Top KOLs Discussing PANKU-Lung01
PANKU-Lung01 Key Slides
ESMO 2026 slides
| Iza-bren (N=216) | Platinum-pemetrexed (N=206) | Stratified HR (95% CI) | |
|---|---|---|---|
| Median PFS, months (95% CI) | 11.1 (9.2–12.7) | 5.7 (5.5–5.9) | 0.40 (0.31–0.51), P < 0.0001 (one-sided) |
| Events | 128 | 164 | — |
| 6-month PFS rate | 75.1% | 42.9% | — |
| 9-month PFS rate | 58.2% | 24.4% | — |
| 12-month PFS rate | 46.5% | 14.4% | — |
| Iza-bren (N=216) | Platinum-pemetrexed (N=206) | HR (95% CI) | |
|---|---|---|---|
| Median OS, months (95% CI) | Not reached (19.3–NR) | 19.4 (16.4–22.5) | 0.66 (0.47–0.91) (abstract and discussant slide, Ekman); P = 0.0058 (discussant slide only); not on the presenter’s OS slide |
| Deaths | 64 | 82 | — |
| 12-month OS rate (95% CI) | 83.0% (77.3–87.5) | 72.9% (66.1–78.5) | — |
| 18-month OS rate (95% CI) | 68.8% (60.9–75.5) | 55.3% (46.8–63.0) | — |
Same or overlapping slides also posted by @TommyJohn00, @OncologyMarwarD, @AdamJanuszewski.
Same or overlapping slides also posted by @DrRiyazShah.
Same or overlapping slides also posted by @youngkwangchae.
Same or overlapping slides also posted by @ryangentzler.
What physicians are debating
The comparator: platinum-pemetrexed alone
Giannis Mountzios, MD, wrote that “Carbo+pem not SoC anymore” and that chemotherapy plus amivantamab is approved by the FDA and EMA. In MARIPOSA-2, amivantamab plus carboplatin-pemetrexed improved PFS over carboplatin-pemetrexed (6.3 vs 4.2 months, HR 0.48), as the discussant’s algorithm slide also shows. Ryan Gentzler, MD, posted that the global IZABRIGHT-Lung01 study, enrolling in the US, had a recent amendment to allow a chemotherapy plus amivantamab control arm.
Invited discussant slides (Simon Ekman, ESMO 2026) · FDA: amivantamab + carboplatin-pemetrexed approval, Sep 2024Where it fits: SAFFRON, HARMONi and other post-osimertinib options
Mountzios asked how the data compare with oncogene-driven approaches such as savolitinib plus osimertinib in MET-driven disease (SAFFRON). Yakup Ergün, MD, wrote that the optimal treatment sequence “remains unanswered.” Simon Ekman’s discussion listed amivantamab plus chemotherapy, ivonescimab plus chemotherapy (HARMONi; see also HARMONi-A), datopotamab deruxtecan, fourth-generation EGFR inhibitors and the AMAZE-lung combination, and concluded that the field needs to “define the optimal treatment sequences and combinations.” HERON-Lung01 (ruzaltatug rezetecan, LBA72), presented in the same session after a third-generation EGFR TKI, was discussed alongside it by Ekman; Riyaz Shah, MD, posted its PFS HR as 0.47.
Invited discussant slides (Simon Ekman, ESMO 2026)Overall survival is immature
The OS analysis is interim and immature at this cut: median not reached vs 19.4 months, 64 vs 82 deaths; HR 0.66 (0.47–0.91), P = 0.0058 on the discussant’s slide, with no source stating whether a significance boundary was crossed. Yakup Ergün, MD, described it as a trend (“OS remains immature, although the trend is encouraging”). The chemotherapy arm received more subsequent therapy, including an ADC in 29.1% vs 2.8% of patients, which bears on how future OS results are read.
LBA71 presentation slides (Li Zhang, ESMO 2026) · ESMO 2026 abstract LBA71 (programme; click Abstract under LBA71)Toxicity and dose modifications
Osman Kostek, MD, called toxicity “a challenge” (grade ≥3 TRAEs 78.7% vs 62.1%), and Antonio Calles, MD, described the safety profile as “not such favorable compared to chemotherapy.” Stephen Liu, MD, noted “High reduction/interruption rates but low discontinuation rates,” and Riyaz Shah, MD, “lots of dose adjustments.” Treatment-related ILD occurred in 0.9% (2 patients), and Shah later asked whether HERON-Lung01’s tolerability looks “somewhat more palatable.”
