The European Commission has approved the use of Roche‘s Tecentriq (atezolizumab) in combination with Abraxane (nab-paclitaxel) chemotherapy to treat certain adults with advanced triple-negative breast cancer (TNBC), an aggressive and difficult-to-treat malignancy.
The combo is intended for people whose tumors cannot be removed by surgery (unresectable), are locally advanced or metastatic (spread to other parts in the body), and are positive for the PD-L1 factor. This combination therapy is also intended for patients who have not received prior chemotherapy for metastatic breast cancer.
Given accelerated approval by U.S. Food and Drug Administration in March, Tecentriq-Abraxane now becomes the first cancer immunotherapy regimen available in Europe specifically for TNBC.
“For the past 30 years, we have been dedicated to transforming the lives of people with breast cancer. Now, we are pleased to build on this foundation with the news that the first immunotherapy treatment for triple-negative breast cancer is available to people in Europe with PD-L1-positive, metastatic triple-negative breast cancer,” Sandra Horning, MD, Roche’s chief medical officer and head of global product development said in a press release.
“The European approval of this Tecentriq combination represents a significant step forward in the treatment of this aggressive breast cancer, where the unmet medical need is great.”
Tecentriq is an immune checkpoint inhibitor (developed by Genentech, a Roche subsidiary) that prevents cancer cells from evading immune system surveillance.
It is an engineered antibody that targets and blocks PD-L1, a protein found in higher amounts in many cancer cells, which acts like a “brake” that keeps the body’s immune responses from attacking the tumor.
Abraxane is a standard chemotherapy used in patients with advanced forms of breast cancer; it is also approved in combination with other agents to treat some patients with advanced non-small cell lung cancer and pancreatic cancer.
EU approval was based on positive results from the IMpassion130 Phase 3 trial (NCT02425891), where the combo reduced the risk of disease progression or death, and extended patient survival compared to Abraxane alone.
IMpassion130 enrolled 902 people to study the combination as a first-line treatment for metastatic TNBC patients with locally advanced disease who could not receive surgery. Patients were randomly assigned to either Tecentriq plus Abraxane or placebo plus Abraxane, all given as intravenous (into the vein) infusions, and received treatment until they experienced signs of disease progression or toxicity.
Results showed that the combination significantly reduced the risk of disease worsening or death by 38% in a subset of patients whose tumors were positive for PD-L1, a biomarker of response to treatments like Tecentriq.
Moreover, an intermediate analysis demonstrated that the combo prolonged the life of the total population of patients (positive and negative for PD-L1) by a median of seven months — from 18.7 months to 21 months — though the results did not reach statistical significance.
The combo’s safety appeared consistent with the known safety profiles of Tecentriq and Abraxane. No new safety signals were observed. Severe or life-threatening adverse events were reported in 49% of people on the combo, compared to 42% of those given Abraxane only.
Determining PD-L1 on tumor-infiltrating immune cells is essential for identifying TNBC patients most likely to benefit from this Tecentriq combination, Roche said.
For the trial, PD-L1 status was assessed by the Roche’s Ventana PD-L1 Assay, a companion diagnostic tool approved in Europe and the U.S. to assist in the identification of PD-L1-positive patients eligible to receive Tecentriq.
Seven ongoing Phase 3 studies are investigating Tecentriq in TNBC patients, including early and advanced stages of the disease.