TALZENNA (talazoparib)

Key points

Favourable opinion for reimbursement in HER2-negative locally advanced or metastatic breast cancer with germline BRCA1/2-mutations

What therapeutic improvement?

No clinical added value compared to single-agent chemotherapy (capecitabine, vinorelbine, eribulin or gemcitabine).

Role in the care pathway?

The choice of systemic treatment in locally advanced or metastatic breast cancer is dependent on the histological characteristics of the tumour, predictive factors for response to treatments (hormone receptor and/or HER2 receptor expression), previously administered treatments and their tolerability, metastatic disease presentation, the time to relapse, the patient’s general health status and comorbidities.

For patients with HER2-/RH- breast cancer, following treatment with anthracyclines and/or taxanes, there is no standard treatment in the advanced stage. Several single-agent chemotherapies are used sequentially: capecitabine or eribulin or vinorelbine. Gemcitabine, or retreatment with anthracyclines or taxanes and platinum-based therapies are other alternatives. Multi-agent chemotherapy is an alternative decided on a case-by-case basis.

For patients with HER2-/RH+ breast cancer, in case of of slow-progressing disease without any symptomatic and life-threatening organ involvement, the preferred treatment is endocrine-based therapy, potentially combined with a CDK4/6 inhibitor or a selective mTOR inhibitor. In the event of progression under various endocrine-based therapy lines or rapid progression of the disease (with, in particular, the development of organ metastases), chemotherapy becomes the standard treatment, with similar treatment to that in HER2-/RH- cancers.

Role of TALZENNA in the care pathway for HER2- advanced breast cancer 

In patients having received (neo)adjuvant treatment with an anthracycline and/or a taxane for locally advanced or metastatic cancer, and whose cancer has germline BRCA1/2-mutations, monotherapy with oral TALZENNA (talazoparib) is a therapeutic alternative to the single-agent chemotherapies recommended in the first or later-line treatment of advanced HER2- breast cancer.

In the event of hormone receptor expression (RH+), given the absence of comparative data versus endocrine-based therapy combined with a CDK4/6 inhibitor, the role of TALZENNA is not determined compared to this treatment option that has recently been included in the care pathway. In accordance with the wording of the indication and the study inclusion criteria, the Committee considers that the role of TALZENNA comes after endocrine-based therapy, particularly in combination with a CDK 4/6 inhibitor, which can lead to use at a later treatment line.

No data is available to establish the optimal treatment sequence with single-agent chemotherapies used sequentially.

Given the concomitant development with LYNPARZA (olaparib) in this indication, the role of TALZENNA (talazoparib) compared to this other PARP inhibitor is not known. The choice between TALZENNA (talazoparib) and LYNPARZA (olaparib) should be made on a case-by-case basis taking into account the safety profile of each of these treatments.

In addition, in the absence of comparative data, the role of TALZENNA compared to platinum-based therapies is not known