Roche’s Tecentriq in combination with Abraxane approved for metastatic triple-negative breast cancer in Europe.
Roche announced on Thursday, August 29, that Tecentriq (atezolizumab) in combination with Abraxane (protein-bound paclitaxel) had been approved in Europe for patients with PD-L1-positive, metastatic triple-negative breast cancer (TNBC). The Tecentriq combination marks the first cancer immunotherapy regimen to be available in Europe for TNBC, which is an aggressive and difficult-to-treat disease. Tecentriq was approved in patients whose tumours have PD-L1 expression (≥1%) and who have not received prior chemotherapy for metastatic disease.
The approval is based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in patients with PD-L1-positive metastatic TNBC. Specifically, Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death (progression-free survival, PFS) by 38% compared with Abraxane alone (median PFS=7.4 vs. 4.8 months) in PD-L1-positive patients with unresectable locally advanced or metastatic TNBC who had not received prior chemotherapy for metastatic disease.
Tecentriq’s approval will help Roche in the highly competitive immuno-oncology market and strengthen its position against its rivals, notably Merck/MSD, whose Keytruda has been one of the market leaders, mainly due to its strong position in non-small cell lung cancer (NSCLC).
TNBC is an aggressive and hard-to-treat subtype of breast cancer, representing around 15% of all breast cancer worldwide, approximately 300,000 cases every year.
Patients who are PD-L1 positive represent a subgroup of about 40% of this total. There are seven ongoing Phase III studies investigating Tecentriq in TNBC, including early and advanced stages of the disease.
By Jack Ziomek – Project Manager, Web Platforms
Roche, Media Release, 29 August 2019. Available at: https://www.roche.com/media/releases/med-cor-2019-08-29.htm