Immunotherapy for bladder cancer! The first-line treatment of Roche tecentriq + platinum containing chemotherapy was successful in phase III, which significantly prolonged the progression free survival period!

October 8, 2019 / BIOON / -- Roche, a Swiss pharmaceutical giant, recently announced the positive results of imvigor130, a phase III clinical study of PD-L1 tumor immunotherapy tecentriq (atezolizumab) in the treatment of urothelial carcinoma It is worth mentioning that this study is the first positive phase III study to evaluate the first-line treatment of advanced bladder cancer patients with an immunocombination therapy The data shows that tecentriq combined chemotherapy reduces the risk of disease progression or death compared with chemotherapy Imvigor130 is a multicenter, partially blind, randomized study conducted in patients with locally advanced or metastatic urothelial carcinoma (MUC) who have not previously received systemic therapy for metastatic diseases It evaluated the efficacy and safety of tecentriq + chemotherapy, tecentriq monotherapy, chemotherapy for first-line (initial) treatment A total of 1213 patients were enrolled in the study, who received (1) tecentriq + platinum containing chemotherapy (gemcitabine combined with cisplatin or carboplatin); (2) tecentriq single drug treatment; (3) platinum containing chemotherapy (gemcitabine combined with cisplatin or carboplatin) + placebo (control group) In this study, the common primary end point of the tecentriq combination therapy group was the progression free survival (PFS) and total survival (OS) assessed by investigators using RECIST v1.1 The secondary end points were the objective response rate (ORR) and duration of response (DOR) assessed by the investigator using RECIST v1.1, and the PFS assessed by the independent review agency The results showed that tecentriq + chemotherapy significantly improved the progression free survival (PFS) compared with platinum chemotherapy (median PFS: 8.2 months vs 6.3 months; HR = 0.82, 95% CI: 0.70-0.96, P = 0.007) In the intention to treat (ITT) population, tecentriq + chemotherapy also achieved encouraging results in terms of overall survival (OS) compared with chemotherapy, but these data were not statistically significant at the mid-term analysis (median OS: 16.0 months vs 13.4 months, HR = 0.83, 95% CI: 0.69-1.00) In this study, the safety of tecentriq combined chemotherapy group was consistent with the known safety of single drug, and no new safety signal was found Roche also published additional data on tecentriq monotherapy in patients with ITT and those with different levels of PD-L1 expression The results showed that in the PD-L1 overexpression (IC2 / 3) population, tecentriq single drug therapy observed encouraging OS results, but these data were not formally tested according to the stratified design of the trial The follow-up work will continue to the next analysis Sandra horning, Roche's chief medical officer and head of global product development, said: "we are satisfied with the positive results from the imvigor130 study, which indicates that tecentriq + chemotherapy may provide meaningful benefits for newly diagnosed patients with advanced bladder cancer For patients with advanced bladder cancer, high-level treatment is still needed, and chemotherapy is the current standard of care These results strengthen the role of immunotherapy in the treatment of this invasive disease " Tecentriq is the first cancer immunotherapy approved for advanced bladder cancer Tecentriq has been approved by the FDA to treat patients with locally advanced or metastatic urothelial cancer, including those who are not eligible for cisplatin chemotherapy and have high expression of PD-L1, and those who are not eligible for platinum containing chemotherapy regardless of the expression status of PD-L1 This accelerated approval also includes patients with disease progression during or after platinum containing chemotherapy and patients with disease progression within 12 months of preoperative (neoadjuvant) or postoperative (adjuvant) chemotherapy These accelerated approvals are based on data on tumor remission rates and remission persistence Continued approval in these types of bladder cancer may depend on the validation and description of clinical benefits in confirmatory trials Currently, Roche is carrying out four phase III clinical studies to evaluate tecentriq as a single drug therapy and in combination with other drugs for early and advanced bladder cancer The company has a wide range of development projects for tecentriq, including a number of ongoing planned phase III studies across lung cancer, urogenital, skin, breast, gastrointestinal, gynecological and head and neck cancers, including studies to evaluate tecentriq as a single drug and in combination with other drugs Original source: Genentech presentations positive phase III results for tecentriq (atezolizumab) in combination with platform based chemotherapy in people with previously untreated advanced blade cancer