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Xevinapant Takes the Lead: Merck’s Bold Market Strategies to Outshine Rivals 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
| Asset | Xevinapant {Inhibitor of Apoptosis Protein (IAP) inhibitor} |
| Class | First in Class |
| Molecule Type | Small Molecule |
| Addressable Patient Pool | 60% LA-HNSCC (HPV +/-) |
| ROA/Dose | Oral/ 200 mg per day |
| Intervention | Xevinapant + CRT (Cisplatin eligible)Xevinapant + RT (Cisplatin-ineligible) |
| Clinical Differentiating Attributes | 67% Reduction of Risk of Death or progression over long-term |
| Radiosensitizer: Synergistic Affect with Radiotherapy | |
| Commercial Differentiating Attributes | Potential 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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