LBA71 presentation slides (Li Zhang, ESMO 2026)A China-only population and access
All 432 patients were enrolled at 73 sites in China. Ekman’s discussion asked about translatability; Young Kwang Chae, MD, summarized it as “Global Translatability outside China is the key.” Tom John, MD, wrote “Access will be key,” and Adam Januszewski, MD, said he is opening the global IZABRIGHT-Lung01 trial at Barts. Brain metastases were uncommon (about 10% per arm) and the CNS subgroup HR was 0.75 (0.37–1.50); Ekman flagged CNS activity as an open question.
Invited discussant slides (Simon Ekman, ESMO 2026) · Hong et al., The Lancet, Oct 26, 2026PANKU-Lung01 conversations on X
This post is about HERON-Lung01 (ruzaltatug rezetecan, LBA72); it is shown because it compares tolerability with iza-bren.
Context: Shaodong Hong, MD, is first author of The Lancet paper; Li Zhang, MD, PhD, presented LBA71 at ESMO 2026.
Physician reactions to PANKU-Lung01
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
#ESMO26 Bispecific EGFRxHER3 targeting ADC IZA-BREN entering dynamic the #EGFR arena with the PANKU-Lung 01 trial post 3rd gen TKI: ✅ PFS 11,1 vs 5,7 m HR =0.4 ✅OS NR vs 19.4 data immature ✅ ORR 60.2 vs 34.5 ❌ Carbo+pem not SoC anymore , chemo+ami approved by FDA/EMA, SacTMT in FDA ( Optitrop Lung 06) ❓ How do those data compare with oncogene -driven approaches , like EGFR+MET in SAFFRON? #ESMOAmbassadors
Izalontamab brengitecan versus platinum-based chemotherapy in EGFR-mutated advanced non-squamous non-small-cell lung cancer after progression on third-generation EGFR tyrosine kinase inhibitors (PANKU-Lung01): https://t.co/6cEK7HHfeT
#ESMO26 Landmark Phase III PANKU-Lung01 presentation by Dr. Li Zhang (Sun Yat-sen University Cancer Center): 🧬 Drug: Izalontamab Brengitecan (iza-bren, BL-B01D1) — bispecific EGFR×HER3 Topo-I ADC 👥 Population: EGFRm NSCLC progressing on 3rd-gen EGFR TKI (N=432) 📊 Primary & Secondary Endpoints: • mPFS (BICR): 11.1 mo vs 5.7 mo | HR 0.40 (95% CI 0.31-0.51), p<0.0001 • cORR: 60.2% vs 34.5% | mDoR: 10.4 mo vs 5.7 mo • OS: Immature, 18-mo OS rate 68.8% vs 55.3% • Safety: Hematologic AEs manageable with standard care; ILD rate 0.9% Dr. Zhang's presentation highlights iza-bren as a transformative targeted strategy for post-TKI EGFRm NSCLC! #LCAD #NSCLC #OncoX #ESMO26
Iza-Bren continues to impress in 2nd line phase 3 for EGFR-mut lung cancer. Global study enrolling in the US with recent amendment to allow chemo+amivantamab control arm. NCT07100080 #ESMO26 https://t.co/NOiDW7FVyr https://t.co/TlgXLXPIoP
Iza-Bren seems to provide efficacy in pretreated EGFR-mutated NSCLC compared to pt-based chemotherapy. Better ORR and PFS, OS still immature, safety profile not such favorable compared to chemotherapy. Interesting to see global data, optimized AEs management. Good to have more potential options available. #ESMO26 #LCSM
#ESMO26 Dr. Li Zhang presents PANKU-Lung01: phase III izalontamab brengitecan (iza-bren, HER3:EGFR ADC) vs platinum based chemo in EGFR+ NSCLC after 3G TKI. Iza bren improved PFS: 11.1 vs 5.7m, HR 0.40! OS immature but 1y rates 83% vs 73%. High reduction/interruption rates but low discontinuation rates. Most common toxicities were hematologic in nature. Very exciting data here: ADCs here to stay. #ESMOAmbassadors
🚨 #ESMO2026 | PANKU-Lung01 EGFR×HER3 bispecific ADC iza-bren vs chemotherapy in post-EGFR-TKI NSCLC: ✅ ORR: 60.2% vs 34.5% ✅ DoR: 10.4 vs 5.7 months ⚠️ Grade ≥3 TRAEs: 78.7% vs 62.1% Promising efficacy, but toxicity remains a challenge. #LungCancer @OncoAlert @myESMO https://t.co/GbdBdJnA4D
Li Zhang: Ph3 PANKU trial. Again TKI not continued. Note doubling of PFS and improved OS. AEs similar in both arms. Another ADC meets it's primary endpoint in EGFRm NSCLC. Access will be key #LCSM #ESMO26 https://t.co/35TEExIKN2
Context: on the LBA71 slides, treatment-related adverse events of any grade occurred in 100% vs 99.0%, grade ≥3 in 78.7% vs 62.1%, and serious ones in 42.6% vs 19.4%; OS was immature at this interim analysis.
