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Xevinapant Takes the Lead: Merck’s Bold Market Strategies to Outshine Rivals in LA-HNSCC !

Mellalta Meets: Xevinapant Takes the Lead in LA-HNSCC

For patients with unresected Locally Advanced Head & Neck Cancer (LA-SCCHN) who cannot undergo surgical resection, the current standard of care is high-dose cisplatin-based CRT which has shown to improve locoregional control, PFS and OS compared with radiotherapy alone. Infact, the treatment options for patients with LA SCCHN who are eligible for cisplatin-based CRT have remained unchanged for more than a decade, and innovative treatments are needed. 

In the LA-HNSCC space, it’s interesting to see How Merck will position itself in the disease landscape. Mellalta Meets has deep-dived to provide the high-level Key summary for Merck’s Xevinapant, which is below:

  • Merck’s leading asset in LA-HNSCC: Xevinapant {Inhibitor of Apoptosis Protein (IAP) inhibitor}; 1st-in-class 
  • Differentiating attributes of Xevinapant
    • Unique MoA of Xevinapant:  Xevinapant has a unique MoA as it restores cancer cell sensitivity to apoptosis, thereby increasing the anticancer effects of chemotherapy as well as radiotherapy.
    • High efficacy of Xevinapant: In a 3-year follow-up analysis, Xevinapant has been shown to offer a 67% risk reduction of death. The percentage of patients with a complete response at 6 months following the end of CRT was increased with xevinapant versus placebo, suggesting the effects of xevinapant may extend beyond the end of the CRT treatment period.
  • Has the potential to become a personalized treatment option
  • Positioning of Merck in cisplatin-eligible/ineligible LA-HNSC
    • Merck is currently conducting pivotal Phase III studies, including the TrilynX and XRAY VISION trials, to further evaluate the remarkable effectiveness and safety profile of Xevinapant for patients with cisplatin-eligible LA-HNSCC
    • These trials are designed to provide a comprehensive assessment of both efficacy and safety, catering to both cisplatin-eligible and cisplatin-ineligible patient cohorts.

Merck’s Position in Locally Advanced Head & Neck Cancer (LA-HNSCC):  A Summary by Melallata Meets

AssetXevinapant {Inhibitor of Apoptosis Protein (IAP) inhibitor}
ClassFirst in Class
Molecule TypeSmall Molecule
Addressable Patient Pool60% LA-HNSCC (HPV +/-)
ROA/DoseOral/ 200 mg per day
InterventionXevinapant + CRT (Cisplatin eligible)Xevinapant + RT (Cisplatin-ineligible)
Clinical Differentiating Attributes67% Reduction of Risk of Death or progression over long-term
Radiosensitizer: Synergistic Affect with Radiotherapy
Commercial Differentiating AttributesPotential for Personalised Treatment Approach: Expression levels of cIAP1 and XIAP, can serve as markers to predict the sensitivity or resistance of HNSCC cells to xevinapant treatment.

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