Top KOLs Discussing HARMONi-GI1
HARMONi-GI1 Key Slides & Visuals
ESMO 2026 slides
| Ivonescimab + chemo (N=340) | Durvalumab + chemo (N=342) | Stratified HR (95% CI) | |
|---|---|---|---|
| Median OS, months (95% CI) | 14.9 (12.9–NE) | 12.1 (11.0–13.4) | 0.75 (0.61–0.92), P = 0.0031 (one-sided) |
| 12-month OS rate | 59.7% | 50.7% | — |
| 18-month OS rate | 44.0% | 32.5% | — |
| Ivonescimab + chemo (N=340) | Durvalumab + chemo (N=342) | Stratified HR (95% CI) | |
|---|---|---|---|
| Median PFS, months (95% CI) | 8.4 (7.5–9.3) | 5.8 (5.6–7.2) | 0.61 (0.51–0.72), P < 0.0001 (one-sided) |
| 6-month PFS rate | 68.7% | 49.3% | — |
| 9-month PFS rate | 49.3% | 31.7% | — |
Same slides also posted by @LorenzaRimassa, @DrAngelaLamarca, @HHorinouchi, @bin_abeid, @OncBrothers, @Tony_Calles, @CathyEngMD, @DraMartinezLago.
Same slides also posted by @DrYukselUrun.
Same slides also posted by @DraMartinezLago, @DrSamMikhail.
Same slides also posted by @bin_abeid.
Same slides also posted by @Erman_Akkus, @dr_yakupergun.
KOL-Made Infographics
Summary graphics designed by physicians (not conference slides). The last two were made before the numbers were released. Values are as the authors drew them. Click to enlarge.
@ChandrakanthMv
@ChandrakanthMv
@ChandrakanthMv
@ChandrakanthMv
@ChandrakanthMv
@DrRishabhOnco
@SuyogCancer
@ozdogan_md
@ChandrakanthMv
@ozdogan_mdHARMONi-GI1 conversations on X
Physician reactions to HARMONi-GI1
HARMONi-GI1: ivonescimab + gem/cis vs durvalumab + gem/cis, 1L biliary tract cancer (China, n=682). Open: applicability outside China? #ESMO26 https://t.co/GCz9bu4c2r
4. HARMONi-GI1: PhIII, Ivonescimab + gem/cis vs durva + gem/cis in 1L advanced BTC (n=682 🇨🇳 only study): - mOS 14.9 vs 12.1mos (HR 0.75) - mPFS 8.4 vs 5.8mos (HR 0.61) - ORR 54% vs 33% *Global confirmation needed… but we’ll likely see Ivo/PD1-VEGFi in our practice soon* 5/5 https://t.co/FBnWx8ahKl https://t.co/4lva04uqlh
We already know that ivonescimab is effective. However, something else caught my attention on this slide. In the control arm, 7% of patients received “Traditional Chinese Medicine” as subsequent antitumor therapy, compared with only 0.6% in the ivonescimab arm. What exactly are these treatments? Have they demonstrated any survival benefit, or is their efficacy no better than placebo? And the crucial question: Could this imbalance have influenced OS, given the substantially higher use in the control arm? Have similar treatments been reported in other randomized oncology trials? #ESMO26
🔬Ivonescimab now represent a promising emerging therapeutic option - exciting progress for cholangiocarcinoma and biliary tract cancer patients @curecc https://t.co/H750CgmfiG
Ivonescimab is the next pan tumor blockbuster drug . Full stop . @OncBrothers @OncoAlert @myESMO #ESMO26 @JacobPlieth https://t.co/vST2xcvV5u
HARMONi-GI1: OS 14.9 vs 12.1 months. Grade 3–4 AEs: 82% vs 72%. A meaningful survival gain, with added toxicity. @myESMO @OncoAlert @OpenMedicineHQ #ESMO26 https://t.co/17ZBsufXOl
