KEYTRUDA (pembrolizumab) - Cancer du sein triple négatif

Key points

Favourable opinion for reimbursement in the indication extension: KEYTRUDA, in combination with chemotherapy in the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease.

What therapeutic improvement?

Therapeutic improvement compared to chemotherapy alone in the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in patients whose tumours express PD-L1 with a CPS ≥ 10.

Role in the care pathway?

In the event of relapse at an advanced stage or in patients initially diagnosed at the advanced stage, the treatment of metastatic breast cancer will depend, first of all, on the presence/absence of BRCA1/2 mutation and determination of the PD-L1 status. In the event of PD-L1-positive triple-negative breast cancer, the favoured option in patients whose tumours express a CPS ≥ 10 is combination of pembrolizumab with chemotherapy.

In the event of triple-negative breast cancer with BRCA1/2 mutation, PARP (poly-ADP ribose polymerase) inhibitors are recommended as first-line treatment or for later-line treatments if they have not previously been used (olaparib and talazoparib). Platinum-based chemotherapies may also be alternative options. In the second and later-line treatment of patients having already received a PARP inhibitor, the treatments that can be used are the same as for non-mutated BRCA1/2 patients.

For non-mutated BRCA1/2 and PD-L1-negative patients, the preferred first-line treatments are taxanes and anthracyclines, particularly if they have not been used previously (at the localised stage). A paclitaxel + bevacizumab combination may also be envisaged for aggressive tumours.  Platinum-based chemotherapies as monotherapy or, in certain cases (rapid progression, organ crises, need to rapidly control disease symptoms) in combination with another chemotherapy, may also be used.

Role of the medicinal product in the care pathway

KEYTRUDA (pembrolizumab) in combination with chemotherapy is a first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in patients whose tumours express PD-L1 with a CPS ≥ 10.

In the absence of any comparison, the role of this combination as first-line treatment compared to PARP tumours in the event of a tumour with a BRCA1/2 mutation, remains to be determined.

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 15 mars 2022. L’avis économique porte sur une indication superposable à celle demandée au remboursement, à savoir le pembrolizumab en association à une chimiothérapie dans le traitement des patients adultes atteints d’un cancer du sein triple négatif localement récurrent non résécable ou métastatique, dont les tumeurs expriment PD-L1 avec un CPS ≥ 10 et qui n'ont pas reçu de chimiothérapie antérieure pour la maladie métastatique.

La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de 138 765 €/QALY versus chimiothérapie (paclitaxel, nab-paclitaxel et gemcitabine/carboplatine), au prix revendiqué.

L’impact budgétaire associé à l’introduction du pembrolizumab en association représente une augmentation des dépenses de l’assurance maladie dans l’indication de 151%.

> KEYTRUDA - Avis économique (pdf)