ENHERTU (trastuzumab deruxtecan) - HER2-low breast cancer

The Committee deems that the clinical benefit of ENHERTU 100 mg (trastuzumab deruxtecan) powder for concentrate for solution for infusion is substantial in the MA indication.

Considering:

• demonstration in a phase 3, comparative, randomised, open-label study of the superiority of trastuzumab deruxtecan compared to the investigator’s choice of chemotherapy (capecitabine, eribuline, gemcitabine, paclitaxel or nab-paclitaxel), for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, in terms of:
  • progression-free survival, with a median difference of +4.8 months and an HR = 0.50, CI95%[0.40; 0.63];
  • overall survival, with a median difference of +6.6 months and an HR = 0.64, CI95%: [0.49; 0.84]);
• and despite the absence of any formal conclusion that can be drawn based on the quality of life results;
• a safety profile deemed to be acceptable compared to chemotherapy but marked by an excess toxicity having led to more frequent treatment discontinuations in the trastuzumab deruxtecan group, with, in particular, more gastrointestinal (constipation, vomiting) and haematological (anaemia) adverse events, as well as diffuse interstitial lung disease/pneumonitis;
• a concomitant development with TRODELVY (sacituzumab govitecan) and for which no direct comparison was expected on the date of this assessment;

the Committee deems that ENHERTU 100 mg (trastuzumab deruxtecan) powder for concentrate for solution for infusion provides a moderate clinical added value (CAV III) compared to chemotherapy.