First-Line Pembrolizumab Monotherapy for Metastatic Pd-L1-Positive Nsclc: creal-World Analysis of Time on Treatment

Abstract

Aim: To determine real-world time on treatment (rwToT) with first-line pembrolizumab monotherapy for metastatic non-small-cell lung cancer (NSCLC) with programmed death ligand-1 (PD-L1) tumor proportion score (TPS) ≥50%. Methods: The Kaplan–Meier rwToT was estimated from electronic health record data for adults who initiated first-line pembrolizumab monotherapy for stage IV, PD-L1 TPS ≥50% NSCLC, with negative/unknown EGFR/ALK aberrations, and ≥6 months’ follow-up until database cutoff. Results: A total of 386 patients with ECOG 0–1 had a median rwToT of 6.9 months (95% CI: 5.6–8.3) and 12-month on-treatment rate of 36.4% (31.2–41.6) versus 40.3% (32.5–47.9) and 37.6% (31.9–43.4) in KEYNOTE-024 (KN024) and KN042 (stage IV/TPS ≥50% subpopulation), respectively. The 24-month restricted-mean rwTOT (extrapolated) was 10.5 months (9.4–11.7), versus 11.0 (9.5–12.5) and 10.4 (9.3–11.5) in KN024 and KN042, respectively. Conclusion: First-line pembrolizumab monotherapy rwToT in metastatic PD-L1 TPS ≥50% NSCLC for trial-matched patients is similar to treatment duration in KN024 and KN042.

Treatment patterns and clinical outcomes in patients with advanced non-small cell lung cancer initiating first-line treatment in the US community oncology setting: a real-world retrospective observational study

“…They reported a median rwTOT of 6.9 months vs a median TOT of 7.9 months in KEYNOTE-024 and 6.6 months in KEYNOTE-042. The median TTD of 3.5 months with IO monotherapy in our study was considerably shorter than the Velcheti et al (2019) estimates.…”

“…However, few studies have examined the real-world treatment patterns and clinical outcomes of these therapies. These studies have mostly included patients with previously treated advanced NSCLC, lacked comparisons between treatments, and/or limited the patient population to those with PD-L1 expression (Khozin et al 2018;Molife et al 2019;Nadler et al 2018;Schwartzberg et al 2019;Velcheti et al 2019;Weis et al 2019). Further research on IO use in patients with advanced NSCLC treated in the community oncology setting is needed, as there may be differences in real-world clinical outcomes compared with clinical trial outcomes due to underlying variation in patient populations and methodology (Khozin et al 2019a).…”

“…Additionally, the TTD in this study may be shorter than treatment durations observed in clinical trials. For example, Velcheti et al (2019) compared the real-world time on treatment (rwTOT) vs TOT in KEYNOTE-024 and -042 among patients with metastatic NSCLC and an ECOG PS of 0/1 treated with 1L pembrolizumab. They reported a median rwTOT of 6.9 months vs a median TOT of 7.9 months in KEYNOTE-024 and 6.6 months in KEYNOTE-042.…”

Development of therapeutic antibodies for the treatment of diseases

“…Pembrolizumab is a humanized antibody used in cancer immunotherapy to treat melanoma, lung cancer, head and neck cancer, Hodgkin’s lymphoma, and stomach cancer [53–55]. Pembrolizumab is a first-line treatment for NSCLC if cancer cells overexpresse PD-L1 and have no mutations in EGFR or in anaplastic lymphoma kinase [56, 57]. Large randomized clinical trials indicated that NSCLC patients treated with nivolumab and pembrolizumab (both approved by the US FDA in 2014) showed increased overall survival compared with docetaxel, the standard second-line treatment [58].…”

Pancreatic undifferentiated carcinoma with osteoclast-like giant cells curatively resected after pembrolizumab therapy for lung metastases: a case report

“…In addition, DNA mismatch repair (MMR) deficiency is an important factor for immune checkpoint inhibitor sensitive mechanism in solid tumors [10,11]. Pembrolizumab, a humanized monoclonal antibody against PD-1, has been reported to have strong antitumor activity in advanced non-small-cell lung cancer (NSCLC) [5,12], although it has not shown sufficient therapeutic effects in PC. A case of UCOGC that was curatively resected following pembrolizumab monotherapy that was highly effective for metastatic lung cancer is presented.…”