Tyvyt (sintilimab)

Perhaps relevant that when FDA rejected sintilimab for advanced NSCLC, one of the reasons was that the control arm of ORIENT-11 trial did not reflect standard of care in the USA. It didn't matter that the control arm was SOC in other countries. (slide 13 https://t.co/E9BWG0xisI) (@ac_palmer)

Sintilimab/Axitinib Combo Shrinks FH-Deficient RCC Tumors @AmerUrological #kcsm #AUA23 https://t.co/GFLaaDzhh1 (@OncLive)

Update of ORIENT-31 trial of sintilimab (PD1) in #EGFR NSCLC @LancetRespirMed. Adding sintilimab to chemo improved PFS (HR 0.72) over chemo alone but not as much as triplet of sintilimab + IBI305 (VEGF) + chemo with PFS (HR 0.51). Similar OS across arms. https://t.co/KYtK67XtqL (@StephenVLiu)

A four-drug regimen — sintilimab, IBI305, pemetrexed, and cisplatin — improved survival in patients with EGFR-mutated non–small-cell lung cancer, with no new safety signals, a new study found. https://t.co/sqhNJEmeod #LungCancer @JPatelMD (@JWatch)

Dr. @TonyMok9 discussing ORIENT-31 study at #ESMO22. Suggestion of benefit when adding sintilimab (PD1) to chemotherapy over chemotherapy alone in #EGFR NSCLC, even without VEGF blockade. But this is not what we expected based on IMMUNOTARGET by Dr. @JulienMazieres (@StephenVLiu)

#ESMO22 Positive trial - addition of sintilimab to chemotherapy improved outcomes in #EGFR mutant NSCLC - better PFS and RR (OS immature). Interesting data - chemo-IO providing benefit without VEGF in EGFR? (@StephenVLiu)

Dr. Shun Lu presents update of ORIENT-31: sintilimab +/- IBI305 + chemo in #EGFR mutant NSCLC post TKI therapy. Three arm study: chemo vs chemo + sintilimab vs chemo + sintilimab + IBI305 (angiogenesis). #ESMO22 (@StephenVLiu)

Baseline characteristics show a fairly high proportion of never smokers. SUNRISE excluded EGFR, ALK, and ROS1 - would like details on testing methods and presence of other drivers. More pts with brain and liver metastases in the sintilimab + anlotinib arm. #ESMO22 (@StephenVLiu)

Dr. Baohui Han presents SUNRISE: randomized phase II study of sintilimab (PD1) and anlotinib (anti-angiogenic TKI) in metastatic NSCLC. #ESMO22 (@StephenVLiu)

Results from ORIENT-31 @TheLancetOncol. 444 pts with #EGFR mutant NSCLC post TKI randomized to cisplatin + pemetrexed alone or with sintilimab+/- IBI305 (anti-VEGF). Adding sintilimab + IBI305 sig improved PFS (6.9 vs 4.3m, HR 0.46). Other data pending. https://t.co/rXBZ1zDeOx (@StephenVLiu)

#ASCO22 Dr. @ryangentzler discusses recurrent #SCLC including abstract #8516 by Dr. Shuxiang Ma of sintilimab (PD1) plus anlotinib. RR 49%, DCR 80%, mPFS 6m, mOS 16m. Is #VEGF inhibition important for IO here? Note 43% never smokers. (@StephenVLiu)

Three year follow up from single arm phase Ib of neoadjuvant sintilimab (PD1) in NSCLC @JTOonline. After 2 doses, 37/40 underwent resection; 11% had pCR. 3y OS rate 89% and 3y DFS rate 75%. Median EFS 44.4m overall and in PDL1+ subset, 3y EFS rate 82%. https://t.co/qJkGrOrvzP (@StephenVLiu)

Excellent discussions - especially related to recent decision on sintilimab, and role of new, me-too PD1, PDL1 drugs in clinic - Should $$ be a factor in @FDA approvals? #TTLC22 @IASLC #LCSM (@CharuAggarwalMD)

IMO, many oncs would appreciate @US_FDA directly considering cost when making decisions. Sintilimab or sugemalimab at significantly lower cost vs. other IOs offers real incremental benefit. OTOH, approving cemiplimab as 3rd agent vs high PD-L1 NSCLC & at same price is useless. (@JackWestMD)

Abstract for the ORIENT-31 trial @Annals_Oncology. This phase III showed PFS benefit with adding sintilimab (PDL1) and IBI305 (VEGF) to cis/pem in #EGFR mutant NSCLC. Await results from third arm (cis/pem + sintilimab) for comparison. #ESMOVirtualPlenary https://t.co/zZYreBHGY7 (@StephenVLiu)

