2017 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Metastatic
Type: Oral Abstract Session
Time: Tuesday June 6, 9:45 AM to 12:45 PM
Location: Hall D1
Progression after the next line of therapy (PFS2) and updated OS among patients (pts) with advanced NSCLC and PD-L1 tumor proportion score (TPS) ≥50% enrolled in KEYNOTE-024.
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 9000)
Author(s): Julie R. Brahmer, Delvys Rodriguez-Abreu, Andrew George Robinson, Rina Hui, Tibor Csõszi, Andrea Fülöp, Maya Gottfried, Nir Peled, Ali Tafreshi, Sinead Cuffe, Mary O'Brien, Suman Rao, Katsuyuki Hotta, Melanie A. Leiby, Jessica McLean, Yue Shentu, Reshma A. Rangwala, Martin Reck; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD; Hospital Universitario Insular de Gran Canaria, Las Palmas, Spain; Cancer Centre of Southeastern Ontario, Kingston, ON, Canada; Westmead Hospital and University of Sydney, Sydney, Australia; Jász-Nagykun-Szolnok County Hospital, Szolnok, Hungary; Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary; Meir Medical Center, Kfar-Saba, Israel; Davidoff Cancer Center, Petah Tikva, Israel; Southern Medical Day Care Centre, Wollongong, Australia; St. James’s Hospital and Cancer Trials Ireland (formerly ICORG – All Ireland Cooperative Oncology Research Group), Dublin, Ireland; The Royal Marsden Hospital, Surrey, United Kingdom; MedStar Franklin Square Hospital, Baltimore, MD; Okayama University Hospital, Okayama, Japan; Merck & Co., Inc., Kenilworth, NJ; Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), member of the German Center for Lung Research (DZL), Grosshansdorf, Germany
Background: In KEYNOTE-024 (NCT02142738), pembrolizumab (pembro) was superior to chemotherapy (chemo) as first-line (1L) therapy for advanced NSCLC with PD-L1 TPS ≥50% and no sensitizing EGFR mutations or ALK translocations. After a median follow-up of 11.2 mo, HR was 0.50 for PFS by independent central radiologic review (P< 0.001) and 0.60 for OS (P= 0.005). Here we present PFS2 and updated OS. Methods: 305 pts were randomly assigned to pembro 200 mg Q3W (n = 154) or investigator (INV)-choice platinum-doublet chemo with optional pemetrexed maintenance for nonsquamous histology (n = 151). Pts in the chemo arm could cross over to pembro upon PD. Poststudy anticancer therapy and INV-assessed outcomes were collected. Kaplan-Meier PFS2 and OS were calculated in all allocated pts. PFS2 was defined as time from randomization to PD per INV after start of 2L+ therapy or death, whichever occurred first; pts alive and without 2L+ PD were censored at last known survival. Kaplan-Meier OS was defined as time from randomization to death. There was no adjustment for multiplicity (cutoff: Jan 5, 2017). Results: 2L+ therapy was received by 48 (31.2%) pts in the pembro arm and 97 (64.2%) in the chemo arm, including 80 pts who crossed over from chemo to pembro per protocol and 14 pts who received anti–PD-1 therapy outside of crossover. 56 (36%) 1L pembro pts were on 1L pembro therapy or in follow-up as of data cutoff. Updated median OS and PFS2 results are in the Table. Conclusions: Fewer pembro pts received 2L+ therapy vs chemo pts because of the significant improvement in PFS observed for pembro in the 1L setting. Median PFS2 was substantially improved for pembro (not reached [NR]) vs chemo (8.6 mo). Updated OS with median follow-up of 19 mo maintained consistent superiority of 1L pembro, despite increased crossover from 1L chemo. Clinical trial information: NCT02142738
n = 154
n = 151
|Events, n (%)||63 (40.9)||84 (55.6)|
|HR (95% CI)||0.63 (0.46-0.88); nominal P = 0.003|
|Median (95% CI), mo||NR (19.4-NR)||14.5 (9.8-19.6)|
|12 mo, % (95% CI)||70.3 (62.3-76.9)||54.8 (46.4-62.4)|
|HR (95% CI)||0.48 (0.34-0.66); nominal P< 0.001|
|Median (95% CI), mo||NR||8.6 (7.4-14.4)|
|12 mo, % (95% CI)||67.2 (59.0-74.1)||44.4 (36.1-52.3)|
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