Posted by Michael Wonder on 02 Jul 2019
CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer
28 June 2019 - First positive Phase III cancer immunotherapy study for people with metastatic triple-negative breast cancer.
Roche today announced that the EMA's CHMP has recommended the approval of Tecentriq (atezolizumab) plus chemotherapy (Abraxane; nab-paclitaxel) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours have PD-L1 expression (≥ 1%) and who have not received prior chemotherapy for metastatic disease.
The CHMP recommendation is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (progression-free survival; PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; HR=0.62, 95% CI: 0.49–0.78, p<0.0001) in people who were tested positive for PD-L1 expression on tumour-infiltrating immune cells.
