Mirvetuximab-Soravtansin (2) – Elahere®

Adult female patients with FR-α-positive, platinum-resistant, high-grade serous epithelial carcinoma of the ovaries or fallopian tubes, or with primary peritoneal carcinoma, who have already received 1 to 3 previous courses of treatment

• Overall, the G-BA has established that mirvetuximab soravtansin offers considerable additional benefit for patients with FR-α-positive, platinum-resistant, high in terms of overall survival and significant advantages in terms of side effects compared to standard of care-grade serous epithelial carcinoma of the ovaries, fallopian tubes or primary peritoneal carcinoma, who have already received 1 to 3 prior lines of treatment.
• The certainty of evidence for the established additional benefit is classified overall as an indication.
• mortality
  • Overall survival is defined in the MIRASOL and FORWARD 1 studies as the time from randomisation to death from any cause.
  • For the endpoint of overall survival, the MIRASOL study and the meta-analysis show a statistically significant advantage in favour of mirvetuximab soravtansin. The extent of the prolongation in overall survival achieved is assessed as a relevant improvement.
• morbidity
  • Progression-free survival (PFS) was defined in the MIRASOL and FORWARD 1 studies as the time from randomisation to the first occurrence of radiological disease progression or death from any cause, whichever occurred first.
  • For the PFS endpoint, both the MIRASOL study and the meta-analysis show a statistically significant advantage in favour of mirvetuximab soravtansin.
• Health-related quality of life
  • Health-related quality of life was assessed using the EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires.
  • The response rates for the first scheduled follow-up assessment (week 8/9) in the control arm were less than 70% and are therefore unsuitable for benefit assessment.
• Side effects
  • Statistically significant advantages were observed in favour of mirvetuximab soravtansin for the endpoints of SAE, severe AEs and therapy discontinuations due to AEs.
  • In detail, statistically significant disadvantages were observed for mirvetuximab soravtansin compared to other agents in terms of specific adverse events relating to eye diseases (adverse events and severe adverse events) and pneumonitis (adverse events). In detail, statistically significant advantages were observed in favour of mirvetuximab soravtansin with regard to dyspnoea (AEs), stomatitis (AEs), disorders of the skin and subcutaneous tissue (AEs), small bowel obstruction (SUEs), disorders of the blood and lymphatic system (severe AEs) and fatigue (severe AEs).
  • Overall, within the ‘side effects’ endpoint category, there is a clear advantage for mirvetuximab soravtansin compared with paclitaxel, pegylated liposomal doxorubicin or topotecan.
• Overall assessment
  • For the endpoint of overall survival, the MIRASOL study and the meta-analysis show a statistically significant advantage in favour of mirvetuximab soravtansin. The extent of the prolongation in overall survival achieved is assessed as a relevant improvement.
  • No evaluable data are available regarding morbidity and health-related quality of life.
  • For the endpoint category of side effects, there are statistically significant advantages in terms of SAEs, severe AEs and therapy discontinuations due to AEs, which are assessed as a clear improvement. In detail, there are both advantages and disadvantages regarding specific AEs.
  • Overall, the G-BA concludes that mirvetuximab soravtansin offers a considerable additional benefit, based on relevant advantages in overall survival and significant advantages regarding side effects.

Courtesy translation only, please refer to the German original.