Ivosidenib (4) – Tibsovo®

• Clinical trials
  • The pharmaceutical manufacturer submitted data from the pivotal, randomised, double-blind, placebo-controlled Phase III ClarIDHy trial for the benefit assessment.
  • In this trial, ivosidenib was compared with placebo; in both treatment arms, additional supportive measures in the form of best supportive care (BSC) in accordance with the standard of the respective trial centre were permitted.

Adults with locally advanced or metastatic cholangiocarcinoma harbouring an IDH1 R132 mutation who have received at least one prior line of systemic therapy

• An additional benefit is not proven.
• With the Phase III ClarIDHy trial, the pharmaceutical manufacturer has presented a single-comparator study in which, in the comparator arm, treatment with placebo plus BSC was the only option.
• It was therefore not possible for the investigator to make an individualised treatment decision tailored to the patient.
• The data from this single-comparator study are not suitable for assessing additional benefit.
• The study presented neither allows for a comparison with an individualised therapy, as there was no choice available, nor is it suitable for drawing conclusions for patients for whom best-standard care (BSC) represents the most appropriate choice from the treatment options of the individualised therapy defined as the appropriate comparator therapy.
• An additional benefit of ivosidenib for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma harbouring an IDH1 R132 mutation, following at least one prior line of systemic therapy, is not proven.

Courtesy translation only, please refer to the German original.