Health Canada approves TECENTRIQ® combination therapy for first-line treatment of metastatic non-squamous non-small cell lung cancer

加拿大批准罗氏TECENTRIQ联合疗法用于转移性非鳞状非小细胞肺癌一线治疗

2019-05-30 18:09:00 BioSpace

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Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved TECENTRIQ® (atezolizumab) in combination with bevacizumab, paclitaxel and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC), with no epithelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic non-squamous NSCLC.2 Lung cancer is one of the most common cancers in Canada and remains one of the leading causes of death from cancer as it is often diagnosed in the most advanced and aggressive stages of the disease.3, 4 NSCLC accounts for approximately 80-85% of all lung cancer cases in Canada,5 and is comprised of squamous cell and non-squamous carcinomas. Non-squamous lung cancer includes lung adenocarcinoma and large cell lung cancer, and makes up around 55% of all NSCLCs.6 The estimated five-year survival rate for patients with metastatic NSCLC is 2-13%.7 "Immunotherapies like TECENTRIQ represent a cornerstone in lung cancer treatment, and are crucial to providing personalized treatment approaches for many patients," says Dr. Mark Vincent, Medical Oncologist. "Clinical data support this combination as a first-line therapy that can extend survival for certain lung cancer patients." This approval is based on results from the Phase III IMpower150 study, which showed that TECENTRIQ in combination with bevacizumab and chemotherapy (carboplatin and paclitaxel) helped people live significantly longer, compared with bevacizumab and chemotherapy alone (median overall survival [OS] was 19.2 versus 14.7 months; hazard ratio [HR] was 0.78; 95% CI: 0.64–0.96; p=0.0164) in the intention-to-treat wild-type (ITT-WT) population.8 "There is a high unmet need in lung cancer. The Canadian Cancer Statistics indicate that approximately half are diagnosed at stage 4, a late stage,"9 says Shem Singh, Executive Director, Lung Cancer Canada. "With this approval, Canadians living with NSCLC now have another first-line treatment option to fight the disease. It is important we continue to push forward additional research in lung cancer to increase survivorship and improve quality of life for patients and their families."
Hoffmann-La Roche Limited (罗氏(Roche) Canada )今天宣布,加拿大卫生部已批准 TETECTRIQ ®( atezolizumab )联合贝伐单抗、紫杉醇和卡铂,用于转移性非小细胞非小细胞肺癌(NSCLC)成人的一线治疗。没有上皮生长因子受体( EGFR )或间变性淋巴瘤激酶( ALK )基因肿瘤异常,也没有对转移性非鳞状非小细胞肺癌(NSCLC)进行系统化疗。2 肺癌是加拿大最常见的癌症之一,它仍然是癌症死亡的主要原因之一,因为它经常被诊断在疾病的最高级和侵略性阶段。3、4非小细胞肺癌约占加拿大非小细胞肺癌(NSCLC)病例的80-85%,5例为鳞状细胞癌和非鳞癌。非鳞癌包括肺癌和大细胞肺癌,约占所有非小细胞肺癌的55%。6转移性非小细胞非小细胞肺癌(NSCLC)患者5年生存率为2-13%。7 “像 TECTENTERIQ 这样的免疫治疗药物是肺癌治疗的基石,对于为许多患者提供个性化治疗方法至关重要,”医学肿瘤学家 MarkVincent 博士说。“临床数据支持这种结合作为一线治疗,可以延长某些肺癌患者的生存期。” 这项批准是基于第三期 IMpower150研究的结果,该研究表明 TETETETETERIQ 与贝伐单抗联合化疗(卡铂和紫杉醇)能显著延长人们的寿命。与贝伐单抗和单纯化疗相比(中位生存期[ OS ]为19.2,14.7个月;危险比[ HR ]为0.78;95% CI :0.64-0.96; p =0.0164)在打算治疗野生型( ITT-WT )人群中。8 “肺癌有一个很高的未被满足的需求。加拿大癌症统计数据显示,大约一半的人在4级晚期被诊断出来。“通过这一批准,加拿大人与非小细胞非小细胞肺癌(NSCLC)现在有另一个一线治疗选择,以对抗疾病。我们必须继续推动对肺癌的进一步研究,以提高患者及其家属的存活率和生活质量。”

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