Real-world use of first-line pembrolizumab + platinum + taxane combination regimens in recurrent / metastatic head and neck squamous cell carcinoma

Christopher M Black; Dandan Zheng; Gleicy M Hair; Lei Ai; Liya Wang; Daisuke Goto; Nati Lerman; Behzad Bidadi; Glenn J Hanna

doi:10.3389/fonc.2024.1348045

Real-world use of first-line pembrolizumab + platinum + taxane combination regimens in recurrent / metastatic head and neck squamous cell carcinoma

Front Oncol. 2024 Feb 8:14:1348045. doi: 10.3389/fonc.2024.1348045. eCollection 2024.

Authors

Christopher M Black¹, Dandan Zheng¹, Gleicy M Hair¹, Lei Ai¹, Liya Wang¹, Daisuke Goto¹, Nati Lerman², Behzad Bidadi², Glenn J Hanna³

Affiliations

¹ Center for Observational and Real-World Evidence (CORE), Merck & Co., Inc., Rahway, NJ, United States.
² Oncology Late Stage Development, Merck & Co., Inc., Rahway, NJ, United States.
³ Center for Head & Neck Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.

Abstract

Introduction: The programmed death-1 (PD-1) immune checkpoint inhibitor pembrolizumab is currently approved in the US for the first-line (1L) treatment of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), either alone or in combination with platinum and 5-fluorouracil (5-FU). However, the toxicity of 5-FU has motivated the study of alternate combinations that replace 5-FU with a taxane. The objective of the current study was to describe the baseline characteristics, treatment patterns and sequences, and real-world outcomes of individuals receiving pembrolizumab + platinum + taxane as 1L treatment for R/M HNSCC in the US.

Methods: This was a retrospective study of US adults ≥18 years of age receiving pembrolizumab + platinum + taxane as 1L treatment for R/M HNSCC, using electronic health record data from a nationwide de-identified database. Real-world overall survival (rwOS), time on treatment (rwToT), and time to next treatment (rwTTNT) outcomes were assessed using Kaplan-Meier analysis.

Results: The study population comprised 83 individuals (80.7% male) with a median age of 64 years. The most common tumor site was the oropharynx (48.2%); 70.0% of these tumors were HPV-positive. A total of 71.1% of the study population had an Eastern Cooperative Oncology Group performance status of 0-1 at index date, 71.8% had a combined positive score for programmed death ligand-1 (PD-L1) expression of ≥1, and 30.8% had a score of ≥20. The median (95% CI) rwOS was 14.9 (8.8-23.3) months, rwToT was 5.3 (4.0-8.2) months, and rwTTNT was 8.7 (6.8-12.3) months. Among the 24 individuals who received a subsequent therapy, the most common second-line therapies were cetuximab-based (n = 9) or pembrolizumab-containing (n = 8) regimens.

Conclusions: The rwOS and other real-world outcomes observed for this study population further support pembrolizumab + platinum + taxane combination therapy as a potential 1L treatment option for R/M HNSCC.

Keywords: Kaplan-Meier estimate; PD-1; antineoplastic agents; head and neck squamous cell carcinoma; patient outcomes; real-world observational study; taxanes; treatment patterns.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. The study was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. The funder provided support in the forms of salaries or consulting fees for all authors but did not have any additional role in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.