🚨 #ESMO26 Iza-bren 🇨🇳 Ph3 in EGFRm NSCLC post-TKI: 📈 PFS 11.1 vs 5.7m (HR 0.40) 📈 OS HR 0.66 (immature) ✅ ILD 0.9% A top contender among 2L ADCs? 🇬🇧 Excited to open global Ph3 IZABRIGHT-Lung01 at Barts in the next 2 weeks! https://t.co/8l05gWEsDh
#ESMO26 | PANKU-Lung01 In this phase III trial, iza-bren, an EGFR×HER3 bispecific ADC, nearly doubled PFS compared with platinum-based chemotherapy after EGFR-TKI progression (11.1 vs 5.7 months; HR 0.40). OS remains immature, although the trend is encouraging. Treatment options after EGFR-TKI progression are expanding rapidly, making treatment decisions increasingly complex. The key question is no longer just whether a new drug works, but where it fits in an increasingly crowded treatment landscape. Impressive efficacy, but the optimal treatment sequence remains unanswered.
6/ PANKU-Lung01 (LBA71), Oct 26, 09:14 CET Iza-bren (EGFR×HER3 bispecific ADC) vs platinum–pemetrexed after 3rd-gen EGFR TKI. Interim PFS met per Sichuan Biokin. First effect sizes: how big, and at what toxicity? @LungCancerRx @OncoAlert @oncodaily https://t.co/8x3oom1gGh
Part of a pre-congress thread of top thoracic picks, posted October 23.
🆙 #ESMO26 Proffered Paper II: #LCSM Mets 🔥PANKU-Lung01: Randomized Phase III Study of Izalontamab Brengitecan (Iza-Bren) in EGFR-Mutant Non-Squamous NSCLC After Progression on a Third Generation EGFR TKI 🎙️Dr. Li Zhang 🔢LBA71 🎯Met Primary PFS Endpoint at Interim Analysis ☑️NCT06382116 🔗 https://t.co/M4ccE0iSMW @OncoAlert @Larvol @myESMO @IASLC @EGFRResisters
Another positive press release…. Now on Iza-bren. What a week..and it is only Wed Seems like no European-style Summer vacations for clinical trials.. https://t.co/4WZHyDBQSt https://t.co/lTpNzGMsJe
Posted on August 19, after the topline announcement and before any numbers were released.
🔥PANKU-Lung01 (BL-B01D1-301): "Interim analysis met primary endpoint of PFS, with a favorable trend also observed in OS" 🆙 Sichuan Biokin Pharmaceutical 👥Patients: EGFR-sensitizing mutation-positive, locally advanced or metastatic non-squamous NSCLC, progressed on prior EGFR-TKI therapy 3⃣Phase III ⚖️Iza-bren (BL-B01D1, EGFR×HER3 bispecific ADC) ⚖️Platinum-based chemotherapy 🔢NCT06382116 #LCSM @OncoAlert @Larvol 🔗 https://t.co/sCW7O24lRU
Posted on August 19, after the topline announcement and before any numbers were released.
Phase III Panku-Lung01 study of iza-bren (EGFR-HER3 bispecific ADC) vs platinum doublet chemotherapy positive in EGFR mutant NSCLC post TKI. Iza-bren showed superior PFS with OS trend, per press release. Global Izabright-Lung01 trial ongoing. https://t.co/qrEZHvQjlc
Posted on August 19, after the topline announcement and before any numbers were released.
PANKU-Lung01 Trial Design
PANKU-Lung01 asked whether iza-bren, a bispecific antibody-drug conjugate that binds EGFR and HER3 and carries a topoisomerase I inhibitor payload (Ed-04, drug-to-antibody ratio 8), improves progression-free survival over platinum-pemetrexed once EGFR-mutant non-squamous NSCLC progresses on a third-generation EGFR TKI. It is the first phase 3 trial of a bispecific ADC in this setting, according to the sponsors. The trial is sponsored by Sichuan Baili Pharmaceutical (CT.gov sponsor; the press release names parent company Sichuan Biokin) with Baili-Bio (Chengdu) and was funded by Baili-Bio (Chengdu).
Study Design
Randomized 1:1, open-label, multicenter phase 3 at 73 sites in China (NCT06382116, BL-B01D1-301). 432 randomized (217 vs 215); 422 treated (216 vs 206) formed the modified ITT population. Stratified by ECOG PS, CNS metastases and prior anti-angiogenic therapy.
