Cemiplimab (1) – Libtayo®

• Clinical trials
  • The R2810-ONC-1540 study is an ongoing, open-label, uncontrolled, multicentre Phase II study of cemiplimab.
  • Furthermore, the pharmaceutical manufacturer provides data from the publication by Hillen et al., 2018, which describes a retrospective, non-interventional cohort study by the Dermatologic Cooperative Oncology Group.

a) Adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma for whom curative surgery or curative radiotherapy is not an option; who have not yet received prior drug therapy

• No additional benefit is proven for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma for whom curative surgery or curative radiotherapy is not an option and who have not yet received prior drug therapy.
• mortality
  • The pharmaceutical manufacturer provides the number of events occurring during the course of the study for the endpoint of overall survival.
  • However, due to differences in observation periods, these cannot be meaningfully compared.
  • Furthermore, survival rates at various time points were presented, which were estimated using the Kaplan-Meier method in the respective study arms.
  • Based on the results presented, no statistically significant difference was observed at any point in time.
  • The effect estimates for overall survival presented here are not large enough to rule out the possibility that they might be caused solely by systematic bias.
  • Consequently, it is not possible to infer any additional benefit for the endpoint of overall survival based on the available results.
• No further comparisons were presented for the patient-relevant endpoints of symptoms, health-related quality of life and side effects.
• Insofar as the monotherapy or combination (chemo)therapies used in the submitted documentation were not administered in accordance with their authorised indications, no conclusions can be drawn from this regarding their appropriateness for off-label use in the standard care of patients covered by statutory health insurance.
• Such an assessment would be subject to the decision under Section 35c of the Social Code, Book V (SGB V).
• Overall assessment
  • An assessment of the additional benefit is not possible on the basis of the available data.
  • The non-adjusted indirect comparison submitted by the pharmaceutical manufacturer is not suitable for deriving any additional benefit.
  • Consequently, an additional benefit is not proven.

b) Adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma for whom curative surgery or curative radiotherapy is not an option; whose cancer has progressed following prior drug therapy

• For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma for whom curative surgery or curative radiotherapy is not an option and whose cancer has progressed following prior drug therapy, an additional benefit is not proven.
• The pharmaceutical manufacturer has not provided any suitable data for the assessment of the additional benefit of cemiplimab compared with the appropriate comparator therapy, best supportive care.
• On the basis of the available evidence, the additional benefit cannot be assessed.
• Consequently, the additional benefit is not proven.

Courtesy translation only, please refer to the German original.