Interim analysis of HARMONi-GI1 phase III findings of #Ivonescimab (bispecific Ab for PD-1/VEGF) + chemo vs. durvalumab + chemo for treatment-naive #biliarytract #cancer (N=682). 👏👏 🔹Primary endpoint: OS of 14.9M vs. 12.1 (HR = 0.75) 🔹PFS: 8.4 vs. 5.8M; HR = 0.61 🔹ORR = 53.8% vs. 32.5% 🔹Subsequent therapies was 31.8% vs. 45.9% (more so in control arm) @curecc #cancer #cancerresearch @OncoAlert @SMMT_TX
HARMONi-GI1 phase 3 trial of ivonescimab + chemo in 1L advanced #BTC -OS 14.9 vs 12.1 mos HR 0.75 p 0.0031 -PFS 8.4 vs 5.8 mos HR 0.61 p<0.0001 -ORR 53.8 vs 32.5% p<0.0001 A new standard of care in China. Do we need a trial in Western countries? #ESMO26 #ESMOAmbassadors @myESMO https://t.co/b2U1WNUHf6
HARMONI-GI1 at the @myESMO #ESMO26 #Presidential of CisGem + #ivonescimab vs durvalumab in #firstline #BiliaryMalignancies ✅OS HR 0.75, mOS 12.1vs14.9 ✅PFS HR 0.61, mPFS 6.8vs8.4 ✅ORR 53.8vs32.5 🌐China only BUT 😊This is a positive trial 🥳VEGF is back #ESMOAmbassadors https://t.co/lK6iJSkPlN
Context: per the LBA8 abstract and slides, median PFS was 8.4 months with ivonescimab plus chemotherapy vs 5.8 months with durvalumab plus chemotherapy, and median OS was 14.9 vs 12.1 months.
HARMONI-Gi comparing Ivonescimib plus chemo vs Durvalumab plus chemo in 1L advance BTC, Ivonescimib significantly improves PFS and OS over Durvalumab. #ESMO2026 @myESMO @curijoey @OncoAlert https://t.co/lh2yTJgD30
#ESMO26 Ivonescimab!!! We should judge trials by the quality of their data and the benefit they bring to patients, not by their country of origin. Scientific scrutiny should follow the same standards for everyone; political biases must not delay patients’ access to effective treatments. Clearly, these studies were considered scientifically worthy of presidential presentation—just look at how many came from China!
🚨 #ESMO26 Plenary | HARMONi-GI1 Ivonescimab + chemo improves outcomes vs durvalumab + chemo in 1L advanced BTC 🇨🇳 - OS: 14.9 vs 12.1 mo (HR 0.75) - PFS: 8.4 vs 5.8 mo (HR 0.61) - ORR: 53.8% vs 32.5% @OncoAlert #GIOncology @myESMO https://t.co/YbaDUktknQ
🔥HARMONi-GI1 ph3 advanced #BTC ➡️ivonescimab/GC v durva/GC mFU 14.3mths; China only & interim ✅ iCCA 58% ORR 53.8v32.5%; mPFS 8.4 v 5.8mths ✅mOS 14.9 v12.1mths HR0.75 ➡️AE rate high in both Control arm OS represents❗️VEGF in BTC ⭐️ looks promising @myESMO #ESMO26 @OncoAlert https://t.co/8HVkjxvaFq
📣 Second Presidential Symposium #ESMO26 👉🏽 Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: A randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1) 🗣️ Dr. Zhou 📌 PFS 8.4 vs 5.8m HR 0.61 📌 OS 14.9 vs 12.1m HR 0.75 ☣️ Most frequent hematologic, AST elevation, proteinuria ☣️ Grade 3 or higher 82 vs 72% @OncoAlert @myESMO @ASCO @_SEOM @UTMDAnderson @NEJM @brunolarvol 👇🏽👇🏽
#ESMO26 | HARMONi-GI1 Ivonescimab + chemotherapy improving both OS and PFS over the current standard, durvalumab + chemotherapy, in advanced biliary tract cancer is an important result. If accessible, the new standard of care. https://t.co/NVeoBrmbZ4 https://t.co/zeEzRRvCD8
#ESMO26 🚀 HARMONi-GI1 | Phase III 🇨🇳 682 pts | 1L advanced BTC 💊 Ivonescimab+GemCis vs Durva+GemCis 🏆 OS: 14.9 vs 12.1 mo (HR 0.75) 📈 PFS: 8.4 vs 5.8 mo (HR 0.61) 🎯 ORR: 53.8% vs 32.5% ⚠️ G3–4 AEs: 82% vs 72.3% 💡 Potential new 1L SoC @OncoAlert https://t.co/Xcnb18yFqT
