Data from Tumor Mutational Burden as a Predictor of Survival with Durvalumab and/or Tremelimumab Treatment in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

• DOI: 10.1158/1078-0432.c.6489322.v2
• Publication Date: 2023-04-05T02:11:12Z
• Authors: Sophie Wildsmith; Weimin Li; Song Wu; Ross Stewart; Nassim Morsli; Rajiv Raja; Qu Zhang; Jiabu Ye; Philip He; Jagdish Shetty; Alejandro Yovine; Nicholas Holoweckyj; Katia Real; Jill Walker; Magdalena Wrona; Melissa de los Reyes; Craig Barker; Jessica Whiteley; Robert Haddad; Lisa Licitra; Robert Ferris; Jérôme Fayette; Dan P. Zandberg; Lillian L. Siu; Ricard Mesía
• Keywords: Tremelimumab; Durvalumab

<div>AbstractPurpose:<p>Biomarkers that predict response to immune checkpoint inhibitors (ICI) in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) are needed. This retrospective study assessed tumor mutational burden (TMB) outcomes the phase II HAWK CONDOR III EAGLE studies of durvalumab with without tremelimumab platinum-resistant R/M HNSCC.</p>Patients Methods:<p>Tumor samples from HAWK/CONDOR (<i>N</i> = 153) blood 247) were analyzed for TMB. Associations survival evaluated tissue TMB (tTMB) at cutoffs 10 20 mutations/megabase (mut/Mb) plasma (bTMB) 8 24 mut/Mb.</p>Results:<p>In HAWK/CONDOR, overall (OS) was longer high versus low tTMB: statistically significant differences observed plus tTMB ≥ mut/Mb [HR, 0.52 (95% confidence interval, CI, 0.28–0.98)] 12 0.46 0.24–0.86)]. In EAGLE, a OS benefit chemotherapy bTMB≥16 0.39 0.20–0.76) 0.38 0.19–0.78), respectively] but not bTMB < 16 0.92 (0.61–1.37) 0.62–1.36), respectively]. A progression-free also ICI arms mut/Mb.</p>Conclusions:<p>Findings support as biomarker predicting patients HNSCC treated ICIs. The analysis demonstrated predictive treatment large, randomized controlled population.</p></div>