First line immunotherapy for non squamous lung cancer! Tecentriq + chemotherapy protocol review of Roche tumor immunotherapy was extended by US FDA for 3 months

September 2, 2019 / BIOON / -- gene tech, a subsidiary of Roche, a Swiss pharmaceutical giant, recently announced that the US Food and Drug Administration (FDA) has extended the examination time of a supplementary biological product license application (SBLA) for PD-L1 tumor immunotherapy tecentriq (atezolizumab) for three months The SBLA applied for the approval of tecentriq combined with chemotherapy drugs Abraxane (NAB paclitaxel, albumin binding paclitaxel) and carboplatin in the first-line treatment of patients with metastatic non squamous non-small cell lung cancer (NSQ NSCLC) without any mutations in EGFR and alk genes This extended review will give FDA time to review additional information related to supporting SBLA FDA is expected to make a final review decision on December 2, 2019 This SBLA is based on data from the multicenter, randomized, open label phase III study, impower 130 (nct02367781) A total of 724 patients with stage IV non-small cell lung cancer were enrolled in the study These patients did not receive any treatment for metastatic diseases These patients were randomly divided into two groups: group A (tecentriq + Abraxane + carboplatin, n = 483 cases) and group B (Abraxane + carboplatin, n = 241 cases) Group A: during the induction treatment period, patients were treated with tecentriq (the first day of each cycle, a cycle every 21 days), carboplatin (the first day of each cycle, a cycle every 21 days), Abraxane (the first, eighth and 15th days of each cycle, a cycle every 21 days) for 4-6 cycles or until the loss of clinical benefits, whichever occurs first; during the maintenance treatment period Patients received tecentriq maintenance therapy Group B: in the induction treatment period, patients received carboplatin (the first day of each cycle, one cycle every 21 days), Abraxane (the first, eighth and 15th days of each cycle, one cycle every 21 days) treatment for 4-6 cycles or until the loss of clinical benefits, whichever occurs first; in the maintenance treatment period, patients received the best support care During the maintenance treatment, patients can be converted to Alimta (pemetrexed), and patients who get the consent before the approval of the 5th version of the protocol will also have the right to choose to cross receive the single drug treatment of tecentriq until the disease progresses The aim of the study was to determine whether tecentriq improved overall survival (OS) and progression free survival (PFS) in patients, with secondary endpoints including overall response rate (ORR), duration of response (DOR), and adverse events The results showed that the study achieved 2 main goals: compared with the chemotherapy group, the median OS in the Tecentriq+ chemotherapy group was significantly prolonged (18.6 months vs 13.9 months), and the risk of disease progression or death was reduced by 36% In this study, the safety data of combination therapy were consistent with the known safety of each individual component 73.2% of the patients who received tecentriq combined therapy experienced serious or life-threatening adverse events, compared with 60.3% in the chemotherapy group Tecentriq belongs to PD - (L) 1 tumor immunotherapy It targets to bind PD-L1 protein expressed on tumor cells and tumor infiltrating immune cells, and blocks its interaction with PD-1 and B7.1 receptors Tecentriq can activate T cells by inhibiting PD-L1 Up to now, tecentriq has been approved by many countries as a single drug therapy and combined targeted therapy and / or chemotherapy to treat various types of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), some types of metastatic urothelial cancer (MUC), PD-L1 positive triple negative breast cancer (TNBC) Original source: Genentech provides update on supplemental biology license app app lication (SBLA) for tecentriq in first line metastatic non square non small cell lung cancer (NSCLC)