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. 2024 Mar 20;5(6):100667.
doi: 10.1016/j.jtocrr.2024.100667. eCollection 2024 Jun.

Brief Report: Long-Term Follow-Up of Adjuvant Pembrolizumab After Locally Ablative Therapy for Oligometastatic NSCLC

David J Cantor  1 , Christiana Davis  1 , Christine Ciunci  1   2 , Charu Aggarwal  1 , Tracey Evans  1   3 , Roger B Cohen  1 , Joshua M Bauml  1   4 , Corey J Langer  1
Affiliations

Brief Report: Long-Term Follow-Up of Adjuvant Pembrolizumab After Locally Ablative Therapy for Oligometastatic NSCLC

David J Cantor et al. JTO Clin Res Rep. .

Abstract

Introduction: Patients with oligometastatic NSCLC benefit from locally ablative therapies (LAT); the role of adjuvant systemic therapies, however, remains less clear. In a single-arm, phase II clinical trial, we found that patients with oligometastatic NSCLC treated with a year of pembrolizumab after LAT had superior progression-free survival (PFS) compared with a historical control cohort. Herein, we present long-term follow-up on PFS and overall survival (OS).

Methods: From February 1, 2015, to September 30, 2017, 45 patients with synchronous or metachronous oligometastatic (≤4 metastatic sites) NSCLC treated with LAT to all sites received adjuvant pembrolizumab every 21 days for up to 16 cycles. The primary efficacy end point was PFS from the start of pembrolizumab. Secondary end points included OS and safety. Median duration of follow-up was 66 months, and data cutoff was December 1, 2022.

Results: A total of 45 patients were enrolled and treated with pembrolizumab after LAT (median age, 64 y [range, 46-82]; 21 women [47%]; 31 with a solitary oligometastatic site [69%]). At the data cutoff, 32 patients had progressive disease, 19 patients had died, and 13 patients had no evidence of relapse. Median PFS was 19.7 months (95% confidence interval: 7.6-31.7 mo); median OS was not reached (95% confidence interval: 37.7 mo-not reached). OS at 5 years was 60.0% (SE, 7.4%). Metachronous oligometastatic disease was associated with improved OS and PFS through Cox proportional hazard models.

Conclusions: Pembrolizumab after LAT for oligometastatic NSCLC results in promising PFS and OS with a tolerable safety profile.

Keywords: LAT; NSCLC; Oligometastatic; Pembrolizumab.

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Conflict of interest statement

Dr. Cantor reports receiving honoraria from HMP. Dr. Aggarwal reports receiving institutional research funding from 10.13039/100004325AstraZeneca, 10.13039/100004328Genentech, 10.13039/100017655Incyte, 10.13039/100019794Macrogenics, 10.13039/501100004628Medimmune, and 10.13039/100009947Merck Sharp and Dohme, and receiving consultation fees from Genentech, Lilly, Celgene Merck, AstraZeneca, Blueprint Genetics, Shionogi, Daiichi Sankyo, Regeneron, Sanofi, Eisai, BeiGene, Turning Point, Pfizer, Janssen, and Boehringer Ingelheim. Dr. Evans reports receiving honoraria from Merck. Dr. Cohen reports receiving institutional research funding from F-Star Biotechnology, Innate Biopharma, and Cantargia. Dr. Bauml is currently employed by Janssen Research and Development but all work for this study was done as an employee at the University of Pennsylvania, and reports owning stock in Johnson & Johnson. Dr. Langer reports receiving institutional research funding from AstraZeneca, Eli Lilly, 10.13039/501100002424Fujifilm, 10.13039/100008897Janssen Pharmaceuticals, 10.13039/100016255Inovio, 10.13039/100004334Merck, Oncocyte, Takeda, and Trizell; receiving consulting fees from AstraZeneca, Boehringer Ingelheim, Genentech, Roche, Gilead, GlaxoSmithKline, Merck, Mirati, Novocure, Pfizer, Regeneron, Sanofi-Aventis, and Takeda; and having participation on a safety monitoring board or advisory board for Amgen, OncocyteDX, the Radiation Therapy Oncology Group Foundation, and the Veterans Administration. The remaining authors declare no conflict of interest.

Figures

Figure 1
Figure 1
PFS and OS. (A) PFS and (B) OS from the start of pembrolizumab therapy. Shaded areas represent the 95% CI. Data cutoff was December 1, 2022. CI, confidence interval; NR, not reached; OS, overall survival; PFS, progression-free survival.
Figure 2
Figure 2
OS following disease progression. OS of patients following disease progression. Shaded areas represent the 95% CI. n =30. CI, confidence interval; NR, not reached; OS, overall survival.
See this image and copyright information in PMC

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