Slide 1: A Phase II Study of Perioperative Ivonescimab in Resectable NSCLC
A Phase II Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer Changli Wang1, Xiaoliang Zhao1, Lianmin Zhang1, Dongsheng Yue1, Zhenfa Zhang1, Meng Wang1, Ziqiang Tian2, Shengguang Wang1, Chong Pang1, Bin Zhang1, Qiang Zhang1, Wei Wei1, Yu Z
Slide 2: Background
Background • Recent phase III trials have demonstrated the efficacy of neoadjuvant PD-(L)1 inhibitors combined with chemotherapy followed by surgery and adjuvant PD-(L)1 inhibitors for resectable non-small cell lung cancer (NSCLC), including KEYNOTE 6711, CheckMate 77T2, AEGEAN3, Neotorch4, and RATI
Slide 3: Study Design
Study Design Neoadjuvant treatment Surgery Adjuvant treatment (Within 4-6 weeks (Start within 3-8 weeks post-neoadjuvant treatment) after surgery) Key Eligibility Criteria Cohort 1 Ivonescimab 20mg/kg Ivonescimab 20mg/kg Surgery • Resectable NSCLC (stage II- Q3W, 3-4 cycles Q3W, 16 cycles IIIB[N2],
Slide 4: Patient Disposition
Patient Disposition 60 patients were enrolled 11 were enrolled to Cohort 1 49 were enrolled to Cohort 2 10 did not complete surgery 1 did not complete surgery 6 Subject request 1 Disease progression 1 Disease progression 1 Adverse event 10 completed R0 resection 39 completed R0 resection 2 Other 36
Slide 5: Baseline Characteristics
Baseline Characteristics Changli Wang | A Phase II Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer 5
Slide 6: Pathological Response
Pathological Response Cohort 1 Ivonescimab monotherapy Pathological Regression (%) Cohort 1 Cohort 2 (N=10) (N=39) MPR 60.0% 71.8% - RVT*＜5% 50.0% 69.2% pCR 30.0% 43.6% Cohort 2 Ivonescimab + CT Pathological Regression (%) *RVT：residual viable tumor cells in both primary tumor and lymph nodes. Chang
Slide 7: MPR and pCR by Subgroups in Cohort 2
MPR and pCR by Subgroups in Cohort 2 100% 100.0% 85.7% 83.3% 70.0% 73.7% 80% 68.8% 70.3% 71.4% 66.7% 60% 57.1% 53.3% 50.0% 47.4% 40.6% 40.5% 40.0% 40% 33.3% 22.2% 20% 11.1% 0% Stage II Stage III N0 Stage N1/2 Stage Squamous Non-squamous PD-L1<1% PD-L1≥1% Ivonescimab Ivonescimab (n=7) (n=32) (n=2) (n
Slide 8: EFS
EFS Cohort 1 Ivonescimab monotherapy (n=11) Cohort 2 Ivonescimab + CT (n=49) Median Follow-up (95% CI) 17.64 (12.3, 21.2) Median Follow-up (95% CI) 8.94 (6.6, 12.2) No. of Events/No. of Patients (%) 4/11 (36.4%) No. of Events/No. of Patients (%) 8/49 (16.3%) Median EFS (95% CI) NR (6.9, NE) Median E
Slide 9: Tumor Response and Stage Change in Neoadjuvant Phase
Tumor Response and Stage Change in Neoadjuvant Phase ORR DCR Cohort 1 Ivonescimab Monotherapy Cohort 2 Ivonescimab + CT (n=11) (n=49) 95.9% 90.9% 81.8% 81.6% Cohort 1 Cohort 2 Cohort 1 Cohort 2 ORR, objective response rate; DCR, disease control rate. Changli Wang | A Phase II Study of Perioperative
Slide 10: Safety Profile
Safety Profile Cohort 1 Cohort 2 Total TRAEs, n (%) Ivonescimab monotherapy Ivonescimab + CT (N=60) (N=11) (N=49) Any grade 9 (81.8) 42 (85.7) 51 (85.0) Grade≥3 4 (36.4) 16 (32.7) 20 (33.3) SAE 2 (18.2) 1 (2.0) 3 (5.0) Leading to treatment delay of ivonescimab 3 (27.3) 6 (12.2) 9 (15.0) Leading to d
Slide 11: Conclusions
Conclusions • Perioperative ivonescimab monotherapy or combined with chemotherapy for resectable NSCLC demonstrated high rates of pCR and MPR in this phase II study. • Compared with ivonescimab monotherapy, rates of MPR and pCR in ivonescimab combined with chemotherapy were numerically higher, and a
Slide 12: Acknowledgements
Acknowledgements • Thanks to all patients, their families, and their caregivers for their participation • Thanks to all investigators who supported this clinical trail • Thanks to all staff members for their contributions Changli Wang | A Phase II Study of Perioperative Ivonescimab Alone or Combined