Keynote 189 overall survival update full#
Keynote 189 overall survival update trial#

6 Hospices Civils de Lyon Cancer Institute, Lyon, France.5 Princess Alexandra Hospital, Brisbane, QLD, Australia.4 Melanoma Institute Australia, the University of Sydney, and Mater and Royal North Shore Hospitals, Sydney, NSW, Australia.3 Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.Electronic address: 2 Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, Netherlands. 1 Princess Máxima Center, Utrecht, Netherlands University Medical Center Utrecht, Utrecht, Netherlands.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-80.įollow the Oncology Center of Excellence on Twitter out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology.Alex Menzies, Thierry Lesimple, Michele Maio, Gerald Linette, Michael Brown, Peter Hersey, Inge Marie Svane, Laurent Mortier, Jacob Schachter, Catherine Barrow, Ragini Kudchadkar, Xinni Song, Caroline Dutriaux, Pietro Quaglino, Friedegund Meier, Paola Queirolo, Daniil Stroyakovskiy, Lars Bastholt, Bernard Guillot, Claus Garbe, Pablo Luis Ortiz Romero, Florent Grange, Peter Mohr, Alain Algazi, Oliver Bechter, Micaela Hernberg, Jean-Philippe Arnault, Philippe Saiag, Carmen Loquai, Frank Meiss, Jan-Christoph Simon, Gil Bar-Sela, Vanna Chiarion Sileni, Bernard Fitzharris, Mike McCrystal, Phillip Parente, Jean-Francois Baurain, Patrick Combemale, Célèste Lebbe, Axel Hauschild, Naoya Yamazaki, Reinhard Dummer, Mohammed Milhem, Marcin Dzienis, John Walker, Lionel Geoffrois, Marie-Thérèse Leccia, Lutz Kretschmer, Daniel Hendler, Michal Lotem, Andrzej Mackiewicz, Lidija Sekulovic, Elaine Dunwoodie, Christoph Hoeller, Laurent Machet, Jessica Hassel, Geke A P Hospers, Maria-Jose Passos, Max Levin, Martin Fehr, Philippa Corrie, Ashita Waterston, Sigrun Hallmeyer, Henrik Schmidt, Vincent Descamps, Jean-Philippe Lacour, Carola Berking, Felix Kiecker, Pier Francesco Ferrucci, Kenji Yokota, Maureen Aarts, Michael Jameson, Anna Katharina Winge-Main, Paula Ferreira, Kevin Kim, Catriona McNeil, Reiner Hofmann-Wellenhof, Joseph Kerger, François Aubin, Jochen Utikal, Virginia Ferraresi, Takashi Inozume, Yoshio Kiyohara, Gerard Groenewegen, Helena Kapiteijn, Suzana Matkovic, Wolf-Henning Boehncke, Richard Casasola, Timothy Crook, Ernest Marshall, Tanja Skytta, Marie-Francoise Avril, Thomas Jouary, Rüdiger Hein, Patrick Terheyden, Jun Aoi, Tatsuya Takenouchi, Oddbjorn Straume, César Martins, Guzel Mukhametshina, Paul Nathan This is the second FDA approval using the Real Time Oncology Review pilot program that enabled the FDA review team to begin analyzing data before the application submission.

Keynote 189 overall survival update full#

View full prescribing information for KEYTRUDA.

The recommended pembrolizumab dose and schedule for NSqNSCLC is 200 mg as an intravenous infusion over 30 minutes every 3 weeks. The most common adverse reactions reported in ≥20% of patients in KEYNOTE-189 were fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia.

Keynote 189 overall survival update trial#

The trial demonstrated a statistically significant improvement in OS for patients randomized to pembrolizumab and chemotherapy (HR 0.49 95% CI: 0.38, 0.64 p0.00001)>0.00001).> The primary efficacy outcome measures were overall survival (OS) and progression-free survival (PFS), as assessed by a blinded independent committee review (RECIST 1.1.) Treatment with pembrolizumab continued until disease progression, unacceptable toxicity, or a maximum of 24 months. Patients were randomized (2:1) to receive pembrolizumab (or placebo) in combination with pemetrexed, and investigator’s choice of either cisplatin or carboplatin every 3 weeks for 4 cycles followed by pembrolizumab (or placebo) and pemetrexed. This action is based on the results of KEYNOTE-189 (NCT02578680), a randomized, multicenter, double-blind, active controlled study enrolling 616 patients receiving first-line treatment for metastatic NSqNSCLC. Today’s approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product. Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. On August 20, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.