TRUQAP (capivasertib) - Cancer is a serious HER2-negative
Opinions on drugs -
Posted on
Jul 31 2025
Reason for request
First listing
Summary of opinion
Favourable opinion for reimbursement in the following indication: “TRUQAP is indicated in combination with fulvestrant for 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. In pre- or perimenopausal women, TRUQAP plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of an LHRH agonist according to current clinical practice standards should be considered.”
Clinical Benefit
Low
The clinical benefit of TRUQAP 160 mg and 200 mg (capivasertib) film-coated tablets in combination with fulvestrant is low in the MA indication.
Clinical Added Value
no clinical added value
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.
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