TEST:

VENTANA PD-L1 (SP263) Assay

Another “gee whiz” moment for immunotherapy: FDA approves an uncommonly used PD-L1 assay (SP263) as CDx for Adjuvant Atezolizumab in Stage II-IIIA NSCLC (IMpower010 trial) where SP142 used for eligibility. Yet most PD-L1 in USA is Dako22c3 & will remain so https://t.co/4rKEFKn0VF (@drgandara)

Landmark approval of atezolizumab in adjuvant NSCLC. Couple practical clinical points to consider-1) While Ventana SP263 tumor cell (TC) is how study was done, many centers utilize DAKO 22C3 (from KN24 days). Both these assays are congruent by Blueprint https://t.co/BIO7ewrSiF (@PatelOncology)

Just in 👉 @FDAOncology approves adjuvant Atezolizumab (after surgery +platinum-chemoRx) in pts with stage II-IIIA NSCLC #lungcancer with tumor PD-L1 expression on 1% or more tumor cells as determined by VENTANA PD-L1 (SP263) Assay. https://t.co/e9Pqddmm5w @OncoAlert (@neerajaiims)

TNBC LABC with Ki67>90% with TPS<1%,CPS>1% Ventana SP263 platform on Nab Paclitaxel ,Carboplatin and Atezo. After recent Roche ruling should these Pts be made devoid of this combo!!@oncologician @SewantiLimaye @hoperugo (@ravi0273)

If adjuvant atezo becomes SOC for PDL1 >=1% NSCLC patients, what do we do about the assay? We (and I think most places) use Dako 22C3 for PDL1 IHC, would you feel comfortable treating based on that assay versus needing SP263? #ASCO21 #LCSM (@n8pennell)

#ASCO21 Looking at subgroups of the all-randomized stage II-IIIA dataset, we see greater DFS benefit for PDL1 high (TC, SP263) with HR 0.43 compared to 0.66 for PDL1 positive and 0.97 for PDL1 negative. What we need to see is PDL1 low (1-49%). #LCSM (@StephenVLiu)

#ASCO21 IMpower 010 study design shown here. Resected stage IB-IIIA (AJCC7) NSCLC with randomization post-chemotherapy to 1y of atezolizumab or BSC. PDL1 stratification by TC/IC but primary endpoint of DFS by PDL1 expression used TC only (with SP263). #LCSM (@StephenVLiu)

#ASCO21 IMpower 010 used a hierarchical statistical design first looking at DFS in PDL1+ (TC, SP263) stage II-IIIA (AJCC7). If positive, then DFS in all II-III over all PDL1 strata. If that was positive, then DFS ITT (IB-IIIA). Only then will OS be formally analyzed. #LCSM (@StephenVLiu)

Remember that PD-L1 testing was performed using SP142 and then later SP263 assay #LCSM #ASCO21 @ASCO (@CharuAggarwalMD)

Total N=1280, 1269 pts rec’d 4 cycles of cisplatin-based adj chemo, #IMPOWER010, 1005 were subsequently randomized 1:1 to 16 cycles of atezo 1200 mg Q3W or BSC. Primary endpoint investigator-assessed DFS PD-L1 TC ≥1% (SP263) subgroup with Stage II-IIIA disease #LCSM #ASCO21 (@CharuAggarwalMD)

Delighted to share our work on dual PD-L1 expression (SP142 & SP263) performance for whole slides from matched bladder cancer tissue (TURBT, RC & LN+) @joostboormans @SpringerPath #PathTwitter cc @Markuseckstein3 @AndreaNecchi @ewanagibb @IBCN1997 https://t.co/8vHi8onHZ5 (@JoepJdeJong)

#WCLC20 First question: outcomes any different with a different PDL1 assay (Ventana SP263)? First answer: they are not. Not for RR and not for PFS. #LCSM @IASLC (@StephenVLiu)

Intesrting what about this. M/75 y never smoker. PS2 brain mets, bone, liver, NSLCL adeno. PDL1 (SP263 80%) EGFR mut G719x. (@patch_cpcl)

#ESMO20 Biomarkers from IMpower 133 included tissue PDL1 expression (Ventana SP263) and blood based #TMB. Neither with utility in patient selection for benefit with atezolizumab (all subgroups had better outcomes with addition of immunotherapy). #LCSM (@StephenVLiu)