Merck and Exelixis team up to test new cancer combination therapies

Merck & Co, known internationally as MSD outside the United States and Canada, has entered into a collaboration with Exelixis to explore new combination therapies for head and neck cancer as well as renal cell carcinoma (RCC). This partnership aims to evaluate the efficacy of combining Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy, with Exelixis’ investigational tyrosine kinase inhibitor zanzalintinib in clinical trials.

One of the key studies in this collaboration is a pivotal phase 3 trial that will assess the combination of Keytruda and zanzalintinib in patients suffering from head and neck squamous cell carcinoma (HNSCC). Additionally, other trials, including a phase 1/2 trial and two phase 3 trials, aim to evaluate the combination of zanzalintinib with another Merck drug, Welireg (belzutifan), an oral hypoxia-inducible factor-2 alpha inhibitor, specifically for RCC.

In the United States, head and neck cancer, which encompasses various tumors that develop in the throat, larynx, nose, sinuses, and mouth, is expected to see more than 58,450 new cases diagnosed in 2024. Kidney cancer diagnoses are also significant, with an estimated 81,600 new cases expected this year, predominantly RCC.

Zanzalintinib has been designed to target cancer-related pathways that contribute to resistance against multiple therapies. Early trials have shown promise, particularly in a phase 1b study involving patients who had previously been treated for clear cell RCC.

Amy Peterson, who serves as the executive vice president of product development and medical affairs, and chief medical officer at Exelixis, highlighted the potential benefits of this collaboration. She pointed out that both Keytruda and Welireg are already approved therapies that have led to improved outcomes for some cancer patients. Peterson expressed enthusiasm about collaborating with Merck’s clinical development team to explore the potential benefits of combining these therapies with zanzalintinib.

As part of the agreement, Merck will supply Keytruda for the ongoing STELLAR-305 trial, which is sponsored by Exelixis and focuses on previously untreated PD-L1 positive recurrent or metastatic HNSCC. For the RCC studies, Merck will sponsor the trials and finance one of the phase 3 studies, while Exelixis will co-fund the phase 1/2 trial and the other phase 3 study. Exelixis will also provide zanzalintinib and cabozantinib for these trials.

Marjorie Green, the senior vice president and head of oncology at Merck Research Laboratories, expressed her optimism about the collaboration. She emphasized that Merck is committed to advancing clinical trials in partnership with Exelixis and is eager to build on previous progress by strategically evaluating new combination regimens. The ultimate goal is to improve outcomes for a broader range of patients.

This collaboration marks a significant step in the ongoing efforts to develop more effective cancer treatments by combining different therapeutic approaches. The integration of Merck's and Exelixis' resources and expertise is aimed at offering new hope to patients battling head and neck cancer and RCC, potentially leading to more effective treatments and improved survival rates.