EORTC-ETOP trial opens to study pembrolizumab for patients with early stage non-small cell lung cancer

Lung Cancer is the leading cause of cancer-related deaths world-wide. In 2012, there were an estimated 313,000 new cases in Europe and 1,825,000 worldwide, and, alarmingly, there were 268,000 estimated deaths in Europe and 1,590,000 deaths worldwide.

Approximately 80% of all lung cancer diagnoses are non-small cell lung cancers, and only about 20% of these are diagnosed at an early stage when the disease is still potentially curable by surgery. Survival of patients with completely resected non-small cell lung cancer remains poor, even with standard adjuvant chemotherapy which does increase the survival chances.

“There is a need to improve treatment for this disease, and the EORTC in collaboration with European Thoracic Oncology Platform (ETOP) and with the sponsorship of MSD (known as Merck in the U.S. and Canada) has now opened EORTC-ETOP trial 1416 to investigate the use of pembrolizumab in patients with early stage non-small cell lung cancer after resection and completion of standard adjuvant therapy,” says Dr. Benjamin Besse of Institut Gustave Roussy and Chair of the EORTC Lung Cancer Group.

Dr. Mary O’Brien (photo) of the Royal Marsden Hospital, initiator and EORTC coordinator of this study says, “Tumors take advantage of numerous biological pathways to avoid being destroyed by the body’s immune system. One of these pathways involves the programmed death receptor 1 (PD1) which is useful to avoid an inappropriate overreaction, such as an auto-immune disease, in healthy individuals.”

“However,” adds Prof. Luis Paz-Ares of the Hospital Universitario 12 De Octubre in Madrid and ETOP coordinator of this study, “in patients with cancer this receptor, when expressed, puts the immune system into a sleeping state. Pembrolizumab blocks this receptor and effectively wakes up the immune system to target and destroy cancer cells.”

EORTC-ETOP trial 1416 will assess whether adjuvant treatment with pembrolizumab after completion of radical surgery with standard adjuvant chemotherapy as indicated for stage IB-II-IIIA non-small cell lung cancer patients, improves disease-free survival compared to placebo injections.

The phase 3, randomized, EORTC-ETOP trial 1416 is coordinated by the EORTC Lung Cancer Group in collaboration with the ETOP and plans to accrue 1380 patients at 130 sites located in 19 countries: Austria, Belgium, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Poland, Portugal, Slovenia, Spain, Switzerland, The Netherlands, and the United Kingdom.

This EORTC-ETOP trial is fully supported and sponsored by MSD.