🆙#ESMO26 Presidential Symposium II 🔥HARMONi-GI1: Ivonescimab Plus Chemotherapy Versus Durvalumab Plus Chemotherapy as First-Line Treatment for Advanced Biliary Tract Cancer: A Randomized, Controlled, Double-Blinded, Phase 3 Trial 🎙️Dr. Jian Zhou 🔢LBA8 🎯Met Primary Endpoint 🎯OS (14.9 vs 12.1mo, HR 0.75, p=0.0031; n=682) 🎯PFS (8.4 vs 5.8mo, HR 0.61) 🎯ORR (53.8% vs 32.5%) 🎯No New Safety Signals ☑️NCT06591520 🔗 https://t.co/bIUj6lFjno @OncoAlert @Larvol @myESMO
💥 Ivonescimab, bi-specific PD-1/VEGF, hits a 4th positive Phase III randomized clinical trial, first outside lung cancer indications already approved in China. ✅ 1 L Biliary-tract carcinoma: Ivo + chemo >> Durva + chemo, better ORR, PFS, and OS #ESMO26 https://t.co/2BrYeqTfpH
🔥Presidential session at ESMO 2026 🔥 HARMONi-GI1 ph-3: Ivonescimab + CTx vs durvalumab + CTx as 1L for BTC #ESMO26 #ESMOAmbassadors 👉ORR: 53.8 vs. 32.5 % 👉mPFS: 8.4 vs 5.8 mo 👉mOS: 14.9 vs. 12.1 mo 🧐 Very promising Chinese data, would be great to see data in a global population @myESMO @ASCO
#ESMO26 new treatment option in biliary cancers ? https://t.co/k8PuuIz8Qj
🚨 #ESMO26: Durvalumab’s first-line dominance in biliary tract cancer challenged! HARMONi-GI1 | Phase III Ivonescimab + GemCis vs Durvalumab + GemCis 🔥 OS: 14.9 vs 12.1 months (HR 0.75) 📈 PFS: 8.4 vs 5.8 months (HR 0.61) 🎯 ORR: 53.8% vs 32.5% PD-1/VEGF bispecific therapy could redefine first-line BTC treatment. @my_esmo @ESMO_open @ASCO @OncoAlert
💍 THE TOPAZ RING CHANGES HANDS! At ESMO 2026, HARMONi-GI1 challenges the TOPAZ-1 standard in 1L advanced biliary tract cancer. Ivonescimab + GemCis vs Durvalumab + GemCis 📊 Median OS: 14.9 vs 12.1 months | HR 0.75 Dual PD-1 × VEGF targeting delivers a survival advantage over PD-L1 inhibition. 💎 The ring has a new contender. Will practice follow? Ref: HARMONi-GI1, ESMO 2026, LBA8. @myESMO @OncoAlert @larvol #ESMO26 #BiliaryTractCancer #MVOnco
HARMONi-GI1 | ESMO 2026 | LBA8 TWO TARGETS BEAT ONE! 🎯 Ivonescimab (PD-1 × VEGF) challenges durvalumab (PD-L1) in 1L advanced biliary tract cancer. Phase III | n=682 | Both + GemCis 📊 OS: 14.9 vs 12.1 mo | HR 0.75 (p=0.0031) PFS: 8.4 vs 5.8 mo | HR 0.61 ORR: 53.8% vs 32.5% ✅ Significant OS benefit against an established immunotherapy standard. ⚠️ Safety appears manageable, but VEGF-related toxicity deserves scrutiny. China-only population and 14.3-month median follow-up warrant caution. The verdict: A compelling new first-line contender. Global practice change will require further validation and regulatory approval. Ref: Zhou J et al. HARMONi-GI1. ESMO 2026; LBA8. @myESMO @OncoAlert #ESMO26 #BTC #Ivonescimab #MVOnco
HARMONi-GI1: A meaningful OS gain. But benefit-risk matters. Will the full safety data confirm acceptable VEGF-related toxicity in biliary cancer? @myESMO @OncoAlert @OpenMedicineHQ #ESMO26 https://t.co/xnW9ApaiyQ
Is this going to be story for #ESMO2026 day 3 ? One thing is for sure , u may love it or u may not love it but u can not ignore it -ivonescimab After NSCLC , it is BTC . @dr_yakupergun @JackWestMD @GABOUALFA @GIcancerDoc @GlopesMd @Timothee_MD @OncBrothers @OncoAlert @myESMO https://t.co/YhV7obtNt7
