Relationship Between Short‐Term Outcomes and PD‐L1 Expression Based on Combined Positive Score and Tumor Proportion Score in Recurrent or Metastatic Head and Neck Cancers Treated With Anti‐PD‐1 Antibody Monotherapy
ABSTRACT Background PD‐L1 expression in tumors and immune cells is a biomarker for the efficacy of anti‐PD‐1 antibody (APA) therapy across diverse cancers. Based on the results from the KEYNOTE‐048 trial, pembrolizumab monotherapy is indicated for platinum‐sensitive recurrent/metastatic head and nec...
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| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2025-01-01
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| Series: | Cancer Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cnr2.70125 |
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| Summary: | ABSTRACT Background PD‐L1 expression in tumors and immune cells is a biomarker for the efficacy of anti‐PD‐1 antibody (APA) therapy across diverse cancers. Based on the results from the KEYNOTE‐048 trial, pembrolizumab monotherapy is indicated for platinum‐sensitive recurrent/metastatic head and neck squamous cell carcinoma (R/M‐HNSCC) with a positive combined positive score (CPS). Conversely, nivolumab is utilized for platinum‐pretreated R/M‐HNSCC regardless of the positive tumor proportion score (TPS) following the results of the CheckMate‐141; however, its subgroup analysis indicated that TPS‐positive population tended to have a relatively high overall response rate and progression‐free survival (PFS). Although, the superior PD‐L1 evaluation method for predicting APA therapy efficacy in R/M‐HNSCC and the appropriate cut‐off value remain undetermined. This study aims to elucidate the relationship between short‐term outcomes and PD‐L1 expression based on CPS and TPS in R/M‐HNSCC patients undergoing APA monotherapy. Methods R/M‐HNSCC patients receiving APA monotherapy from 2018 to 2021 with available samples were enrolled. An experienced pathologist evaluated CPS and TPS utilizing the PD‐L1 IHC 22C3 pharmDx assay. Short‐term outcomes were assessed by clinical benefit rate (CBR), objective response rate (ORR), and PFS. Results Fifty‐three R/M‐HNSCC patients received APA monotherapy. Forty‐seven had CPS ≥ 1, and 44 had TPS ≥ 1%. By receiver‐operating characteristic curve analysis, the CPS cut‐off value for predicting better CBR was determined to be 50. The ORR/CBR tended to be higher when CPS was positive. Although differences in PFS were not observed for a cut‐off value of 1 or 20, they were observed for 50 (3.2 vs. 8.4 months; hazard ratio 0.44, p = 0.02). ORR and CBR were respectively 12.5% and 12.5% in the TPS < 1% group and 33.3% and 48.9% in the ≥ 1% group. The TPS < 1% group showed significantly poorer PFS (1.9 vs. 4.5 months, hazard ratio 0.40, p = 0.01). Conclusion The short‐term efficacy of APA monotherapy in R/M‐HNSCC patients tended to be better when CPS was positive. TPS helps predict the population that does not benefit from APA monotherapy. |
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| ISSN: | 2573-8348 |