Amivantamab (1) – Rybrevant®

• Clinical trials
  • The CHRYSALIS trial is an ongoing, open-label, non-randomised, multicentre trial.
  • The study included adults with histologically or cytologically confirmed metastatic or unresectable NSCLC.

a) Adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon-20 insertion mutations following failure of platinum-based chemotherapy, for whom further chemotherapy is indicated

• The additional benefit is not proven.
• The G-BA concludes that, for amivantamab in the treatment of patients with advanced or metastatic NSCLC with activating EGFR exon-20 insertion mutations following failure of platinum-based chemotherapy, who are eligible for further chemotherapy, additional benefit is not proven compared with the appropriate comparator therapy.
• mortality
  • The indirect comparisons presented provide results only for overall survival, but not for other patient-relevant endpoints.
  • Furthermore, the effects observed for the overall survival endpoint are not large enough to rule out the possibility that they are explained exclusively by systematic bias given the current data.
• Overall assessment
  • Due to significant uncertainties arising from the identification and completeness of confounders, missing data on patient characteristics and their impact on the composition of the analysed patient populations and on the adjustment for confounders, the indirect comparison presented in the dossier is not suitable for assessing the additional benefit of amivantamab.
  • Overall, the remaining uncertainties are so serious that the comparisons presented cannot be used for the benefit assessment.
  • Notwithstanding this, results relating to only one patient-relevant endpoint are insufficient.
  • Taken together, the data submitted by the pharmaceutical manufacturer are not suitable for a benefit assessment and do not allow for an adequate comparison of amivantamab with the appropriate comparator therapy.

b) Adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon-20 insertion mutations following failure of platinum-based chemotherapy, for whom no further chemotherapy is indicated

• An additional benefit is not proven.
• The pharmaceutical manufacturer did not submit any data with the dossier to support an assessment of the additional benefit of amivantamab compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.