Top KOLs Discussing HERON-Lung01
HERON-Lung01 Key Slides
ESMO 2026 slides
| Ruzaltatug rezetecan (n=250) | Chemotherapy (n=248) | Stratified HR (95% CI) | |
|---|---|---|---|
| Median PFS, months (95% CI) | 8.3 (6.9–9.9) | 5.4 (4.4–5.6) | 0.47 (0.36–0.60), one-sided P < 0.0001 |
| Events, n (%) | 108 (43.2) | 156 (62.9) | — |
| 6-month PFS rate | 59.8% | 32.4% | — |
| 9-month PFS rate | 46.3% | 16.7% | — |
| PFS by investigator (secondary) | — | — | 0.46 (0.36–0.60) |
Same or overlapping slides also posted by @HHorinouchi.
| Ruzaltatug rezetecan (n=250) | Chemotherapy (n=248) | Stratified HR (95% CI) | |
|---|---|---|---|
| Deaths, n (%) | 29 (11.6) | 37 (14.9) | 0.70 (0.43–1.14) |
| 6-month OS rate | 93.8% | 88.6% | — |
| 12-month OS rate | 76.8% | 71.5% | — |
| Subsequent systemic therapy | 28.0% | 44.8% (19.4% crossed over) | — |
Same or overlapping slides also posted by @TommyJohn00.
What physicians are debating
Is it a new standard? Tolerability vs toxicity
The presenter concluded the drug is a “new standard-of-care option.” Antonio Calles, MD, disagreed: “Significant toxicities. Not a SoC yet to me.” Riyaz Shah, MD, asked whether tolerability “looks somewhat more palatable than izabren?”, and Stephen Liu, MD, noted “Low rates of discontinuation, ILD rate 2.4% and most toxicity hematologic.” Grade ≥3 treatment-related events were similar between arms (40.7% vs 38.9%), but alopecia, nausea and decreased appetite were more frequent with the ADC.
LBA72 presentation slides (Chongrui Xu, ESMO 2026)The control arm: chemotherapy without the EGFR TKI
The comparator was platinum-pemetrexed, and the EGFR TKI was not continued in either arm. Tom John, MD, flagged “no TKI continuation”; Urs Weber, MD, wrote that ADCs “clearly have a role in this space, but I’d like to see the EGFR TKI continued.” Simon Ekman’s discussion placed the result against amivantamab plus chemotherapy (MARIPOSA-2, PFS HR 0.48) and ongoing programs, and concluded the field needs to “define the optimal treatment sequences and combinations.”
Invited discussant slides (Simon Ekman, ESMO 2026) · FDA: amivantamab + carboplatin-pemetrexed approval, Sep 2024OS immature, with crossover
OS (HR 0.70, 95% CI 0.43–1.14) is immature, with 66 deaths across both arms, and 19.4% of chemotherapy patients crossed over to ruzaltatug rezetecan. Stephen Liu, MD, called it an “OS trend”; Adam Januszewski, MD, wrote “More mature OS & global data needed.”
LBA72 presentation slides (Chongrui Xu, ESMO 2026) · ESMO 2026 abstract LBA72 (program; click Abstract under LBA72)Biomarkers, the brain and a China-only population
Tom John, MD, noted “No biomarker data presented” and “Access will be key.” Per Young Kwang Chae, MD, Ekman raised the need for predictive biomarkers beyond HER3 expression, CNS activity (the brain-metastases subgroup HR was 0.61, 95% CI 0.36–1.02) and “Global Translatability outside China.”
Invited discussant slides (Simon Ekman, ESMO 2026)Two ADCs in one session: HERON-Lung01 and PANKU-Lung01
HERON-Lung01 was discussed with PANKU-Lung01 (iza-bren, an EGFRxHER3 bispecific ADC), and both appeared in The Lancet the same day. Alfredo Addeo, MD, asked whether this is “A new era for EGFR-mutant NSCLC?” The trials differ in drug, follow-up and population, so cross-trial comparisons are not reliable. Other ADCs after an EGFR TKI include sacituzumab tirumotecan (OptiTROP-Lung04).
Invited discussant slides (Simon Ekman, ESMO 2026) · Xu et al., The Lancet, Oct 26, 2026Physician reactions to HERON-Lung01
Two positive ADC trials (ruzaltatug rezetecan, izalontamab brengitecan) vs platinum chemo in EGFR-mutant mNSCLC post EGFR TKI from China presented at @myESMO #ESMO26 and published in @TheLancet. ADCs clearly have a role in this space, but I’d like to see the EGFR TKI continued.
