Merck have announced that the Phase 3 KEYNOTE-42 trial of Keytruda® therapy has met its primary endpoint, which was overall survival[i]. The trial focused on first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). Professionals and patients within the mesothelioma community may find the results of this trial to be useful, as both NSCLC and mesothelioma share similarities.
Keytruda is an immunotherapy anti-cancer drug, which means that its mode of action is to ‘wake up’ the immune system in order to fight cancer. It has been trialed as a treatment for a range of cancer types, including mesothelioma. At this stage, it is an expensive experimental treatment for mesothelioma, and claims for private therapy could result in defendants paying large sums for a treatment which is not fully understood. Studies are underway to determine how successful the treatment is at increasing overall survival, progression-free survival, and disease control. We have previously discussed Keytruda in issues 167, 176, 206, 208, 214 and most recently, edition 215 of BC Disease News (here).
The latest findings relate to the use of Keytruda in NSCLC patients. KEYNOTE-042 is an international phase 3 study, comparing Keytruda success with standard, platinum-based chemotherapy treatments. The study enrolled 1,274 patients, who were randomly allocated to receive either Keytruda or chemotherapy. An interim analysis of the trial data demonstrated that treatment with Keytruda resulted in significantly longer overall survival than platinum-based chemotherapy in patients with tumours, in which more than 1% of the cells have the PD-L1 protein present on the surface.
The trial will continue to evaluate progression-free survival.
Dr. Tony Mok, Professor of Clinical Oncology at the Chinese University of Hong Kong, stated:
‘Improvement in overall survival is the ultimate objective in the treatment of advanced lung cancer. KEYNOTE-042 is the first randomized Phase 3 study of a single-agent immunotherapy using overall survival as the primary endpoint that has demonstrated significant benefit as first-line therapy in NSCLC patients who tested positive for PD-L1 at 1 percent or higher’.
[i] KEYTRUDA ® (pembroliumab) Monotherapy Met Primary Endpoint in Phase 3 KEYNOTE-042 Study, Significantly Improving OS as First-Line Therapy in Locally Advanced or Metastatic NSCLC Patients Expressing PD-L1 in at Least 1 Percent of Tumor Cells. 9 April 2018 http://www.mrknewsroom.com/news-release/oncology-newsroom/keytruda-pembrolizumab-monotherapy-met-primary-endpoint-phase-3-keyno (Accessed 12 April 2018)