We had previously-mentioned Merck’s December 2023 FDA approval for Welireg®, in renal cell carcinoma patients.
Now, Welireg will be tried in combination with Exelixis’s Zanzalintinib candidate (in what amounts to a “supply agreement on steroids“, for Merck). The same sort of enhanced supply arrangement will obtain with Merck’s Keytruda® — which will be studied by Exelixis, in head and neck cancers with Zanzalintinib — for added progression free survival / efficacy. Here’s all of that good news, this afternoon:
…Exelixis and Merck announced that the companies have entered into a clinical development collaboration to evaluate the combination of Exelixis’ investigational tyrosine kinase inhibitor, or TKI, zanzalintinib with Merck’s anti-PD-1 therapy Keytruda in a phase 3 pivotal trial for the treatment of patients with head and neck squamous cell carcinoma, or HNSCC, and zanzalintinib with Welireg, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor, in a phase 1/2 trial and two phase 3 pivotal trials for the treatment of patients with renal cell carcinoma, or RCC.
Under the terms of the collaboration, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase 3 STELLAR-305 pivotal trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC. In addition, Merck will sponsor a phase 1/2 trial and two phase 3 pivotal trials in RCC.
Merck will fund one of these phase 3 studies, and Exelixis will co-fund the phase 1/2 trial and the other phase 3 study, as well as supply zanzalintinib and cabozantinib. Exelixis maintains all global commercial and marketing rights to zanzalintinib….
Now you know — be excellent to one another. Onward. Ever, onward… toward Europa by the decade’s end. Smile.
नमस्ते
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