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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

Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001.

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 #338)

J Clin Oncol 37, 2019 (suppl; abstr LBA9015)

Author(s): Edward B. Garon, Matthew David Hellmann, Enric Carcereny Costa, Natasha B. Leighl, Myung-Ju Ahn, Joseph Paul Eder, Ani Sarkis Balmanoukian, Charu Aggarwal, Leora Horn, Amita Patnaik, Matthew A. Gubens, Suresh S. Ramalingam, Enriqueta Felip, Cathie Scalzo, Erin Jensen, Debra A. Kush, Rina Hui; David Geffen School of Medicine at University of California, Los Angeles, Santa Monica, CA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Catalan Institute of Oncology Badalona, Badalona, Spain; Princess Margaret Cancer Centre, Toronto, ON, Canada; Samsung Medical Center, Seoul, South Korea; Yale University, New Haven, CT; The Angeles Clinic and Research Institute, Los Angeles, CA; Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; Vanderbilt-Ingram Cancer Center, Nashville, TN; South Texas Accelerated Research Therapeutics, San Antonio, TX; University of California San Francisco, San Francisco, CA; Winship Cancer Institute of Emory University, Atlanta, GA; Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology, Barcelona, Spain; Merck & Co., Inc., Kenilworth, NJ; Westmead Hospital and the University of Sydney, Sydney, NSW, Australia

Abstract Disclosures


Background: Pembrolizumab (pembro) monotherapy has demonstrated durable antitumor activity in advanced PD-L1–expressing NSCLC. We present 5-y OS for patients (pts) enrolled in the phase 1b KEYNOTE-001 study (NCT01295827), the first trial evaluating pembro in advanced NSCLC. These data provide the longest efficacy/safety follow-up for NSCLC pts treated with pembro. Methods: Pts had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by IHC using the 22C3 antibody. Pts received pembro 2 mg/kg Q3W or 10 mg/kg Q2W or Q3W. The primary efficacy endpoint was ORR. OS was a secondary endpoint. Results: 550 pts were enrolled (treatment-naive, n=101; previously treated, n=449). As of November 5, 2018 (data cutoff), median (range) follow-up was 60.6 (51.8–77.9) mo; 82% (n=450/550) had died. Estimated 5-y OS rates were 23.2% for treatment-naive pts and 15.5% for previously treated pts (Table). ORR (by investigator per irRC) was 42% (95% CI, 32–52) for treatment-naive pts and 23% (95% CI, 19–27) for previously treated pts. Median (range) DOR was 16.8 (2.1+ to 55.7+) mo and 38.9 (1.0+ to 71.8+) mo, respectively. Immune-mediated AEs had occurred in 17% of pts at 5 y, similar to the incidence reported at 3-y follow-up. Additional results, including outcomes in key subgroups and detailed safety follow-up data, will be presented. Conclusions: In KEYNOTE-001, 5-y OS rate was 23.2% in treatment-naive pts and 15.5% in previously treated pts with advanced NSCLC treated with pembro, compared to a historical rate of ~5% (per SEER 2008–2014), prior to the introduction of anti–PD-1 therapy. 5-y OS rate was at least 25% in pts with PD-L1 TPS ≥50% in both pt populations in KEYNOTE-001. Clinical trial information: NCT01295827

OS by PD-L1 TPS.

nMedian OS (95% CI), mo36-mo OS rate, %60-mo OS rate, %
Treatment-naive101*22.3 (17.1‒32.3)37.023.2
- TPS ≥50%2735.4 (20.3‒63.5)48.129.6
- TPS 1%–49%5219.5 (10.7‒26.3)27.515.7
Previously treated44910.5 (8.6‒13.2)20.915.5
- TPS ≥50%13815.4 (10.6‒18.8)30.425.0
- TPS 1%–49%1688.5 (6.0‒12.6)16.912.6
- TPS <1%908.6 (5.5–10.6)11.13.5

*PD-L1 TPS was <1% in 12 pts (data not reported due to small pt numbers) and was unknown in 10 pts. PD-L1 TPS was unknown in 53 pts.

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