Merck & Co – known as MSD outside the US and Canada – and Exelixis have entered into a clinical development collaboration to evaluate new combination treatments for head and neck cancer and renal cell carcinoma (RCC).
A combination of Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) and Exelixis’ investigational tyrosine kinase inhibitor zanzalintinib will be evaluated in a pivotal phase 3 trial of patients with head and neck squamous cell carcinoma (HNSCC).
A phase 1/2 trial and two phase 3 trials will also evaluate zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha inhibitor Welireg (belzutifan) in RCC.
More than 58,450 new cases of head and neck cancer, which describes a number of different tumours that develop in or around the throat, larynx, nose, sinuses and mouth, are expected to be diagnosed in the US in 2024. Meanwhile, approximately 81,600 new diagnoses of kidney cancer will be made in the country this year, with RCC accounting for the vast majority of cases.
Zanzalintinibis is designed to inhibit cancer-related pathways that play a role in resistance to multiple therapies, and the candidate has already shown promise in a phase 1b trial of patients with previously treated clear cell RCC.
Amy Peterson, executive vice president, product development and medical affairs, and chief medical officer at Exelixis, which will maintains all global commercial and marketing rights to zanzalintinib, said: “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 organisation to evaluate the potential of these therapies in combination with zanzalintinib.”
The agreement will see Merck supply Keytruda for the ongoing, Exelixis-sponsored STELLAR-305 trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC.
Merck will sponsor the RCC trials and fund one of the two phase 3 studies, with Exelixis co-funding the phase 1/2 trial and other phase 3 study. Exelixis will also supply zanzalintinib and cabozantinib.
Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said the company “[looks] forward to working with [its] colleagues at Exelixis to advance these clinical trials”, adding that it “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”.