Exelixis partners with Merck for colorectal cancer trial

INVESTING.COMMay 19, 12:05 PM UTC

Key insights

  • Exelixis partners with Merck for a Phase 3 colorectal cancer trial (STELLAR-316) using Keytruda QLEX. The trial, expected to start in mid-2026, will evaluate zanzalintinib with and without Keytruda QLEX. Exelixis' strong financial health and positive analyst revisions suggest potential for future growth, but the trial's distant start date limits immediate market impact.
Exelixis partners with Merck for colorectal cancer trial

ALAMEDA, Calif. - Exelixis Inc. (NASDAQ:EXEL) announced today a clinical development collaboration with Merck to supply KEYTRUDA QLEX for a planned phase 3 trial in patients with resected stage II/III colorectal cancer. The biotech company, valued at $12.5 billion, maintains an "EXCELLENT" financial health score according to InvestingPro analysis, with liquid assets comfortably exceeding short-term obligations.

Under the agreement, Exelixis will sponsor the STELLAR-316 pivotal trial, while Merck will supply KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), its subcutaneous anti-PD-1 therapy, according to a press release statement.

The STELLAR-316 trial will evaluate zanzalintinib with and without KEYTRUDA QLEX in patients with resected stage II/III colorectal cancer who have tested positive for molecular residual disease following definitive therapy and have no radiographic evidence of disease. The primary endpoint will be disease-free survival, with circulating tumor DNA clearance as a key secondary endpoint.

Exelixis expects to initiate the trial in mid-2026. In January 2026, the company announced a collaboration with Natera for STELLAR-316, with Natera providing its Signatera assay to identify molecular residual disease-positive patients for trial enrollment.

Zanzalintinib is an investigational oral kinase inhibitor that targets TAM kinases, MET and VEGF receptors. In February 2026, the U.S. Food and Drug Administration accepted Exelixis’s New Drug Application for zanzalintinib in combination with atezolizumab for metastatic colorectal cancer treatment. The FDA assigned a target action date of December 3, 2026.The company’s strong financial position supports its clinical development pipeline. Exelixis posted a return on assets of 31% over the last twelve months, while trading at a P/E ratio of 16.6. According to InvestingPro Tips, 8 analysts have revised their earnings upwards for the upcoming period, and the stock appears undervalued based on InvestingPro’s Fair Value analysis—placing it among companies on the Most Undervalued list. Investors seeking deeper insights can access 11 additional ProTips and comprehensive Pro Research Reports covering Exelixis and 1,400+ other US equities.

Approximately 159,000 new colorectal cancer cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease, according to the press release. Colorectal cancer is the third most common cancer in the U.S.The company’s shares have gained 11.5% over the past year, trading near their 52-week high of $51.63.

Zanzalintinib is not approved for any use and remains under clinical investigation.

In other recent news, Exelixis Inc. has reported strong financial results for the first quarter of 2026, exceeding both earnings and revenue projections. The company achieved an earnings per share (EPS) of $0.87, surpassing the anticipated $0.77, which represents a 12.99% surprise. Revenue for the quarter reached $611 million, slightly above the forecast of $608.95 million. These results highlight Exelixis’s solid performance in the recent quarter. Investors showed a positive reaction to this news. The earnings and revenue figures suggest that Exelixis is maintaining a strong financial position. These developments are part of the company’s ongoing financial reporting and strategy execution.

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