Abstract 1307P
Background
Pembro was approved and fully reimbursed in Japan in February 2017 for 1L monotherapy of unresectable advanced/metastatic NSCLC with PD-L1 tumor proportion score (TPS) ≥50%. In KEYNOTE-024 (KN024), median pembro treatment duration was 7.9 months (mo), and Kaplan-Meier (KM) 24-month overall survival (OS) was 51.5% for metastatic NSCLC with TPS ≥50%. Our aim was to describe real-world outcomes of 1L pembro monotherapy for advanced NSCLC in Japan, including the subgroup of patients (pts) ≥75 years old, who are under-represented in clinical trials.
Methods
Conducted at 23 sites, this retrospective chart review study included pts ≥20 years old initiating 1L systemic anticancer therapy from 1 July 2017 – 20 December 2018 for unresectable stage IIIB/C–IV NSCLC without actionable mutations (no EGFR/ALK/ROS1/BRAF genomic aberration); clinical trial participants were excluded. We identified pts initiating 1L pembro with PD-L1 TPS ≥50% and ECOG performance status (PS) 0–2 or unknown. OS, real-world progression-free survival (rwPFS), and real-world time on treatment (rwToT) were estimated using the KM method. Data cutoff was 30 September 2019.
Results
441 pts (78% men) were included, with median pt follow-up time of 13.5 mo (range <0.1–26.9) from start of 1L pembro. Median age was 70 years (range 30–89). Most pts (89%) were current or former smokers; 64% had nonsquamous NSCLC; 92 (21%) had brain metastasis. Median OS was not reached (NR). For 240 (54%) pts with PS 0–1, median OS was NR and median rwPFS was 10.0 mo (95% CI 7.2–14.0). Overall, 161 pts (37%) received second-line therapy (76% platinum doublet); 74 (17%) received third-line (68% non-platinum cytotoxic agent). Table: 1307P
Outcomes with 1L pembro monotherapy
| All Patientsa | PS 0–1 | |
| N | 441 | 240 |
| Median rwToT (95% CI), mo | 5.6 (4.4–6.7) | 5.7 (4.2–6.7) |
| On-treatment rate, % (95% CI) | ||
| At 12 mo | 25.8 (21.7–30.1) | 26.3 (20.8–32.2) |
| Median OS (95% CI), mo | NR | NR |
| OS rate, % (95% CI) | ||
| At 12 mo | 72.2 (67.5–76.3) | 75.6 (69.4–80.7) |
| At 24 mo | 57.9 (50.8–64.3) | 57.5 (46.8–66.9) |
| Median rwPFS (95% CI), mo | 10.0 (8.2–11.8) | 10.0 (7.2–14.0) |
| rwPFS rate, % (95% CI) | ||
| At 12 mo | 44.6 (39.6–49.4) | 45.2 (38.5–51.7) |
| Age ≥75 years, n (%) | 138 (31) | – |
| Median rwToT (95% CI), mo | 5.6 (3.7–7.0) | – |
| Median OS (95% CI), mo | 23.5 (16.2–NR) | – |
| OS rate at 24 mo, % (95% CI) | 48.0 (34.1–60.7) | – |
| Median rwPFS (95% CI), mo | 9.5 (6.2–14.2) | – |
aIncludes PS 2 (8%) & unknown PS (37%).mo, months; NR, not reached.
Conclusions
Real-world clinical outcomes with 1L pembro monotherapy for high PD-L1–expressing (TPS ≥50%), advanced NSCLC were consistent with KN024 clinical trial data, although the rwToT estimate was somewhat shorter than KN024 treatment duration.
Clinical trial identification
Editorial acknowledgement
Editorial assistance was provided by Elizabeth V. Hillyer, DVM (freelance); this assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Legal entity responsible for the study
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Funding
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
Disclosure
Y. Goto: Financial Interests, Personal, Advisory Role: Eli Lilly; Financial Interests, Personal, Advisory Role: Chugai Pharmaceutical; Financial Interests, Personal, Advisory Role: Taiho Pharmaceutical; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: GlaxoSmithKline; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Guardant Health; Financial Interests, Personal, Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Advisory Role: Kyorin; Financial Interests, Personal, Advisory Role: Illumina; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: Taiho Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Shionogi Pharma; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Institutional, Funding, Research Funding: AbbVie; Financial Interests, Institutional, Funding, Research Funding: Eli Lilly; Financial Interests, Institutional, Funding, Research Funding: Taiho Pharmaceutical; Financial Interests, Institutional, Funding, Research Funding: Bristol Myers Squibb; Financial Interests, Institutional, Funding, Research Funding: Ono Pharmaceutical; Financial Interests, Institutional, Funding, Research Funding: Daiichi Sankyo; Financial Interests, Institutional, Funding, Research Funding: Pfizer; Financial Interests, Institutional, Funding, Research Funding: Novartis; Financial Interests, Institutional, Funding, Research Funding: Kyorin; Financial Interests, Institutional, Funding, Research Funding: Chugai; Financial Interests, Institutional, Funding, Research Funding: Guardant Health. M.L. Santorelli: Financial Interests, Personal, Full or part-time Employment: MSD/Merck; Financial Interests, Personal, Stocks/Shares: Merck. K. Taniguchi: Financial Interests, Personal, Full or part-time Employment: MSD KK; Financial Interests, Personal, Stocks/Shares: Merck. T. Kamitani: Financial Interests, Personal, Full or part-time Employment: MSD KK; Financial Interests, Personal, Stocks/Shares: Merck. M. Irisawa: Financial Interests, Personal, Full or part-time Employment: MSD KK; Financial Interests, Personal, Stocks/Shares: Merck. K. Kanda: Financial Interests, Personal, Full or part-time Employment: MSD KK. M. Abe: Financial Interests, Personal, Full or part-time Employment: MSD KK; Financial Interests, Personal, Stocks/Shares: Merck. T. Burke: Financial Interests, Personal, Full or part-time Employment: MSD/Merck; Financial Interests, Personal, Stocks/Shares: Merck. H. Nokihara: Non-Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Non-Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical; Non-Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Non-Financial Interests, Personal, Speaker’s Bureau: Taiho Pharmaceutical; Non-Financial Interests, Personal, Speaker’s Bureau: MSD; Non-Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Non-Financial Interests, Personal, Speaker’s Bureau: Novartis; Non-Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Non-Financial Interests, Institutional, Research Grant: MSD; Non-Financial Interests, Institutional, Research Grant: Pfizer; Non-Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical; Non-Financial Interests, Institutional, Research Grant: Regeneron; Non-Financial Interests, Institutional, Research Grant: Takeda Pharmaceutical.