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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

Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: First-line durvalumab (D) ± tremelimumab (T) versus chemotherapy (CT) in metastatic (m) NSCLC.

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
9016

Poster Board Number:
Poster Discussion Session (Board #339)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 9016)

Author(s): Naiyer A. Rizvi, Byoung Chul Cho, Niels Reinmuth, Ki Hyeong Lee, Alexander Luft, Myung-Ju Ahn, Michel van den Heuvel, Manuel Cobo Dols, David Vicente, Alexey Smolin, Vladimir Moiseyenko, Scott Joseph Antonia, Kazuhiko Nakagawa, Sarah B. Goldberg, Edward S. Kim, Jill Walker, Rajiv Raja, Feng Liu, Urban J. Scheuring, Solange Peters; Columbia University Medical Center, New York, NY; Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea; Asklepios Lung Clinic, Munich-Gauting, Germany; Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea; Leningrad Regional Clinical Hospital, Oncology Department, Lunacharskogo Prospect, Russian Federation; Samsung Medical Center, Seoul, South Korea; Department of Thoracic Oncology, Netherlands Cancer Institute (NKI), Amsterdam, Netherlands; Hospital Universitario Regional Málaga, Instituto de Investigaciones Biomédicas Málaga (IBIMA), Málaga, Spain; Hospital Universitario Virgen Macarena, Seville, Spain; Main Military Hospital, Moscow, Russian Federation; Clinical Research Center, Pesochny, St. Petersburg, Russian Federation; Moffitt Cancer Center, Tampa, FL; Kindai University Hospital, Osaka, Japan; Yale University School of Medicine, New Haven, CT; Levine Cancer Institute, Charlotte, NC; AstraZeneca, Cambridge, United Kingdom; MedImmune, Gaithersburg, MD; AstraZeneca, Gaithersburg, MD; Centre Hospitalier Universitaire Vaudois, Lausanne University, Lausanne, Switzerland

Abstract Disclosures

Abstract:

Background: MYSTIC, an open-label, Ph3 trial of first-line D (anti-PD-L1) ± T (anti-CTLA-4) vs platinum-based CT, showed an improvement in OS with D vs CT in pts with tumor cell PD-L1 expression ≥25% (PD-L1 TC ≥25%; HR 0.76 [97.54% CI 0.56–1.02], p = 0.036). Exploratory analyses showed bTMB was a predictive biomarker for OS with D±T vs CT. We report further exploratory analyses of OS according to PD-L1 and bTMB. Methods: Immunotherapy/CT-naïve pts with mNSCLC were randomized (1:1:1) to D, D+T or CT. bTMB levels (mut/Mb) were evaluated with the GuardantOMNI platform (Guardant Health), and PD-L1 TC expression with the VENTANA PD-L1 (SP263) IHC assay. Results: D improved OS vs CT in pts with PD-L1 TC ≥25% across bTMB levels (PD-L1 TC ≥25%/bTMB≥20 HR 0.79 [95% CI 0.45, 1.39]; PD-L1 TC ≥25%/bTMB < 20 HR 0.64 [95% CI 0.45, 0.90]). In contrast, D+T improved OS vs CT in pts with bTMB≥20 across different PD-L1 TC expression levels (Table; PD-L1 TC ≥25%/bTMB≥20 HR 0.44 [95% CI 0.23, 0.84]; PD-L1 TC < 1%/bTMB≥20 HR 0.42 [95% CI 0.17, 0.97]). Additional cutoffs and outcomes in subgroups defined by both biomarkers will be presented. Conclusions: These exploratory analyses from MYSTIC support PD-L1 TC expression as an appropriate predictive biomarker for OS with D vs CT, while suggesting bTMB as a predictive biomarker for OS with D+T in mNSCLC. These biomarkers appear to be independent and both may be important for mNSCLC treatment decisions. Interpretation of these data may be limited by small sample sizes; further investigations are warranted. Clinical trial information: NCT02453282

D
D+T
PD-L1 TC ≥25%PD-L1 TC ≥1%PD-L1 TC < 1%PD-L1 TC ≥25%PD-L1 TC ≥1%PD-L1 TC < 1%
All pts, nN = 163N = 279N = 95N = 163N = 296N = 76
HR* (95% CI)0.76 (0.56, 1.02)†0.88 (0.73, 1.07)1.18 (0.86, 1.62)0.85 (0.61, 1.17)‡1.01 (0.83, 1.21)0.73 (0.51, 1.04)
bTMB ≥20, nN = 40N = 61N = 16N = 32N = 49N = 15
HR* (95% CI)0.79 (0.45, 1.39)0.74 (0.48, 1.13)0.68 (0.32, 1.42)0.44 (0.23, 0.84)0.52 (0.32, 0.83)0.42 (0.17, 0.97)
bTMB < 20, nN = 91N = 152N = 57N = 81N = 164N = 40
HR* (95% CI)0.64 (0.45, 0.90)0.79 (0.61, 1.03)1.38 (0.89, 2.18)1.16 (0.83, 1.63)1.21 (0.95, 1.55)0.99 (0.60, 1.62)

*HRs refer to comparison of immunotherapy to CT; †97.54% CI; ‡98.77% CI

 
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

 

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