Keynote 189
![keynote 189 keynote 189](https://i.ytimg.com/vi/6xjM89umbcI/maxresdefault.jpg)
Rodriguez-Abreu: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Roche Honoraria (self), Speaker Bureau / Expert testimony: AstraZeneca Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: BMS Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Boehringer Ingelheim Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution), Travel / Accommodation / Expenses: MSD Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Pfizer Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Novartis. Gadgeel: Advisory / Consultancy: Boehringer-Ingelheim Advisory / Consultancy: Xcovery Advisory / Consultancy: AstraZeneca Advisory / Consultancy: Novocure Advisory / Consultancy, Travel / Accommodation / Expenses: Genentech/Roche Advisory / Consultancy: Takeda Research grant / Funding (institution): Merck Sharp & Dohme Advisory / Consultancy: Pharmamar.
#KEYNOTE 189 TRIAL#
Meanwhile, Bristol-Myers Squibb - which dropped the ball in first-line NSCLC when Opdivo failed a pivotal trial in 2016 - is waiting on the results of its CHECKMATE-227 of PD-1 blocker Opdivo and CTLA4 inhibitor Yervoy (ipilimumab), and AstraZeneca is hoping for better news when its MYSTIC trial of PD-L1 drug Imfinzi (durvalumab) and CTLA4-targeting tremelimumab reports towards the end of this year.S.
#KEYNOTE 189 PLUS#
Leerink analysts said the data will ‘solidify’ Merck’s lead in first-line NSCLC, although they cautioned that there are plenty of other studies that could be a threat, including Roche’s recently-reported Impower150 study of PD-L1 inhibitor Tecentriq (atezolizumab) plus Avastin (bevacizumab) and chemotherapy. Merck says it will share the results fully at an upcoming medical meeting. Moreover, the drug hit its objective around a year earlier than expected - Merck was not due to report survival data from the study until early 2019. The company hasn’t revealed the top-line data just yet but said Keytruda’s improvement over Alimta and platinum drugs alone was statistically significant. The data means it can likely move quickly to refile Keytruda in first-line NSCLC in Europe, while in the US - where it is already approved in this setting - the survival data will help the company make an even stronger case to prescribers. To address the deficiency Merck revamped KEYNOTE-189, recruiting additional patients and adding overall survival as a prospective endpoint. That’s important because Merck recently withdrew its marketing application for Keytruda as a first-line treatment alongside chemotherapy for NSCLC in Europe, after the EMA said it wasn’t comfortable reviewing the drug on the strength of phase II data alone. Interim data from the KEYNOTE-189 study showed that adding Keytruda to Eli Lilly’s Alimta (pemetrexed) plus a platinum drug improved both progression-free survival (PFS) and overall survival, which will reassure physicians, regulators and healthcare payers about the clinical value of the drug in this setting. Keytruda (pembrolizumab) has become the first drug in the class to improve overall survival when given in combination with chemotherapy in previously-untreated patients with advanced non-small cell lung cancer (NSCLC). Merck & Co’s already dominant position in the market for cancer immunotherapies for first-line lung cancer looks like it’s set to continue after its PD-1 inhibitor Keytruda aced another clinical trial.