NEW KCRS26 — Kidney Cancer Research Summit: top KOL voices, trial buzz & every slide, decoded View Full Coverage →
KOL Pulse — Trial Profile

BL-B01D1 (iza-bren) Development Program Trial

Locally advanced or metastatic solid tumors (particularly EGFR-mutant NSCLC; also urothelial, NPC, HNSCC, SCLC) — Baili-Bio (Chengdu) Pharmaceutical / SystImmune, Inc.

Locally advanced or metastatic solid tumors (particularly EGFR-mutant NSCLC; also urothelial, NPC, HNSCC, SCLC)iza-bren (investigational)ASCO 2023 / IASLC WCLC 2025 / ASCO Educational Book 2025
Discover KOL Sentiment on BL-B01D1 →

BL-B01D1 (iza-bren) Development Program Key Takeaways

Design - First-in-class EGFRxHER3 bispecific ADC (iza-bren), multi-tumor Phase 1/2 development program (lead FIH NCT05983432; Phase 3 e.g. NCT06382116); featured data in EGFR-mutant NSCLC (ASCO 2023 / IASLC WCLC 2025).

Efficacy (EGFR-mutant NSCLC, IASLC 2025, n=50) - At 2.5 mg/kg D1D8 Q3W: ORR 66.0%, confirmed ORR 56.0%, median PFS 12.5 mo, median duration of response 13.7 mo.

OS - Median not reached in the EGFR-mutant NSCLC subgroup; 12-month OS rate 80.3%; broader multi-tumor OS immature.

Safety - Predominantly hematologic - grade >=3 neutropenia 34%, leukopenia 30%, thrombocytopenia 19%, anemia 15%; all-grade anemia ~91%; nausea, alopecia.

Regulatory - Investigational - not FDA approved for any indication; registrational Phase 3 studies ongoing (largely in China).

Sponsor / drug - SystImmune / Baili-Bio (Chengdu); BL-B01D1 (izalontamab brengitecan, iza-bren; also BMS-986507).

Compiled and reviewed by the KOL Pulse research team, led by Brian Shields, Founder, KOL Pulse. Last updated July 21, 2026.

Top KOLs Discussing BL-B01D1 (iza-bren) Development Program

Giannis Mountzios
Giannis Mountzios
@g_mountzios
7.9K impressions
Dr Rishabh Jain
Dr Rishabh Jain
@DrRishabhOnco
6.3K impressions
Hidehito HORINOUCHI
Hidehito HORINOUCHI
@HHorinouchi
4.3K impressions
Mario Balsa
Mario Balsa
@MarioBalsaMD
964 impressions
OncLive.com
OncLive.com
@OncLive
435 impressions
Bhaarath PG
Bhaarath PG
@BhaarathP10039
344 impressions

BL-B01D1 (iza-bren) Development Program Key Slides & Visuals

Official trial slides and relevant visuals shared by KOLs at ASCO 2023 / IASLC WCLC 2025 / ASCO Educational Book 2025. Click any image to expand.

