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Adjuvant pembrolizumab after lung cancer surgery delayed recurrence for everyone, but, unexpectedly, not for the group with the most PD-L1 on their tumour.
KEYNOTE-091, run as PEARLS by the EORTC Lung Cancer Group and the European Thoracic Oncology Platform, recruited 1,177 of 1,955 screened patients from 196 centres in 29 countries between January 2016 and May 2020. Eligible patients had completely resected stage IB (4 cm or more), II or IIIA disease of any histology and any PD-L1 level; adjuvant chemotherapy was to be considered for stage IB and strongly recommended for stage II and IIIA. Randomisation was 1:1, triple-blind, stratified by stage, previous adjuvant chemotherapy, PD-L1 expression and region.
At the second interim analysis, disease-free survival was significantly longer with pembrolizumab in the overall population, but the co-primary endpoint in the PD-L1 tumour proportion score 50 percent or greater subgroup (168 and 165 patients) was not met. That inversion, the opposite of what PD-L1 predicts in metastatic disease, is the trial's lasting puzzle and has not been explained.
The FDA approved adjuvant pembrolizumab on 26 January 2023 for stage IB (T2a 4 cm or more), II or IIIA disease after resection and platinum-based chemotherapy, without a PD-L1 requirement. In England NICE TA1037 (5 February 2025) recommends it within its marketing authorisation for resected disease at high risk of recurrence after platinum chemotherapy, subject to the commercial arrangement.
Shares KEYNOTE-671, CheckMate 816, Resectable stage I to III non-small-cell lung cancer, PD-1.
Shares KEYNOTE-671, Resectable stage I to III non-small-cell lung cancer, Pembrolizumab, Immune checkpoint inhibitors.
Shares KEYNOTE-671, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer, PD-1.
Shares KEYNOTE-671, CheckMate 816, Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types).
Shares KEYNOTE-671, CheckMate 816, Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types).
Shares Resectable stage I to III non-small-cell lung cancer, Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors.
Shares CheckMate 816, Resectable stage I to III non-small-cell lung cancer, PD-1.
Shares Resectable stage I to III non-small-cell lung cancer, Pembrolizumab, Immune checkpoint inhibitors.