Vol 16, No 5 (2020)
Research paper
Published online: 2020-10-29

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Indirect comparison of treating patients with advanced/metastatic melanoma with nivolumab or pembrolizumab — multicenter analysis

Bożena Cybulska-Stopa1, Marcin Ziętek23, Grażyna Kamińska-Winciorek4, Anna M. Czarnecka56, Karolina Piejko1, Łukasz Galus78, Barbara Ziółkowska9, Stanisław Kieszko10, Natasza Kempa-Kamińska2, Jacek Calik2, Tomasz Kubiatowski10, Rafał Suwiński9, Jacek Mackiewicz711, Piotr Rutkowski5
Oncol Clin Pract 2020;16(5):295-300.

Abstract

Introduction. The development of a new class of drug — checkpoint inhibitors has changed the prognosis of cancer patients. A particular class of drugs are antibodies against the programmed cell death type 1 receptor/ligand of the programmed cell death type 1 receptor (nivolumab and pembrolizumab). There are, however, no trials with a random selection of the patients which directly compare nivolumab and pembrolizumab. Because of the development of immunotherapy and many new drugs registered as anti-PD-1, it is important to determine whether there are differences in respect to effectiveness and safety in using nivolumab and pembrolizumab.

Material and method. 499 patients with non-resectable or metastatic melanoma treated in the years 2016–2019 in five oncological reference centers in Poland (Cracow, Gliwice, Lublin, Poznań, Wrocław) were included in the analysis. The criterion for inclusion in the analysis was first-line treatment with anti-PD-1 (nivolumab or pembrolizumab).

Results. Median OS and PFS in the whole analyzed group were 19.9 and 7.9 months, respectively. Estimated median OS and PFS were 20.1 and 18.1 months and 8.5 and 6.0 months for nivolumab and pembrolizumab, respectively. No statistically significant difference was observed in median OS and PFS in the group of patients receiving nivolumab and pembrolizumab (respectively P = 0.6291 [HR = 1.06; Cl 95% 0.8–1.4] and P = 0.0956 [HR = 1.20; Cl 95% 0.97–1.48]). The percentage of grade G3 or/and G4 irAEs was similar in both groups treated with nivolumab or pembrolizumab, 5.8 and 5.2%, respectively. Conclusions. No differences in the range of OS, PFS and ORR was observed between therapy with nivolumab and pembrolizumab in previously untreated patients with advanced/metastatic melanoma. No differences were found in the frequency of irAEs of grade G3 or G4. The treatment with a specific preparation should be based on the preferences of the patient and the clinician.

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References

  1. Wang C, Thudium KB, Han M, et al. In vitro characterization of the anti-PD-1 antibody nivolumab, BMS-936558, and in vivo toxicology in non-human primates. Cancer Immunol Res. 2014; 2(9): 846–856.
  2. Guo L, Zhang H, Chen B. Nivolumab as programmed death-1 (PD-1) inhibitor for targeted immunotherapy in tumor. J Cancer. 2017; 8(3): 410–416.
  3. Longoria TC, Tewari KS. Evaluation of the pharmacokinetics and metabolism of pembrolizumab in the treatment of melanoma. Expert Opin Drug Metab Toxicol. 2016; 12(10): 1247–1253.
  4. Rutkowski P, Wysocki PJ, Nasierowska-Guttmejer A, et al. Cutaneous melanomas. Oncol Clin Pract. 2020; 16(4): 163–182.
  5. Mok TSK, Wu YL, Kudaba I, et al. KEYNOTE-042 Investigators. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial. Lancet. 2019; 393(10183): 1819–1830.
  6. Carbone DP, Reck M, Paz-Ares L, et al. CheckMate 026 Investigators. First-Line Nivolumab in Stage IV or Recurrent Non-Small-Cell Lung Cancer. N Engl J Med. 2017; 376(25): 2415–2426.
  7. https://www.gov.pl/web/zdrowie/choroby-onkologiczne (last access: 26th Jun 2020).
  8. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009; 45(2): 228–247.
  9. Common Terminology Criteria for Adverse Events version 4.0) published: May 28, 2009 U.S. Department of Health and Human Services National Institutes of Health, National Cancer Institute.
  10. Moser JC, Wei G, Colonna SV, et al. Comparative-effectiveness of pembrolizumab vs. nivolumab for patients with metastatic melanoma. Acta Oncol. 2020; 59(4): 434–437.
  11. Robert C, Schachter J, Long GV, et al. KEYNOTE-006 investigators. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015; 372(26): 2521–2532.
  12. Robert C, Long GV, Brady B, et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015; 372(4): 320–330.
  13. Ascierto PA, Long GV, Robert C, et al. Survival outcomes in patients with previously untreated BRAF wild-type advanced melanoma treated with nivolumab therapy: three-year follow-up of a randomized phase 3 trial. JAMA Oncol. 2019; 5(2): 187–194.
  14. Robert C, Schachter J, Long G, et al. Abstract CT188: 5-year survival and other long-term outcomes from KEYNOTE-006 study of pembrolizumab (pembro) for ipilimumab (ipi)-naive advanced melanoma. Clinical Trials (13 Supplement). 2019.