Giannis Mountzios
Giannis Mountzios @g_mountzios
BL-B01D1 (iza-bren) Development Program Data
7.9K impressions · 84 likes · Mar 25, 2026
View on X ↗
[Slide 1] Promising Efficacy Seen in Treatment-naïve Patients Total BOR, n (%) (N = 77) Iza-bren 2.5 mg/kg D1D8Q3W Iza-bren D1D8 Q3W+Serplulimab 4.5 mg/kg Q3W PR (N = 40) Iza-bren 2.75 mg/kg D1D8Q3W (N = 37) Confirmed PR 68 (88.3) 34 (85.0) PR pending confirmation¹¹ 60 (77.9) 34 (91.9) 31 (77.5) SD 1 (1.3) 29 (78.4) 0 PD 5 (6.5) 1 (2.7) 3 (7.5) 4 (5.2) 2 (5.4) ORR, % (95% CI) 3 (7.5) 88.3 (79.0, 94.5) 1 (2.7) cORR, % (95% CI) 85.0 (70.2, 94.3) 77.9 (67.0, 86.6) 91.9 (78.1, 98.3) DCR, % (95% CI) 77.5 (61.5,89.2) 94.8 (87.2, 98.6) 78.4 (61.8, 90.2) mDOR, mo (95% CI) 92.5 (79.6, 98.4) 97.3 (85.8,99.9) 7.3 (5.6, 8.3) mPFS, mo (95% CI) 7.3 (5.3,8.3) 8.0 (5.5,8.6) 8.2 (6.7, 9.6) 8.2 (4.4,9.6) Median FU for PFS, mo (95% CI) 8.3 (6.9,9.7) 10.8 (8.3, 12.3) 9.8 (8.1, 12.4) 10.8 (8.3, 12.5) 12-mo OS rate, % (95% CI) 80.8 (66.1, 89.6) 85.7 (68.7, 93.9) 76.5 (51.4, 89.8) Median FU for OS, mo (95% CI) 10.5 (9.7, 11.3) 10.5 (9.7, 11.6) 10.4 (9.2,11.7) Patients with at least one post baseline scan were included in the analysis. [1] Patients still on study with tumor assessment of PR who have not yet reached to the next time point of tumor assessment Cl: confidence interval; cORR: confirmed objective response rate; PR: partial response; SD: stable disease; PD: progressive disease; FU: follow-up time. Data cutoff: November 30th, 2025 Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. ESMO IASLC INTERNATIONAL g FOR STUDY ESTRO 2 ETOP-IBCSG of Lund CANCER PARTNERS FOUNDATION --- [Slide 2] Study Design Presented Key Eligibility Criteria Stage I Stage II ES-SCLC confirmed by Pts who failed standard treatment Treatment-naive pts histopathology and/or cytology Failed standard treatment (Stage I) or treatment-naive (Stage II) Iza-bren 2.75 mg/kg D1D8Q3W Iza-bren 2.5 mg/kg D1D8Q3W ECOG performance status of 0-1 + Serplulimab* 4.5 mg/kg Q3W + Serplulimab 4.5 mg/kg Q3W At least one measurable lesion per RECIST v1.1 Iza-bren 2.75 mg/kg D1D8Q3W Adequate organ and marrow function + Serplulimab 4.5 mg/kg Q3W Primary: ORR, RP2D (for combination treatment) Secondary: PFS, DCR, DOR, OS, PK, immunogenicity, DDI, safety Safety and efficacy results for stage II are presented. ECOG: Eastern Cooperative Oncology Group; ORR: objective response rate; RP2D: recommended phase 2 dose; PFS: progression-free survival; DCR: disease control rate; DOR: duration of response; OS: overall survival; PK: pharmacokinetics; DDI: drug-drug interaction : PD-1 inhibitor, which has been approved in China as first-line treatment for ES-SCLC in combined with carboplatin/etoposide. Fei Zhou, MD, PhD Organisers Content of this presentation is copyright and responsibility of the author. Permission is required for re-use Partners ESMD IASLC INTERNATIONAL FOR STUDY OF LONG CANCER ESTRO L ETOP-IBCSG PARTNERS FOUNDATION --- [Slide 3] Conclusions Iza-bren ES-SCLC. combined with serplulimab as a first-line treatment showed a tolerable and manageable safety profile in patients with Hematologic support. toxicities were the most common AEs, but were effectively managed by supportive care and growth factor Rate of iza-bren treatment discontinuation due to TRAEs was low overall (7.3%), with rates of 2.4% in the iza-bren 2.5 mg/kg D1D8Q3W cohort and 12.2% in the 2.75 mg/kg D1D8Q3W cohort. Encouraging antitumor activity was observed with iza-bren combined with serplulimab in 1L ES-SCLC: In the cohort of iza-bren 2.5 mg/kg D1D8Q3W, ORR: 85.0%, cORR: 77.5%; mDOR: 7.3 mo; mPFS: 8.2 mo. In the cohort of iza-bren 2.75 mg/kg D1D8Q3W, ORR: 91.9%, cORR: 78.4%; mDOR: 8.0 mo; mPFS: 8.3 mo. Iza-bren at 2.5 mg/kg D1D8 Q3W was selected as RP3D for combination with a PD-1 inhibitor and phase III study in China is in preparation for ES-SCLC. Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. INTERNATIONAL ESMO IASLC ASSOCIATION FOR THE STUDY ESTRO OF LUNG CANCER --- [Slide 4] Study Design Presented Key Eligibility Criteria Stage I Stage II ES-SCLC confirmed by Pts who failed standard treatment Treatment-naive pts histopathology and/or cytology Failed standard treatment (Stage I) or treatment-naive (Stage II) Iza-bren 2.75 mg/kg D1D8Q3W Iza-bren 2.5 mg/kg D1D8Q3W ECOG performance status of 0-1 + Serplulimab* 4.5 mg/kg Q3W + Serplulimab 4.5 mg/kg Q3W At least one measurable lesion per RECIST v1.1 Iza-bren 2.75 mg/kg D1D8Q3W Adequate organ and marrow function + Serplulimab 4.5 mg/kg Q3W Primary: ORR, RP2D (for combination treatment) Secondary: PFS, DCR, DOR, OS, PK, immunogenicity, DDI, safety Safety and efficacy results for stage II are presented. ECOG: Eastern Cooperative Oncology Group; ORR: objective response rate; RP2D: recommended phase 2 dose; PFS: progression-free survival; DCR: disease control rate; DOR: duration of response; OS: overall survival; PK: pharmacokinetics; DDI: drug-drug interaction : PD-1 inhibitor, which has been approved in China as first-line treatment for ES-SCLC in combined with carboplatin/etoposide. Fei Zhou, MD, PhD Organisers Content of this presentation is copyright and responsibility of the author. Permission is required for re-use Partners ESMD IASLC INTERNATIONAL ASSOCIATION FOR STUDY OF LONG CANCER ESTRO L ETOP-IBCSG PARTNERS FOUNDATION --- [Slide 5] Promising Efficacy Seen in Treatment-naïve Patients Total BOR, n (%) (N=77) Iza-bren 2.5 mg/kg D1D8Q3W Iza-bren D1D8 Q3W+Serplulimab 4.5 mg/kg Q3W PR (N = 40) Iza-bren 2.75 mg/kg D1D8Q3W (N = 37) Confirmed PR 68 (88.3) 34 (85.0) PR pending confirmation¹¹ 60 (77.9) 34 (91.9) 31 (77.5) SD 1 (1.3) 29 (78.4) 0 PD 5 (6.5) 1 (2.7) 3 (7.5) 4 (5.2) 2 (5.4) ORR, % (95% CI) 3 (7.5) 88.3 (79.0, 94.5) 1 (2.7) cORR, % (95% CI) 85.0 (70.2, 94.3) 77.9 (67.0, 86.6) 91.9 (78.1, 98.3) DCR, % (95% CI) 77.5 (61.5, 89.2) 94.8 (87.2, 98.6) 78.4 (61.8, 90.2) mDOR, mo (95% CI) 92.5 (79.6, 98.4) 97.3 (85.8, 99.9) 7.3 (5.6, 8.3) mPFS, mo (95% CI) 7.3 (5.3,8.3) 8.0 (5.5,8.6) 8.2 (6.7, 9.6) 8.2 (4.4,9.6) Median FU for PFS, mo (95% CI) 8.3 (6.9,9.7) 10.8 (8.3, 12.3) 9.8 (8.1, 12.4) 10.8 (8.3, 12.5) 12-mo OS rate, % (95% CI) 80.8 (66.1, 89.6) 85.7 (68.7, 93.9) 76.5 (51.4, 89.8) Median FU for OS, mo (95% CI) 10.5 (9.7, 11.3) 10.5 (9.7, 11.6) 10.4 (9.2,11.7) Patients with at least one post baseline scan were included in the analysis. [1] Patients still on study with tumor assessment of PR who have not yet reached to the next time point of tumor assessment Cl: confidence interval; cORR: confirmed objective response rate; PR: partial response; SD: stable disease; PD: progressive disease; FU: follow-up time. Data cutoff: November 30th, 2025 Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. ESMO IASLC INTERNATIONAL 9 FOR STUDY ESTRO 2 ETOP-IBCSG of Lund CANCER PARTNERS FOUNDATION --- [Slide 6] Depth & Duration of Response Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab 4.5 mg/kg Q3W #0 Iza-bren 2.75 mg/kg D1D8Q3W+Serplulimab 4.5 mg/kg Q3W so ORR = 85.0% I Confirmed Partial Response Partal Response as Stable Decease Deease 40 40 ORR = 91.9% . Contened Response Partal Response I Disease Onego Basellne I (%) 20 43 Criwn 0 I 2 Chenge I I # Griends 1 8 - 40 40 40 40 40 80 100 100 60 mDOR = 7.3 mo Partial Response 40 Stable Disease . Person Response 40 Progressive Disease mDOR = 8.0 mo Disease 43 Deesse 20 20% Growth 29 0 Change from Baseline, Chenge I # I 9 20 30% Numer 3 40 40 40 60 # 80 -100 100 0 3 Q 13 1 12 Month Month Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -64.4 (-92.4, -3.1). Iza-bren 2.75 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -63.6 (-100.0, - -19.6). Data cutoff: November 30th, 2025 Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. INTERNATIONAL MD IASLC FOR THE STUDY ESTRO L ETOP OF LUNG CANCER PARTNER --- [Slide 7] Conclusions Iza-bren ES-SCLC. combined with serplulimab as a first-line treatment showed a tolerable and manageable safety profile in patients with Hematologic support. toxicities were the most common AEs, but were effectively managed by supportive care and growth factor Rate mg/kg of iza-bren treatment discontinuation due to TRAEs was low overall (7.3%), with rates of 2.4% in the iza-bren 2.5 D1D8Q3W cohort and 12.2% in the 2.75 mg/kg D1D8Q3W cohort. Encouraging antitumor activity was observed with iza-bren combined with serplulimab in 1L ES-SCLC: In the cohort of iza-bren 2.5 mg/kg D1D8Q3W, ORR: 85.0%, cORR: 77.5%; mDOR: 7.3 mo; mPFS: 8.2 mo. In the cohort of iza-bren 2.75 mg/kg D1D8Q3W, ORR: 91.9%, cORR: 78.4%; mDOR: 8.0 mo; mPFS: 8.3 mo. Iza-bren at 2.5 mg/kg D1D8 Q3W was selected as RP3D for combination with a PD-1 inhibitor and phase III study in China is in preparation for ES-SCLC. Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use. INTERNATIONAL ESMO IASLC ASSOCIATION FOR THE STUDY ESTRO 2 OF LUNG CANCER
Dr Rishabh Jain
Dr Rishabh Jain @DrRishabhOnco
BL-B01D1 (iza-bren) Development Program Data
4.3K impressions · 20 likes · Mar 25, 2026
View on X ↗
[Slide 1] single-arm phase II Frontline ES-SCLC ADC + PD-1 in ES-SCLC Topoisomerase-1 ADC + PD-1 strategy ORR: 77 evaluable pts 88.3% mPFS: 8.2 mo L Follow-up: 10.5 mo 2.5 mg/kg 2.75 mg/kg DOSE SIGNAL 2.5 mg/kg 85% KEY OUTCOMES 2.75 mg/kg 91.9% cORR: 77.9% DCR: 94.8% SAFETY Early 12-mo OS 80.8% ! Hematologic toxicity high L mDOR: 7.3 mo Anemia 93.9% Thrombocytopenia 72% @DrRishabhOnco Neutropenia 62% ! Discontinuation: 7.3% ! 2 treatment-related deaths High ORR (88.3%) in single-arm Phase II ADC + PD-1 Encouraging early OS signal and manageable safety no control arm 2.5 mg/kg selected
Hidehito HORINOUCHI
Hidehito HORINOUCHI @HHorinouchi
BL-B01D1 (iza-bren) Development Program Data
3.1K impressions · 15 likes · Mar 25, 2026
View on X ↗
[Slide 1] Study Design Key Eligibility Criteria Presented Stage 1 Stage И ES-SCLC confirmed by Pts who failed standard treatment elcc histopathology and/or cytology Treatment have pts European Lung Cancer Congress 2026 Failed standard treatment (Stage 1) or treatment-naive (Stage 11) Iza-bren 2.75 mg/kg D1D8Q3W 12a bren 25 mg/kg D1D8Q3W ECOG performance status of 0-1 Serplulimab* 4.5 mg/kg Q3W Serplulimab 45 mg/kg Q3W At least one measurable lesion per RECIST v1.1 iza bren 2.75 mg/kg D1D8Q3W Adequate organ and marrow function Serplulimab 4.5 mg/kg Q3W Primary: ORR, RP2D (for combination treatment) Secondary: PFS, DCR, DOR, OS, PK, immunogenicity, DDI, safety Safety and efficacy results for stage 11 are presented. ECOG: Eastern Cooperative Oncology Group; ORR: objective response caler, RP2D: recommended phase 2 dose, PFS: progression tree survively DCR: disease conted 100, DOR: d response, % and survival; PK: pharmacokinelics; DDI: drug-drug interaction PD-1 inhibitor, which has been approved in China as first line treatment for ES-SCLC n combined with carboplain/reloposide. Fel Zhou, MD, PhD Organises have Content of this presentation is copyright and responsibility of the author Permission is required for 00-USA ASLC ESTRO ETOP-IBCSG elcc European Lung Cancer Congress 2026 --- [Slide 2] Depth & Duration of Response za bren 2.5 mg/kg D1D8Q3W Serplulimab 4.5 mg/kg Q3W lza bren 2 75 mg/kg D1D8Q3W Serplulimab 4.5 Q3W ORR 85.0% ORR 91.9% elcc European Lung Cancer Congress 2026 mDOR 7.3 mo mDOR 8.0mo Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -64.4 (-92.4,-3.1). Iza-bren 2.75 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -63.6(-100.0, -19.6). Data cutoff: November 10th, 2025 Fei Zhou, MD, PhD Organisers haves Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASUC ESTRO ETOP-MCSS elcc European Lung Cancer Congress 2026 --- [Slide 3] PFS 100% Total lica-bren 2.5 mgkg / AS many cow Us-bren Consored 2.75 mg/kg 45 mykg can elcc European Lung Cancer Congress 2026 Progression-free 50% survival 75% probability 25% mPFS (95% CI) Total: 8.2 (6.7, 9.6) Iza-bren 2.5 mg/kg D1D8Q3W + Serplulimab: 8.2 (4.4,9.6) Iza-bren 2.75 mg/kg D1D8Q3W + Serplulimab: 8.3 (6.9,9.7) 0% 0 $ 12 Months Subjects at risk 77 61 42 20 40 32 21 11 of 37 29 21 3 OS was immalure at the time of DCO. Data cutsff: November VP. 2025 Fel Zhou, MD, PhD Organisers Patients Content of this presentation is copyright and responsibility of the author Permission is required for re-use ASLC - ESTRO TOP BCSO elcc European Lung Cancer Congress 2026 --- [Slide 4] TRAEs with Frequency ≥ 30% Anaemia Thrombocytopenia Gradez3 TRAEs which were predominantly hematologic in nature, Leukopenia were able to be effectively managed with standard supportive measures including dose reductions and growth factor support. Neutropenia 9.8% of patients had dose reduction and 1.2% of patients had dose Decreased appetite discontinuation due to neutropenia. The median time to resolution of elcc European Lung ALT increased Cancer Congress 2026 Grade 3 or 4 neutropenia was 3 days. Most only had 1 episode. Preferred Term Asthenia Neutropenic fever rate was 2.4%. Nausea 6.1% of patients had dose reduction and 0 patient had dose AST increased discontinuation due to anaemia. The median time to resolution of Hypoalbuminaemia Grade 3 anaemia was 7 days. Most had 2 episodes. Stomatitis All grade and grade>3 infection related AEs rate were 20.7% and 8.9%. Hyponatraemia Two deaths related to iza-bren (one due to multiple organ dysfunction Rash syndrome, and one due to pneumonia and respiratory failure) were Lymphocyte count decreased reported. 100 60 60 40 20 0 20 40 60 80 100 Incidence (%) Two cases (2.4%) of ILD were reported (one Grade 2, iza-bren 25 Iza-bren 2.5mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade 1-2 mg/kg D1D8Q3W cohort; one Grade 3, 2.75 mg/kg D1D8Q3W cohort). Iza-bren 2.75mg/kg D1D8Q3W Serplulimab 5mg/kg Q3W Grade 1-2 No new safety signals were identified. Iza-bren 2.5mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade as TRAE: treatment related adverse event; Iza-bren 2.75mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade 23 Data cutoff: November 30°, 2025 Patients Fei Zhou, MD, PhD Organisers IASLC I ESTRO ETOP-IBCSG Content of this presentation is copyright and responsibility of the author. Permission is required for re-use ESMO lcc European Lung Cancer Congress 2026
Hidehito HORINOUCHI
Hidehito HORINOUCHI @HHorinouchi
BL-B01D1 (iza-bren) Development Program Data
1.1K impressions · 8 likes · Mar 26, 2026
View on X ↗
[Slide 1] Study Design Presented Key Eligibility Criteria Stage I Stage II ES-SCLC confirmed by Pts who failed standard treatment Treatment-naive pts histopathology and/or cytology Failed standard treatment (Stage I) Iza-bren 2.5 mg/kg D1D8Q3W or treatment-naïve (Stage II) Iza-bren 2.75 mg/kg D1D8Q3W + Serplulimab 4.5 mg/kg Q3W ECOG performance status of 0-1 + Serplulimab 4.5 mg/kg Q3W At least one measurable lesion per Iza-bren 2.75 mg/kg D1D8Q3W RECIST v1.1 + Serplulimab 4.5 mg/kg Q3W Adequate organ and marrow function Primary: ORR, RP2D (for combination treatment) Secondary: PFS, DCR, DOR, OS, PK, immunogenicity, DDI, safety Safety and efficacy results for stage II are presented ECOG: Eastem Cooperative Oncology Group ORR: objective response rate; RP2D: recommended phase 2 dose; PFS: progression free survival; DCR: disease control rate; DOR: duration of response; OS: overall survival PK: pharmacokinetics, DDI: drug-drug interaction : PD-1 inhibitor, which has been approved in China as first-line treatment for ES-SCLC in combined with carboplatin/etoposide. Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use ADERNATIONAL ESMO IASLC ESTRO ETOP-IBCSG or LUNG CANCER PARTNERS FOUNDATION --- [Slide 2] TRAEs with Frequency ≥ 30% Anaemia Grade>3 TRAEs which were predominantly hematologic in nature, Thrombocytopenia were able to be effectively managed with standard supportive Leukopenia measures including dose reductions and growth factor support. Neutropenia 9.8% of patients had dose reduction and 1.2% of patients had dose Decreased appetite discontinuation due to neutropenia. The median time to resolution of ALT increased Grade 3 or 4 neutropenia was 3 days. Most only had 1 episode. Preferred Term Asthenia Neutropenic fever rate was 2.4%. Nausea 6.1% of patients had dose reduction and 0 patient had dose discontinuation due to anaemia. The median time to resolution of AST increased Grade 3 anaemia was 7 days. Most had 2 episodes. Hypoalbuminaemia All grade and grade>3 infection related AEs rate were 20.7% and Stomatitis 8.9%. Hyponatraemia Two deaths related to iza-bren (one due to multiple organ dysfunction Rash syndrome, and one due to pneumonia and respiratory failure) were Lymphocyte count decreased reported. 100 80 60 40 20 0 20 40 60 80 100 Incidence (%) Two cases (2.4%) of ILD were reported (one Grade 2, iza-bren 2.5 Iza-bren 2.5mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade 1-2 mg/kg D1D8Q3W cohort; one Grade 3, 2.75 mg/kg D1D8Q3W cohort). Iza-bren 2.75mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade 1-2 No new safety signals were identified. Iza-bren 2.5mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade 23 TRAE: treatment related adverse event; Iza-bren 2.75mg/kg D1D8Q3W Serplulimab 4.5mg/kg Q3W Grade a3 Data cutoff: November 30th, 2025 Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASLC ESTRO L ETOP-IBCSG or CANCER PARTNERS --- [Slide 3] PFS 100% Total Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab 4.5 mg/kg Q3W Iza-bren 2.75 mg/kg D1D8Q3W+Serplulmab 4.5 mg/kg Q3W + Censored 75% Progression-free survival probability 50% 25% mPFS (95% CI) Total: 8.2 (6.7, 9.6) Iza-bren 2.5 mg/kg D1D8Q3W + Serplulimab: 8.2 (4.4, 9.6) Iza-bren 2.75 mg/kg D1D8Q3W + Serplulimab: 8.3 (6.9, 9.7) 0% 0 3 6 9 12 15 Months Subjects at risk 77 61 42 20 8 0 40 32 21 11 5 0 37 29 21 9 3 0 OS was immature at the time of DCO Data cutoff: November 30th, 2025 Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author Permission is required for re-use ESMO IASLC INTERNATIONAL STUDY ESTRO LUNG CANCER L ETOP-IBCSG PARTNERS FOUNDATION --- [Slide 4] Depth & Duration of Response Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab 4.5 mg/kg Q3W Iza-bren 2.75 mg/kg D1D8Q3W+Serplulimab 4.5 mg/kg Q3W ORR = 85.0% ORR = 91.9% - mDOR = 7.3 mo Disease mDOR = 8.0 mo Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -64.4 (-92.4, -3.1). Iza-bren 2.75 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -63.6 (-100.0, -19.6). Data cutoff: November 30th, 2025 Fei Zhou, MD, PhD Organisers Partners Content of this presentation is copyright and responsibility of the author. Permission is required for re-use ESMO IASLC ESTRO L ETOP-IBCSG PARTNERS FOUNDATION
Mario Balsa
Mario Balsa @MarioBalsaMD
BL-B01D1 (iza-bren) Development Program Data
964 impressions · 13 likes · Mar 25, 2026
View on X ↗
[Slide 1] TRAEs with Frequency ≥ 30% Grade23 TRAEs which were predominantly hematologic in nature, Anna were able to be effectively managed with standard supportive measures including dose reductions and growth factor support. Leukopensa 9.8% of patients had dose reduction and 1.2% of patients had dose Neutriperia discontinuation due to neutropenia. The median time to resolution of Decreased appellite Grade 3 or 4 neutropenia was 3 days. Most only had 1 episode. ALT increased Term Neutropenic fever rate was 2.4%. Assenia 6.1% of patients had dose reduction and 0 patient had dose Names discontinuation due to anaemia. The median time to resolution of AST increased Grade 3 anaemia was 7 days. Most had 2 episodes All grade and grade23 infection related AEs rate were 20 7% and I 8.9% Two deaths related to iza-bren (one due to multiple organ dysfunction Resh syndrome, and one due to pneumonia and respiratory failure) were Lymphoryte - decreased reported 100 so 00 40 20 0 20 40 00 80 100 Incidence (%) Two cases (2.4%) of ILD were reported (one Grade 2, iza-bren 2.5 Lie-bren 1. fing kg 010033W Suptutions limplig ase Gode 1-2 mg/kg D1D8Q3W cohort; one Grade 3, 2.75 mg/kg D1D8Q3W cohort). - tree 1 Hinging DIDBCTOR Singhg I I Date 1-2 No new safety signals were identified. - 1 Singleg 010439W - I Grade is - 2. Timghg DID#GOW 4. I I Gase as TRAE: treatment related adverse meet, Data cuteff November 300, 2025 Fal Thou, NO, PhO Signature Person Content of the presentation a appyinght and responsibility of the author Permission a required for . - ESMD IASLC I ESTRO L STOP-IBCS --- [Slide 2] Promising Efficacy Seen in Treatment-naïve Patients ZA bren D1D8 Q3W+Serplulimab 4.5 mg/kg Q3W Total za bren 2.5 mg/kg D1D8Q3W za- bren 2.75 mg/kg D1D8Q3W (N=77) (N 40) (N 37) BOR, n (%) PR 68 (88.3) 34 (85.0) 34(91.9) Confirmed PR 60 (77.9) 31 (77.5) 29(78.4) PR pending confirmation¹ 1(1.3) 0 1(27) SD 5 (6.5) 3 (7.5) 2(5.4) PD 4 (5.2) 3 (7.5) 1 (2.7) ORR, % (95% CI) 88.3(79.0,94.5) 85 (70.2, 94.3) 91.9(78.1,96.3) cORR, % (95% CI) 77.9(67.0,86.6) 77.5(61.5,89.2) 78.4(61.8,90.2) DCR, % (95% CI) 94.8 (87.2,98.6) 92.5 (796,98.4) 973(658,999) mDOR, mo (95% CI) 7.3 (5.6,8.3) 7,3(5,8,8.3) 8.0(5.5,8.6) mPFS, mo (95% CI) 8.2 (6.7,9.6) 8.2 (4.4,9.6) 8.3(6.9,9,9.7) Median FU for PFS, mo (95% CI) 10.8 (8.3, 12.3) 9.8(8.1,12.4) 10.8(8.3, 12.5) 12-mo os rate, % (95% CI) 80. 8(66.1,89.6) 657(68.7,93.9) 76.5(51.4,89.8) Median FU for os, mo (95% CI) 10.5 (97,11.3) 10.5(9.7,11.6) 10.4(0.2,11.7) Patients with at less one post baseline scan were included in the analysis [1] Patients is on study with tumor assessment of PR who have not yet reached to the new time paint of fundr assessment CL: confidence interval, CORR numbermed abjective response rate; PR parial response; 10: stable decesse, PD: progressue finease FU. follow-up time Data cutaff November 100, 2025 Fel Day, MD, PMD Departments Patient's Contant of his presentation a copyment and responsibility of be author Permission a required for - use ESMD IASLC ESTRO X STOP 6 - - MARER 2016 --- [Slide 3] Study Design Presented Key Eligibility Criteria Stage I Stage II ES-SCLC confirmed by Pts who failed standard treatment Treatment have pts histopathology and/or cytology Failed standard treatment (Stage 1) za bren 25 mg/kg D1D8Q3W or treatment-naive (Stage II) Iza-bren 2.75 mg/kg D1D8Q3W Serplulimab 4.5 mg/kg Q3W ECOG performance status of 0-1 + Serplulimab 4.5 mg/kg Q3W At least one measurable lesion per Iza bren 2.75 mg/kg D1D8Q3W RECIST v1.1 Serplulimab 4.5 mg/kg Q3W Adequate organ and marrow function Primary: ORR, RP2D (for combination treatment) Secondary: PFS, DCR, DOR, OS, PK, immunogenicity, DDI, safety Salety and officacy results be stage a any presented ECOO Easien Cooperative Oneslogy Crisp, ORR, objective response - RP20: recommended phose 2 dose, PFS: progression to survivel DCR, danate control rate, DOR: duration of response, 05: overall and PK pharmacoknetics, DDI aug any interaction PD 1 whole which has teen approved in China as line line beatment or ES-SCLO n combined with carboplation/uloposide Fel they, MD, PEO Organizers Tature Centent of to peneration a appyinght and responsability of be subbor Permission . required for use ESMD ARE ESTR9 X EYOP-ISCSO 026 --- [Slide 4] TRAEs with Frequency ≥ 30% Grade23 TRAEs which were predominantly hematologic in nature, Antenia were able to be effectively managed with standard supportive Thromborytopens measures including dose reductions and growth factor support. Leukapenia 9.8% of patients had dose reduction and 1.2% of patients had dose Neutroperia discontinuation due to neutropenia. The median time to resolution of Decreased appealle Grade 3 or 4 neutropenia was 3 days Most only had 1 episode. ALT increased Personal 1 Neutropenic fever rate was 2.4% Alberia 6.1% of patients had dose reduction and 0 patient had dose I discontinuation due to anaemia The median time to resolution of AST increased Grade 3 anaemia was 7 days. Most had 2 episodes, Hypeabuminasma All grade and grade23 infection related AEs rate were 20.7% and I 8.9% Hyperolismis Two deaths related to iza-bren (one due to multiple organ dysfunction Rash syndrome, and one due to pneumonia and respiratory failure) were Lymphoryte - decreased reported. 100 00 00 2 20 9 20 8 8 a 100 incidence (%) Two cases (2.4%) of ILD were reported (one Grade 2, iza-bren 2.5 - 1. finglig 010633W Septutimes 4. Singlig are Grade I mg/kg D1D8Q3W cohort, one Grade 3, 2.75 mg/kg D1D8Q3W cohort). - bren 1 Hinghg DIDBQ3W Segistrial Linghg 00w One 1-2 No new safety signals were identified. - 2.5mg/kg fingling GSW I Grade a - 1. ringhg 0100G3W Septiment 4. Singhing any Gate 13 TRAE: treatment related adverse east, Data cuteff: November 30°, 2025 Fel thou, NO, Pb0 Departments Person Contant of to presentation . appyright and responsibility of the author Permassion is required to 10 use ESMD ARC ESTRO h ETOP-IBCS --- [Slide 5] Promising Efficacy Seen in Treatment-naïve Patients za bren D1DB Q3W+Serplulimab 4.5 mg/kg Q3W Total za bren 25 mg/kg D1D8Q3W za bren 2.75 mg/kg D1D8Q3W (N=77) (N=40) (N=37) BOR, n (%) PR 68 (88.3) 34(85.0) 34(91.9) Confirmed PR 60 (77.9) 31(77.5) 29(78.4) PR pending confirmation¹ 1(1.3) 0 1(27) SD 5(6.5) 3(7.5) 2 (5.4) PD 4(5.2) 3(7.5) 1 (2.7) ORR, % (95% CI) 88,3(79.0,94.5) 85.0(70.2,94.3) 91.9(781,98.3) cORR, % (95% CI) 77.9(67.0,86.6) 77.5(61.5,89.2) 78.4(61.8,90.2) DCR, % (95% CI) 948(872,986) 92.5(796,98.4) 97.3(858,999) mDOR, mo (95% CI) 7.3(5,8,8.3) 7.3(5,8.3) 8.0(5,5,8.6) mPFS, mo (95% CI) 8.2(6.7,9.6) 8.2(4.4,9.6) 8.3(6.9,9,9.7) Median FU for PFS, mo (95% CI) 10.8(8,123) 9.8(8.1,12.4) 10.8(8.3,12.5) 12-mo os rate, % (95% CI) 80.8(66.1,89.6) 65.7(68.7,93.9) 76.5(51.4,89.8) Median FU for OS, mo (95% CI) 10.5(9.7,11.3) 10.5(9.7,11.6) 10.4(0.2,11.7) Patients - # less one post benefine scan were included in the analysis [1] Patients a on study with tumor assessment of PR who have not yet reached to the need time paint of fundr assessment Ct: confidence interval, CORR nonfirmed abjective response rate PR partal response, 10 stable doesse, PD: progressue deesse, FU. follow-up time Data cutaff: November 10", 2025 Fel Zoou, MD, PtD Organizers - Contant of his presentation is aspymght and responsibility of be author Permission a required for to use ESMD LAME ESTRO X STOP 6 elcc - -- BARER - --- [Slide 6] Depth & Duration of Response ta bren 2.5 mg/kg D1D8Q3W+Serplulimab 45 mg/kg Q3W iza bren 2 75 mg/kg D1D8Q3W Serplulimab 4.5 mg/kg Q3W ORR R 85.0% ORR . 91 9% mDOR = 7.3 mo In mDOR = 8.0 mo E If Iza-bren 2.5 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -64.4 (-92.4, -3.1). Iza-bren 2.75 mg/kg D1D8Q3W+Serplulimab: 100% of patients with tumor shrinkage and the median (range) shrinkage (%) was -63.6 (-100.0, -19.6). Data cutoff November 30°, 2023 Fel Zhou, MD, PhD I Content of the presentation . supyright and responsibility of the author Permission is required for re-use ESMD ARC ESTRO X TOP-IBC

BL-B01D1 (iza-bren) Development Program Top Tweets

Top tweets by impressions — click to view on X

Giannis Mountzios
Giannis Mountzios@g_mountzios

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…

👁 7.9K ♡ 84 ↻ 41 Mar 25, 2026
Dr Rishabh Jain
Dr Rishabh Jain@DrRishabhOnco

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…

👁 4.3K ♡ 20 ↻ 11 Mar 25, 2026
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🆙 #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

👁 3.1K ♡ 15 ↻ 9 Mar 25, 2026
Dr Rishabh Jain
Dr Rishabh Jain@DrRishabhOnco

🔥 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…

👁 2K ♡ 10 ↻ 5 Mar 25, 2026
Hidehito HORINOUCHI
Hidehito HORINOUCHI@HHorinouchi

🔁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

👁 1.1K ♡ 8 ↻ 4 Mar 26, 2026
Mario Balsa
Mario Balsa@MarioBalsaMD

✨ 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…

👁 964 ♡ 13 ↻ 6 Mar 25, 2026
OncLive.com
OncLive.com@OncLive

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

👁 435 ♡ 1 ↻ 0 Mar 25, 2026
Bhaarath PG
Bhaarath PG@BhaarathP10039

@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

👁 344 ♡ 1 ↻ 0 Mar 25, 2026
Targeted Oncology
Targeted Oncology@TargetedOnc

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…

👁 280 ♡ 3 ↻ 0 Mar 25, 2026

About the BL-B01D1 (iza-bren) Development Program Trial

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.

Trial Methodology & Results

Safety, Tolerability, MTD, RP2D, ORR (Phase 1 FIH) — Primary Endpoints

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).

✓ EGFR-mut NSCLC: ORR 66%, mPFS 12.5 mo (IASLC 2025, 2.5 mg/kg D1D8 Q3W)

📄 Source: KOL commentary on X →

Overall Survival (OS)

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.


📄 Source →

Safety & Tolerability

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.

✓ Manageable hematologic toxicity; no ILD; 1.2% discontinuation

📄 Source →

Clinical Implications

🔬 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.

BL-B01D1 (iza-bren) Development Program FAQ

What is BL-B01D1 (iza-bren)?

BL-B01D1 (izalontamab brengitecan, 'iza-bren'; also BMS-986507) is a first-in-class EGFRxHER3 bispecific antibody-drug conjugate that pairs dual-receptor targeting with a topoisomerase-I payload. It is being developed by SystImmune/Baili-Bio across a multi-tumor program, with the most-discussed data in EGFR-mutant non-small cell lung cancer. The lead first-in-human study is NCT05983432.

What efficacy has BL-B01D1 shown in EGFR-mutant NSCLC?

In the EGFR-mutant NSCLC cohort reported at IASLC WCLC 2025 (n=50, at 2.5 mg/kg on days 1 and 8 every 3 weeks), BL-B01D1 produced an objective response rate of 66.0% (confirmed 56.0%), a median progression-free survival of 12.5 months, and a median duration of response of 13.7 months, with a 12-month overall survival rate of 80.3%. Overall survival was not yet mature.

Is BL-B01D1 FDA approved?

No. BL-B01D1 (iza-bren) is investigational and is not FDA approved for any indication. Registrational Phase 3 studies are ongoing, largely in China (for example, in EGFR-mutant NSCLC after third-generation TKI progression). Its efficacy and safety are still being established in randomized trials.

What is the safety profile of BL-B01D1?

Toxicity is predominantly hematologic. Grade 3 or higher events included neutropenia (34%), leukopenia (30%), thrombocytopenia (19%), and anemia (15%), with high all-grade rates of anemia (about 91%), leukopenia, neutropenia, and thrombocytopenia, plus nausea and alopecia. This myelosuppression profile is an important consideration for its development and combination strategies.

Why is an EGFRxHER3 bispecific ADC of interest?

Targeting both EGFR and HER3 with a single antibody-drug conjugate may improve tumor delivery of the cytotoxic payload and address resistance driven by HER3 signaling, which is relevant after EGFR-TKI failure in NSCLC and across several EGFR/HER3-expressing tumors. BL-B01D1 is the first-in-class molecule pursuing this dual-target ADC approach.

BL-B01D1 (iza-bren) Development Program in the News

Key KOL Sentiments — BL-B01D1 (iza-bren) Development Program

DoctorSentimentComment
Giannis Mountzios ● POSITIVE 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 carbo-Etop- free 1L treatment in SCLC? @myESMO @IASLC https://t.co/aAL5wSiDTy
Targeted Oncology ● POSITIVE 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 more: https://t.co/1DQ7TXOoO6 #SCLC #LungCancer #ELCC2026
Dr Rishabh Jain ● NEUTRAL 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 evaluable pts, China Median follow-up: 10.5 months Trial arms 💉 Iza-bren 2.5 mg/kg + https://t.co/IHKvVMBGAw https://t.co/RcEdOIgc4y
Hidehito HORINOUCHI ● NEUTRAL 🆙 #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 @Larvol #LCSM https://t.co/ciRydsj5oL https://t.co/HLtYL9bk1Y
Dr Rishabh Jain ● NEUTRAL 🔥 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 0–1 ➡️ Stage II (treatment-naïve) ➡️ Iza-bren (DLL3-targeted) + PD-1 inhibitor 💥 https://t.co/BtydhPxtz6 https://t.co/aFisKrRc5y
Hidehito HORINOUCHI ● NEUTRAL 🔁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 https://t.co/Cno63wio99 https://t.co/Usp2gCBi5o
Mario Balsa ● NEUTRAL ✨ 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 &amp; 2.75mg/kg arms) ORR: 88.3% (cORR 77.9%) || DCR: 94.8% 💥 Responses deep &amp; consistent across cohorts 👍 TRAEs: 20.7% all https://t.co/eb3BfwiAHF
OncLive.com ● NEUTRAL 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 #oncology https://t.co/ZPhPNTyMIh
Bhaarath PG ● NEUTRAL @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 #serplulimab #obrixtamig #ezabenlimab #EGFR #KRAS #TP53 #DLL3 #ClinicalTrials https://t.co/O7swJLjyOr