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Clinical Trial
. 2018 Sep;13(9):1393-1399.
doi: 10.1016/j.jtho.2018.05.002. Epub 2018 Jul 17.

Phase II Study of Maintenance Pembrolizumab in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC)

Shirish M Gadgeel  1 , Nathan A Pennell  2 , Mary Jo Fidler  3 , Balazs Halmos  4 , Philip Bonomi  3 , James Stevenson  2 , Bryan Schneider  5 , Ammar Sukari  6 , Jaclyn Ventimiglia  6 , Wei Chen  6 , Cathy Galasso  6 , Antoinette Wozniak  6 , Julie Boerner  6 , Gregory P Kalemkerian  5
Affiliations
Clinical Trial

Phase II Study of Maintenance Pembrolizumab in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC)

Shirish M Gadgeel et al. J Thorac Oncol. 2018 Sep.

Abstract

Objective: The aim of this study was to assess the efficacy of maintenance pembrolizumab in patients with extensive-stage SCLC after treatment with platinum and etoposide.

Methods: Patients with extensive-stage SCLC with a response or stable disease after induction chemotherapy were eligible. Pembrolizumab at a dose of 200 mg administered intravenously every 3 weeks was initiated within 8 weeks of the last cycle of chemotherapy. The primary end point of the study was progression-free survival (PFS) from study registration, with overall survival (OS) as a key secondary end point. Available tumor tissue was assessed for expression of programmed death ligand 1 (PD-L1) both in the tumor cells and in the surrounding stroma. Blood for circulating tumor cells was collected before the first, second, and third cycles of pembrolizumab.

Results: Of the 45 patients enrolled, 56% were male and 22% had treated brain metastases. The median PFS was 1.4 months (95% confidence interval [CI]: 1.3-2.8), with a 1-year PFS of 13%. The median OS was 9.6 months (95% CI: 7.0-12), with a 1-year OS of 37%. Of the 30 tumors that could be assessed, three had PD-L1 expression (≥1%) in the tumor cells. A total of 20 tumors could be assessed for PD-L1 expression in the stroma. The median PFS in the eight patients with tumors positive for expression of PD-L1 at the stromal interface was 6.5 months (95% CI: 1.1-12.8) compared with 1.3 months (95% CI: 0.6-2.5) in 12 patients with tumors negative for this marker. No unexpected toxicities were observed.

Conclusion: Maintenance pembrolizumab did not appear to improve median PFS compared with the historical data. However, the 1-year PFS rate of 13% and OS rate of 37% suggest that a subset of patients did benefit from pembrolizumab.

Keywords: Maintenance; Metastatic; Pembrolizumab; SCLC.

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Figures

Figure 1.
Figure 1.
Progression-free survival (PFS) from study registration (N = 45). CI, confidence interval.
Figure 2.
Figure 2.
Overall survival (OS) from study registration (N = 45). CI, confidence interval.
Figure 3.
Figure 3.
Programmed death ligand 1 (PD-L1) expression in the tumor cells (A) and at the stromal interface (B).
See this image and copyright information in PMC

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