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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

Early clearance of plasma EGFR mutations as a predictor of response to osimertinib and comparator EGFR-TKIs in the FLAURA trial.

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 #343)

J Clin Oncol 37, 2019 (suppl; abstr 9020)

Author(s): Caicun Zhou, Fumio Imamura, Ying Cheng, Isamu Okamoto, Byoung Chul Cho, Meng Chih Lin, Margarita Majem, Oliver Gautschi, Jhanelle Elaine Gray, Michael J. Boyer, Juliann Chmielecki, Ryan Hartmaier, Krishna Bulusu, J Carl Barrett, Rachel Hodge, Matilde Saggese, Astrid McKeown, Suresh S. Ramalingam; Shanghai Pulmonary Hospital, Tongji University, Shanghai, China; Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan; Department of Oncology, Jilin Province Cancer Hospital, Changchun, China; Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea; Division of Pulmonary and Critical Care Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University, Kaohsiung, Taiwan; Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; University of Berne and Cantonal Hospital of Lucerne, Lucerne, Switzerland; Department of Thoracic Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL; Department of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, Australia; Translational Sciences, IMED Biotech Unit, AstraZeneca, Waltham, MA; Bioscience, IMED Biotech Unit, AstraZeneca, Cambridge, United Kingdom; Biometrics and Information Sciences, AstraZeneca, Cambridge, United Kingdom; Global Medical Development Oncology, AstraZeneca, Cambridge, United Kingdom; Emory University, Winship Cancer Institute, Atlanta, GA

Abstract Disclosures


Background: In the Phase III FLAURA trial (NCT02296125), osimertinib, a third generation EGFR-TKI, showed superior efficacy to comparator EGFR-TKIs as first line treatment for EGFR mutation-positive (EGFRm) advanced NSCLC. In an exploratory analysis, we investigated clinical outcomes associated with detection of plasma EGFRm at 3 or 6 weeks (wks) after start of treatment. Methods: Treatment-naïve patients (pts) with EGFRm (ex19del or L858R) locally advanced or metastatic NSCLC were randomized 1:1 to receive osimertinib 80 mg once daily (QD) or comparator EGFR-TKIs (gefitinib 250 mg QD or erlotinib 150 mg QD). Plasma EGFR mutation analysis was conducted at baseline (BL), wks 3 and 6 by droplet digital PCR. Clearance was defined as undetectable levels of EGFRm in ctDNA at wks 3/6, where they were detectable at BL. Progression-free survival (PFS) was investigated based on early clearance of EGFRm. Results: In total 489/556 (88%) pts (osimertinib: 244/279; comparator: 245/277) had evaluable ctDNA at BL and wks 3/6. Of these, 342/489 (70%; osimertinib: 168/244; comparator: 174/245) had detectable BL EGFRm and were included in this analysis. See table. Conclusions: Clearance of plasma EGFRm after 3/6 wks of EGFR-TKI therapy was associated with a numerical improvement in PFS. The efficacy of osimertinib was superior to comparator EGFR-TKIs regardless of clearance status. Clinical trial information: NCT02296125

Osimertinib + Comparator EGFR-TKIsWk 3
Wk 6
D EGFRm (n = 126)ND EGFRm (n = 208)D EGFRm (n = 69)ND EGFRm (n = 258)
mPFS, mo (95% CI)9.5 (7.0, 10.9)13.5 (11.1, 15.2)8.3 (6.8, 10.9)13.5 (11.1, 15.2)
D EGFRmOsimertinib (n = 56)Comparator (n = 70)Osimertinib (n = 30)Comparator (n = 39)
mPFS, mo (95% CI)11.3 (9.5, 16.5)7.0 (5.6, 8.3)11.1 (6.8, 13.8)8.2 (5.5, 9.9)
HR (95% CI); p value0.50 (0.3, 0.8); p = 0.0010.70 (0.4, 1.2); p = 0.191
ND EGFRmOsimertinib (n = 106)Comparator (n = 102)Osimertinib (n = 134)Comparator (n = 124)
mPFS, mo (95% CI)19.8 (15.1, NC)10.8 (9.7, 11.1)19.8 (15.1, NC)10.2 (9.5, 11.1)
HR (95% CI); p value0.41 (0.3, 0.6); p < 0.00010.40 (0.3, 0.6); p < 0.0001

CI, confidence interval; D, detectable; HR, hazard ratio; mo, months; mPFS, median PFS; NC, non-calculable; ND, non-detectable

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