2019 ASCO Annual Meeting!
Session: Using Real-World Data to Advance Research and Care
Type: Clinical Science Symposium
Time: Monday June 3, 9:45 AM to 11:15 AM
Location: Hall D1
Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 110)
Author(s): Sean Khozin, Mark S. Walker, Monika Jun, Li Chen, Edward Stepanski, Wendy S. Rubinstein, George Anthony Komatsoulis, Jeremy Roberts, Jizu Zhi, Robert S. Miller, Ryan Fukushima, Denise Lau, Brigham Hyde; U.S. Food and Drug Administration, Silver Spring, MD; ACORN Research LLC, Memphis, TN; Concerto HealthAI, Boston, MA; American Society of Clinical Oncology’s (ASCO) CancerLinQ, Alexandria, VA; Tempus, Chicago, IL
Background: Anecdotal and early evidence suggest ICIs are being used in patients with advanced malignancies and history of AD, despite such patients being typically excluded from traditional clinical trials. We compared the outcomes of patients with or without AD, all of whom had ICI treatment for aNSCLC. Methods: We conducted a retrospective, observational cohort study using de-identified, curated data in ASCO’s CancerLinQ. Patients with Stage III or IV NSCLC who received ≥1 dose of an ICI and had ≥2 visits from Jan 2011 to Nov 2018 were included. AD status prior to ICI treatment was identified using ICD-9/ICD-10 codes or AD medications (including steroids). Symphony claims data were linked via tokenization to build cohorts. Time to treatment discontinuation (TTD), time to next treatment (TTNT), real-world progression-free survival (rwPFS) and overall survival (OS) were compared across the two cohorts using the log-rank test. Cox Proportional Hazards Model was used to adjust for covariates. Adverse events (AEs) were compared using Chi-Square and Fisher’s Exact Test. Active AD was defined as evidence of autoimmune disease in the year prior to starting ICIs. Results: Among 2425 patients with aNSCLC treated with ICIs, AD was present in 22% (N=538). Median OS in all patients was 12.4 months (95% CI 11.3-13.5). TTD, TTNT, rwPFS and OS did not differ between the two cohorts (Table). There was no association between AD status and outcomes. There was no increased incidence of AEs in the AD group; however a sub-analysis among patients with active AD showed higher rates of select AEs including endocrine, GI and blood disorders. Conclusions: This analysis demonstrates that patients with evidence of AD prior to receiving ICI have similar outcomes compared to patients with no evidence of AD. Further research is needed to better understand the impact of active AD on the risk of AEs and patient outcomes.
|Endpoints||Evidence of AD|
|No Evidence of AD|
|TTD||3.68 (3.35 - 4.6)||4.24 (3.94 - 4.60)||0.1|
|TTNT||12.2 (9.0 - 15.5)||12.5 (11.1 - 13.8)||0.6|
|rwPFS||4.24 (3.58 - 4.90)||4.17 (3.78 - 4.64)||0.7|
|OS||11.5 (9.63 - 13.2)||12.8 (11.51 - 14.2)||0.2|