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Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.

FDA analysis of outcomes in Asian patients (pts) with metastatic non-small cell lung cancer (mNSCLC) receiving immune checkpoint inhibitors (ICI).

Sub-category:
Metastatic Non-Small Cell Lung Cancer

Category:
Lung Cancer—Non-Small Cell Metastatic

Meeting:
2019 ASCO Annual Meeting

Abstract No:
e20690

Citation:
J Clin Oncol 37, 2019 (suppl; abstr e20690)

Author(s): Elaine Chang, Yutao Gong, Jonathon Joseph Vallejo, QI LIU, Luckson Noe Mathieu, Brian Booth, Rajeshwari Sridhara, Julia A. Beaver, Richard Pazdur, Gideon Michael Blumenthal; Food and Drug Administration, Silver Spring, MD; U.S. Food and Drug Administration, Silver Spring, MD; US Food and Drug Administration, Silver Spring, MD; Johns Hopkins Hosp, Baltimore, MD

Abstract Disclosures

Abstract:

Background: Asian pts tend to be well-represented in mNSCLC clinical trials, and drug development in Asia is growing. We sought to investigate outcomes of Asian pts enrolled in clinical trials testing ICI in mNSCLC. Methods: We identified 11 ICI mNSCLC randomized trials submitted to FDA 2014-2018. We divided the trials into 3 groups: 1st-line monotherapy (1L-M), 1st-line combination with chemotherapy [chemo] (1L-C), and 2nd-line monotherapy (2L-M). Overall survival (OS) and progression-free survival (PFS) were evaluated with Kaplan-Meier methodology. We performed meta-analyses to assess if treatment effect is consistent across Asian and non-Asian populations. Results: There were 3399 patients enrolled in five 2L-M trials, 1579 in two 1L-M trials, and 2500 in four 1L-C trials. Most Asian pts were located geographically in Asia (90%). Asians comprised 15% of patients enrolled in 2L-M trials, 27% in 1L-M, and 11% in 1L-C. Compared to non-Asians, a higher proportion of Asians were never-smokers (32% vs. 13%) and EGFR-mutated (13% vs. 4%). Asian pts had better unadjusted and adjusted OS than non-Asian pts for each treatment in each line of therapy. The 3 covariates with greatest prognostic impact on OS in 2L-M were race, performance status, and histology. The magnitude of ICI treatment effect relative to chemo was similar for Asian and non-Asian pts. Conclusions: Asians appear to have better prognosis than non-Asians; no uniquely better or worse benefit was observed from ICI when compared to chemotherapy.

Meta-analyses of NSCLC trials.

Treatment setting and populationNOS
PFS
Medians (months)HR (95% CI)Medians (months)HR (95% CI)
2L-M* Asians: ICI vs. chemo47020.9 vs 13.60.73 (0.55, 0.97)3.9 vs 4.81.03 (0.83, 1.28)
2L-M* non-Asians: ICI vs. chemo211012.0 vs 8.70.70 (0.62, 0.78)3.0 vs 3.50.86 (0.78, 0.95)
1L-M Asians: ICI vs. chemo42223.4 vs 16.40.80 (0.61, 1.05)6.3 vs 6.30.94 (0.75, 1.18)
1L-M non-Asians: ICI vs. chemo115715.8 vs 11.30.77 (0.66, 0.89)5.9 vs 6.30.90 (0.79, 1.03)
1L-C Asians: ICI vs. chemo28624.0 vs 20.90.72 (0.48, 1.07)7.0 vs 5.80.72 (0.55, 0.96)
1L-C non-Asians: ICI vs. chemo221419.5 vs 13.40.68 (0.60, 0.78)8.1 vs 5.80.62 (0.56, 0.69)

*EGFR WT only

 
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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