Results of two EORTC studies have been published in NEJM and the Lancet Oncology

The results of two studies led by EORTC have been published in The New England Journal of Medicine (NEJM) and The Lancet Oncology after their abstracts were presented at ESMO in September 2022.

The first one is Professor Alexander Eggermont’s paper presenting results from the randomized phase III double-blind EORTC 1325/KEYNOTE-054 trial 1 of the immunotherapy pembrolizumab vs placebo in 1019 patients who had their high-risk stage III melanomas surgically removed. Between August 2015 and November 2016, patients were given either 200 mg of immunotherapy or a placebo every three weeks until disease recurrence or unacceptable toxicity was observed. At five years media follow-up, the researchers found that recurrence-free survival, distant metastasis-free survival, and the time from randomization until a second disease recurrence, progression of the first recurrence, or death, were all significantly improved in the patients who had received the active treatment. The full article is available at the following link: Five-Year Analysis of Adjuvant Pembrolizumab or Placebo in Stage III Melanoma

The second one is Professor Solange Peters’ paper on the PEARLS/KEYNOTE-091 randomised, triple-blind, phase 3 trial, published in the Lancet Oncology. This further study of pembrolizumab, this time in early-stage non-small cell lung cancer, investigates the effect of pembrolizumab on patients who had had complete surgical resection of stage IB to IIIA tumors. The further analysis, which was presented at ESMO, focused on a sub-group of patients who had increased levels of PD-L1, a protein that allows cancer cells to evade the immune system. Earlier results from the trial had appeared to show that pembrolizumab had little benefit in patients with high levels of PD-LI, but further, more detailed analysis showed that disease-free survival in those patients with the highest levels of the protein was improved. The lack of statistically significant benefit for these patients in the earlier analysis most likely results from placebo overperformance, the need for a longer follow-up, and smaller population size. But in any event, the researchers state that the data support the benefit of the treatment for all stage IB to IIIA resected patients, regardless of PD-LI expression.
Read the full article here: Pembrolizumab versus placebo as adjuvant therapy for completely resected stage IB–IIIA non-small-cell lung cancer (PEARLS/KEYNOTE-091): an interim analysis of a randomised, triple-blind, phase 3 trial