KOLs Discussing HARMONi-6
HARMONi-6 Key Slides & Visuals
Plenary slides from ASCO 2026 (LBA4, presented May 31, 2026 by Prof Shun Lu) plus earlier presentations of the primary PFS analysis (WCLC 2025 / The Lancet). Click any image to expand.
Top Tweets on HARMONi-6
$SMMT, Akeso, HARMONI 6 I’m going to guess that we see a 4.5 month Overall Survival differential this weekend.
$SMMT $AKESF $XBI ASCO I’m guessing that ivonescimab in HARMONI-6 shows a +4.5 mo differential in OS, with an HR of around 0.72. > HARMONi-6 PFS showed mPFS 11.14 as compared to 6.90 months, HR 0.60, +4.24 months PFS, with higher ORR and DoR, and powered assuming OS HR h
Here we, go #ASCO26. Ivonescimab HARMONi-6 for $SMMT Akeso and all those interested in PD1/VEGFs STAT's @matthewherper story in the next post. OS HR 0.66 mOS ivo+chemo 28 months v tis+chemo 24 months The KM curve https://t.co/0N7GYi1VwR
Some reactions to the ivo H-6 data: $SMMT co-CEO Bob Duggan said the data mean the company has “a very valuable business with a very valuable product that is in its early stages.” Yale/Dartmouth lung cancer expert Roy Herbst: “This isn’t a home run… I’d say it’s a good
LBA4 #ASCO2026 Ivosnescimab + chemotherapy improved OS vs tislelizumab + chemotherapy in untreated advanced squamous NSCLC: • Median OS: 27.9 vs 23.7 months • HR 0.66 (34% reduction in risk of death) • PD-L1 <1%: HR 0.64 • PD-L1 ≥1%: HR 0.68 In keynote 407 - https://t.co/4
Here it is, the #ASCO26 slide you've all been waiting for: OS curves from Harmoni-6. Looks like ivo blasted Tevimbra out of the water, HR=0.66; how will it fare vs Keytruda in Harmoni-3? $SMMT Via Shun Lu https://t.co/fhUCuJATFk
Impressive results from the phase 3 Harmoni 6 trial of chemotherapy plus ivonescimab or anti-PD1 for advanced squamous lung cancer. HR for overall survival 0.66. May lead to approval in EU, results of Harmoni 3 awaited! #lcsm https://t.co/LaPyP0GWEX
$SMMT $AKESF $XBI ASCO I’m guessing that ivonescimab in HARMONI-6 shows a +4.5 mo differential in OS, with an HR of around 0.72. > HARMONi-6 PFS showed mPFS 11.14 as compared to 6.90 months, HR 0.60, +4.24 months PFS, with higher ORR and DoR, and powered assuming OS HR h
HARMONi-6: In patients with untreated advanced squamous NSCLC, ivonescimab plus chemotherapy showed significantly improved progression-free survival compared with tislelizumab plus chemotherapy, regardless of PD-L1 status. https://t.co/C6kHHPmbLa #ESMO25
< 3 wks to #ASCO26, here is a📝 of 🔑abstracts for general onc that could guide our SoC! - #RASolute302 - #EPISODE3 - #LIBRETTO432 - #HARMONi6 - #PROTEUS - #EV302 - #SARC041 - #persevERA - #origAMI5 - #MajesTEC9 & #SUCCESOR2 #OncTwitter @ASCO @OncoAlert @OncUpdates
Ivonescimab + chemo improved PFS over tislelizumab + chemo (11.1 vs 6.9 mo, HR 0.60, p<0.0001) in 1L sq-NSCLC. Benefit seen across PD-L1 groups. Dual target strategy keeps moving, VEGF still matters. #ESMO25 @TeresaSAmaral @E_de_Azambuja @JyotiBajpai01 @ArBayle https://t.c
This is the China-only Harmoni-6 trial. First ph3 study to show PFS benefit for PD-1/VEGF+chemo over PD-1+chemo. (The control arm uses Beigene's PD-1 tisletizumab, not $MRK Keytruda)
About HARMONi-6
HARMONi-6 (AK112-306, NCT05840016) is a single-region, multi-center, randomized Phase 3 trial conducted in China and sponsored by Akeso. It enrolled 532 patients with previously untreated, locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression, with approximately 63% centrally located tumors and 33.8% with multi-site / liver / brain metastases. The primary endpoint was investigator-assessed PFS (met at interim, HR 0.60); the key secondary endpoint was OS, which crossed the pre-specified efficacy boundary at the planned interim analysis (data cutoff Feb 27, 2026).
Design
Randomized, double-blind, active-controlled Phase 3 (China). 1:1 randomization. Stratified by stage (IIIB/C vs IV) and PD-L1 TPS (<1% vs ≥1%).
Population
n=532. Previously untreated locally advanced or metastatic squamous NSCLC, irrespective of PD-L1. ~63% centrally located tumors; 39% PD-L1 TPS <1%.
