TRODELVY - (sacituzumab govitecan) - Cancer du sein triple négatif

Key points

Favourable opinion for reimbursement as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them given for an advanced form of the disease.

What therapeutic improvement?

Therapeutic improvement in the management of the disease

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.

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). These are the only targeted therapies currently available for triple-negative breast cancer. In this same population of patients with BRCA1/2 mutation, platinum-based chemotherapies as monotherapy 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 patients, the first and later-line treatments are usually single-agent chemotherapies and will primarily depend on the prior therapies and their history:

• 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.

In the event of PD-L1 expression, the latest NCCN international guidelines recommend the pembrolizumab + chemotherapy combination 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.

• in second and later-line therapy, there is no standard treatment, with single-agent chemotherapies such as capecitabine, eribuline, vinorelbine, gemcitabine or cyclophosphamide being used. Overall, the choice of treatment should be made based on the treatment history and the characteristics of patients and their disease.

Role of the medicinal product in the care pathway

TRODELVY (sacituzumab govitecan) is a treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them given for an advanced form of the disease.

Considering the recent introduction into the care pathway of immunotherapy (pembrolizumab) as a first-line treatment of triple-negative breast cancer, the role of sacituzumab govitecan in the event of a tumour with PD-L1 expression remains to be defined. 

Avis économique

Ce produit a fait l'objet d'un avis économique rendu par la Commission d'évaluation économique et de santé publique le 7 juin 2022. L’avis économique porte sur une indication superposable à celle demandée au remboursement, à savoir les patients adultes atteints de cancer du sein triple négatif (TNBC) non résécable ou métastatique ayant déjà reçu au moins deux traitements systémiques, dont au moins un pour une forme avancée de la maladie

La CEESP a été en mesure de conclure sur le niveau d’efficience du produit, avec un ratio différentiel coût-résultat (RDCR) de
250 086 €/QALY versus bras mixte de chimiothérapies.

L’impact budgétaire associé à l’introduction du sacituzumab govitecan représente une augmentation des dépenses de l’assurance maladie dans l’indication de +524%, pour une population cible de 10 060 patients cumulés sur 5 ans.

> TRODELVY -  Avis économique (pdf)