Abstract 1321P
Background
IO monotherapies were approved and fully reimbursed for first-line (1L) therapy of unresectable advanced/metastatic NSCLC in February 2017 in Japan. Our aims were to describe treatment patterns and clinical outcomes for advanced NSCLC by regimen type in real-world clinical settings in Japan after the introduction of 1L IO monotherapy.
Methods
Patients (pts) ≥20 years old initiating 1L systemic anticancer therapy for unresectable stage IIIB/C–IV NSCLC from 1 July 2017 – 20 December 2018 were identified by retrospective chart review at 23 study sites. Eligible pts had recorded tumor PD-L1 test results and no actionable mutation documented at treatment start, and clinical trial participants were excluded. Real-world time on treatment (rwToT) with 1L IO monotherapy (IO mono), and overall survival (OS) and real-world progression-free survival (rwPFS) were estimated by regimen type using Kaplan-Meier, after excluding pts with ECOG performance status (PS) 3–4 according to a prespecified statistical analysis plan, with data cutoff on 30 September 2019.
Results
Of 1208 eligible pts, 647 (54%) received platinum doublet (platinum), 463 (38%) IO mono (459 received pembrolizumab), and 98 (8%) non-platinum cytotoxic regimen (non-platinum) as 1L therapy. PD-L1 tumor proportion score was ≥50%, 1–49% and <1% for 44%, 30%, and 25%, respectively (1% not evaluable). Median rwToT with 1L IO mono was 5.2 months (95% CI 4.2–6.5). Overall, 621 (51%) pts continued to 2L (48% IO mono; 26% platinum; 26% non-platinum), and 281 (23%) continued to 3L (65% non-platinum, 27% IO mono, 6% platinum). Excluding 26 pts (2%) with PS 3–4 (Table), median pt follow-up was 11.3 months (range <0.1–26.9). Table: 1321P
| Platinum | IO Mono | Non-platinum | |
| N | 635 | 452 | 95 |
| Men, n (%) | 522 (82) | 353 (78) | 79 (83) |
| Age, median (range) | 69 (27–83) | 70 (30–89) | 80 (45–92) |
| Current/former smoker, n (%)a | 567 (92) | 398 (89) | 79 (84) |
| PS 0–1, n (%) | 366 (58) | 242 (54) | 40 (42) |
| PS 2 | 38 (6) | 38 (8) | 17 (18) |
| PS unknown | 231 (36) | 172 (38) | 38 (40) |
| Brain metastasis, n (%) | 96 (15) | 92 (20) | 6 (6) |
| Nonsquamous, n (%)a | 383 (60) | 270 (60) | 45 (47) |
| Median OS (95% CI), mo | 16.3 (14.0–20.1) | NR | 14.4 (10.3–21.2) |
| OS rate, % (95% CI) | |||
| At 12 mo | 60.8 (56.6–64.8) | 72.1 (67.5–76.2) | 60.0 (48.0–70.0) |
| At 24 mo | 40.3 (34.4–46.1) | 57.8 (50.9–64.2) | 31.1 (16.4–47.1) |
| Median rwPFS (95% CI), mo | 5.8 (5.3–6.3) | 9.7 (8.1–11.1) | 4.9 (3.5–5.7) |
| rwPFS rate, % (95% CI) | |||
| At 12 mo | 22.3 (18.3–26.4) | 44.1 (39.1–48.9) | 19.3 (10.4–30.2) |
aPercentages are of known totals. NR, not reached.
Conclusions
This study describes treatment patterns and real-world clinical outcomes for pts with advanced NSCLC without actionable mutations treated in real-world clinical settings after access to IO for 1L therapy in Japan.
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
H. Nokihara: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Chugai Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Taiho Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical; Financial Interests, Institutional, Research Grant: Regeneron; Financial Interests, Institutional, Research Grant: Takeda Pharmaceutical. 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. 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.