Roche announced Thursday that a Phase III trial of Tecentriq (atezolizumab) in combination with chemotherapy for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression, met its primary endpoint of pathological complete response (pCR). The company noted that data from the IMpassion031 study will be discussed with health authorities, including the FDA and the European Medicines Agency.
The trial randomised 333 people with previously untreated, early TNBC to receive Tecentriq in combination with chemotherapy, consisting of Bristol Myers Squibb's Abraxane (nab-paclitaxel) followed by doxorubicin and cyclophosphamide, in comparison to placebo plus chemotherapy in the neoadjuvant setting. Roche said that Tecentriq plus chemotherapy demonstrated a significant and clinically meaningful improvement in pCR versus placebo and chemotherapy, with fewer patients given the PD-L1 inhibitor having evidence of tumour tissue detectable at the time of surgery.
Along with pCR, other endpoints of the trial include overall survival, event-free survival, disease-free survival and quality of life measures. The drugmaker indicated that the safety profile of Tecentriq in combination with chemotherapy appeared to be consistent with prior studies. Further results from the trial will be presented at an upcoming medical meeting.
Tecentriq in combination with Abraxane is currently approved in more than 70 countries worldwide, including the US and Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1. Sales of the drug in the first quarter of 2020 jumped 99% to CHF 644 million ($677 million), partly driven by growth in TNBC.
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