A new era for EGFR-mutant NSCLC? Two phase III trials, two promising ADCs, and potentially a major step forward for patients progressing after EGFR TKIs! Izalontamab brengitecan (EGFR × HER3) and ruzaltatug rezetecan (HER3) are reshaping the treatment landscape.! Exciting science at #ESMO26! #ESMOAmbassadors #LungCancer #NSCLC #EGFR #ADC #ESMO26
Great discussion at #ESMO2026 by Dr. Simon Ekman (Karolinska University Hospital) addressing LBA71 (PANKU-Lung01) and LBA72 (HERON-Lung01): "Has the Achilles' heel been found?" 🧬🔍 Key insights & questions raised on HER3-directed ADCs in post-EGFR TKI NSCLC: 💡 Discussion Points: • CNS Activity: Promising intracranial efficacy observed, though further evaluation of brain metastasis subgroup responses remains key. • Predictive Biomarkers Needed: Beyond expression levels alone, addressing HER3 heterogeneity, membrane localization, linker stability, and payload mechanics. • Algorithm Positioning: Determining exact optimal treatment sequencing and combination regimens post-3rd gen EGFR-TKI. • Global Translatability outside China is the key. There are ongoing trials expanding to 1L combinations. #OncoTwitter #LungCancer #EGFR #NSCLC #Oncology #ESMO26 #MedicalResearch
Excited to see the phase 3 HERON-Lung01 trial results presented at #ESMO2026 by Dr. Chong-Rui Xu (lead author Prof. Yi-Long Wu)! 🧬✨ Ruzaltatug rozetecan (SHR-A2009)—a novel HER3-directed ADC—shows significant PFS improvement vs platinum-based chemo in EGFRm NSCLC after TKI progression: 📊 Key Highlights: • mPFS: 8.3 mo vs 5.4 mo (HR 0.47 [95% CI 0.36–0.60], p < 0.0001) • ORR: 60.0% vs 34.3% • OS Trend: Favors ruzaltatug rezetecan (HR 0.70) despite chemo crossover • Safety: Differentiated & manageable safety profile with low ILD rates (2.4%) Positioning ruzaltatug rezetecan as a strong potential new standard of care in EGFR-TKI resistant NSCLC! 👏 #OncoTwitter #LungCancer #NSCLC #Oncology #MedicalResearch #ESMO2026
HERON-Lung01: Ruzaltatug rezetecan (SHR-A2009), antiHER3 ADC, showed increased efficacy in terms of ORR and PFS, but OS not mature yet compared to pt-based chemotherapy. Significant toxicities. Not a SoC yet to me. #ESMO26 #LCSM https://t.co/r0feshFC5z
Ruzaltatug rezetecan versus chemotherapy for EGFR-mutated advanced non-small-cell lung cancer progressing after EGFR tyrosine kinase inhibitor therapy (HERON-Lung01): interim analysis of a randomised, open-label, phase 3 trial in China - The Lancet https://t.co/8eOEPJXLJM
🆙#ESMO26 Proffered Paper II: #LCSM Mets 🔥HERON-Lung01: Ruzaltatug Rezetecan, a HER3-Directed ADC, vs Platinum-Based Chemotherapy (PBC) in EGFR-Mutated Advanced NSCLC Progressing After EGFR-TKI: Interim Analyses (IA) From the Phase 3 Trial 🎙️Dr. Chongrui Xu 🔢LBA72 🎯Met Primary Endpoint: BICR-PFS 8.3 vs 5.4mo (HR 0.47, p<0.0001; n=498) 🎯ORR 60.0% vs 34.3% 🎯OS Immature, Favorable (HR 0.70) 🎯Grade≥3 TRAEs 40.7% vs 38.9%; ILD 2.4% ☑️NCT06671379 🔗 https://t.co/M4ccE0iSMW @OncoAlert @Larvol @myESMO @IASLC @EGFRResisters
C Xu: HERON Ph3 trial using HER3 ADC. Crossover permitted for this study. Also no TKI continuation. Another ADC meets it’s primary endpoint in EGFRm NSCLC. No biomarker data presented. Access will be key. #LCSM #ESMO26 https://t.co/VUCh0wGaG3
HERON-lung01; Ruzaltatug rezetecan (will we call this Ruiz-Rez is my overriding thought?) in common mEGFR; n498; mPFS HR 0.47 -3m longer ; mDOR 8.5m ; tolerability looks somewhat more palatable than izabren? #ESMO26 https://t.co/Zmmy9YuuiN
#ESMO26 Dr. Chongrui Xu presents phase III HERON-Lung01 trial: ruzaltatug rezetecan (HER3 ADC) vs platinum chemo in EGFR NSCLC post TKI. ADC superior: PFS 8.3 vs 5.4m, HR 0.47 with OS trend (HR 0.70, ns) despite crossover. RR 60% vs 34% Low rates of discontinuation, ILD rate 2.4% and most toxicity hematologic. #ESMOAmbassadors
🚨 #ESMO26 Another promising ADC in 2L EGFRm NSCLC! Ph3 HER3 ADC ruzaltatug rezetecan vs chemo: 📈 PFS 8.3 vs 5.4m (HR 0.47) 📈 ORR 60% vs 34% 📈 OS HR 0.70 (immature) ⚠️ ILD 2.4% Competitive ADC landscape! More mature OS & global data needed. https://t.co/fBtB02MUoz
🆙 #ESMO26 Proffered Paper II: #LCSM Mets 🔥HERON-Lung01: Ruzaltatug Rezetecan, a HER3-Directed ADC, vs Platinum-Based Chemotherapy in EGFR-Mutated Advanced NSCLC Progressing After EGFR-TKI 🎙️Dr. Yi-Long Wu @ThomasW35874311 🔢LBA72 🎯Met Primary Endpoint at Interim Analysis: Statistically Significant PFS Improvement by BICR vs Chemo ☑️NCT06671379 🔗 https://t.co/M4ccE0ikXo @OncoAlert @Larvol @myESMO @IASLC @EGFRResisters
Context: the LBA72 presentation on October 26 was given by Chongrui Xu, MD; Yi-Long Wu, MD, is the abstract’s first author.
