Slide 1: Phase I/II SOHO-01 study of sevabertinib in HER2-mutant NSCLC: Asian patients
Phase I / II SOHO-01 study of sevabertinib (BAY 2927088) in HER2-mutant non-small cell lung cancer: safety and efficacy in Asian patients Daniel Shao-Weng Tan National Cancer Centre Singapore and Duke–National University of Singapore Medical School, Singapore Friday, December 5 Daniel Shao-Weng Tan,
Slide 2: Declaration of interests
Declaration of interests Daniel Shao-Weng Tan I have the following financial relationships to disclose: • Consulting fees: Amgen, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, DKSH, Genmab, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Regeneron, Roche, Takeda, and Zyme
Slide 3: Sevabertinib is an oral, reversible HER2 TKI
Sevabertinib is an oral, reversible HER2 TKI • Sevabertinib is an oral, reversible TKI with anti-HER2 activity in preclinical models1 • The ongoing Phase I / II SOHO-01 study is evaluating sevabertinib in patients with advanced EGFR- or HER2-mutant NSCLC2 • Sevabertinib has demonstrated anti-tumor a
Slide 4: SOHO-01 study design (NCT05099172)
SOHO-01 study design (NCT05099172) PRIMARY ENDPOINT EXPANSION AND EXTENSIONa (extension phase) Cohorts of patients with HER2 mutationsb • ORR per RECIST v1.1 DOSE by BICR ESCALATION To evaluate the safety, tolerability, and efficacy, and to characterize SECONDARY AND BACKFILL the pharmacokinetics, o
Slide 5: Baseline characteristics (Asian patients in Cohorts D, E, and F)
Baseline characteristics (Asian patients in Cohorts D, E, and F) Cohort Da Cohort Eb Cohort Fc Cohort Da Cohort Eb Cohort Fc (n=57) (n=32) (n=51) (n=57) (n=32) (n=51) Female, n (%) 33 (58) 20 (63) 31 (61) HER2 TKD mutation, n (%) Median age, years (range) 59 (29-82) 61 (35-79) 66 (34-80) Yes 50 (88)
Slide 6: Response by BICR: Asian patients in Cohort D
Response by BICR: Asian patients in Cohort D Best objective response, n (%) Cohort D CR 1 (2) (previously treated but naïve to HER2-targeted therapies) PR 34 (60) n=57 SD 16 (28) Median follow-up: 12.2 months PD 4 (7) Not evaluablea 2 (4) Not available 0 35 (61) BICR ORRb, n (%) [95% CI] [47.6, 74.0
Slide 7: Response by BICR: Asian patients in Cohort E
Response by BICR: Asian patients in Cohort E Best objective response, n (%) Cohort E CR 2 (6) (previously treated with HER2-targeted ADCs) PR 13 (41) n=32 SD 14 (44) Median follow-up: 10.8 months PD 2 (6) Not evaluablea 1 (3) Not available 0 15 (47) BICR ORRb, n (%) [95% CI] [29.1, 65.3] ORR 47% 26
Slide 8: Response by BICR: Asian patients in Cohort F
Response by BICR: Asian patients in Cohort F Best objective response, n (%) Cohort F CR 2 (4) (naïve to systemic therapy for advanced disease) PR 32 (63) n=51 SD 13 (26) Median follow-up: 7.6 months PD 3 (6) Not evaluablea 0 Not available 1 (2) 34 (67) BICR ORRb, n (%) [95% CI] [52.1, 79.2] ORR 67%
Slide 9: Sevabertinib safety and tolerability in Asian patients
Sevabertinib safety and tolerability in Asian patients Most frequent treatment-related adverse events (≥10% of total)a • Treatment-related adverse events were Grade 1 / 2 Grade 3 Cohorts Db, Ec – 20 mg BID (n=89) Cohort Fd – 20 mg BID (n=51) reported in 98%, 100%, and 100% of Asian 89 15 74 Diarrhea
Slide 10: Conclusions
Conclusions • Sevabertinib demonstrated robust and durable responses in Asian patients with HER2-mutant advanced NSCLC in both pretreated and first-line settings • The most common side effect of sevabertinib was diarrhea, which was manageable; there were no reported cases of interstitial lung diseas
Slide 11: Acknowledgments
Acknowledgments • We thank the patients and their families for participation in the SOHO-01 study • We thank the investigators and their team members at each of the 90 study sites • This study was sponsored by Bayer AG • Caudex, an IPG Health company, provided medical writing and editorial assistanc
Slide 12: Presented by: Daniel Shao-Weng Tan Content of this presentation is copyright and responsibility of
Presented by: Daniel Shao-Weng Tan Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Slide 13: Thank you!
Thank you! European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org