New Clinical Trials: Exelixis and Merck Aim to Boost Cancer Treatment Options

Exelixis, Inc. and Merck, known as MSD outside the US and Canada, have announced a clinical development collaboration to assess the combination of Exelixis' investigational tyrosine kinase inhibitor, zanzalintinib, with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in a Phase 3 pivotal trial for head and neck squamous cell carcinoma (HNSCC). They will also evaluate zanzalintinib in combination with WELIREG® (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in a Phase 1/2 trial and two Phase 3 pivotal trials for renal cell carcinoma (RCC). 

Merck will provide KEYTRUDA for the Exelixis-sponsored Phase 3 STELLAR-305 trial, which targets previously untreated PD-L1 positive recurrent or metastatic HNSCC, as a part of the collaboration. Merck will also lead the Phase 1/2 trial and two Phase 3 studies in RCC. Merck is funding one of the Phase 3 studies, while Exelixis will co-fund the Phase 1/2 trial and the other Phase 3 study, along with supplying zanzalintinib and cabozantinib. Exelixis retains all global commercial and marketing rights to zanzalintinib.

Amy Peterson, M.D., executive vice president of product development & medical affairs and chief medical officer of Exelixis, said in a statement, “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 with unmet clinical needs. KEYTRUDA and WELIREG are approved therapies that have improved outcomes for some cancer patients, and we are pleased to collaborate with Merck’s clinical development organisation 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.” 

Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, mentioned, “We look forward to working with our colleagues at Exelixis to advance these clinical trials. Merck remains committed to building upon the progress made by strategically evaluating the potential of new combination regimens to improve outcomes for more patients.”