The phase III IMpassion031 study assessing Tecentriq plus chemotherapy (Abraxane, albumin-bound paclitaxel, nab-paclitaxel, followed by doxorubicin and cyclophosphamide) comparison to placebo plus chemotherapy reached its primary endpoint by showing a statistically significant and clinically meaningful improvement in pathological complete response (pCR) to treat people with TNBC, regardless of PD-L1 expression.
Tecentriq is a monoclonal antibody designed to combine with a PD-L1 protein, which is expressed on tumour cells and tumour-infiltrating immune cells, enabling to block its interactions with both PD-1 and B7.1 receptors. Tecentriq may facilitate the activation of T-cells by inhibiting PD-L1.
Roche’s IMpassion031 study is said to be the second positive phase III study from the company showing the benefit of Tecentriq in TNBC while the first Tecentriq study to show benefit in early TNBC.
The IMpassion031 is a multicentre, randomised and a double-blind study assessing the efficacy and safety of Tecentriq plus chemotherapy in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC.
The trial randomised 333 people in a 1:1 ratio to secure Tecentriq or placebo plus chemotherapy in the neoadjuvant (before surgery) setting.
Roche study’s primary endpoint is pCR using the American Joint Committee on Cancer (AJCC) staging system in the intention-to-treat (ITT) population and in the PD-L1-positive population, while the secondary endpoints comprise of overall survival (OS), event-free survival, disease-free survival and quality of life measures.
Currently, Tecentriq plus nab-paclitaxel secured approval in over 70 countries, including the US and Europe, to treat adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1 (IC≥1%).
Roche chief medical officer and global product development head Dr Levi Garraway said: “Triple-negative breast cancer remains an aggressive disease with high rates of recurrence.
“Our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure. Adding Tecentriq to chemotherapy now has the potential to help women with TNBC at multiple different stages of the disease.”
In May, Roche announced the commencement of phase III clinical study of Actemra/RoActemra plus remdesivir in hospitalised patients with severe Covid-19 pneumonia.