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Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer
By: News Feed | Last updated: 9th March 2019 | In: Breast Cancer, ImmunoOncology, Immunotherapy, Oncology, US FDA Onc\Haem Approvals
atezolizumab, breast cancer, CDx, FDA, Genentech, nab-paclitaxel, PD-L1, Roche, SP142, Tecentriq, Ventana
On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).1FDA website
The multicenter, double-blind, placebo-controlled, IMpassion130 (NCT02425891) trial randomised 902 chemotherapy-naïve unresectable locally advanced or metastatic TNBC patients 1:1 to receive either atezolizumab plus nab-paclitaxel or placebo plus nab-paclitaxel. Participants were stratified according to the PD-L1 expression as per the SP142 Assay as determined at a central laboratory. The PD-L1 results were used to define the biomarker positive population. The outcomes measures included progression-free survival (PFS), objective response rate (ORR), and overall survival (OS).
The median PFS in patients with tumour PD-L1 expression measured 7.4 months (6.6-9.2) in the atezolizumab plus nab-paclitaxel group vs 4.8 months (3.8-5.5) in the placebo plus nab-paclitaxel group (stratified HR=0.60; 95% CI, 0.48-0.77; P<0.0001). The ORR for patients with confirmed responses was 53% in patients receiving atezolizumab plus nab-paclitaxel vs 33% in patients receiving placebo plus nab-paclitaxel. With 43% deaths in the intent to treat (ITT) population at the time of data cut-off, the OS data remained immature.
Common adverse reactions in ≥20% of patients treated with atezolizumab plus nab-paclitaxel included alopecia, peripheral neuropathies, fatigue, nausea, diarrhoea, anaemia, constipation, cough, headache, neutropenia, vomiting, and decreased appetite.
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