OPDIVO (nivolumab) - Carcinome urothélial infiltrant le muscle (CUIM)

The Committee deems that the actual clinical benefit of OPDIVO (nivolumab) is substantial in the restricted indication only: as a monotherapy in the adjuvant treatment of adult patients with muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after complete removal, whose tumour cells express PD-L1 at a threshold of ≥ 1%:

• who received neoadjuvant chemotherapy;
• or who did not receive neoadjuvant chemotherapy and were ineligible for and/or refused cisplatin-based adjuvant chemotherapy.

In the rest of the scope of the marketing authorisation indication, the Committee considers that the actual clinical benefit is insufficient to justify public funding.

Considering:

• the evidence of a gain in disease-free survival compared to surveillance alone in a randomised double-blind study (median not attained (95% CI: 21.19; N.A) in the nivolumab group versus 8.41 months (95% CI: 5.59; 21.19) in the placebo group, HR: 0.55 (98.72% CI: 0.35; 0.85), p = 0.0005),
• the inability to draw conclusions about overall survival due to the immaturity of the data on this criterion,
• the toxicity profile marked by the occurrence of adverse events of grades ≥ 3 in almost every other patient,

the Committee deems that on the basis of the current evidence, OPDIVO (nivolumab) provides minor clinical added value (CAV IV) in the adjuvant treatment strategy for adult patients with muscle-invasive urothelial carcinoma (MIUC) at high risk of recurrence after complete removal, whose tumour cells express PD-L1 at a threshold of ≥ 1%:

• who received neoadjuvant chemotherapy;
• or who did not receive neoadjuvant chemotherapy and were ineligible for and/or refused cisplatin-based adjuvant chemotherapy.