Roche Announces Positive Phase III IMpassion031 Trial Results for Tecentriq Plus Chemotherapy in Early-Stage Triple-Negative Breast Cancer

By Baihuawen

On June 18, Roche announced that the Phase III IMpassion031 study evaluating Tecentriq in combination with chemotherapy for the treatment of early-stage triple-negative breast cancer (TNBC) had met its primary endpoint of pathological complete response (pCR), regardless of PD-L1 status.

The IMPassion031 study is a randomized, double-blind, multicenter Phase III trial designed to evaluate the efficacy and safety of neoadjuvant Tecentriq in combination with chemotherapy for triple-negative breast cancer (TNBC). A total of 333 patients were enrolled and randomized in a 1:1 ratio to receive either Tecentriq plus chemotherapy (nab-paclitaxel; doxorubicin and cyclophosphamide) or placebo plus chemotherapy. Patients who received neoadjuvant Tecentriq subsequently continued with adjuvant Tecentriq treatment.

The primary endpoint of the study was pathological complete response (pCR) in the intent-to-treat (ITT) population and the PD-L1-positive population. Secondary endpoints included overall survival (OS), event-free survival, disease-free survival, and quality-of-life metrics.

The results showed that, compared with the placebo plus chemotherapy group, a lower proportion of patients in the Tecentriq plus chemotherapy group had detectable tumor tissue at surgery, regardless of PD-L1 status. The safety profile was consistent with previous studies, and no new safety signals were identified. Detailed data from this study will be presented at upcoming medical conferences and discussed with regulatory authorities in the United States and the European Union.

The IMpassion031 study is the second Phase III clinical trial demonstrating benefit of Roche’s Tecentriq in triple-negative breast cancer (TNBC), and the first Phase III trial to show benefit in early-stage TNBC. The combination regimen of Tecentriq plus nab-paclitaxel has currently been approved in more than 70 countries, including the United States and the European Union, for the treatment of unresectable, locally advanced or metastatic TNBC in patients whose tumors express PD-L1 (IC ≥ 1%).