Population
Locally advanced or metastatic non-squamous NSCLC with EGFR exon 19 deletion or L858R, progression on a third-generation EGFR TKI (up to 2 prior lines of EGFR TKI), no previous chemotherapy for advanced disease; treated or stable CNS metastases allowed; ECOG PS 0–1. Median age 59.5 vs 61.0; CNS metastases 9.7% vs 10.2%.
Interventions
Iza-bren 2.5 mg/kg IV on days 1 and 8 every 3 weeks, vs pemetrexed 500 mg/m² plus cisplatin 75 mg/m² or carboplatin AUC 5 every 3 weeks for 4–6 cycles, with pemetrexed maintenance permitted.
Endpoints
Primary: PFS by blinded independent central review (RECIST v1.1). Key secondary: OS. Other secondary: investigator-assessed PFS, ORR, DCR and DoR (BICR and investigator), safety, PK and immunogenicity.
Presenter & Discussant
Presenter: Li Zhang, MD, PhD (Sun Yat-sen University Cancer Center, Guangzhou), principal investigator. Invited discussant: Simon Ekman, MD, PhD (Karolinska University Hospital, Stockholm). Lancet first author: Shaodong Hong, MD.
Data Cut
Data cutoff July 15, 2026. The prespecified interim analysis served as the final analysis for PFS and the interim analysis for OS. Median follow-up for PFS 14.6 vs 15.2 months; for OS 16.6 months overall.
PANKU-Lung01 in the News
PANKU-Lung01 Questions
What is the PANKU-Lung01 trial?
PANKU-Lung01 (BL-B01D1-301, NCT06382116) is a randomized, open-label phase 3 trial run at 73 sites in China, sponsored by Sichuan Baili Pharmaceutical (CT.gov sponsor; the press release names parent company Sichuan Biokin). It compared izalontamab brengitecan (iza-bren, BL-B01D1), a bispecific EGFRxHER3 antibody-drug conjugate, with pemetrexed plus cisplatin or carboplatin in 432 patients with EGFR-mutant non-squamous NSCLC whose disease progressed on a third-generation EGFR TKI. Design: Trial Design.
What did PANKU-Lung01 show at ESMO 2026?
At the prespecified final PFS analysis (data cutoff July 15, 2026), median PFS by blinded independent central review was 11.1 vs 5.7 months, HR 0.40 (95% CI 0.31–0.51), one-sided P < 0.0001. Confirmed ORR was 60.2% vs 34.5%. OS was immature at this interim analysis: median not reached vs 19.4 months, with HR 0.66 (95% CI 0.47–0.91) in the abstract and on the invited discussant’s slide (Simon Ekman), which also prints P = 0.0058. Figures: At a Glance.
Is iza-bren approved for lung cancer?
No. Iza-bren is not approved for lung cancer in any country, and it is not approved for any use in the US or Europe. Its first approval, by China’s NMPA in June 2026, is for previously treated recurrent or metastatic nasopharyngeal carcinoma. In the US it holds FDA Breakthrough Therapy Designation (August 2025) for EGFR-mutant NSCLC that progressed after an EGFR TKI and platinum chemotherapy, a later line than PANKU-Lung01.
How toxic was iza-bren compared with chemotherapy?
Grade ≥3 treatment-related adverse events occurred in 78.7% vs 62.1% of patients and treatment-related serious adverse events in 42.6% vs 19.4%, mostly hematologic. Dose reductions (60.2% vs 23.3%) and interruptions (53.7% vs 23.8%) were more common with iza-bren, while discontinuation for treatment-related adverse events was 1.9% in each arm. Treatment-related ILD occurred in 2 patients (0.9%). Details: At a Glance.
Why did physicians question the comparator?
The control arm was platinum-pemetrexed alone. Giannis Mountzios, MD, noted on X that carboplatin-pemetrexed is no longer the standard of care, as chemotherapy plus amivantamab is approved by the FDA and EMA. (In the US, amivantamab plus carboplatin-pemetrexed is approved after an EGFR TKI, based on MARIPOSA-2.) Ryan Gentzler, MD, posted that the global IZABRIGHT-Lung01 trial was recently amended to allow a chemotherapy plus amivantamab control arm. See Discussion Threads and Physician Reactions.
Will the results be tested outside China?
Yes. PANKU-Lung01 enrolled patients in China only. Bristol Myers Squibb is running the global phase 2/3 IZABRIGHT-Lung01 trial (NCT07100080) of iza-bren vs platinum-based chemotherapy after EGFR TKI, and IZABRIGHT-Lung02 (NCT07680790) in the first-line setting, per the presenter’s conclusions slide.