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.

...Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.

PD-L1 expression positive (≥1%-49%)…Adenocarcinoma, large cell, NSCLC NOS…other recommended…Carboplatin + albumin-bound paclitaxel + atezolizumab

For patients with negative (TPS 0%) and low positive (TPS 1% to 49%) PD-L1 expression, non-SCC, and PS 0 to 1, clinicians may offer atezolizumab/carboplatin/nab-paclitaxel…

The open-label, single-arm phase III/IV TAIL study (NCT03285763) evaluated atezolizumab monotherapy in patients with previously treated NSCLC...In the biomarker-evaluable population, patients with PD-L1 expression on ≥1% of tumor cells had median OS of 15.5 (95% CI 14.2 to 21.7) months, compared with 11.7 (95% CI 7.9 to 13.7) months in the PD-L1-negative population (<1% tumor cell expression)...

IMpower010 showed a disease-free survival benefit with atezolizumab versus best supportive care after adjuvant chemotherapy in patients with resected stage II–IIIA NSCLC, with pronounced benefit in the subgroup whose tumours expressed PD-L1 on 1% or more of tumour cells, and no new safety signals. Atezolizumab after adjuvant chemotherapy offers a promising treatment option for patients with resected early-stage NSCLC.

Roche...today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer (NSCLC) whose tumours express PD-L1≥1%, as determined by an FDA-approved test,

Atezo showed statistically significant DFS benefit vs BSC in the PD-L1 TC ≥1% Stage II-IIIA and all randomized Stage II-IIIA populations...IMpower010 met its primary endpoint, showing DFS benefit with adjuvant atezo vs BSC after adjuvant chemo in pts with resected Stage II-IIIA NSCLC, with pronounced benefit in the PD-L1 TC ≥1% subgroup.

Atezo showed statistically significant DFS benefit vs BSC in the PD-L1 TC ≥1% Stage II-IIIA and all randomized Stage II-IIIA populations...IMpower010 met its primary endpoint, showing DFS benefit with adjuvant atezo vs BSC after adjuvant chemo in pts with resected Stage II-IIIA NSCLC, with pronounced benefit in the PD-L1 TC ≥1% subgroup.

...Phase III IMpower010 study evaluating Tecentriq® (atezolizumab), compared with best supportive care (BSC), met its primary endpoint of disease-free survival (DFS) at the interim analysis. Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIIA populations with non-small cell lung cancer (NSCLC). The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.

NON-SUPPORTIVE EVIDENCE: Patients had PD-L1–selected (≥1% PD-L1 on TC or IC [TC1/2/3 or IC1/2/3]; VENTANA SP142 IHC assay), chemotherapy-naive, stage IV NSCLC and an ECOG PS of 0-1. Patients were randomised 1:1 to Arm A (atezolizumab 1200 mg IV q3w)...At the final OS analysis, IMpower110 did not show statistical significance in TC2/3 or IC2/3-WT patients. Exploratory updated analysis in TC3 or IC3-WT patients showed continued clinically meaningful OS benefit in the atezolizumab vs chemotherapy arm.

Atezo had a favorable safety profile vs chemo (table); safety data were consistent with data from a pooled atezo mono pop...Atezo was better tolerated than chemo and imAEs were generally low grade. Overall, the safety experience with atezo mono in IMpower110 was consistent with its known safety profile...

...patients with a bTMB-MSAF score<20 showed improvement in OS (HR 0.56; P < 0.001) and progression-free survival (PFS) (HR 0.74; P = 0.0023), and these patients who concurrently had programmed death ligand 1 (PD-L1) expressing on over 50% tumor cells or over 10% of tumor-infiltrating immune cells (TC3 or IC3) had the greatest OS improvements (HR 0.44; P = 0.007) and promising PFS benefits (HR 0.54; P = 0.019).

Genentech...announced today that it has received a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A (anti-PDL1). The designation was granted for the treatment of people with PD-L1 (Programmed Death-Ligand 1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and an appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor).

IMpower110 evaluated atezo as 1L tx in PD-L1–selected pts independent of tumour histology….In the TC3 or IC3 WT population, atezo monotherapy improved median OS by 7.1 mo (HR, 0.595; P = 0.0106) vs chemo

Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening

While baseline TMB appeared prognostic in this patient population, this exploratory analysis suggests that adjuvant atezolizumab is associated with improved DFS in the PD-L1-positive stage II-IIIA population, irrespective of TMB status.

The median OS (months) in the Atezo, Doce, and Doce+Ram groups were 17.5, 7.6, and 11.5, respectively; and were 29.5, 7.2, and 6.9, respectively in the PD-L1 > 50% subgroups. The Atezo group showed significantly greater OS improvement compared with the Doce group (HR 0.42, 95% CI 0.26 – 0.66, p = 0.001**). This benefit appears greater and remains statistically significant in the PD-L1 > 1% (HR 0.39, 95% CI 0.22 – 0.71, p = 0.005**) and PD-L1 > 50% (HR 0.37, 95% CI 0.15 – 0.91, p = 0.022*) subgroups....We observed statistically significant and clinically meaningful PFS and OS benefits of atezolizumab monotherapy compared with docetaxel in patients with advanced NSCLC who were pretreated with IO. The OS benefits of atezolizumab over docetaxel +/- ramucirumab was greater in PD-L1 > 1% and PD-L1 > 50% subgroups.

Regardless of Post-OP ctDNA status, atezo was associated with improved DFS vs BSC in PD-L1+ subgroups (TC ≥1%, 1-49%, ≥50%) but not the PD-L1− subgroup (TC <1%)….Adjuvant atezo is linked to improved DFS vs BSC in early NSCLC in PD-L1+ subgroups regardless of ctDNA status. Chemo ctDNA clearance is associated with longer DFS and atezo may control ctDNA levels and delay disease recurrence better than BSC.

...retrospective study of 2nd and 3rd line NSCLC patients in the POPLAR Ph2 clinical study...Benefit of A vs D was found in both test classification groups for PD-L1 positive patients.

Patients received neoadjuvant atezolizumab 1200 mg intravenously every 3 weeks for ≤2 cycles followed by surgical resection...Data suggest MPR was positively associated with PD-L1 expression and negatively associated with EGFR/ALK alterations.

Pts received by nivolumab (87.2%), pembrolizumab (7.7%) or atezolizumab (5.1%)….PD-L1 status was assessed in 18 tumours (46.1%). In PDL1+ pts, ORR was 53.3% (8/15) and DCR was 66.7% (10/15).

Improvement correlated with PD-L1 immunohistochemistry expression on tumour cells and tumour-infiltrating immune cells, suggesting that PD-L1 expression is predictive for atezolizumab benefit.