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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

A phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952).

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
9014

Poster Board Number:
Poster Discussion Session (Board #337)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 9014)

Author(s): Lyudmila Bazhenova, Mary Weber Redman, Scott N. Gettinger, Fred R. Hirsch, Philip C. Mack, Lawrence Howard Schwartz, David R. Gandara, Jeffrey D. Bradley, Tom Stinchcombe, Natasha B. Leighl, Suresh S. Ramalingam, Susan S Tavernier, Katherine Minichiello, Karen Kelly, Vassiliki Papadimitrakopoulou, Roy S. Herbst; University of California, San Diego, La Jolla, CA; SWOG Statistical Center; Fred Hutchinson Cancer Research Center, Seattle, WA; Yale Cancer Center, New Haven, CT; University of Colorado Cancer Center, Denver, CO; UC Davis Comprehensive Cancer Center, Sacramento, CA; Columbia University Medical Center, New York, NY; University of California, Davis, Sacramento, CA; Washington University School of Medicine in St. Louis, St. Louis, MO; Duke Cancer Institute, Durham, NC; Princess Margaret Cancer Centre, Toronto, ON, Canada; Winship Cancer Institute, Emory University, Atlanta, GA; Idaho State University, Pocatello, ID; University of California Davis Comprehensive Cancer Center, Sacramento, CA; The University of Texas MD Anderson Cancer Center, Houston, TX; Yale University, New Haven, CT

Abstract Disclosures

Abstract:

Background: Lung-MAP is a master protocol for patients (pts) with stage IV previously treated SqNSCLC. S1400I enrolled pts who were not eligible for a biomarker-matched sub-study. Methods: S1400I is phase III randomized trial for immunotherapy-naïve patients with ECOG 0-1 not selected by PD-L1 expression. Pts were assigned 1:1 to nivolumab and ipilimumab (N+I) vs nivolumab (N). N was given at 3 mg/kg q 2w, I was given at 1 mg/kg q 6w. The primary endpoint was overall survival (OS). Secondary endpoints: investigator-assessed progression-free survival (IA-PFS), response by RECIST 1.1, and toxicity. Results: From December 18, 2015 to April 23, 2018, 275 pts enrolled and 252 determined eligible (125 N+I and 127 N). The study was closed for futility at an interim analysis. Baseline characteristics were similar across arms. mOS was 10.0 m (8.0-12.8) and 11.0 m (8.2-13.5) for N+I and N. HR 0.97 (0.71-1.31), p 0.82. mPFS was 3.8 m (2.3-4.2) and 2.9 m (1.8-3.9) for N+I and N. HR 0.84 (0.64-1.09), p 0.19. Outcomes based on PD-L1 and TBM subsets are shown in table. Response rates were 18% (12-25%) and 17% (11-24%) for N+ I and N. Median follow up for patients still alive was 17.4 m. Grade ≥3 treatment-related AEs occurred in 48(39%) of pts on N+I vs 38(31%) on N. irAE reported in 39% of pts on N+I and 34% of patients on N. Drug-related AEs led to discontinuation in 25% and 16% of pts on N+I and N. There were 5 grade 5 AE in N+I arm and 1 in N arm. Conclusions: S1400I failed to show improvement in outcomes with N+I. Study was closed for futility at interim analysis. Toxicities were not different between two arms. Clinical trial information: 02785952.

N+I
Median in months
N
Median in months
HRp
OS PD-L1 ≥514.1 (5.8-17.5)12.0 (8.2-19.8)1.06 (0.58-1.92)0.86
OS PD-L1 < 58.3 (6.0-10.7)10.3 (6.3-13.5)1.01 (0.62-1.65)0.97
OS TMB ≥1013.1 (9.3-17.0)11.4 (8.2-16.1)0.86 (0.56-1.32)0.48
OS TMB < 107.6 (5.7-10.2)10.0 (6.3-15.2)1.08 (0.68-1.71)0.74
PFS PD-L1 ≥ 53.9 (1.7-7.1)2.9 (1.8-4.7)0.65 (0.38-1.08)0.10
PFS PD-L1 < 54.4 (2.1-6.0)1.6 (1.5-3.0)0.64 (0.41-1.01)0.06
PFS TMB ≥ 104.2 (3.4-5.9)3.4 (1.8-5.3)0.75 (0.52-1.10)0.15
PFS TMB < 101.9 (1.5-4.1)2.7 (1.6-3.3)0.92 (0.62-1.39)0.70

 
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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