Roche’s phase III IMpassion031 study of Tecentriq in combo with chemotherapy to treat early triple-negative breast cancer meets primary endpoint
Roche announced that the phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.
“Triple-negative breast cancer remains an aggressive disease with high rates of recurrence,” said Levi Garraway, M.D, Ph.D, Roche’s chief medical officer and head of global product development. “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 the study, fewer patients who received the Tecentriq combination as a neoadjuvant (before surgery) treatment had evidence of tumour 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 tumour's size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect and can be assessed more quickly than traditional endpoints in early stage breast cancer.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. Tecentriq in combination with nab-paclitaxel is currently approved in more than 70 countries worldwide, including the US and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1 (IC=1%).
The IMpassion031 study is a phase III, multicentre, randomised, double-blind study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC.
The study enrolled 333 people who were randomised in a 1:1 ratio to receive Tecentriq or placebo plus chemotherapy in the neoadjuvant (before surgery) setting. Treatment with Tecentriq continued adjuvantly (after surgery) for those in the Tecentriq arm of the study. The 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. Secondary endpoints include overall survival (OS), event-free survival, disease-free survival and quality of life measures.
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year. TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification. Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.
Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=128952&sid=2
“Triple-negative breast cancer remains an aggressive disease with high rates of recurrence,” said Levi Garraway, M.D, Ph.D, Roche’s chief medical officer and head of global product development. “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 the study, fewer patients who received the Tecentriq combination as a neoadjuvant (before surgery) treatment had evidence of tumour 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 tumour's size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect and can be assessed more quickly than traditional endpoints in early stage breast cancer.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. Tecentriq in combination with nab-paclitaxel is currently approved in more than 70 countries worldwide, including the US and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumours express PD-L1 (IC=1%).
The IMpassion031 study is a phase III, multicentre, randomised, double-blind study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (nab-paclitaxel; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC.
The study enrolled 333 people who were randomised in a 1:1 ratio to receive Tecentriq or placebo plus chemotherapy in the neoadjuvant (before surgery) setting. Treatment with Tecentriq continued adjuvantly (after surgery) for those in the Tecentriq arm of the study. The 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. Secondary endpoints include overall survival (OS), event-free survival, disease-free survival and quality of life measures.
Breast cancer is the most common cancer among women with more than 2 million diagnosed worldwide each year. TNBC represents ~15% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. It is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification. Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer.
Source:http://www.pharmabiz.com/NewsDetails.aspx?aid=128952&sid=2
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