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Genentech's Tecentriq-Chemotherapy Study Meets Primary Endpoint On Triple-negative Breast Cancer

Genentech, a member of the Roche Group (RHHBY), said that the Phase III IMpassion031 study met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response or pCR for the treatment of people with early triple-negative breast cancer or TNBC, regardless of PD-L1 expression.

The study evaluated Tecentriq in combination with chemotherapy in comparison to placebo plus chemotherapy.

In the study, fewer patients who received the Tecentriq combination as a neoadjuvant (before surgery) treatment had evidence of tumor tissue detectable at the time of surgery (known as pCR), regardless of PD-L1 expression, in comparison to the control arm.

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working, and may also reduce a tumor's size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early-stage breast cancer.

The company said 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.

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