KEY TAKEAWAYS
- The BURAN phase III trial aimed to evaluate biomarkers to inform treatment selection after immune modulatory therapy.
- The efficacy endpoints were PFS and OS in treatment vs. control and within treatment arms.
- The study found a new analysis of Buparlisib and Paclitaxel in metastatic SCCHN pts shows promise, with further exploration in the BURAN trial.
Previous genomic analysis of the BERIL-1 trial expanded to focus on immune biomarkers in metastatic squamous cell carcinoma of the head and neck(SCCHN). Researchers aimed to evaluate biomarkers to inform treatment selection after immune modulatory therapy.
The study analysis examined genomic changes in both tumor and plasma samples. They found over 50 genes with differing alterations between these sample types. Combining these samples gives a more accurate view of patients’ genetic status. There were no notable differences in alteration frequency between treatment and placebo groups. The connection between specific biomarkers and improvements in Progression-Free Survival (PFS) and Overall Survival (OS) was also studied in both treatment and control groups and within the treatment group.
The most frequently altered genes included TP53 (49%), NOTCH1 (21%), PIK3CA (19%), FAT1 (15%), and CDKN2A (13%). Previous analysis revealed that TP53 mutations and high immune infiltration (>10% intratumoral or stromal TILs) were associated with better PFS and OS. Further OS improvement was seen in individuals with high immune infiltration and TP53 (P= .031, HR = 0.52), PIK3CA (P= .005, HR = 0.34), NOTCH1 (P= .046, HR = 0.13), or FAT1 (P= .007, HR = 0.28) alterations compared to those without alterations in the treatment group. Enhanced PFS was observed in subjects with high immune infiltration and TP53 (P= .031, HR = 0.52) or FAT1 (P= .006, HR = 0.23) alterations in the treatment arm, while NOTCH1 alterations showed promising trends for improved PFS. A significant improvement in OS (P= .052, HR = 0.44) was noted in cases with a high tumor mutational burden (TMB) and alterations in the TP53 pathway.
The study found the new analysis of buparlisib and paclitaxel in metastatic SCCHN pts shows promise, with further exploration in the BURAN trial.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.e18030
Clinical Trial: https://clinicaltrials.gov/study/NCT04338399
Denis Soulieres, Justin Lucas, Sherry Xu, Sunny Lu, Kevin Dreyer, Nanhai He, Tom Tang, Lars E Birgerson, Lisa F. Licitra, and Sandrine Faivre. DOI: 10.1200/JCO.2023.41.16_suppl.e18030 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) e18030-e18030.
