Keytruda marches on . . .13 Apr 2019 01:34
Keytruda - ''significant improvement in OS compared with chemotherapy alone in certain patients''. It will be interesting to learn what CRUK find out in Combo with SCIB2 - in due course !
''Cancer drug Keytruda can now be used as a first-line treatment for patients with stage three non-small cell lung cancer (NSCLC), whose treatment options are limited. The US Food and Drug Administration (FDA) has approved Merck & Co’s Keytruda (pembrolizumab) for patients who cannot have surgery or definitive chemoradiation, or who have metastatic NSCLC with a PD-L1, or certain genetic mutations.
Dr Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories, said: “This expanded first-line indication now makes Keytruda monotherapy an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate.” The expanded use approval is based on results from a phase 3 trial, in which overall survival (OS) was sequentially tested as part of a pre-specified analysis plan. When used as a monotherapy, Keytruda demonstrated a statistically significant improvement in OS compared with chemotherapy alone in certain patients. The randomised trial, which involved 1,274 patients, showed that the frontline treatment resulted in a median overall survival (OS) of 16.7 months, compared with 12.1 months with standard chemotherapy in patients who had advanced or metastatic NSCLC and a tumour proportion score (TPS) of =1%.''
https://pharmaphorum.com/news/fda-expands-keytruda-approval-nsclc-treatment/?