Exelixis, Inc. (EXEL) and Merck & Co. Inc. (MRK) have announced a strategic partnership to explore the combined efficacy of Exelixis' investigational tyrosine kinase inhibitor, zanzalintinib, with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab). This collaboration will be part of a phase 3 pivotal trial focused on treating patients with head and neck squamous cell carcinoma (HNSCC).
Additionally, the collaboration will assess the potential of zanzalintinib alongside Merck's WELIREG (belzutifan), an oral hypoxia-inducible factor-2 alpha (HIF-2) inhibitor. This research will span a phase 1/2 trial and two phase 3 pivotal trials, targeting patients with renal cell carcinoma (RCC).
Per the agreement, Merck will supply KEYTRUDA for Exelixis' ongoing phase 3 STELLAR-305 pivotal trial, which involves patients with previously untreated PD-L1 positive recurrent or metastatic HNSCC. Furthermore, Merck will spearhead a phase 1/2 trial and two phase 3 pivotal trials in RCC, funding one of these phase 3 studies. Exelixis will contribute to the funding of the phase 1/2 trial and the other phase 3 study, as well as providing zanzalintinib and cabozantinib.
Exelixis retains exclusive global commercial and marketing rights for zanzalintinib.
Amy Peterson, Executive Vice President of Product Development & Medical Affairs and Chief Medical Officer at Exelixis, remarked, "This collaboration reflects our confidence in zanzalintinib's potential to enhance patient outcomes when used in combination with immunotherapy or targeted therapy, addressing unmet clinical needs in HNSCC and RCC. With KEYTRUDA and WELIREG being approved therapies that have shown improved outcomes for some cancer patients, we are eager to work alongside Merck's clinical development team to further evaluate their combined potential with zanzalintinib."