🚀Presidential #ESMO26 HARMONi-GI1 in advanced BTC 🟢Ivonescimab-GemCis vs Durva-Gemcis ✅mOS: 14.9 vs. 12.1 months; HR 0.75, 95% CI 0.61-0.92, P = 0.0031 ✅mPFS: 8.4 vs. 5.8 months, HR 0.61, 95% CI 0.51-0.72, P <0.0001 ✅ORR: 53.8 % vs. 32.5 % (P <0.0001) #cancer #oncology #MedX @OncoAlert #biliary #cholangiocarcinoma #gallbladder
#ESMO26 | HARMONi-GI1| Presidential Session-2 In 1L advanced biliary tract cancer, ivonescimab + chemo vs durvalumab + chemo: 🔹 OS: 14.9 vs 12.1 mo 🔹 PFS: 8.4 vs 5.8 mo 🔹 ORR: 53.8% vs 32.5% A clinically meaningful improvement in OS and PFS against an active SoC comparator https://t.co/haLYmXJHBw
ESMO 2026 presidential 2 | HARMONi-GI1: Ivonescimab beats durvalumab in advanced biliary tract cancer! Phase III trial (n=682): Ivonescimab (PD-1/VEGF bispecific antibody) + gemcitabine/cisplatin vs durvalumab + gemcitabine/cisplatin in 1L advanced BTC. 📊 Key results: ✅ Median OS: 14.9 vs 12.1 months (HR 0.75; p=0.0031) ✅ Median PFS: 8.4 vs 5.8 months (HR 0.61; p<0.0001) ✅ ORR: 53.8% vs 32.5% (p<0.0001) ✅ Manageable safety profile; no new safety signals. 🔥 25% reduction in risk of death and 39% reduction in risk of progression! A rare head-to-head phase III victory against an established immunotherapy standard in BTC. Could PD-1/VEGF bispecific antibodies replace conventional PD-L1 inhibition in first-line BTC? @OncoAlert @myESMO #ESMO26 #BiliaryTractCancer #Oncology
Raising the Bar in Advanced Biliary Tract Cancer: OS Superiority Against an Active Standard In advanced BTC, the bar is an active standard—not placebo. HARMONi-GI1: ivonescimab + chemotherapy showed OS superiority vs durvalumab + chemotherapy; PFS and ORR were also positive. Now we need magnitude, toxicity and generalisability beyond China. @myESMO #ESMO26
Posted on October 21, after the topline announcement and before any numbers were released.
👑 HARMONi-GI1 | Is Durvalumab’s Throne Under Threat? Phase III trial in advanced biliary tract cancer: Ivonescimab (PD-1 × VEGF) + chemo vs Durvalumab + chemo ✅ OS superiority met — sponsor-reported ✅ PFS and response-rate endpoints met ⚠️ Detailed efficacy and safety data awaited. 📍 ESMO 2026 | October 25 | LBA8 Presidential Symposium II | Jian Zhou ❓ How many extra months of survival? ❓ Will gallbladder cancer benefit too? 🎯 A new first-line standard? The numbers will decide. #ESMO2026 #HARMONiGI1 #Ivonescimab #BiliaryTractCancer #GallbladderCancer #MVOnco
Posted on October 19, after the topline announcement and before any numbers were released.
HARMONi-GI1 Trial Design
HARMONi-GI1 asked whether replacing durvalumab with ivonescimab, a bispecific antibody that targets both PD-1 and VEGF, improves survival when added to gemcitabine and cisplatin as first-line treatment for advanced biliary tract cancer. Durvalumab plus gemcitabine-cisplatin is the standard first-line regimen. The trial is sponsored and funded by Akeso Biopharma (Zhongshan, China), which generated, managed and analyzed the data; Summit Therapeutics holds ivonescimab rights in the US, Europe and other territories. Results were presented by Jian Zhou, MD, PhD, at ESMO 2026 (LBA8, Presidential Symposium II, October 25, 2026), with James J. Harding, MD, as invited discussant.