HERON-Lung01 Trial Design
HERON-Lung01 asked whether ruzaltatug rezetecan (SHR-A2009), an antibody-drug conjugate built on a fully human anti-HER3 IgG1 antibody with a cleavable peptide linker and a topoisomerase I inhibitor payload, improves progression-free survival over platinum-pemetrexed once EGFR-mutant non-squamous NSCLC progresses on an EGFR TKI. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals (CT.gov sponsor) and funded by its parent, Jiangsu Hengrui Pharmaceuticals.
Study Design
Randomized 1:1, open-label phase 3 at 62 sites in China (NCT06671379, SHR-A2009-301). 498 randomized (250 vs 248) between November 2024 and January 2026. Stratified by brain metastases, EGFR mutation type and prior first-line third-generation EGFR TKI. Crossover allowed at progression.
Population
Age 18–75; locally advanced or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R, progression during or after an EGFR TKI (prior third-generation TKI required for T790M tumors), no other prior systemic therapy; ECOG PS 0–1. Prior third-generation TKI 98.4% vs 96.4%; brain metastases 19.2% vs 19.0%.
Interventions
Ruzaltatug rezetecan 8 mg/kg IV every 3 weeks, vs pemetrexed 500 mg/m² plus carboplatin AUC 5 or cisplatin 75 mg/m² every 3 weeks for 4 cycles, then pemetrexed maintenance.
Endpoints
Primary: PFS by blinded independent central review (BICR) in the ITT population. Secondary: OS, investigator-assessed PFS, ORR, DCR and DoR (BICR and investigator), safety.
Presenter & Discussant
Presenter: Chongrui Xu, MD (Guangzhou, China), Lancet first author. Abstract first author: Yi-Long Wu, MD. Invited discussant: Simon Ekman, MD, PhD (Karolinska University Hospital).
Data Cut
Prespecified interim PFS analysis, data cutoff April 15, 2026; median follow-up 7.7 months. OS immature.
HERON-Lung01 in the News
HERON-Lung01 Questions
What is the HERON-Lung01 trial?
HERON-Lung01 (NCT06671379, SHR-A2009-301) is a randomized, open-label phase 3 trial at 62 sites in China comparing ruzaltatug rezetecan (SHR-A2009), an investigational HER3-directed antibody-drug conjugate from Jiangsu Hengrui Pharmaceuticals, with pemetrexed plus carboplatin or cisplatin in 498 patients with EGFR-mutant (exon 19 deletion or L858R) non-squamous NSCLC that progressed on an EGFR TKI. Design: Trial Design.
What did HERON-Lung01 show at ESMO 2026?
At the prespecified interim PFS analysis (data cutoff April 15, 2026; median follow-up 7.7 months), median PFS by blinded independent central review, the primary endpoint, was 8.3 vs 5.4 months, HR 0.47 (95% CI 0.36–0.60), one-sided P < 0.0001. ORR by BICR was 60.0% vs 34.3%. OS was immature: HR 0.70 (95% CI 0.43–1.14), with 19.4% of the chemotherapy arm crossing over. Figures: At a Glance.
Is ruzaltatug rezetecan approved?
No. Ruzaltatug rezetecan is investigational and is not approved by the FDA, the EMA or China’s NMPA in any indication. Hengrui reported in July 2026 that China’s NMPA accepted its marketing application for EGFR-mutant non-squamous NSCLC that progressed after EGFR-TKI therapy, based on HERON-Lung01.
How does its safety compare with chemotherapy?
Grade ≥3 treatment-related adverse events occurred in 40.7% vs 38.9% and serious TRAEs in 15.3% vs 15.1%; TRAEs led to discontinuation in 1.2% vs 1.3%. The most common grade ≥3 event was decreased neutrophil count (25.8% vs 19.2%). Interstitial lung disease occurred in 6 patients (2.4%), one of them grade 3. One death of unknown cause occurred with ruzaltatug rezetecan.
How does HERON-Lung01 relate to PANKU-Lung01?
Both were presented in the same ESMO 2026 session and published in The Lancet the same day, and both compared an ADC with platinum-pemetrexed in EGFR-mutant NSCLC after an EGFR TKI in China. PANKU-Lung01 tested iza-bren, a bispecific EGFRxHER3 ADC; HERON-Lung01 tested a HER3-directed ADC. Simon Ekman discussed them together. They are separate trials with different populations and follow-up, so their numbers should not be compared directly. See PANKU-Lung01.