Roche’s Phase III IMpassion031 study meets primary endpoint

The Phase III IMpassion031 study evaluating the efficacy and safety of Tecentriq® (atezolizumab) in combination with chemotherapy (Abraxane®, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) versus placebo plus chemotherapy (including Abraxane), demonstrated a statistically significant and clinically meaningful improvement in pathological complete response for the treatment of patients with previously untreated early triple-negative breast cancer, regardless of PD-L1 expression.

Of the 333 patients involved in the study, fewer who received the Tecentriq combination before surgery had evidence of tumour tissue detectable at the time of surgery, regardless of PD-L1 expression, versus the control group. Safety for the Tecentriq combination appeared to be consistent with the known safety profiles of the individual medicines and no new safety signals were identified.

Roche’s Chief Medical Officer and Head of Global Product Development, 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.”