Targeted therapy or immunotherapy for advanced or metastatic disease...PD-L1≥1%...first-line therapy...Carboplatin/albumin-bound paclitaxel/ atezolizumab (nonsquamous)

PFS and OS benefit was observed in all PD-L1 subgroups, and consistently across all subgroups….IMpower130 showed statistically significant, clinically meaningful improvements in OS and statistically significant improvements in PFS with atezo + CnP, vs CnP, in 1L, stage IV non-squamous NSCLC...

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.

...PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population`OS as Determined by the Investigator Using Recist v1.1 in the ITT Population`OS as Determined by the Investigator Using RECIST v1.1 in the PD-L1 Expression Population and PD-L1 Expression WT Population`Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population`Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT Population, PD-L1 Expression Population, and PD-L1 Expression WT Population`Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population, ITT Population, and PD-L1 Expression Population and PD-L1 Expression WT Population`Event Free Rate (%) at Year 1 and 2 in ITT-WT Population and ITT Population`Event Free Rate (%) at Year 1 and 2 in PD-L1 Expression Population and PD-L1 Expression WT Population`Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population`Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale`Percentage of Participants With Adverse Events`Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab`Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm`Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel`Plasma Concentrations of Carboplatin`Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel...

...- Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening...

...- Willingness to undergo a biopsy ≤ 6 weeks of the start of study treatment to obtain formalin-fixed paraffin-embedded tumor specimens in paraffin blocks (blocks are preferred) or at least 15 unstained slides, with an associated pathology report, for central testing of tumor PD-L1 expression....

...Patients with EGFR activating mutations or ALK- positive tumour mutations should also have received targeted therapy (Cohort 3 LOT1 NSCLC) or (4) In combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC) or (5) As a monotherapy, for the treatment of metastatic NSCLC with high PD-L1 expression, previously untreated (Cohort 5 LOT1 NSCLC) or (6) In combination with bevacizumab for unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy (Cohort 6 LOT1 HCC) ....

The objective response rate of 53.3% (95% CI 45.1–57.8) in the ACN group was higher than the 29.7% (26.1–32.8) observed in the CN group (p = 0.008) (Table 2). For patients in the ACN group, the ORR was 11.7%, 18.3%, and 23.3% for cohorts TC1, TC2, and TC3, respectively....Subgroup analyses demonstrated that for individuals with TC3 PD-L1-expressing cells, the median OS was 23.7 months in the ACN group versus 16.1 months in the CN group (HR 0.25; p = 0.001)....The findings of this study demonstrate that the atezolizumab plus carboplatin and nab-paclitaxel regimen as front-line management might provide greater survival benefits in PD-L1-positive metastatic nonsquamous NSCLC patients in a selected population than the carboplatin and nab-paclitaxel regimen, with a tolerable safety profile.