First line immunotherapy for lung cancer! The treatment of PD-L1 overexpression NSCLC with single drug of Roche tecentriq was given priority review, and the survival period was significantly prolonged

February 20, 2020 / BIOON / -- Roche's gene tech recently announced that the U.S Food and Drug Administration (FDA) has accepted a supplementary biological product license application (SBLA) from tecentriq (tezolizumab, atzumab) for anti PD-L1 therapy and granted priority review The SBLA sought to approve tecentriq as a first-line (initial) monotherapy for the treatment of advanced non squamous and squamous non-small cell lung cancer (NSCLC) patients with high PD-L1 expression (TC3 / IC3 wild-type [wt]), no EGFR or ALK mutations, as determined by PD-L1 biomarker testing FDA is expected to make an approval decision by June 19, 2020 Levi Garraway, MD, chief medical officer and head of global product development, Roche, said: "in the impower 110 study, patients newly diagnosed with a specific type of advanced non-small cell lung cancer treated with tecentriq alone had a significant improvement in overall survival (OS) compared to chemotherapy We are working closely with the FDA to provide these patients with this chemotherapy free treatment option as soon as possible " The SBLA is based on the results of the phase III impower 110 study This is a randomized, open label phase III study of programmed death ligand 1 (PD-L1) biomarkers To evaluate the efficacy and safety of tecentriq as a single drug therapy in the first-line (initial) treatment, it was carried out in patients with advanced non squamous or squamous non-small cell lung cancer (NSCLC) who had not received chemotherapy (initial treatment), had no ALK or EGFR mutation (WT) A total of 572 patients (555 WT) enrolled in the study were randomly assigned in a 1:1 ratio to receive (1) tecentriq monotherapy until clinical benefits were lost (as assessed by the study investigator), (2) cisplatin or carboplatin (as determined by the investigator) in combination with pemetrexed (non scaly) or gemcitabine (scaly), and then pemetrexed (non scaly) or optimal Supportive therapy (scaling) until disease progression, unacceptable toxicity, or death The main outcome was the total survival time (OS) of PD-L1 subgroup (TC3 / ic3-wt; TC2 / 3 / IC2 / 3-wt; tc1,2,3 / ic1,2,3-wt), which was measured by sp142 Key secondary endpoints included progression free survival (PFS), objective response rate (ORR), and duration of response (DOR) as assessed by study investigators The results showed that the main end point of this study was reached at the time of mid-term analysis: in patients with high expression of PD-L1 (TC3 / ic3-wt), tecentriq single drug first-line treatment significantly increased the total survival time (OS) by 7.1 months compared with chemotherapy (median OS: 20.2 months vs 13.1 months, HR = 0.595, 95% CI: 0.398-0.890, P = 0.0106) Encouraging OS was also observed in patients with moderate PD-L1 expression (TC2 / 3 or IC2 / 3-wt) (median OS: 18.2 months vs 14.9 months, HR = 0.717, 95% CI: 0.520-0.989), but the data were not statistically significant at the mid-term analysis This study will continue with the final analysis of patients with low PD-L1 expression In the study, the security of tecentriq is consistent with the known security profile, and no new security signal is found The above data show that, compared with chemotherapy, in patients with squamous or non squamous NSCLC with high expression of PD-L1, tecentriq alone as a first-line (initial) treatment has significant survival benefits and can provide patients with additional treatment options Lung cancer is the main cause of cancer death in the world Every year, 1.76 million people die from the disease; that means more than 4800 people die every day around the world Lung cancer can be roughly divided into two categories: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) NSCLC is the most common type, accounting for about 85% of all cases NSCLC includes non squamous cell lung cancer and squamous cell lung cancer Squamous cell carcinoma is characterized by flat cells covering the airway surface when observed under a microscope Tecentriq belongs to PD - (L) 1 tumor immunotherapy It is a protein named PD-L1 expressed on tumor cells and tumor infiltrating immune cells, and blocks its interaction with PD-1 and B7.1 receptors By inhibiting PD-L1, tecentriq can activate T cells, which has the potential to be used as a basic combination therapy for cancer immunotherapy, targeted drugs and various cancer chemotherapy programs Up to now, tecentriq has been approved in the United States, the European Union and other countries in the world as a single drug therapy, as well as 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) In China, tecentriq was approved in February 2020 to treat patients with extensive small cell lung cancer (es-sclc) in combination with chemotherapy (carboplatin + etoposide) It is worth mentioning that tecentriq is the second PD-L1 drug approved in China after the approval of AstraZeneca anti PD-L1 therapy imfinzi (yingfeifan, general name: durvalumab, duvalizumab) by the State Food and Drug Administration on December 10, 2019 In addition to 6 PD-1 drugs, 8 PD-1 / L1 drugs are currently on the market in China At present, the supplementary application of tecentriq combined with Avastin for the first-line treatment of unresectable liver cancer (HCC) is being reviewed by a number of regulatory agencies, including the United States, China and Japan HCC is the most common type of liver cancer The application is based on the results of the phase III imbrave150 study The data shows that compared with the current standard nursing drug sorafenib (sorafenib), tecentriq + Avastin regimen has a statistically significant and clinically significant improvement in total survival (OS) and progression free survival (PFS) Roche has developed a wide range of development plans for tecentriq, including a number of ongoing and planned phase III studies involving various types of lung cancer, urogenital cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer and head and neck cancer This includes studies of tecentriq alone or in combination with other drugs Original source: FDA grants priority review to Genentech's tecentriq monthly as first line treatment of certain people with advanced non small cell lung cancer