INTRODUCTION: BV, an ADC targeting CD30, has shown activity in lymphomas with low CD30 expression. BV+CHP was effective in patients with PTCL with CD30 ≥10%.
METHODS: SGN35-032 (NCT04569032) is a phase 2 study. Patients received 21-day cycles of BV 1.8mg/kg, cyclophosphamide 750mg/m2, and doxorubicin 50mg/m2 and prednisone 100mg up to 6-8 cycles. Primary endpoint: ORR; secondary endpoints: safety and additional efficacy outcomes.
OBJECTIVES: Report primary analysis results of BV+CHP in patients with non-sALCL PTCL with CD30 < 10%.
RESULTS: At median follow-up of 15.7 months, 82 patients received ≥1 BV+CHP dose (CD30 < 1%: n=34; CD30 1–10%: n=48) and all patients were off study treatment. Median age was 63.5 years (range, 24-80), 66% with IPI score of 2-3, and 90% with ECOG PS ≤1. Common (≥30%) disease subtypes included PTCL-not otherwise specified (45%) and angioimmunoblastic T-cell lymphoma (32%).
ORR (95% CI) was 77% (66.2-85.4) and CR rate was 63% (52.0-73.8). Median (95% CI) PFS and OS were 12.7 months (9.0-not estimable [NE]) and not reached (NR; 24.4-NE). Median (95% CI) DOR was 15.9 months (8.3-NE), but NR in either cohort.
TEAEs occurred in 95% of patients (grade ≥3 in 59%). Common (≥15%) grade ≥3 TEAEs included neutropenia (18%) and febrile neutropenia (17%). Grade 5 treatment-related TEAEs occurred in 2% (n=2); 23% (n=19) reported a BV-related serious TEAE.
CONCLUSIONS: As frontline therapy, BV+CHP demonstrated clinically meaningful efficacy with a safety profile consistent with previous reports in patients with non-sALCL PTCL and low CD30 expression.
©2025 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was previously presented at the 2025 ASCO Annual Meeting. All rights reserved.
