Amivantamab (3) – Rybrevant®

• Clinical trials
  • This is an ongoing, open-label, randomised, multicentre Phase III trial in which amivantamab in combination with lazertinib, carboplatin and pemetrexed (Arm A), and amivantamab in combination with carboplatin and pemetrexed (Arm C), are being compared with chemotherapy comprising carboplatin and pemetrexed (Arm B).

a) Adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations following failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI); ECOG PS 0–1

• The additional benefit is not proven.
• For the benefit assessment, the pharmaceutical manufacturer did not provide any directly comparative studies in the dossier of amivantamab in combination with carboplatin and pemetrexed against the appropriate comparator therapy. Furthermore, no indirect comparison was provided.
• Overall, therefore, there are no suitable data available to enable an assessment of the additional benefit of amivantamab in combination with carboplatin and pemetrexed.
• Overall assessment
  • The G-BA designated atezolizumab in combination with bevacizumab, carboplatin and paclitaxel as the appropriate comparator therapy. In the comparator arm of the MARIPOSA-2 study, patients were treated with chemotherapy comprising carboplatin and pemetrexed. This does not correspond to the appropriate comparator therapy for patient group a (ECOG PS 0–1). Consequently, there are no suitable data available for an assessment of the additional benefit of amivantamab.

b) Adults with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations following failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI); ECOG PS 2

• The additional benefit is not proven.
• For the benefit assessment, the pharmaceutical manufacturer did not provide any direct comparative studies in the dossier of amivantamab in combination with carboplatin and pemetrexed against the appropriate comparator therapy. Furthermore, no indirect comparison was provided.
• Overall, therefore, there are no suitable data available to enable an assessment of the additional benefit of amivantamab in combination with carboplatin and pemetrexed.
• Overall assessment
  • The G-BA identified various chemotherapy regimens (and combinations thereof) as the appropriate comparator therapy. Although the chemotherapy regimen comprising carboplatin and pemetrexed in the comparator arm of the MARIPOSA-2 study corresponds to the appropriate comparator therapy for patient group b (ECOG-PS 2), only patients with ECOG-PS 0–1 were included in the study. Consequently, there are no suitable data available for assessing the additional benefit of amivantamab.

Courtesy translation only, please refer to the German original.