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EXEL Collaborates With MRK for Late-Stage Colorectal Cancer Study
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Key Takeaways
Exelixis and Merck will study zanzalintinib plus Keytruda Qlex in phase III CRC trial STELLAR-316.
EXEL plans to launch STELLAR-316 in mid-2026 for MRD-positive stage II/III colorectal cancer.
Zanzalintinib NDA with Tecentriq in metastatic CRC faces FDA action date of Dec. 3, 2026.
Exelixis (EXEL - Free Report) announced a clinical development collaboration with pharma giant Merck & Co. (MRK - Free Report) to evaluate its pipeline candidate, zanzalintinib, in combination with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study for resected stage II/III colorectal cancer (CRC).
Under the agreement, Exelixis will sponsor the STELLAR-316 study, while Merck will provide Keytruda Qlex for use in the study.
Exelixis expects to initiate STELLAR-316 in mid-2026.
Year to date, Exelixis’ shares have risen 11.1% against the industry’s decline of 2.7%.
Image Source: Zacks Investment Research
More on EXEL’s Efforts to Advance Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MeR), MET and VEGF receptors.
The late-stage STELLAR-316 will evaluate zanzalintinib with and without Keytruda Qlex in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease — a high-risk population with substantial unmet need.
Keytruda is approved for several types of cancer.
The collaboration with Merck adds external validation to the zanzalintinib program.
Earlier this year, Exelixis partnered with Natera (NTRA - Free Report) , a global leader in cell-free DNA and precision medicine, for this study.
Natera will supply its Signatera assay to identify eligible MRD-positive patients for enrollment, further integrating precision medicine into the program.
EXEL Seeks to Diversify Portfolio Beyond Cabometyx
Zanzalintinib represents the company’s most significant near-term catalyst.
Exelixis’ new drug application seeking approval of zanzalintinib in combination with Roche’s (RHHBY - Free Report) Tecentriq for previously treated metastatic CRC is under review in the United States. The targeted population includes patients who have already received standard chemotherapy regimens, including fluoropyrimidine-, oxaliplatin- and irinotecan-based therapies, as well as anti-EGFR treatment for RAS wild-type disease.
The regulatory body set a target action date of Dec. 3, 2026.
A potential approval will broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.
Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer.
Exelixis collaborated with MRK in October 2024 to advance zanzalintinib.
In April 2026, MRK initiated LITESPARK-034, a phase III study evaluating zanzalintinib plus Welireg (belzutifan) versus Welireg and placebo in previously treated advanced renal cell carcinoma (RCC) patients who progressed after PD-1/L1 and VEGFR-TKI therapies.
This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.
Exelixis also announced two additional studies of zanzalintinib — STELLAR-202, a planned phase II trial evaluating the drug in combination with MRK’s blockbuster drug Keytruda (pembrolizumab) as maintenance therapy in squamous non-small cell lung cancer, and a new expansion cohort in the ongoing phase Ib/II STELLAR-002 study assessing zanzalintinib plus docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease.
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Image: Bigstock
EXEL Collaborates With MRK for Late-Stage Colorectal Cancer Study
Key Takeaways
Exelixis (EXEL - Free Report) announced a clinical development collaboration with pharma giant Merck & Co. (MRK - Free Report) to evaluate its pipeline candidate, zanzalintinib, in combination with subcutaneous Keytruda Qlex in the planned phase III STELLAR-316 study for resected stage II/III colorectal cancer (CRC).
Under the agreement, Exelixis will sponsor the STELLAR-316 study, while Merck will provide Keytruda Qlex for use in the study.
Exelixis expects to initiate STELLAR-316 in mid-2026.
Year to date, Exelixis’ shares have risen 11.1% against the industry’s decline of 2.7%.
Image Source: Zacks Investment Research
More on EXEL’s Efforts to Advance Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MeR), MET and VEGF receptors.
The late-stage STELLAR-316 will evaluate zanzalintinib with and without Keytruda Qlex in patients with resected stage II/III CRC who, following definitive therapy, have tested positive for molecular residual disease (MRD+) and have no radiographic evidence of disease — a high-risk population with substantial unmet need.
Keytruda is approved for several types of cancer.
The collaboration with Merck adds external validation to the zanzalintinib program.
Earlier this year, Exelixis partnered with Natera (NTRA - Free Report) , a global leader in cell-free DNA and precision medicine, for this study.
Natera will supply its Signatera assay to identify eligible MRD-positive patients for enrollment, further integrating precision medicine into the program.
EXEL Seeks to Diversify Portfolio Beyond Cabometyx
Zanzalintinib represents the company’s most significant near-term catalyst.
Exelixis’ new drug application seeking approval of zanzalintinib in combination with Roche’s (RHHBY - Free Report) Tecentriq for previously treated metastatic CRC is under review in the United States. The targeted population includes patients who have already received standard chemotherapy regimens, including fluoropyrimidine-, oxaliplatin- and irinotecan-based therapies, as well as anti-EGFR treatment for RAS wild-type disease.
The regulatory body set a target action date of Dec. 3, 2026.
A potential approval will broaden the company’s portfolio and reduce dependence on its lead drug, Cabometyx.
Roche’s Tecentriq is a cancer immunotherapy that is approved around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various types of cancer.
Exelixis collaborated with MRK in October 2024 to advance zanzalintinib.
In April 2026, MRK initiated LITESPARK-034, a phase III study evaluating zanzalintinib plus Welireg (belzutifan) versus Welireg and placebo in previously treated advanced renal cell carcinoma (RCC) patients who progressed after PD-1/L1 and VEGFR-TKI therapies.
This marks the second Merck-sponsored phase III study under the collaboration, following LITESPARK-033 (launched in December 2025), which is assessing the combination against cabozantinib in first-line advanced RCC post-adjuvant immunotherapy.
Exelixis also announced two additional studies of zanzalintinib — STELLAR-202, a planned phase II trial evaluating the drug in combination with MRK’s blockbuster drug Keytruda (pembrolizumab) as maintenance therapy in squamous non-small cell lung cancer, and a new expansion cohort in the ongoing phase Ib/II STELLAR-002 study assessing zanzalintinib plus docetaxel in metastatic castration-resistant prostate cancer patients with measurable disease.
EXEL’s Zacks Rank
Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.