Exelixis, MRK Collaborate for Combination Studies on HNSCC and RCC
Exelixis, Inc. EXEL entered into a clinical development collaboration agreement with pharma giant Merck MRK to advance the development of its pipeline candidate, zanzalintinib.
Zanzalintinib, an investigational tyrosine kinase inhibitor (TKI), inhibits multiple cancer-related pathways that play a key role in resistance to multiple therapies, including immune checkpoint inhibitors.
Shares of Exelixis have risen 9.4% year to date compared with the industry’s growth of 6.3%.
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Details of the Collaboration Between EXEL and MRK
Exelixis will evaluate zanzalintinib in combination with Merck’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma (HNSCC).
Both the companies will also evaluate zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan), in a phase I/II study and two phase III studies for the treatment of patients with renal cell carcinoma (RCC).
Per the terms of the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1 positive recurrent or metastatic HNSCC.
Additionally, Merck will sponsor a phase I/II trial and two phase III studies in RCC. While Merck will fund one of these phase III studies, Exelixis will co-fund the phase I/II study and the other phase III study, as well as supply zanzalintinib and cabozantinib.
A positive outcome from these studies should prove zanzalintinib’s potential to drive patient benefit in combination with immunotherapy or targeted therapy in HNSCC and RCC indications.
Exelixis maintains all global commercial and marketing rights to zanzalintinib.
Cabozantinib is Exelixis’ lead drug marketed under the brand name Cabometyx for the treatment of RCC.
Keytruda is approved for several oncology indications.
EXEL’s Efforts to Strengthen Portfolio/Pipeline
The pipeline progress has also been impressive, as Exelixis looks to expand its oncology portfolio beyond Cabometyx.
Cabometyx, a leading TKI, has performed well. This was mainly due to its use in combination with Bristol Myers’ BMY Opdivo in the first-line setting. The drug also maintained growth in the hepatocellular carcinoma indication.
BMY’s Opdivo is one of the leading immuno-oncology drugs, approved for various oncology indications.
Management is also focused on the label expansion of Cabometyx. The FDA accepted EXEL’s supplemental new drug application (sNDA) for cabozantinib for patients with previously treated advanced pancreatic neuroendocrine tumors (pNET) and those with previously treated advanced extra-pancreatic NET (epNET). The FDA assigned a standard review with a target action date of April 3, 2025. The FDA also granted the orphan drug designation to cabozantinib for the treatment of pNET.
A potential label expansion should further propel its growth prospects.
Exelixis also intends to submit an sNDA with the FDA later this year for cabozantinib, in combination with Tecentriq (atezolizumab), for metastatic castration-resistant prostate cancer.
Exelixis also plans to advance phase I efforts for XL309 and XB010.
Meanwhile, EXEL decided to discontinue the development of XB002. It plans to reallocate resources to new pivotal trials with zanzalintinib, advancing XL309 and its growing pipeline.
The successful development of additional drugs should broaden its portfolio and reduce its dependence on its lead drug, Cabometyx.
Zacks Rank & Stock to Consider
EXEL currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Alnylam Pharmaceuticals ALNY, which carries a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
ALNY’s loss per share estimate for 2024 has narrowed from $1.20 to 63 cents in the past 60 days and the same for 2025 has narrowed from 34 cents to 27 cents. ALNY’s shares have rallied 48% year to date.
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Exelixis, Inc. (EXEL) : Free Stock Analysis Report