ADC Therapeutics SA · NYSE:ADCT
ADC Therapeutics SA — 62nd ASH Annual Meeting and Exposition 2020
11 slides from ADC Therapeutics SA's conference presentation, Dec 6, 2020
Slide 1: Preliminary Results of a Phase 2 Study of Camidanlumab Tesirine in R/R Hodgkin Lymphoma
Preliminary Results of a Phase 2 Study of Camidanlumab Tesirine (Cami), a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients With Relapsed or Refractory Hodgkin Lymphoma Alex F. Herrera,1 Carmelo Carlo-Stella,2 Graham P. Collins,3 Kami Maddocks,4 Nancy L. Bartlett,5 Kerry J. Sava
Slide 2: Introduction
Introduction • Patients with R/R cHL who have no response to treatments such as brentuximab vedotin (BV) and PD-1 blockade, or initial response followed by progressive disease, have limited therapeutic options1–10 – Novel treatments are needed to address this significant unmet need • Camidanlumab te
Slide 3: Composition and Mechanism of Action
Composition and Mechanism of Action Cami composition • Human IgG1 anti-CD25 mAb stochastically conjugated to PBD dimer warhead Mechanism of action1–3 • Death of CD25-expressing tumor cells • Depletion of CD25-expressing T cells in HL tumor microenvironment • Possible bystander killing of CD25-negati
Slide 4: Study Methods
Study Methods Study design Key inclusion criteria • Single-arm, multicenter, open-label, Phase 2 • R/R cHL trial (NCT04052997) • Aged ≥16 years (USA), ≥18 years (outside USA) Primary objective Secondary objectives • ≥3 prior lines of treatment (≥2 lines if HSCT-ineligible) • Efficacy of single-agent
Slide 5: Patient Characteristics
Patient Characteristics Characteristic Sex, n (%) Total (n=51) Male 36 (70.6) No. of patients Median Female 15 (29.4) enrolled and (range) Age, years, median (min, max) 36 (20–74) treated with Cami No. of Cami Histology at data cut-off cycles Nodular sclerosis cHL 40 (78.4) Other/unknown/not evaluab
Slide 6: Efficacy – Overall Response Rate
Efficacy – Overall Response Rate ORR (CR+PR) 83.0% (39/47) 100 4.3 NE 90 2.1 95% CI: 69.2, 92.4 10.6 PD 80 70 SD Response (%) 60 44.7 No. of patients No. of patients PR 50 with CR with PR 40 CR 18 (38.3%) 21 (44.7%) 30 20 38.3 10 No. of patients who went on to 0 consolidation with HSCTa Cami 45 µg/k
Slide 7: Safety – TEAEs (1/2)
Safety – TEAEs (1/2) Most common TEAEs (≥20% of patients)a Most common Grade ≥3 TEAEs (≥5% of patients)a Fatigue 26 (51.0) Hypophosphatemia 6 (11.8) Pyrexia 20 (39.2) Gamma-glutamyltransferase increased 5 (9.8) Nausea 19 (37.3) Alanine aminotransferase increased 3 (5.9) Maculopapular rash 18 (35.3)
Slide 8: Safety – TEAEs (2/2)
Safety – TEAEs (2/2) TEAEs thought to be PBD-associated included: Fatal TEAEs Skin reactions and nail disorders Two fatal TEAEs (3.9% of patients): • All grades: 37 (72.5%) • Myocardial infarction • Grade ≥3: 9 (17.6%) – Considered not related to treatment Liver function test abnormalities • Respira
Slide 9: Safety – Study Pause
Safety – Study Pause • Enrollment pause due to meeting protocol-specified criterion: – ≥2 cases of Guillain–Barré syndrome (GBS) or other relevant severe neurologic toxicity • Assessment by independent review • No. of cases of GBS/polyradiculopathy: 3 (6.4%) – Grade 4 GBS (inflammatory demyelinating
Slide 10: Conclusions
Conclusions Encouraging antitumor activity in patients with R/R cHL receiving single-agent treatment with Cami • Patients were heavily pre-treated and 98.0% had received prior BV and PD-1 blockade • ORR (CR+PR) to treatment was high at 83.0%, and 38.3% of patients had CR Five (10.6%) patients went o
Slide 11: Thank you for listening
Thank you for listening Questions are welcome
ADC Therapeutics — 62nd ASH Annual Meeting and Exposition 2020 on 6ix