Exelixis, Merck Sign Clinical Development Deal To Evaluate Zanzalintinib With KEYTRUDA, WELIREG

(RTTNews) - Drug makers Exelixis, Inc. (EXEL) and Merck & Co Inc.(MRK) announced Monday that they have entered into a clinical development collaboration to evaluate the combination of Exelixis' investigational tyrosine kinase inhibitor (TKI) zanzalintinib with Merck's anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma or HNSCC.

The companies will also evaluate zanzalintinib with WELIREG (belzutifan), Merck's oral hypoxia-inducible factor-2 alpha (HIF-2) inhibitor, in a phase 1/2 trial and two phase 3 pivotal trials for the treatment of patients with renal cell carcinoma or RCC.

Under the deal terms, Merck will supply KEYTRUDA for the ongoing, Exelixis-sponsored phase 3 STELLAR-305 pivotal trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC.

In addition, Merck will sponsor a phase 1/2 trial and two phase 3 pivotal trials in RCC. Merck will fund one of these phase 3 studies, and Exelixis will co-fund the phase 1/2 trial and the other phase 3 study, as well as supply zanzalintinib and cabozantinib.

Exelixis maintains all global commercial and marketing rights to zanzalintinib.

Amy Peterson, Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis, said, "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. 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."

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