TEST:

PD-L1 IHC 28-8 pharmDx

OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of...adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab.

NIVO effect was larger in pts with tumors with increasing PD-L1 expression, with a ΔpCR rate (unweighted rate difference between arms A and B) of 16.6% in CPS ≥ 1 (40.4% vs 23.8% in arms A/B; 95% CI, 2.8 to 29.4), 32.4% in CPS ≥ 10 (65.7% vs 33.3% in arms A/B; 95% CI, 7.3 to 52.3), and 52.3% in CPS ≥ 20 (78.9% vs 26.7% in arms A/B; 95% CI, 18.6 to 72.4)....Greater PD-L1 expression was associated with higher pCR and RCB 0–1 rates, suggesting that pts with PD-L1+, high-risk, ER+/HER2− primary BC can achieve substantial pCR rates with the addition of NIVO to NACT.

Patients with both high PD-L1 expression and high TMB showed a good response to ICIs with the response rate of 64% and median progression-free survival of 9.0 months despite of small population.

ONO-4538-52/TASUKI-52 is a randomized, double-blind, placebo-controlled phase III study...Eligible patients had histologically or cytologically confirmed stage IIIB/IV or recurrent non-squamous NSCLC...The enrolled patients were randomly assigned in a 1:1 ratio to the nivolumab (n = 275) and placebo (n = 275) arm...the PFS was significantly longer in patients with PD-L1 expression levels of 1%–49% and ≥50% in the nivolumab arm (median, 11.0 and 9.9 months, respectively) than in the placebo arm (median, 8.4 and 6.9 months, respectively)...

Of treated patients with tumor available for testing, 252 patients (88%) of 288 were evaluable for PD-L1 expression and 98 patients (82%) of 120 for TMB. ORR was 30% overall and 41% and 15% in patients with 1% or greater and less than 1% tumor PD-L1 expression, respectively.