CHMP Recommends EU Approval of Roche’s Tecentriq in Combination with Abraxane as First-Line Treatment for PD-L1-Positive Metastatic Triple-Negative Breast Cancer

June 29, 2019 /Bio ValleyBIOON/ -- Swiss pharmaceutical giant Roche recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of the PD-L1 tumor immunotherapy Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [albumin-bound paclitaxel], nab-paclitaxel) as an initial treatment forTumorPD-L1 expression (≥1%) and unresectable locally advanced or metastatic triple-negative breast cancer in patients who have not previously received chemotherapy for the control of metastatic diseaseBreast Cancer(TNBC) adult patients. The CHMP’s opinion will now be submitted to the European Commission (EC), which will take the CHMP’s opinion into account and issue a final decision within the next 2–3 months.

In the United States, the Tecentriq + Abraxane combination regimen has been approvedFDAApproved forTumorPatients with unresectable locally advanced or metastatic TNBC expressing PD-L1. TNBC is an aggressive disease with a high unmet medical need. This approval makes the Tecentriq + Abraxane combination the first cancer immunotherapy regimen for the treatment of PD-L1-positive metastatic TNBC.

Currently, Roche is conducting seven Phase III studies evaluating Tecentriq for the treatment of triple-negative breast cancer (TNBC), covering both early-stage and advanced-stage disease. Breast cancer is the most common type of cancer in women, with over 2 million new cases diagnosed globally each year. TNBC accounts for approximately 15% of all breast cancers and is more prevalent in women under the age of 50 compared to other breast cancer subtypes. TNBC is specifically defined by the negative expression of estrogen receptors (ER), progesterone receptors (PR), and human epidermal growth factor receptor 2 (HER2). It progresses rapidly, carries a very poor prognosis, and has a five-year survival rate of less than 15%. TNBC does not respond to hormonal therapies or HER2-targeted therapies (such as Herceptin), resulting in very limited clinical treatment options that primarily rely on chemotherapy. Metastatic TNBC is one of the most aggressive and difficult-to-treat forms of breast cancer.

Dr. Sandra Horning, Chief Medical Officer and Global Head of Product Development at Roche, stated: “The CHMP’s positive opinion marks a breakthrough in the treatment of triple-negative breast cancer (TNBC), an aggressive form of breast cancer with high unmet medical needs. With today’s announcement, we hope that patients in Europe with PD-L1-positive metastatic TNBC will soon have a new treatment option.”

The CHMP’s positive opinion is based on data from the Phase III clinical study IMpassion130, the first positive Phase III study of cancer immunotherapy conducted in patients with triple-negative breast cancer (TNBC). This multicenter, randomized, double-blind study enrolled a total of 902 patients with unresectable locally advanced or metastatic TNBC who had not previously received systemic therapy for metastatic breast cancer. It evaluated the efficacy and safety of Tecentriq in combination with Abraxane as first-line treatment, compared with placebo plus Abraxane. Patients were randomized in a 1:1 ratio to one of the two treatment arms. The co-primary endpoints were progression-free survival (PFS) and overall survival (OS), assessed by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1). PFS and OS were evaluated in all randomized patients (i.e., the intent-to-treat [ITT] population) and in PD-L1–positive patients. Secondary endpoints included objective response rate (ORR), duration of response (DOR), and time to deterioration of global health status/health-related quality of life (GHS/HRQoL).

The results showed that, compared with the placebo + Abraxane regimen, the Tecentriq + Abraxane regimen inTumorIn the patient population with positive PD-L1 expression in infiltrating immune cells (IC), the risk of disease progression or death was significantly reduced by 38% (median PFS: 7.5 months vs. 5.0 months; HR=0.62, 95% CI: 0.49–0.78; p<0.0001). Furthermore, in the PD-L1-positive population, the Tecentriq plus Abraxane regimen demonstrated a clinically meaningful improvement in overall survival (OS), extending OS by 7 months compared to the placebo plus Abraxane regimen (median OS: 25.0 months vs. 18.0 months; HR=0.71, 95% CI: 0.54–0.93). Formal testing of OS results in the PD-L1-positive population was not conducted because the difference in OS in the intent-to-treat (ITT) population did not reach statistical significance (median OS: 21.0 months vs. 18.7 months; HR=0.86, 95% CI: 0.72–1.02; p=0.078). In this study, the safety profile of the Tecentriq plus Abraxane combination was consistent with the known safety profiles of each individual drug, and no new safety signals were identified with the combination therapy.

The study will continue to follow up with patients until the next planned analysis. AssessmentTumorPD-L1 expression in infiltrating immune cells (ICs) is critical for identifying patients with triple-negative breast cancer (TNBC) who may benefit from the Tecentriq plus Abraxane combination. In this study, PD-L1 expression status was assessed usingDiagnosisVENTANA PD-L1 (SP142) Assay Kit.(Bio Valley Bioon.com)

Original Source:CHMP recommends EU approval of Roche’s Tecentriq in combination with Abraxane as an initial treatment for people with PD-L1-positive, metastatic triple-negative breast cancer