Intervention
Ivonescimab 20 mg/kg + carboplatin + paclitaxel / nab-paclitaxel (q3w) vs Tislelizumab 200 mg + carboplatin + paclitaxel / nab-paclitaxel (q3w), followed by maintenance.
Endpoints
Primary: PFS (BICR). Key secondary: OS. Other: ORR, DoR, safety, PRO. Independent Data Monitoring Committee assessed pre-specified OS interim.
PI & Site
Prof Shun Lu, MD, PhD — Director, Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine.
Sponsor
Akeso, Inc. (HKEX: 9926.HK) sponsor of record. Summit Therapeutics (NASDAQ: SMMT) holds ex-China rights to ivonescimab.
HARMONi-6 Results
Overall Survival (key secondary endpoint — interim analysis, ASCO 2026 LBA4)
Ivonescimab + chemo demonstrated a statistically significant and clinically meaningful OS benefit vs tislelizumab + chemo at the pre-specified interim. HR 0.66 (95% CI 0.50–0.87; p=0.0017) — a 34% reduction in the risk of death. Median follow-up 21.4 months (data cutoff Feb 27, 2026). Median OS 27.9 months (ivonescimab arm) vs 23.7 months (tislelizumab arm). 24-month OS rates: 64.7% vs 48.6%. OS benefit was consistent across all pre-specified subgroups, including PD-L1-negative (HR ~0.64) and PD-L1-positive (HR ~0.68) patients. Subsequent anticancer therapy was comparable between arms.
34% reduction in risk of death · 4.2-mo median OS gainSummit press release (NASDAQ: SMMT) ↗ Akeso press release (PRNewswire) ↗ Fierce Biotech ASCO 2026 coverage ↗
Progression-Free Survival (primary endpoint — earlier interim, WCLC 2025 / The Lancet)
HARMONi-6 met its primary PFS endpoint at the earlier interim analysis. Median PFS 11.1 months vs 6.9 months (HR 0.60; 95% CI 0.46–0.78; p<0.0001) at median follow-up 10.3 months by BICR — a 40% reduction in disease progression or death. By investigator assessment: HR 0.64 (95% CI 0.50–0.84). PFS benefit was consistent across PD-L1 subgroups (TPS <1%: 9.9 vs 5.7 mo, HR 0.55; TPS ≥1%: 12.6 vs 8.6 mo, HR 0.66). Updated PFS at the ASCO data cut was 11.4 vs 6.9 months (HR 0.60).
40% PFS risk reduction · 4.2-mo PFS gainASCO Post — primary PFS (Lancet 2025) ↗ ASCO Post — ivonescimab PFS review ↗
Response & Duration of Response
Objective response rate was 75.9% (ivonescimab) vs 66.5% (tislelizumab), p=0.008. In PD-L1 TPS ≥1%: ORR 80.1% vs 70.2%. Median duration of response was 11.2 months vs 8.4 months (p=0.0219). Responses were both higher and more durable in the ivonescimab arm — consistent with the OS benefit reported at ASCO 2026.
ASCO Post — Stenger summary ↗ OncoDaily oncolibrary ↗Safety
Overall safety was manageable and comparable between arms. Grade ≥3 treatment-related AEs: 64% (ivonescimab) vs 54% (tislelizumab), driven by decreased neutrophil count (32% vs 26%), decreased WBC (11% vs 9%), and anemia (6% vs 4%). Treatment-related SAEs: 32.3% vs 30.2%. Grade ≥3 hemorrhage was rare but not absent — 1.9% (5 patients) vs 0.8% (2 patients); four of five ivonescimab hemorrhage events had prior hemoptysis, central tumor, or major-vessel encasement. Grade ≥3 immune-related AEs: 9% vs 10%. Treatment-related discontinuation: 3% vs 4%. Treatment-related deaths: 3% vs 4%.
ASCO Post — safety detail ↗ OncoDaily — safety summary ↗Clinical Implications
HARMONi-6 is the first Phase 3 trial in which any regimen has beaten a PD-1 + chemo control on OS in 1L NSCLC head-to-head — a benchmark that single-agent ivonescimab failed to clear vs Keytruda in HARMONi-2 (Chinese 1L PD-L1+ NSCLC, 22.3% death-risk reduction, immature). It also re-opens the door to anti-VEGF mechanisms in squamous NSCLC, a population historically excluded from bevacizumab due to bleeding risk. Ex-China translation remains an open question: the global confirmatory HARMONi-3 squamous cohort missed its interim PFS bar on May 1, 2026, and Summit (NASDAQ: SMMT) shares fell ~25% on the news. Final HARMONi-3 PFS is expected H2 2026.
Fierce Biotech — Brahmer (Johns Hopkins) discussant ↗ Summit Q1 2026 — HARMONi-3 timeline ↗All KOL Reactions
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