#ESMOasiaweek21: Encouraging results w/ sintilimab combo therapy in EGFR-mutated non-squamous #NSCLC. In the first interim analysis of the ORIENT-31 trial, PFS was slightly improved in pts who progressed after EGFR TKI. ➡️ https://t.co/ivK4PMfxKj #lcsm #lungcancer @APassaroMD (@myESMO)

Immunotherapy in #EGFR NSCLC was the focus of the #ESMOVirtualPlenary. Dr. Shun Lu presents the first interim analysis of the ORIENT-31 trial: phase III trial of cis/pem vs cis/pem + sintilimab (PDL1) vs cis/pem + sintilimab + IBI305 (bevacizumab biosimilar) #ESMOasiaweek21 #LCSM (@StephenVLiu)

Pts with advanced #EGFR mutant NSCLC post-TKI were randomized to chemo (cis/pem + pem maintenance) + placebo, chemo + anti-PDL1 (sintilimab), or chemo + PDL1 + VEGF (IBI305, bevacizumab biosimilar). Conditional crossover from chemo to sintilimab allowed. @OncoAlert @myESMO (@StephenVLiu)

Impressive PFS benefit. In #EGFR mutant NSCLC post TKI, cis/pem plus PDL1+VEGF (sintilimab+IBI305) significantly improved PFS over cis/pem + placebos (HR 0.46). Curves split early, mPFS 6.9 vs 4.3m. #LCSM #ESMOasiaweek21 @myESMO (@StephenVLiu)

EGFRmut NSCLC post TKI: Quadriplet CT-IO-antiangiogenic [pemetrexed+cisplatin+Sintilimab (aPD-1 Ab)+IBI305 (bevacizumab biosimilar)] increases efficacy over CT. Activity against CT-IO not reported. No PD-L1 data presented. Confirms the IMpower150 results. #ESMOasiaweek21 (@BenjaminBesseMD)

2️⃣nd #clinicaltrial back to back Same combination as ORIENT-15➡️ORIENT-16 Sintilimab plus chemo 🆚 chemo alone Clinically meaningful OS differences. @OncoAlert #ESOCSM #STCSM but this time adeno 1st line PDL1 cutoffs of >=5 58% ORR >>> 10% improvement PD1⛔️ #ESMO21 @myESMO (@pashtoonkasi)

1️⃣st #clinicaltrial ORIENT-15 Sintilimab plus chemo 🆚 chemo alone Clinically meaningful OS differences. @OncoAlert #ESOCSM Squamous 1st line PDL1 cutoffs of >=10 66% ORR >>> 20% improvement PD1⛔️ (@pashtoonkasi)

MA01.05: Sintilimab, SBRT and GM-CSF for Advanced NSCLC a prospective multicenter trial🤔💡 By Dr Jianjiao from china 🇨🇳 On the World Conference on Lung Cáncer 👏🏻 DAY1 https://t.co/2qpQY9uUWJ JOIN THE CONFERENCE (@Dr_Ivanoncologo)

#WCLC21 Dr. Jianjiao Ni presents data from single arm phase II study of 2L sintilimab (anti-PD1) + GM-CSF + SBRT in driver-negative NSCLC. Safety looks good but need to watch for late toxicity (median f/u ~8m) and too early to comment on efficacy but solid rationale. Await update (@StephenVLiu)

$BGNE tislelizumab just added 1L non-squam NSCLC (competes vs camrelizumab, Tyvyt $IVBXF & Keytruda) & 2L liver (Tecentriq available 1L) to its China approvals. Still awaiting approval for MSI-H/dMMR solid tumours. (@JacobPlieth)

#ASCO21 There were MULTIPLE VEGF inh + PD-1 inh combination trials: ➡️Y Guo, et al (abstr 2514): Fruquintinib + Sintilimab ➡️CA Gomez-Roca, et al (abstr 3564): LEAP-005, Lenva + Pembro ➡️M Fakih, et al (abstr 3560): Rego + nivo ✅In MSS mCRC the ORR was consistently ~20% (@MPishvaian)

#ESMO20 PD-1 ab in 1L sqNSCLC Sintilimab PFS HR 0.621 by IRRC ，OS HR 0.567 Pembrolizumab PFS HR 0.56 ， OS HR 0.64 Different Chemo ，diff effect on PD-1？ (@ksrcristianchen)

Sintilimab is a PD1 antibody and the phase Ib of sintilimab with platinum/pem had RR 68.4% and mPFS 11.4m. Phase III included 397 patients in 47 hospitals in China with treatment naive advanced EGFR/ALK wild type non-squamous NSCLC, stratified by PDL1 expression (22C3). (@StephenVLiu)

#VPS20 @MNagasaka provides a cross trial comparison of sintilimab to pembrolizumab in KN189 (caveats noted) that shows near identical PFS outcomes. Compares favorably to other regimens as well, including in PDL1 high subset. #LCSM #WCLC20 @IASLC (@StephenVLiu)