[Nivolumab in malignant melanoma: contrasting the evidence from pivotal trials with real world evidence (RWE)]

Glanz KA
Record ID 32018001705
German
Original Title: Nivolumab beim malignen melanom: kontrastierung der evidenz aus den zulassungsstudien mit der real world evidenz (RWE)
Authors' objectives: 90% of all skin tumour related deaths are caused by malignant melanoma. Nivolumab is an anti-PD1 checkpoint inhibitor used in patients with advanced malignant melanoma and as adjuvant therapy for patients with high-risk metastatic melanoma. The aim of this work is to evaluate the real world evidence of Nivolumab for the treatment of malignant melanoma in a systematic review and to contrast the results with the evidence from pivotal RCTs.
Authors' results and conclusions: Results: As a result of the comparison, there was good concordance between the outcomes of the included real-world studies and those of the pivotal RCTs across various lines of therapy, with slightly lower response rates. However, it becomes apparent that first-line treatment with Nivolumab, both monotherapy and in combination with Ipilimumab, is associated with a better outcome, and that when given in second- or follow-up-line treatment, outcomes may depend on the type of prior therapy and on other prognostic factors such as the BRAF mutation status. Conclusion: Observational studies under everyday medical conditions are a valuable complement to RCTs for the assessment of therapies. However, due to older and sicker patients, the clinical outcomes are somewhat worse than in the pivotal trials.
Authors' methods: A systematic literature search was carried out. As a result, ten publications with 1,425 patients from 614 references were included and evaluated in the systematic review. All of them were exclusively uncontrolled observational studies. In a further step, the real-world evidence was compared with the evidence of the pivotal studies, differentiated according to therapy lines, in order to assess whether and to what extent the results of the RCTs are also reflected in real clinical application. However, no study for adjuvant use in the real clinical setting could be identified and included.
Details
Project Status: Completed
Year Published: 2021
URL for published report: https://eprints.aihta.at/1341/1/HTA-Projektbericht_Nr.140.pdf
URL for additional information: https://eprints.aihta.at/1341/
English language abstract: An English language summary is available
Publication Type: Full HTA
Country: Austria
MeSH Terms
  • Melanoma
  • Immunotherapy
  • Nivolumab
  • Evidence-Based Medicine
  • Ipilimumab
  • Immune Checkpoint Inhibitors
  • Skin Neoplasms
  • Antineoplastic Combined Chemotherapy Protocols
  • Antineoplastic Agents, Immunological
  • Randomized Controlled Trials as Topic
Keywords
  • Malignant melanoma
  • skin cancer
  • immunotherapy
  • checkpoint inhibitors
  • oncology
Contact
Organisation Name: Austrian Institute for Health Technology Assessment
Contact Address: Garnisongasse 7/20, A-1090 Vienna, Austria
Contact Name: office@aihta.at
Contact Email: office@aihta.at
Copyright: HTA Austria - AIHTA GmbH
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.