Roche Holding Ltd · SIX:RO
Roche — 2023 International Conference on Malignant Lymphoma (ICML)
13 slides from Roche's conference presentation, June 2023
Slide 1: Glofitamab monotherapy induces durable complete remissions in Richter's transformation
Glofitamab monotherapy induces durable complete remissions and has a manageable safety profile in patients with Richter’s transformation Carmelo Carlo-Stella,1 Martin Hutchings,2 Fritz Offner,3 Estefania Mulvihill,4 James Relf,5 Ben Byrne,5 Linda Lundberg,4 Michael Dickinson6 1Humanitas University a
Slide 2: Disclosures: Carmelo Carlo-Stella
Disclosures: Carmelo Carlo-Stella • Current employment: – Humanitas University • Honoraria: – Celgene/BMS, Incyte, F. Hoffmann-La Roche Ltd, Janssen Oncology, Merck Sharp & Dohme, AstraZeneca and Gilead • Consulting or advisory role: – Sanofi, ADC Therapeutics, Karyopharm Tx, Celgene/BMS, F. Hoffman
Slide 3: Background
Background • Richter’s transformation Glofitamab: CD20xCD3 bispecific antibody with 2:1 – Occurs in 2–10% of patients with CLL/SLL1,2 format for increased potency vs 1:1 format5 – Characterized by transformation of CLL/SLL to an aggressive lymphoma, most commonly DLBCL1,3 High avidity binding to CD2
Slide 4: Study overview
Study overview Phase I dose escalation in patients with RT Glofitamab IV administration Glofitamab fixed-dosing schedule • Fixed treatment duration: maximum 12 cycles 1000mg Gpt 0.6 / 1.0 / 1.8 / 10 / 25mg • Dosing: fixed-dosing (0.6–25mg) or SUD in C1 (target dose 16 or 30mg) C1D1 C1D8–C12D1 21-day
Slide 5: Baseline characteristics
Baseline characteristics n (%)* N=11 n (%)* N=11 Median age, years (range) 71.0 (48–77) Prior lines of therapy, median (range) 3 (1–4) Male 4 (36.4) 0 2 (18.2) Median time since last therapy, months (range) 1.8 (1.4–4.6) ECOG PS 1 9 (81.8) Ann Arbor I–II 1 (9.1) Prior CLL therapy 10 (90.9) stage III
Slide 6: Best overall response
Best overall response 100 80 63.6 Patients (%) 60 45.5 40 20 18.2 18.2 18.2 0 ORR* CR PR SD PD Response† High ORR and CR rates were observed *Best overall response by INV. †Response assessment according to Lugano 2014 criteria.1 INV, investigator; CR, complete response; ORR, overall response rate; P
Slide 7: Antitumor activity
Antitumor activity Best percentage change from baseline SPD*†‡ NMR 100 PMR 80 CMR Best % change in SPD (INV) 60 40 20 0 –20 –40 –60 –80 –100 Most patients achieved ≥50% reduction in tumor size *Best response with PET. †SPD data were not available for two patients that had PD as their best overall re
Slide 8: Time on treatment and response
Time on treatment and response Durability of response • Median time on glofitamab treatment: 1.0 – 5.5 months (range: 0.5–7.6) 10 • Median follow-up: Glofitamab dose (mg) 2.5/10/30 – 40.8 months (range: 0–54) 1.8 • Best overall response: 2.5/10/16 – CR rate: 45.5%, ORR: 63.6% 25 Active in follow-up
Slide 9: Adverse event overview
Adverse event overview Adverse events, n (%) N=11 AEs (≥20%) by Grade and relationship with glofitamab (N=11) Any grade AE 11 (100) All AEs Glofitamab-related AEs Glofitamab related 10 (90.9) CRS 72.8 72.8 Serious AE 8 (72.7) Pyrexia* 54.6 18.2 Glofitamab related 6 (54.5) Fatigue 36.4 18.2 Grade 3–4
Slide 10: Cytokine release syndrome
Cytokine release syndrome n (%) of patients with N=11 CRS by cycle and grade ≥1 AE* Any grade CRS 8 (72.7) Glofitamab fixed-dosing (n=5) Glofitamab SUD (n=6) Grade 1 3 (27.3) Grade 2 3 (27.3) Grade 1 100 100 Grade 2 Grade 3† 1 (9.1)‡ C1 C1 Grade 3 80 Grade 4 † 80 Patients (%) § Patients (%) Grade 4
Slide 11: Other adverse events of interest
Other adverse events of interest AE,* n (%) All grades (N=11) Grade ≥3 (N=11) Infections and infestations 6 (54.5) 0 Neutropenia† 5 (45.5) 3 (27.3) Tumor flare 1 (9.1) 0 Neurologic AEs‡§ 5 (45.5) 1 (9.1)¶ ICANS# 2 (18.2)** 1 (9.1)¶ *By SOC. †Neutropenia grouped terms. ‡Neurologic AEs include AEs rep
Slide 12: Conclusions
Conclusions • Glofitamab monotherapy is administered for a fixed treatment duration with a maximum of 12 cycles (approximately 8.3 months) • High CR rates were observed in highly refractory patients with RT; CRs remained durable after completion of treatment • Glofitamab demonstrated a manageable sa
Slide 13: Acknowledgments
Acknowledgments • The patients and their families • The study investigators • The study coordinators and nurses • The sponsor, F. Hoffmann-La Roche Ltd Third-party medical writing assistance, under the direction of all authors, was provided by Dikeledi Matlebjane of Ashfield MedComms, an Inizio comp
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