Abstract 926P
Background
Immunotherapy has significantly improved survival in patients with several solid tumours including head and neck squamous cell carcinoma (HNSCC). Pembrolizumab received approval in the UK in 2020 as first-line treatment for recurrent or metastatic (R/M) HNSCC based on KEYNOTE-048 trial data which demonstrated an extended overall survival (OS) when compared to the EXTREME chemotherapy regime in patients with R/M HNSCC tumours with a combined positive score (CPS)≥1 (Burtness, 2019). Here we, provide real-world data on the clinical outcomes of the use of pembrolizumab as first-line systemic treatment for HNSCC in the United Kingdom (UK).
Methods
Retrospective data analysis of patients with HNSCC treated with pembrolizumab as first-line treatment across 18 centres in UK from 20/03/20 to 31/05/2021.
Results
211 patients were included; the median age was 66.0 (range=39-88.1), 73.0% of patients were male and >65% of patients had a smoking history or alcohol history. In addition to patients with R/M HNSCC, 47 patients had locally advanced disease deemed not suitable for curative treatment at diagnosis; a group of patients not included in KEYNOTE-048. Analysis showed an overall response rate (ORR) of 24.7%, median progression free survival (PFS) of 4.8 months (95% confidence interval [CI]: 3.6-6.1) and median OS of 10.8 months (95% CI 9.0-12.5). 53 patients proceeded to second line treatment and the median PFS2 was 10.2 months (95% CI: 8.8-11.5), similar to PFS2 of 10.3 months for those with CPS≥1 in KEYNOTE-048. The treatment was well-tolerated and only 18 patients (8.5%) stopped pembrolizumab due to an immune-related toxicity (IRT). Moreover, patients with a documented IRT had a statistically significant longer median PFS (11.3 vs 3.3 months; log-rank p-value=<0.001) and median OS (18.8 vs 8.9 months; log-rank p-value <0.001) compared to the groups of patients with no documented IRT.
Conclusions
In this real-world retrospective cohort, we have shown a similar ORR, longer PFS, similar PFS2 and a shorter OS compared to the results of KEYNOTE-48. Those with locally advanced disease deemed not suitable for curative treatment at diagnosis had similar ORR, PFS and OS compared to patients with recurrent or metastatic disease.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Haridass: Non-Financial Interests, Personal, Invited Speaker: MSD. P. Jankowska: Non-Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, BMS, AstraZeneca. R. Moleron: Non-Financial Interests, Advisory Board: MSD, Vasodynamics. A. Kong: Non-Financial Interests, Personal, Advisory Board: MSD; Non-Financial Interests, Institutional, Research Funding: AstraZeneca, PUMA; Non-Financial Interests, Personal, Invited Speaker: Merck, BMS; Non-Financial Interests, Personal, Advisory Role: Avinnity. All other authors have declared no conflicts of interest.
Resources from the same session
942P - Response to salvage chemotherapy with paclitaxel +/- cetuximab after progression on immune checkpoint inhibitors in platinum-refractory recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) patients (CeTax study)
Presenter: Ruth Gabriela Herrera Gomez
Session: Poster session 12
944TiP - Randomized phase II study of immune stimulation with pembrolizumab and radiotherapy of recurrent and/or metastatic head and neck squamous cell carcinoma : The IMPORTANCE trial
Presenter: Bálint Tamaskovics
Session: Poster session 12
1089P - Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 7-y results from CheckMate 238
Presenter: Paolo Ascierto
Session: Poster session 12
1090P - Outcome impact of time from complete resection to start of adjuvant immunotherapy in stage III-IV melanoma patients
Presenter: Sergio Martinez Recio
Session: Poster session 12
1092P - Adjuvant treatment with anti-PD-1 in acral melanoma patients: A nationwide study
Presenter: Manja Bloem
Session: Poster session 12
1093P - Neoadjuvant (NeoAd) intratumoral (IT) TAVO-EP (plasmid IL-12 electro gene transfer) in combination with nivolumab (NIVO) for patients (pts) with operable locoregionally advanced melanoma
Presenter: Ahmad Tarhini
Session: Poster session 12
1094P - Relapse free survival (RFS) at 3 years by pathological (path) response to neoadjuvant systemic treatment (NST) in patients (pts) with surgically resectable, high-risk melanoma
Presenter: Elizabeth Burton
Session: Poster session 12
1095P - Associations between baseline biomarkers and 3-year survival in the PRADO trial testing neoadjuvant ipilimumab and nivolumab in stage III melanoma
Presenter: Irene Reijers
Session: Poster session 12