BL-B01D1-204-01 Trial

[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

No OCR text available for this slide group.

No OCR text available for this slide group.

No OCR text available for this slide group.

[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