutoff. He said the primary analysis is triggered by the number of progression-free survival events and that counting those events is driving the timing. He cautioned against extrapolating too broadly from the result to other zanza trials, which involve different tumor types, treatment settings and combinations.

Earlier-Stage Cancer and Capital Allocation

Exelixis is also studying zanza in an earlier colorectal cancer setting through STELLAR-316. Peters said the study, conducted with Merck, is examining whether zanza alone or with pembrolizumab can help patients who test positive for minimal residual disease and face a high risk of recurrence. He estimated the potential population at 12,000 to 13,000 patients, while noting that it could change as testing increases.

Peters also highlighted studies in kidney cancer, NETs and meningioma, as well as a Phase 2 bladder cancer study in patients previously treated with PADCEV. He said decisions on further trials would depend on patient need, commercial potential and the likelihood of success.

On spending, Peters said Exelixis expects research and development expenses of about $1 billion and expects that level to remain flat going forward. He said the company intends to balance internal investment with external business development and share repurchases, adding that its financial position and lack of debt give it flexibility to pursue all three.

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.

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