International clinical trial shows perioperative immunotherapy prolongs life in non-small-cell lung cancer patients.
SOURCE: MUHC
September 26, 2024
Positive results from a randomized Phase III clinical trial for patients with operable, early-stage non-small cell lung cancer (NSCLC) have recently been published in The Lancet.
These show that an immunotherapy drug called pembrolizumab (KEYTRUDA®), used in conjunction with neoadjuvant chemotherapy (i.e., given before surgery) and again after surgery, improves patients’ lifespan without adversely affecting their quality of life.
Indeed, in this second interim analysis of the KEYNOTE-671 trial:
- 71% of patients in the pembrolizumab group were still alive 36 months after inclusion in the trial, compared with 64% in the placebo group;
- Median event-free survival (i.e., time after treatment that the participant remained free of certain complications or preventable events) was 47 months in the pembrolizumab group and 18 months in the placebo group.
- Grade 3–5 treatment-related adverse events (i.e., severe or life-threatening events, requiring hospitalization or urgent intervention) occurred in 179 (45%) of 396 participants in the pembrolizumab group and 151 (38%) of 399 participants in the placebo group.
“Non-small cell lung cancer is the most common form of lung cancer, and this is the first paper in 30 years of research in this field to show a benefit in terms of overall survival, i.e., lifespan for patients, associated with the addition of neoadjuvant immunotherapy to standard treatment for this type of cancer,” says the first author of the paper and lead surgeon of the study, Dr. Jonathan Spicer, a scientist in the Cancer Research Program at the Research Institute of the McGill University Health Centre (RI-MUHC), a thoracic surgeon at the Montreal General Hospital of the MUHC and the medical director of the McGill Thoracic Oncology Network. “I would like to thank the MUHC and our Thoracic Trials team at the Centre for Innovative Medicine of the RI-MUHC for their essential role in this success.”
These results supplement those of the first interim analysis published in June 2023 in The New England Journal of Medicine, which demonstrated the efficacy of the trial treatment in slowing cancer progression and recurrence, and in reducing the presence of residual tumours, 24 months after randomization of study participants.
All patients enrolled in the trial (797 adult participants) had a surgically removable non-small cell lung cancer of stage II or III. Half of them received neoadjuvant pembrolizumab plus cisplatin-based chemotherapy followed by surgical resection of the tumour and adjuvant pembrolizumab; the other half received neoadjuvant chemotherapy and surgery alone, with a placebo instead of pembrolizumab.
Researchers and patients from 189 medical centres around the world are taking part in this international clinical trial. In Montreal, in addition to the MUHC, the Centre hospitalier de l’Université de Montréal collaborated in the study, under the supervision of Dr. Moishe Liberman.
About the study
Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial
Spicer, Jonathan D, Afanasyev, Sergey et al.