TRUQAP (capivasertib) - Cancer is a serious HER2-negative

The clinical benefit of TRUQAP 160 mg and 200 mg (capivasertib) film-coated tablets in combination with fulvestrant is low in the MA indication.  

Considering:

• the MA indication attributed to a subgroup of patients with PIK3CA/AKT1/PTEN-alterations (41% of patients in the CAPItello-291 study), defined after the inclusion phase, without stratification at randomisation based on this factor;
• a control group (fulvestrant alone) in the CAPItello-291 study that the Transparency Committee deemed to be debatable, or even non-optimal, given the other alternatives available and the heterogeneous population included in this study;
• the improvement in progression-free survival deemed to be modest, with a point estimate of the absolute difference of medians of 4.2 months and an HR= 0.50, 95% CI [0.38; 0.65]; p < 0.001 in the subgroup of patients (41%) with PIK3CA/AKT1/PTEN-alterations;
• the lack of evidence in terms of overall survival on the date of the first interim analysis (p=NS), in the subgroup of patients with PIK3CA/AKT1/PTEN-alteration(s) (final analysis expected in Q1 2026);
• the absence of formal evidence of an improvement in quality of life (exploratory endpoint);
• a safety profile marked by an increase in toxicity, in particular with more frequent grade ≥ 3 adverse events (39.7% versus 14.9%), serious adverse events (18.0% versus 8.6%), AEs having led to treatment discontinuation (14.4% vs. 2.3%) and AE-related deaths (1.7% vs.0.3%);  

the Committee deems that TRUQAP 160 mg and 200 mg (capivasertib) film-coated tablets in combination with fulvestrant provides no clinical added value (CAV V) compared tofulvestrant alone in the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.