Study Design
Randomized 1:1, double-blind (each arm received placebo on the other arm’s maintenance schedule), multicenter phase 3 in China (NCT06591520, AK112-309); 340 vs 342 patients. Stratified by disease status (locally advanced vs metastatic) and primary tumor location (intrahepatic vs extrahepatic cholangiocarcinoma vs gallbladder).
Population
Unresectable locally advanced or metastatic BTC, or recurrent after curative surgery; no prior systemic therapy (neoadjuvant or adjuvant therapy allowed if completed ≥6 months before progression); ECOG PS 0–1. Intrahepatic cholangiocarcinoma 58%; hepatitis B 59.6% (discussant’s slide).
Interventions
Ivonescimab 20 mg/kg Q3W or durvalumab 1500 mg Q3W, each with gemcitabine 1000 mg/m² and cisplatin 25 mg/m² on days 1 and 8 every 3 weeks for up to 8 cycles, then ivonescimab Q3W or durvalumab Q4W maintenance.
Endpoints
Primary: overall survival. Key secondary: PFS and ORR (investigator-assessed, RECIST v1.1). Other secondary (registry): duration of response, disease control rate, time to response, adverse events.
Presenter & Discussant
Presenter: Jian Zhou, MD, PhD (Zhongshan Hospital, Fudan University, Shanghai), principal investigator. Invited discussant: James J. Harding, MD (New York).
Data Cut
Prespecified interim analysis, reviewed by an Independent Data Monitoring Committee according to Akeso; median follow-up 14.3 months; 81.6% maturity (discussant’s slide). The data cutoff date was not shown.
HARMONi-GI1 in the News
HARMONi-GI1 Questions
What is the HARMONi-GI1 trial?
HARMONi-GI1 (AK112-309, NCT06591520) is a randomized, double-blind phase 3 trial run in China by Akeso. It compared ivonescimab, a PD-1/VEGF bispecific antibody, plus gemcitabine and cisplatin with durvalumab plus gemcitabine and cisplatin as first-line treatment in 682 patients with unresectable locally advanced or metastatic biliary tract cancer. Design: Trial Design.
What did HARMONi-GI1 show at ESMO 2026?
At a prespecified interim analysis (median follow-up 14.3 months), the primary endpoint was met: median overall survival was 14.9 vs 12.1 months, HR 0.75 (95% CI 0.61–0.92), one-sided P = 0.0031. Median PFS was 8.4 vs 5.8 months (HR 0.61) and ORR 53.8% vs 32.5%. Figures: At a Glance.
Is ivonescimab approved for biliary tract cancer?
No. Ivonescimab is not approved for biliary tract cancer anywhere. In China it is approved (NMPA) in three lung cancer indications; Akeso says first-line BTC has been proposed for NMPA Priority Review. In the United States and Europe ivonescimab is investigational and not approved for any use. Its first US application, in EGFR-mutant NSCLC, is a separate indication (see HARMONi-A).
How toxic was ivonescimab plus chemotherapy?
Grade 3 or 4 treatment-emergent adverse events occurred in 82.0% vs 72.3% of patients, mostly hematologic; serious adverse events were 43.4% vs 43.7%, and grade ≥3 immune-related events 4.1% in each arm. Treatment exposure was longer with ivonescimab (median 7.8 vs 5.7 months). Details: At a Glance.
Was the trial conducted only in China, and will it be repeated elsewhere?
Yes, HARMONi-GI1 enrolled patients in China only. Physicians debated how far the results apply outside China (see Discussion Threads). In the US, ECOG-ACRIN plans a registration-enabling phase 2/3 trial, EA2251 (NCT07765433), comparing ivonescimab plus chemotherapy with pembrolizumab or durvalumab plus chemotherapy.
What did physicians notice about subsequent therapy?
Fewer patients in the ivonescimab arm received any subsequent anti-tumor therapy (31.8% vs 45.9%). The slide also lists Traditional Chinese Medicine as subsequent therapy in 0.6% vs 7.0%, which Yakup Ergün, MD, questioned on X (see Physician Reactions).