Using next-generation sequencing (NGS) to guide treatment is feasible in patients with platinum-refractory head and neck cancer, according to research published in the Journal of Clinical Oncology.
Researchers tested this principle in the phase 2 TRIUMPH trial (ClinicalTrials.gov Identifier: NCT03292250).
The trial enrolled 203 patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that was not amenable to curative treatment. Researchers used NGS to identify molecular targets and assign the patients to treatment arms matching their genomic profiles.
Patients were assigned to receive the PIK3CA inhibitor alpelisib (n=42), the EGFR/HER2 inhibitor poziotinib (n=16), the FGFR inhibitor nintedanib (n=8), or the CDK4/6 inhibitor abemaciclib (n=32). Patients with no matching targets received durvalumab (n=105).
Patients receiving targeted therapies were permitted to cross over to the durvalumab arm upon disease progression, and patients taking durvalumab could add tremelimumab if their disease progressed.
For patients who received poziotinib, the overall response rate (ORR) was 0%, and the disease control rate (DCR) was 69.2%. The median progression-free survival (PFS) was 3.2 months, and the median overall survival (OS) was 6.1 months.
Patients who received abemaciclib had an ORR of 0% and a DCR of 43.5%. The median PFS in this group was 1.6 months, and the median OS was 9.1 months.
Patients who received alpelisib had an ORR of 21.2% and a DCR of 65.6%. The median PFS was 3.4 months in these patients, and the median OS was 12.4 months.
Patients who received nintedanib had an ORR of 42.9% and a DCR of 57.1%. The median PFS was 5.6 months, and the median OS was 11.1 months.
Patients assigned to durvalumab had an ORR of 15.6% and a DCR of 40.0%. The median PFS was 1.7 months, and the median OS was 12.7 months.
The researchers noted that this trial did not meet the prespecified primary endpoints of DCR in the alpelisib arm and ORR in the other arms. Among the suggested reasons for this was the use of single-agent therapies, “which may not have sufficient efficacy for HNSCC treatment.”
Nevertheless, the researchers concluded that “NGS-based genomic phenotyping is methodologically feasible at a practical level and applicable for matching targeted agents in recurrent and/or metastatic HNSCC.”
Disclosures: Drugs for this trial were provided by Novartis, Hanmi Pharmaceutical, Eli Lilly and Company, Boehringer Ingelheim, and AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Keam B, Hong MH, Shin SH, et al. Personalized biomarker-based umbrella trial for patients with recurrent or metastatic head and neck squamous cell carcinoma: KCSG HN 15-16 TRIUMPH Trial. J Clin Oncol. Published online September 12, 2023. doi:10.1200/JCO.22.02786
This article originally appeared on Cancer Therapy Advisor