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).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
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
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.
|Treatment setting and population||N||OS||PFS|
|Medians (months)||HR (95% CI)||Medians (months)||HR (95% CI)|
|2L-M* Asians: ICI vs. chemo||470||20.9 vs 13.6||0.73 (0.55, 0.97)||3.9 vs 4.8||1.03 (0.83, 1.28)|
|2L-M* non-Asians: ICI vs. chemo||2110||12.0 vs 8.7||0.70 (0.62, 0.78)||3.0 vs 3.5||0.86 (0.78, 0.95)|
|1L-M Asians: ICI vs. chemo||422||23.4 vs 16.4||0.80 (0.61, 1.05)||6.3 vs 6.3||0.94 (0.75, 1.18)|
|1L-M non-Asians: ICI vs. chemo||1157||15.8 vs 11.3||0.77 (0.66, 0.89)||5.9 vs 6.3||0.90 (0.79, 1.03)|
|1L-C Asians: ICI vs. chemo||286||24.0 vs 20.9||0.72 (0.48, 1.07)||7.0 vs 5.8||0.72 (0.55, 0.96)|
|1L-C non-Asians: ICI vs. chemo||2214||19.5 vs 13.4||0.68 (0.60, 0.78)||8.1 vs 5.8||0.62 (0.56, 0.69)|
*EGFR WT only