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Attend this session at the
2019 ASCO Annual Meeting!

Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Session

Time: Sunday June 2, 8:00 AM to 11:00 AM

Location: Hall A

Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Discussion Session

Time: Sunday June 2, 4:30 PM to 6:00 PM

Location: Hall D1

KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC.

Metastatic Non-Small Cell Lung Cancer

Lung Cancer—Non-Small Cell Metastatic

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Discussion Session (Board #336)

J Clin Oncol 37, 2019 (suppl; abstr 9013)

Author(s): Shirish M. Gadgeel, Marina Chiara Garassino, Emilio Esteban, Giovanna Speranza, Enriqueta Felip, Maximilian J. Hochmair, Steven Francis Powell, Susanna Y. Cheng, Helge Bischoff, Nir Peled, Rina Hui, Martin Reck, Takayasu Kurata, Edward B. Garon, Michael J. Boyer, Jing Yang, Maria Catherine Pietanza, Delvys Rodriguez-Abreu; Karmanos Cancer Institute (currently at University of Michigan, Ann Arbor, MI, USA), Detroit, MI; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Hospital Universitario Central de Asturias, Oviedo, Spain; Centre integré de cancérologie de la Montérégie, Université de Sherbrooke, Greenfield Park, QC, Canada; Vall d’Hebron University, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; Department of Respiratory and Critical Care Medicine and Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Vienna, Austria; Sanford Health, Sioux Falls, SD; Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Thoraxklinik, Heidelberg, Germany; Davidoff Cancer Center, Tel Aviv University (currently at Soroka Medical Center, Ben-Gurion University, Beer-Sheeva, Israel), Petah Tikva, Israel; Westmead Hospital and the University of Sydney, Sydney, NSW, Australia; LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany; Kansai Medical University Hospital, Hirakata, Japan; David Geffen School of Medicine at UCLA, Los Angeles, CA; Chris O’Brien Lifehouse, Camperdown, NSW, Australia; Merck & Co., Inc., Kenilworth, NJ; Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas De Gran Canaria, Spain

Abstract Disclosures


Background: Pembro + chemo significantly improved OS and PFS over chemo alone and had manageable safety as 1L therapy for metastatic nonsquamous NSCLC in the KEYNOTE-189 study (NCT02578680). The benefit was observed irrespective of PD-L1 TPS. We present updated OS based on longer follow-up and, for the first time, PFS2. Methods: Eligible pts were randomized 2:1 to pembro (n = 410) or placebo (n = 206) + pemetrexed and carboplatin or cisplatin for 4 cycles followed by pembro or placebo for up to 35 cycles + maintenance pemetrexed. Pts in the chemo arm could crossover to pembro alone upon PD. Poststudy anticancer therapy and outcomes were collected. PFS2 was defined as time from randomization to PD per investigator after start of 2L therapy or death, whichever occurred first. There was no multiplicity adjustment, and all P values are nominal. Data cutoff was 21 Sep 2018. Results: With 18.7-mo median follow-up, pembro + chemo continued to provide longer OS (HR 0.56 [95% CI 0.45-0.70], P< .00001; median 22.0 mo vs 10.7 mo) and PFS (HR 0.48 [95% CI 0.40-0.58], P< .00001). Benefit was seen in all PD-L1 TPS groups (Table). 2L+ therapy was received by 45% in the pembro + chemo arm and 59% (54% 2L+ immunotherapy) in the placebo + chemo arm. PFS2 was longer for 1L pembro + chemo (HR 0.49 [95% CI 0.40-0.59], P< .00001; median 17.0 mo vs 9.0 mo), with no difference by TPS (Table). Conclusions: 1L pembro + pemetrexed/platinum continued to show substantial OS benefit in metastatic nonsquamous NSCLC, regardless of PD-L1 TPS and despite 54% of pts in the placebo + chemo arm receiving subsequent immunotherapy. Median OS, PFS and PFS2 were approximately doubled with pembro + chemo. These data confirm that pembro should be given as part of 1L therapy to maximize outcomes in both PD-L1?expressing and PD-L1?non-expressing NSCLC. Clinical trial information: NCT02578680

PD-L1 TPS ≥50%
n = 202
PD-L1 TPS 1-49%
n = 186
PD-L1 TPS < 1%
n = 190
OS, HR (95% CI)0.59 (0.39-0.88)0.62 (0.42-0.92)0.52 (0.36-0.74)
PFS, HR (95% CI)0.36 (0.26-0.51)0.51 (0.36-0.73)0.64 (0.47-0.89)
PFS2, HR (95% CI)0.47 (0.33-0.69)0.59 (0.41-0.86)0.46 (0.33-0.66)

Other Abstracts in this Sub-Category:


1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


3. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9000 First Author: Kazuhiko Nakagawa
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer