Locally advanced or metastatic solid tumors (particularly EGFR-mutant NSCLC; also urothelial, NPC, HNSCC, SCLC) — Baili-Bio (Chengdu) Pharmaceutical / SystImmune, Inc.
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impressive data in #SCLC26 on IZA-BREN ( EGFRxHER3 ADC) with ICI surplulimab in 1L ES-SCLC:
➡️ ORR 85-92%! across IZABREN doses
➡️ mDOR =7-8 m
➡️ Discontinuation due to TRAEs only 7.3%
Dawn 🌅 of a…
High ORR (88.3%) with a novel ADC + PD-1 combo in frontline ES-SCLC
#ELCC26
Phase II (408O): iza-bren (EGFR x HER3 bispecific ADC) + serplulimab in treatment-naive ES-SCLC
Study population
77…
🆙 #ELCC26 @myESMO 🇩🇰
🔥Proffered Paper session 1
☑️iza-bren (BL-B01D1) + serplulimab in SCLC
🎯ORR 88.3%, mPFS 8.2m, 12m OS rate 80.8%
🎙️Dr. Fei Zhou
🎙️Chair: @peters_solange
📍NCT06437509
@OncoAlert…
🔥 Can chemo-free IO + DLL3 targeting redefine 1L ES-SCLC? #ELCC26
Early-phase data of Iza-bren + Serplulimab shows striking activity in treatment-naïve patients
🧪 Study design
➡️ ES-SCLC | ECOG…
🔁REVIEW #ELCC26 @myESMO 🇩🇰
🔥Proffered Paper session 1
☑️iza-bren (BL-B01D1) + serplulimab in SCLC
🎯ORR 88.3%, mPFS 8.2m, 12m OS rate 80.8%
🎙️Dr. Fei Zhou
📍NCT06437509
@OncoAlert @Larvol #LCSM…
✨ Proffered session 1 at #ELCC26:
iza-bren (BL-B01D1) + serplulimab in ES-SCLC! EGFR x HER3 bispecific ADC + PD-1 (Ph. II, 1L setting)
🎯 Total (2.5mg/kg & 2.75mg/kg arms) ORR: 88.3% (cORR…
Frontline iza-bren in combination with serplulimab was associated with a tolerable and manageable safety profile and elicited responses in ES-SCLC. @myESMO #ELCC26 #ELCC2026 #lcsm…
@myESMO #ELCC26: Top Trials from Day 1
3082-CL-0101 | TOP | BL-B01D1-204-01 | NCT05879978
#ELCC #ELCC2026 #Cancer #Oncology #LungCancer #NSCLC #SCLC #lcsm #setidegrasib #osimertinib #izabren…
Bispecific ADC iza-bren + serplulimab shows striking phase 2 results in treatment-naive ES-SCLC, nearly doubling mPFS vs standard chemo-immunotherapy. A potential first-line paradigm shift? Read…
BL-B01D1 (iza-bren) is the first-in-class EGFRxHER3 bispecific ADC, combining dual-receptor targeting with a novel topoisomerase-I payload (Ed-04). Multi-tumor Phase I/II program from Baili-Bio/SystImmune. Strongest signal in EGFR-mutant NSCLC post-TKI (ORR 66%, mPFS 12.5 mo at IASLC 2025), motivating ongoing Phase III registrational study in China. Also showing activity in urothelial (ORR 43.5%), NPC (45.8%), and EGFR-wt NSCLC (40.5%). Competes with Dato-DXd (TROPION-Lung) and amivantamab + lazertinib (MARIPOSA) in later-line EGFR NSCLC. Hematologic toxicity is principal safety concern; notable absence of ILD given class risk.
Median: 66.0 % ORR (EGFR-mutant NSCLC (prior TKI, chemo-naive) at 2.5 mg/kg D1D8 Q3W). EGFR-mutant NSCLC (IASLC 2025, n=50) rate: 66.0% (ORR) vs. 56.0% (cORR) vs. 12.5% (mPFS months) vs. 13.7% (mDOR months). mOS at 12 months (EGFR-mutant subgroup) rate: 80.3% (12-mo OS rate %) vs. not reached% (mOS). ORR by tumor type (ASCO 2023) rate: 61.8% (NSCLC EGFR-mut) vs. 40.5% (NSCLC EGFR-wt) vs. 45.8% (NPC) vs. 14.3% (SCLC) vs. 7.7% (HNSCC). Urothelial cancer (NCT05785039) rate: 43.5% (ORR) vs. 91.3% (DCR). IASLC WCLC 2025 (most recent data, EGFR-mutant NSCLC subgroup): 50 patients with prior TKI + chemo-naive treated at 2.5 mg/kg D1D8 Q3W. ORR 66.0%, confirmed ORR 56.0%, median PFS 12.5 months, median DOR 13.7 months, mOS not reached (12-mo OS rate 80.3%). ASCO 2023 FIH Phase 1 (N=150, all tumor types): ORR 61.8% (EGFR-mut NSCLC), 40.5% (EGFR-wt NSCLC), 45.8% (NPC), 14.3% (SCLC), 7.7% (HNSCC). Urothelial cancer Phase Ib/II (NCT05785039): ORR 43.5%, DCR 91.3%. MTDs: 3.0 mg/kg D1D8 Q3W and 6.0 mg/kg D1 Q3W. Zhang et al., JCO 41:3001 (2023).
OS data: median not reached in EGFR-mutant NSCLC subgroup (IASLC 2025); 12-month OS rate 80.3%. No mature OS data from ASCO 2023 FIH across broader tumor types. Phase III registrational study ongoing in China as monotherapy for EGFR-mutant NSCLC post-3rd-generation TKI progression. 1.2% of patients discontinued due to TRAEs; no treatment-related deaths reported at IASLC 2025.
Grade ≥3 adverse events: neutropenia 34%, leukopenia 30%, thrombocytopenia 19%, anemia 15%% (hematologic). Key AEs: anemia (all-grade 90.6%; IASLC 2025), leukopenia (all-grade 80.7%), neutropenia (all-grade 78.4%), thrombocytopenia (all-grade 74.3%), nausea (29%), alopecia (30%), vomiting (28%), diarrhea (15%), NO ILD observed. Most common TRAEs are hematologic (anemia, leukopenia, neutropenia, thrombocytopenia all >70% any-grade in IASLC 2025 cohort). Non-hematologic TRAEs mostly low-grade: nausea, alopecia, asthenia. Grade ≥3 diarrhea only 2%; nausea/asthenia/decreased appetite <1% Grade ≥3. No ILD observed — notable given class risk of topoisomerase-I ADCs. Only 1.2% discontinued due to TRAEs. No treatment-related deaths.
🔬 Promising first-in-class EGFRxHER3 bispecific ADC — Phase III ongoing in EGFR-mutant NSCLC post-3rd-gen TKI. BL-B01D1 (iza-bren) is the first-in-class EGFRxHER3 bispecific ADC, combining dual-receptor targeting with a novel topoisomerase-I payload (Ed-04). Multi-tumor Phase I/II program from Baili-Bio/SystImmune. Strongest signal in EGFR-mutant NSCLC post-TKI (ORR 66%, mPFS 12.5 mo at IASLC 2025), motivating ongoing Phase III registrational study in China. Also showing activity in urothelial (ORR 43.5%), NPC (45.8%), and EGFR-wt NSCLC (40.5%). Competes with Dato-DXd (TROPION-Lung) and amivantamab + lazertinib (MARIPOSA) in later-line EGFR NSCLC. Hematologic toxicity is principal safety concern; notable absence of ILD given class risk.