Exelixis, Merck Strike Deal to Develop Zanzalintinib for Multiple Types of Cancer

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Merck and Exelixis have announced plans to enter into a clinical development collaboration to advance the combination of Exelixis’ investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck’s Keytruda (pembrolizumab) for a Phase III pivotal trial in the treatment of patients with head and neck squamous cell carcinoma (HNSCC), as well as the combination of zanzalintinib with Welireg (belzutifan) in a Phase I/II trial and two Phase III trials for renal cell carcinoma (RCC).¹

“This collaboration underscores our belief in zanzalintinib’s potential to drive patient benefit in combination with immunotherapy or targeted therapy in HNSCC and RCC indications that have unmet clinical need,” said Amy Peterson, MD, EVP, product development & medical affairs, chief medical officer, Exelixis, in a press release. “Keytruda and Welireg are approved therapies that have led to improved outcomes for some cancer patients, and we are pleased to collaborate with Merck’s clinical development organization to evaluate the potential of these therapies in combination with zanzalintinib. This collaboration paves the way for further zanzalintinib development in RCC in a pragmatic manner.”

Under terms of the deal, Merck will supply Keytruda for Exelixis’ Phase III STELLAR-305 pivotal trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC. Further, Merck will support the Phase I/II trial and two Phase III trials for RCC. Additionally, Merck and Exelixis will each fund one of the Phase III studies, whereas Exelixis will fund the Phase I/II study.¹

To date, more than 1600 trials are evaluating Keytruda across a range of cancer types and treatment settings. Keytruda has approved indications in melanoma; non-small cell lung cancer; head and neck squamous cell cancer; classical Hodgkin lymphoma; primary mediastinal large B-cell lymphoma; urothelial carcinoma; gastric cancer; microsatellite instability-high or mismatch repair deficient cancer; microsatellite instability-high or mismatch repair deficient colorectal cancer; esophageal cancer; cervical cancer; hepatocellular carcinoma; Merkel cell carcinoma; renal cell carcinoma; endometrial carcinoma; tumor mutational burden-high cancer; cutaneous squamous cell carcinoma; and triple-negative breast cancer.

Globally, around 900,000 people have HNSCC globally, with 71,100 cases coming from the United States. According to UpToDate, there were approximately 63,500 deaths in 2012 in Europe. Overall, HNSCC accounts for an estimated 400,000 deaths on an annual basis.²

“We look forward to working with our colleagues at Exelixis to advance these clinical trials,” said Marjorie Green, SVP, head of oncology, global clinical development, Merck Research Laboratories, in the press release. “Merck remains committed to building upon the progress made to-date by strategically evaluating the potential of new combination regimens to improve outcomes for more patients.”

References

1. Exelixis and Merck Sign Clinical Development Collaboration to Evaluate Investigational Zanzalintinib in Combination With KEYTRUDA® (pembrolizumab) in Head and Neck Cancer and in Combination With WELIREG® (belzutifan) in Renal Cell Carcinoma. Merck. October 14, 2024. Accessed October 15, 2024. https://www.merck.com/news/exelixis-and-merck-sign-clinical-development-collaboration-to-evaluate-investigational-zanzalintinib-in-combination-with-keytruda-pembrolizumab-in-head-and-neck-cancer-and-in-combination-with/

2. Epidemiology and risk factors for head and neck cancer. UpToDate. Accessed October 15, 2024. https://www.uptodate.com/contents/epidemiology-and-risk-factors-for-head-and-neck-cancer#:~:text=Worldwide%2C%20head%20and%20neck%20cancer,African%20American%20men%20%5B6%5D.