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Abstract
Background Anti-PD(L)1-based combination therapy is the standard of care as first-line (1L) treatment for patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) without driver alterations. This study aimed to describe patient characteristics, treatment patterns, and real-world clinical outcomes of eligible patients with NSQ mNSCLC in Japan.
Methods Eligible oncologists/pulmonologists from an existing panel of physicians in Japan participated in this study and completed electronic case report forms between June 2022 and March 2023 for adult patients with NSQ mNSCLC (without EGFR/ALK and no known ROS1 alterations). Eligible patients initiated 1L anti-PD(L)1-based combination therapy between June 2017 and May 2021, with Eastern Cooperative Oncology Group (ECOG) performance status 0–2 and documented PD-L1 expression levels. Overall survival (OS) and time-to-treatment discontinuation (TTD) post index date (1L initiation) were assessed using Kaplan Meier analyses.
Results Overall, 29 physicians (academic: 55.2%, community: 44.8%) contributed de-identified data from 101 patients’ medical charts (median age: 70 years, male: 63.4%, de novo mNSCLC: 83.2%, ECOG 0–1: 99.0%, liver metastases: 40.6%, brain metastases: 24.8%, smoking history: 54.4%). The distribution of PD-L1 expression levels was: 31.7% with tumor proportion score (TPS) <1%, 40.6% with TPS 1%-49%, and 27.7% with TPS ≥50%. Median follow-up from index to earliest of death/loss to follow-up/data collection dates was 20 months (range, 2–54 months). While the majority of patients were initiated on 1L anti-PD(L)1 + chemotherapy (73.3%), a few patients received 1L anti-PD(L)1 + anti-CTLA4 ± chemotherapy (17.8%) and 1L anti-PD(L)1 + chemotherapy + anti-VEGF(R) (8.9%). Among the 88 (87.1%) patients who discontinued 1L treatment, 55.7% (out of 88) initiated a subsequent line of therapy. Median OS was 21.7 months in the overall cohort, and the respective measures for those with TPS <1%, TPS 1%-49% and TPS ≥50% were 19.4 months, 22.1 months and 24.0 months (figure 1). Median TTD was 11.2 months in the overall cohort, and the respective measures for those with TPS <1%, TPS 1%-49% and TPS ≥50% were 9.6 months, 10.1 months, and 13.2 months (figure 2).
Conclusions Our study reports real-world clinical effectiveness of 1L anti-PD(L)1-based combination therapy for NSQ mNSCLC, which is consistent with clinical trials and published real-world studies in Japan. Several on-going phase III trials of immunotherapies in combination with targeted therapies (e.g., anti-VEGF agents) are in progress to identify opportunities to further improve outcomes in patients without oncogene driver mutations.
Acknowledgements Medical writing support was provided by a professional medical writer, Christine Tam, MWC, an employee of Analysis Group, Inc.
Ethics Approval This study received institutional review board exemption from Pearl IRB.
Overall survival of patients with non-squamous mNSCLC who initiated anti-PD(L)1-based combination therapy in 1L for metastatic disease (N=101)
Time to treatment discontinuation among patients with non-squamous mNSCLC who initiated anti-PD(L)1-based combination therapy in 1L for metastatic disease (N=101)
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