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Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic SCLC: Results From the KEYNOTE-028 and KEYNOTE-158 Studies
Open accessAbstract
INTRODUCTION Pembrolizumab has shown clinical benefit in patients with previously treated recurrent/metastatic small-cell lung cancer (SCLC) in the phase 1b multicohort study KEYNOTE-028 (NCT02054806) and the phase 2 multicohort study KEYNOTE-158 (NCT02628067). We present a pooled analysis of patients from KEYNOTE-028 and KEYNOTE-158 who had received ≥2 lines of previous therapy for SCLC. METHODS Eligible patients were ≥18 years, had histologically/cytologically confirmed incurable recurrent/metastatic SCLC, an Eastern Cooperative Oncology Group performance status of ≤1, and had received ≥2 lines of previous therapy. Patients in KEYNOTE-028 were required to have a programmed death ligand 1 (PD-L1)-positive tumor. Patients received pembrolizumab 10 mg/kg every 2 weeks (KEYNOTE-028) or 200 mg every 3 weeks (KEYNOTE-158) for up to 2 years. The primary endpoint was objective response rate (ORR) per RECIST version 1.1; presented here per independent review. RESULTS Eighty-three patients who had received ≥2 lines of previous therapy (KEYNOTE-028, n=19; KEYNOTE-158, n=64) were included. Median follow-up duration was 7.7 months (range, 0.5‒48.7). ORR was 19.3% (95% CI, 11.4‒29.4); 2 patients had a complete response (1 with a PD-L1-positive tumor) and 14 had a partial response (13 with PD-L1-positive tumors). Median duration of response was not reached (range, 4.1‒35.8+ months); 61% of responders had responses lasting ≥18 months. Fifty-one patients (61.4%) experienced any-grade treatment-related adverse events; 8 (9.6%) patients had grade ≥3 events. CONCLUSION Pembrolizumab demonstrated durable antitumor activity in subset of patients with recurrent/metastatic SCLC who had ≥2 previous lines of therapy, regardless of PD-L1 expression. Pembrolizumab was well tolerated.
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Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer
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Self-citationFirst-line atezolizumab plus chemotherapy in extensive-stage small-cell lung cancer
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Self-citationUnravelling the biology of SCLC: implications for therapy
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Metadata
- Authors
- Chung, H. C., Piha-Paul, S. A., Lopez-Martin, J., Schellens, J. H. M., Kao, S., Miller, W. H., Delord, J.-P., Gao, B., Planchard, D., Gottfried, M., Zer, A., Jalal, S. I., Penel, N., Mehnert, J. M., Matos, I., Bennouna, J., Kim, D.-W., Xu, L., Krishnan, S., Norwood, K., & Ott, P. A.
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2020-04
- Volume
- 15
- Issue
- 4
- Pages
- 618-627
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W2995889981
- Cited by
- 408
- References
- 22
- FWCI
- 19.04
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Chung, H. C., Piha-Paul, S. A., Lopez-Martin, J., Schellens, J. H. M., Kao, S., Miller, W. H., Delord, J.-P., Gao, B., Planchard, D., Gottfried, M., Zer, A., Jalal, S. I., Penel, N., Mehnert, J. M., Matos, I., Bennouna, J., Kim, D.-W., Xu, L., Krishnan, S., . . . Ott, P. A. (2020). Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic SCLC: Results From the KEYNOTE-028 and KEYNOTE-158 Studies. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2019.12.109
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