Abstract 1328P
Background
Real-world evidence can be used to understand effectiveness of therapies in patient populations under-represented in clinical trials. In the KEYNOTE-189 trial of platinum + pemetrexed +/- pembrolizumab, ≥75 age group represented only 9% of intent-to-treat patients. We present clinical outcomes of pembrolizumab + carboplatin + pemetrexed (CPP) in nonsquamous metastatic NSCLC patients ≥75 years of age in routine clinical practice in the US.
Methods
Nonsquamous metastatic NSCLC patients, ≥75 years old at diagnosis, initiating CPP as first-line treatment from May 10, 2017 to August 31, 2018 were randomly selected for enhanced manual chart review from the Flatiron Health Advanced NSCLC EHR database. Patients with ECOG performance status (PS) ≥3 and who are EGFR/ALK positive were excluded. Study outcomes were real-world time on treatment (rwToT), real-world tumor response (rwTR), real-world progression-free survival (rwPFS) and overall survival (OS). The data cutoff date was August 31, 2019.
Results
Study included 99 patients with a median follow-up of 21.5 months (range: 12.1, 27.5). The median (range) age was 79 years (range: 75-85); 57% were male; and 59.6%, 13.1%, 27.3% were ECOG PS 0-1, 2, and missing, respectively. PD-L1 TPS distribution was ≥50% (30.3%), 1-49% (26.3%), <1% (29.3%), and not evaluable/unknown (14.1%). Median (95% CI) rwToT for pembrolizumab and pemetrexed were 4.9 (3.8-6.2) and 2.8 (2.2-3.6) months, respectively. Median rwToT for pembrolizumab was 6.2, 5.6, 4.2, and 3.4 months in PD-L1 TPS ≥50%, 1-49%, <1%, and unknown groups, respectively. The overall rwTRR was 54.5%. Median PFS was 6.9 months overall and was 10.9, 9.7, 3.7, 4.8 months in PD-L1 ≥50%, 1-49% <1% and unknown groups, respectively. Median OS was 15.5 months overall and the 18-month OS rate was 48.3%. Median OS was 20.6, 18.0, 8.9 and 4.8 months in PD-L1 ≥50%, 1-49% <1% and unknown groups, respectively. A total of 23.2% of patients received a second-line therapy.
Conclusions
Outcomes from this real-world data analysis show clinical benefits with CPP in elderly patients with metastatic nonsquamous NSCLC and the benefit increases with higher levels of PD-L1 score.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Merck & Co., Inc.
Funding
Merck & Co., Inc.
Disclosure
V. Velcheti: Advisory/Consultancy: Novartis; Advisory/Consultancy: EMD Serono; Advisory/Consultancy: BMS; Advisory/Consultancy: Merck; Advisory/Consultancy: Foundation Medicine; Advisory/Consultancy: AstraZeneca. X. Hu: Full/Part-time employment: Merck & Co. X. Chen, B. Piperdi, T. Burke: Shareholder/Stockholder/Stock options, Full/Part-time employment: Merck.