Roche Holding Ltd · SIX:RO
Roche — European Hematology Association (EHA) Annual Meeting 2024
17 slides from Roche's conference presentation, June 2024
Slide 1: Glofitamab plus GemOx for R/R DLBCL: Results of Phase III STARGLO Trial
Glofitamab▼plus Gemcitabine and Oxaliplatin (Glofit-GemOx) for Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL): Results of a Global Randomized Phase III Trial (STARGLO) Jeremy S. Abramson,1 Matthew Ku,2 Mark Hertzberg,3 Christopher P. Fox,4 Charles Herbaux,5 Maria Fatima de la Cruz V
Slide 2: Disclosures: Jeremy S. Abramson
Disclosures: Jeremy S. Abramson • Consulting/advisory role: AbbVie, ADC Therapeutics, AstraZeneca, BeiGene, BMS, Cellectar, Caribou Biosciences, Celgene, Genentech, Inc., Gilead, Incyte, Interius, Janssen, Lilly, Novartis, F. Hoffmann-La Roche Ltd, Seagen, Takeda • Research funding: BMS, Cellectis,
Slide 3: Background
Background Glofitamab: CD20xCD3 T-cell engaging • Glofitamab is an off-the-shelf, fixed duration treatment bispecific antibody with 2:1 format for R/R LBCL1,2 – Engages and redirects T cells to eliminate malignant B cells High avidity binding to CD20 on B cells* • Phase I/II pivotal trial experience
Slide 4: STARGLO: randomized Phase III trial in ASCT-ineligible patients with R/R DLBCL
STARGLO: randomized Phase III trial in ASCT-ineligible patients with R/R DLBCL Glofit-GemOx (n=183) Glofitamab 30mg administered on Glofitamab plus gemcitabine and oxaliplatin* Day 1 of each cycle Step-up dosing in Cycle 1, Patients R/R DLBCL (N=274) 30mg administered on Day 1 from Cycle 2 onwards •
Slide 5: STARGLO: key endpoints and timing of analysis
STARGLO: key endpoints and timing of analysis Key endpoints Primary endpoint Overall survival Key secondary endpoints Progression-free survival by IRC assessment (hierarchical) Complete response rate by IRC assessment Duration of complete response by IRC assessment Safety endpoints Incidence, nature
Slide 6: Baseline characteristics
Baseline characteristics n (%), unless otherwise stated R-GemOx (n=91) Glofit-GemOx (n=183) Median (range) 68.0 (20–84) 68.0 (22–88) Age, years ≥65 years 56 (61.5) 116 (63.4) Sex Male 53 (58.2) 105 (57.4) Asian 51 (56.0) 86 (47.0) Black or African American 1 (1.1) 2 (1.1) Race White 33 (36.3) 82 (44
Slide 7: Primary endpoint: overall survival
Primary endpoint: overall survival Updated analysis R-GemOx Glofit-GemOx 100 (n=91) (n=183) Glofit-GemOx (n=183) R-GemOx (n=91) Primary analysis (median follow-up: 11.3 months) 80 Censored OS, median 9 (7.3–14.4) NE (13.8–NE) (95% CI); months 60 OS (%) HR (95% CI) 0.59 (0.40–0.89) 40 p-value* 0.011
Slide 8: Progression-free survival by IRC assessment
Progression-free survival by IRC assessment Updated analysis R-GemOx Glofit-GemOx 100 (n=91) (n=183) Glofit-GemOx (n=183) R-GemOx (n=91) Primary analysis (median follow-up: 9.6 months) 80 Censored PFS, median 3.3 (2.5–5.6) 12.1 (6.8–18.3) (95% CI); months 60 PFS (%) HR (95% CI) 0.37 (0.25–0.55) 40 p
Slide 9: Response rates by IRC assessment
Response rates by IRC assessment Response rates at the updated analysis 100 80 • 33.2% difference in CR rate ORR: 68.3% between treatment arms (95% CI: 19.7–44.5) Patients (%) PR: 9.8% 60 40 ORR: 40.7% • CR rate significantly better with PR: 15.4% Glofit-GemOx vs R-GemOx CR: 58.5% (descriptive p-val
Slide 10: OS in pre-specified subgroups: exploratory analysis
OS in pre-specified subgroups: exploratory analysis R-GemOx Glofit-GemOx (n=91) (n=183) Total Median Median 95% Wald Glofit-GemOx R-GemOx Baseline Risk Factors n n Events (Months) n Events (Months) HR CI better better All Patients 274 91 52 12.9 183 80 25.5 0.62 (0.44, 0.89) Sex Male 158 53 36 10.3
Slide 11: Safety profile summary
Safety profile summary n (%), unless otherwise stated R-GemOx (n=88) Glofit-GemOx (n=180) Number of cycles,* median (range) 4 (1–8) 11 (1–13) Any grade AEs 84 (95.5) 180 (100) Rituximab/glofitamab related 58 (65.9) 149 (82.8) Serious AEs 15 (17.0) 98 (54.4) Rituximab/glofitamab related 7 (8.0) 62 (3
Slide 12: Cytokine release syndrome
Cytokine release syndrome n (%) of patients with Glofit-GemOx ≥1 CRS AE* (Glofit exposed) n=172 CRS by cycle and grade in the updated analysis Any grade† 76 (44.2) 100 Grade 1 54 (31.4) Grade 3 90 Grade 2 18 (10.5) Grade 2 80 Grade 3 4 (2.3)‡ 70 Grade 1 Patients (%) Median time to CRS onset, hours (
Slide 13: Other AEs of interest
Other AEs of interest n (%) R-GemOx (n=88) Glofit-GemOx (n=180) Neurological AEs 35 (39.8) 105 (58.3) Grade ≥3 0 12 (6.7) ICANS NA* 4 (2.3)† Grade ≥3 NA* 1 (0.6) Tumor flare 0 1 (0.6) Grade ≥3 0 0 Infections 26 (29.5) 103 (57.2) Grade ≥3 11 (12.5) 42 (23.3) Neutropenia‡ 27 (30.7) 76 (42.2) Grade ≥3
Slide 14: COVID-19 AEs
COVID-19 AEs COVID-19 AE, n (%) R-GemOx (n=88) Glofit-GemOx (n=180) Any grade COVID-19 AE 8 (9.1) 33 (18.3) Grade ≥3 AE 2 (2.3) 11 (6.1) Grade 5 (fatal) AEs associated with COVID-19* 0 7 (3.9) AE leading to treatment discontinuation† 5 (5.7) 22 (12.2) COVID-19-related AE profile should be contextual
Slide 15: Conclusions
Conclusions • Fixed duration glofitamab added to GemOx demonstrated a statistically significant and clinically meaningful OS benefit in patients with R/R DLBCL, who were ineligible for ASCT – Median OS of 25.5 months with Glofit-GemOx compared with 12.9 months with R-GemOx (HR 0.62) – Glofit-GemOx i
Slide 16: Acknowledgments
Acknowledgments • The patients and their families • The study investigators, coordinators, and nurses • The sponsor, F. Hoffmann-La Roche Ltd Third-party medical writing support under the direction of authors, was provided by Sinead Holland, PhD, (Ashfield MedComms, an Inizio company) and funded by
Slide 17: Disclosures
Disclosures JSA: Consulting/advisory role (AbbVie, ADC Therapeutics, AstraZeneca, BeiGene, BMS, Cellectar, Caribou Biosciences, Celgene, Genentech, Inc., Gilead, Incyte, Interius, Janssen, Lilly, Novartis, F. Hoffmann-La Roche Ltd, Seagen, Takeda), and research funding (BMS, Cellectis, Merck, Mustan
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