Atezolizumab (only for patients whose tumors express PD-L1... Other recommended regimen added: Atezolizumab (only for patients whose tumors express PD-L1) (category 2B)

Chugai Pharmaceutical...announced that it obtained regulatory approval for an additional indication of the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq® Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for the adjuvant treatment of PD-L1-positive non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare....VENTANA OptiView PD-L1 (SP263), a pathological testing kit marketed by Roche Diagnostics K.K., should be used to detect PD-L1 expression.

...• Duration of freedom from clinical relapse in Study Subjects showing decrease or stabilization of ctDNA level after treatment with investigational agent• Overall survival after cystectomy in Study Subjects having biochemical relapse• Cancer specific survival after cystectomy in Study Subjects having biochemical relapse• Recurrence free survival after cystectomy in Study Subjects having biochemical relapse• Cancer specific survival after cystectomy in Study Subjects having biochemical relapse stratified for potential predictive biomarkers for response to treatment• Response rate to investigated agent stratified for PD-L1 expression and other predictive biomarkers like TMB, immune cell infiltration, tumor subtypes etc.• Response rate to neoadjuvant chemotherapy measured as down staging to T0 or T<2 at cystectomy and correlation with level of ctDNA in plasma and urine samples• Time to recurrence seen on imaging (symptomatic or asymptomatic)• Quality of life assessment using the EORTC QLQ 30 (Quality of life in cancer patients) and QLQ-BLM30 (Quality of life in patients with Muscle Invasive Bladder Cancer)• Cost-effectiveness modelling analysis• Prolonged CR defined as ctDNA negative status in the plasma samples taken 12 months following completion of IO combined with negative imaging (CT) at the same time point, without administration of other oncologic treatment Yderligere målepunkter omfatter langtidsoverlevelse, effekt af behandling samt vurdering af metoder til at forudsige effekt ud fra forskellige analyser, der kan laves på patientens svulstvæv....

...Tolerability of MPDL3280A`Percentage of subjects with a treatment-related delay for multi-dose cohort`Frequency of all grade treatment-related toxicities occuring prior to surgery in multi-dose cohort`Frequency of all grade treatment-related toxicities during adjuvant therapy in multi-dose cohorts`Pathologic T0 rate in expansion cohort for patients with PD-L1 Immunohistochemistry (IHC) 2/3`2-year relapse-free survival (RFS) rate in expansion cohort Intention-To-Treat (ITT) population`Median RFS in the expansion cohort ITT population`2-year RFS rate in expansion cohort patients with PD-L1 IHC 2/3`Median RFS in expansion cohort patients with PD-L1 IHC 2/3`2-year RFS rate in expansion cohort for subjects undergoing adjuvant MPDL3280A`Median RFS in expansion cohort for subjects undergoing adjuvant MPDL3280A`Pathologic Response in expansion cohort`Association of tumor and T-cell PD-L1/PD-1 immunohistochemical expression with disease response in expansion cohort`Association of prior BCG therapy with tumor PD-L1 expression in expansion cohort`Association of prior BCG therapy with pT0 rate in expansion cohort`Frequency of all grade treatment-related toxicities occuring prior to surgery in expansion cohort`Frequency of all grade treatment-related toxicities during adjuvant therapy in expansion cohort...

...Tumor tissue available from the surgery for central confirmation of the diagnosis and analysis the expression of PD-L1 5....

This single arm, phase II study investigated two cycles of atezolizumab (1200mg given every 3 weeks) prior to RC in MIBC(T2-4aN0M0) (NCT02662309)….The pCR rate was 31% (27/88) [95%CI:21%-41%] in the treated population, meeting the primary endpoint of the study, and was 37% (13/35) [95%CI: 21-55%] in the PD-L1 positive population....Neoadjuvant atezolizumab in patient with MIBC who were ineligible or refused neoadjuvant cisplatin-based chemotherapy confers meaningful clinical responses and is associated with high rates of relapse-free and overall survival.