Atezolizumab FDA approved for unresectable triple-negative breast cancer

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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

Article Keywords

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

IMpassion130

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.

Safety

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.

Full prescribing information TECENTRIQ.

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).