On March 9, Genentech announced that the FDA has accelerated the approval of Tecentriq in combination with Abraxane (albuminol) for the first-line treatment of PD-L1-positive unresectable locally advanced or metastatic triple-negative breast cancer. The FDA approval is based on the IMpassion130 study. After the PFS data, Genentech will continue to conduct confirmatory clinical studies to support Tecentriq's complete approval for this indication.
Triple-Negative Breast Cancer (TNBC) refers to females. Hormone receptor (ER). Progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2) are negative breast cancer types, accounting for 10% to 20% of all breast cancer pathological types, mostly in Premenopausal women. Sanyin breast cancer is the most dangerous type of breast cancer, it is aggressive, easy to metastasize, and the prognosis is very poor. The survival time after diagnosis is usually less than 20 months, and the 5-year survival rate is less than 15%. /p>
Three-negative breast cancer is generally treated according to poor prognosis of breast cancer. Standard therapy is postoperative use of neoadjuvant chemotherapy with anthracyclines or paclitaxel. Because of estrogen receptors in patients with TNBC. Hormone receptor or HER2 receptor In a variety of subtypes, even in the same treatment regimen, the response levels of different patients vary widely. The United States has not previously approved any targeted drugs for the treatment of TNBC.
IMpassion130 study is a multicenter random double A blind phase III clinical trial evaluated the efficacy of Atezolizumab in combination with paclitaxel in the treatment of locally advanced or metastatic triple-negative breast cancer that had not previously received systemic therapy. Safety and pharmacokinetics, enrolled in 902 patients, the primary end point was The PFS and OS evaluated by the RECIST 1.1 criteria were analyzed in all intention-to-treat populations and PD-L1 positive populations.
The results showed that Tecentriq+Abraxane could not receive systemic treatment of PD compared to Abraxane alone. -L1+ patients with advanced or metastatic triple-negative breast cancer have a 40% lower risk of disease progression or death, with PFS of 7.4 and 4.8 months, respectively.
Safety data for the combination of the two drugs and use alone The safety data was consistent and no new adverse reaction signals were found. The most common (≥2%) serious grade 3-4 adverse reactions included decreased white blood cell counts. Stinging or numbness of hands and feet, decreased neutrophil count, and fatigue. Decreased red blood cell count. Blood potassium level decreased. Pneumonia. AST increased.
Tecentriq's global sales in 2018 was 772 million Swiss francs, and triple-negative breast cancer was approved after bladder and lung cancer. 3 major indications, also the first PD-1/PD-L1 immunotherapy drugs approved for breast cancer.