One year ago, Exelixis commenced their phase 2/3 pivotal trial to assess the efficacy of zanzalintinib in combination with pembrolizumab compared to pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Zanzalintinib, an oral drug developed by Exelixis, targets and inhibits receptor tyrosine kinases (RTKs) to impede cancer growth and spread in advanced solid tumors, including kidney, colorectal, and head and neck cancers.

SCCHN encompasses head and neck cancers originating in the squamous cells lining the mucosal surfaces of the head and neck, accounting for approximately 90% of all head and neck cancers. In the United States, around 50,000 new cases of SCCHN are diagnosed annually, with a higher incidence among men and individuals over 50 years old. The five-year survival rate for metastatic SCCHN varies from 4-35%, depending on the cancer site and extent of metastasis.

Recognizing the critical need for advancements in this field, we are examining the ongoing Stellar-305 Phase 2/3 trial, which seeks to address the challenges encountered by patients with SCCHN.

Here is a concise overview of the study:

Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (STELLAR-305)

Study Details | Source

  • Sponsor: Exelixis
  • This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) incurable by local therapies who have not received prior systemic therapy for recurrent or metastatic disease.
  • Conditions:
    • Head and Neck Squamous Cell Carcinoma
  • Interventions:
    • Drug: Zanzalintinib
    • Drug: Zanzalintinib-matched Placebo
    • Biological: Pembrolizumab
  • Primary Outcomes Measures:
    • Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by Blinded Independent Radiology Committee (BIRC)
      • Defined as the time from randomization to the earlier of either radiographic progressive disease (PD) per RECIST 1.1 as determined by the BIRC or death from any cause
      • Approximately 28 months after the first subject is randomized
    • Overall Survival (OS)
      • Defined as the time from randomization to death due to any cause
      • Approximately 40 months after the first subject is randomized

Will the clinical trial meet its endpoint? The outcomes of this trial could potentially influence future guidelines and clinical practices. Your insights are valuable to us, and we encourage you to share your thoughts on this matter. Be sure to sign up for alerts to stay informed about the latest published guidelines and articles.

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