Updated results of a randomized phase 2 clinical trial (NCT02022098) examining xevinapant (Debio 1143) plus standard chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinoma (HNSCC) show improved duration of response and overall survival at 5 years.1
About Locally Advanced Head and Neck Cancers
Head and neck cancer is the eighth most common cancer worldwide with squamous cell carcinoma accounting for over 90% of all head and neck cancers. Most patients are diagnosed with locally advanced disease. The current standard of care is surgery followed by chemoradiotherapy. Within 2 years of completing treatment however approximately half of patients will develop metastatic cancer and their prognosis is poor. New treatments are needed.2-7
About Xevinapant
Xevinapant is a first-in-class, orally available antagonist of inhibitor of apoptosis proteins (IAP) with the potential to enhance the anticancer activity of cisplatin and radiotherapy.
Xevinapant was initially investigated in patients with stage III or IVA/B unresectable, locally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx and more than a 10 pack-year smoking history.
A total of 96 patients were treated with cisplatin chemotherapy and intensity-modulated radiotherapy with or without the addition of xevinapant. Overall, the treatment was well tolerated and 56% of xevinapant treated patients have been reported to survive 5 years from treatment compared to only 28% of those treated with cisplatin chemotherapy and radiation alone. The benefit of xevinapant was consistent in individuals with human papillomavirus status, and smoking status.1
“Adding xevinapant to standard-of-care chemoradiotherapy markedly improved efficacy outcomes without increasing toxicity,” Bourhis, chief of the Radiation Oncology Service at Lausanne University Hospital in Switzerland, said in a presentation of the data. “This is the first study in decades to improve the cure rate by adding a new treatment to the standard of care of cisplatin and radiotherapy – the phase 3 TrilynX clinical trial (NCT04459715) of xevinapant plus chemoradiotherapy vs match placebo in patients with locally advanced HNSCC is ongoing.
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References
1. Bourhis J, Le Tourneau C, Calderon B, et al. 5-year overall survival (OS) in patients (pts) with locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) treated with xevinapant + chemoradiotherapy (CRT) vs placebo + CRT in a randomized, phase II study. Ann Oncol. 2022;33(suppl 7):LBA33. doi:10.1016/annonc/annonc1089
2.https://www.sciencedirect.com/science/article/pii/S0959804922018172
3. H. Sung, J. Ferlay, R.L. Siegel, M. Laversanne, I. Soerjomataram, A. Jemal, et al. CA A Cancer J Clin, 71 (2021), pp. 209-249
4. NCCN Clinical Practice Guidelines in Oncology Head and neck cancer. v1(2022)
5. K.K. Ang Multidisciplinary management of locally advanced SCCHN: optimizing treatment outcomes, Oncologist, 13 (2008), pp. 899-910
6. Y.-G. Lee, E.J. Kang, B. Keam, J.-H. Choi, J.-S. Kim, K.U. Park, et al. Treatment strategy and outcomes in locally advanced head and neck squamous cell carcinoma: a nationwide retrospective cohort study (KCSG HN13–01) BMC Cancer, 20 (2020), p. 813
7. J.P. Machiels, C. René Leemans, W. Golusinski, C. Grau, L. Licitra, V. Gregoire Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol, 31 (2020), pp. 1462-1475
8. Sun XS, Tao Y, Le Tourneau C, et al. Debio 1143 and high-dose cisplatin chemoradiotherapy in high-risk locoregionally advanced squamous cell carcinoma of the head and neck: a double-blind, multicentre, randomised, phase 2 study. Lancet Oncol. 2020;21(9):1173-1187. doi:10.1016/S1470-2045(20)30327-2
