FDA grants Bristol Meyer PD-1 immunotherapy opdivo a priority qualification for the treatment of advanced urothelial cancer

The tumor immunotherapy giant BMS PD-1 immunotherapy opdivo recently received a good news in the US regulatory field The US Food and Drug Administration (FDA) has accepted the supplementary biological product license (SBLA) for opdivo in the treatment of local advanced unresectable or metastatic urothelial carcinoma (MUC) with or after platinum chemotherapy, and has granted priority review fund Lattice In June, the FDA also awarded opdivo a breakthrough drug qualification for the treatment of metastatic urothelial cancer (MUC) FDA has designated the target date of PDUFA as March 2, 2017 The submission of regulatory documents for the treatment of metastatic urothelial carcinoma (MUC) by opdivo is based on data from a phase II clinical study, checkmate-275 The study is a single group study, which was carried out in 270 patients with platinum refractory, metastatic or unresectable urothelial carcinoma (mUC) who were undergoing chemotherapy / post chemotherapy or received neoadjuvant treatment / adjuvant treatment with platinum within one year The proportion of patients with PD-L1 expression ≥ 1% is 46%, and the proportion of patients with PD-L1 expression ≥ 5% is 30% The data showed that the confirmed objective response rate (ORR) was 19.26% (95% CI: 15.0-24.9) after the patients were treated with opdivo; in the study, remission was observed in both the PD-L1 expression group and the non expression group, and the higher orr was observed in the patients with higher PD-L1 expression level, specifically: 23.8% (95%) in the patients with PD-L1 expression ≥ 1% CI: 16.5-32.3); orr confirmed was 16.1% (95% CI: 10.5-23.1) in patients with PD-L1 < 1%; 28.4% (95% CI: 18.9-39.5) in patients with PD-L1 ≥ 5%; orr confirmed was 15.8% (95% CI: 10.8-21.8) in patients with PD-L1 < 5% Among the 52 patients who achieved remission, the median time to achieve remission was 1.9 months (1.6-5.9 months); at the minimum follow-up of 6 months, the median duration of remission (DOR) was not reached in all patients, and 77% of the patients continued to achieve remission In PFS, median PFS was 2.0 months (95% CI: 1.87-2.63) in all patients, 1.87 months (95% CI: 1.77-2.04) in patients with PD-L1 < 1%, and 3.55 months (95% CI: 1.94-3.71) in patients with PD-L1 ≥ 1% In terms of total survival time (OS), median OS was 8.74 months (95% CI: 6.05-n.a.); median OS was 5.95 months (95% CI: 4.30-8.08) in patients with PD-L1 < 1%; median OS was 11.3 months (95% CI: 95% CI: 8.74-n.a.) in patients with PD-L1 ≥ 1% In terms of safety, the safety of opdivo in this study is consistent with that of the drug in other types of tumors Of the 270 patients treated with opdivo, 64.4% experienced any level of treatment-related adverse events (AE), of which 17.8% experienced level 3 or level 4 The most commonly reported treatment-related adverse events at any level were fatigue (16.7%), pruritus (9.3%), diarrhea (8.9%), loss of appetite (8.1%), hypothyroidism (7.8%), nausea (7%), fatigue (5.9%), rash (5.9%) and fever (5.6%) The most common level 3-4 adverse events were fatigue (1.9%), diarrhea (1.9%), fatigue (1.5%), and rash (1.1%) In general, the rate of drug withdrawal due to any level of treatment-related adverse events was 4.8%, and the rate of drug withdrawal due to 3-4 level of treatment-related adverse events was 3.0% In the field of immunotherapy for bladder cancer: Roche tecentriq is the first PD-1 / PD-L1 drug approved to treat UC In May this year, the U.S Food and Drug Administration (FDA) approved Roche tumor immunotherapy tecentriq (atezolizumab) to treat UC, becoming the first PD-1 / PD-L1 immunotherapy approved to treat this kind of cancer At the end of June this year, FDA awarded the breakthrough drug qualification of bestimer opdivo in treating UUC In September this year, the European Drug Administration (EMA) officially accepted the application documents of opdivo in treating UUC In February, AstraZeneca's durvalumab also qualified as a breakthrough drug for the treatment of MUC in US regulation Urothelial carcinoma (UC) is the most common type of bladder cancer, accounting for about 90% of all bladder cancer cases Patients in the late stage face a very high rate of disease recurrence and deterioration, which leads to a huge unmet medical demand in this field Globally, bladder cancer is the ninth most commonly diagnosed cancer type, with an estimated 430000 new cases and more than 165000 deaths per year Most bladder cancers are diagnosed at an early stage, but the rate of recurrence and deterioration is very high About 78% of patients will experience recurrence or deterioration within 5 years The survival rate depends on the stage and type of cancer For stage IV bladder cancer, the 5-year survival rate is only 15% Original source: U.S Food and Drug Administration acceptances for priority review the supplementary biology license application for opdivo (nivolumab) in previously treated patients with advanced form of blade cancer