Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) has been given marketing authorisation by the European Commission (EC) as a monotherapy to treat adult patients with unresectable or metastatic triple-negative breast cancer (TNBC).

The treatment can be given to patients who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy.
Trodelvy is the first antibody-drug conjugate (ADC) to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

Metastatic TNBC is the most aggressive form of breast cancer and for many patients, first-line therapy may be their only line of treatment, creating an urgent need for effective treatment options to be used as early as possible.

TNBC accounts for approximately 15% of all breast cancers and has historically been difficult to treat, disproportionally impacting younger, premenopausal, and black and hispanic women.

TNBC has a higher chance of recurrence and metastases than other breast cancer types. TNBC cells do not have oestrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types.

The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with five years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

The EC’s marketing authorisation is based on data from the phase 3 ASCENT-03 study, which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment.

In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilised a patient-centred crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed.

Mika Kakefuda Derynck, Senior VP, Clinical Development, Oncology at Gilead said: “We have long recognised the challenges that patients and clinicians face with this aggressive cancer, and this approval represents a significant step forward in how we treat people with first-line metastatic TNBC in Europe.”