Legend Biotech Corp. · NASDAQ:LEGN
Legend Biotech — ASCO 2023 Investor Meeting
33 slides from Legend Biotech's conference presentation, Jun 5, 2023
Slide 1: ASCO 2023 Investor Meeting
ASCO 2023 Investor Meeting June 5, 2023 This presentation is for investor relations purposes only - Not for product promotional purposes 1
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Legend Biotech (“Legend Biotech” or the “Company”) solely for information purposes and does not contain all relevant information relating to the Company. The safety and efficacy of the agents and/or uses under investigation discussed in this presenta
Slide 3: Forward-looking Statements
Forward-looking Statements Statements in this presentation about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 19
Slide 4: Agenda
Agenda Introduction Dr. Ying Huang, CEO CARTITUDE-4 Dr. Binod Dhakal, Medical College of Wisconsin CARTITUDE-1 & LEGEND-2 Dr. Shambavi Richard, Mount Sinai Q&A Breakfast This presentation is for investor relations purposes only - Not for product promotional purposes 4
Slide 5: Introduction
Introduction Binod Dhakal, M.D. Shambavi Richard, M.D. Associate Professor Associate Professor of Medicine (Hematology & Cancer Center - Froedtert Hospital Medical Oncology) Medical College of Wisconsin Center of Excellence for Multiple Myeloma, Mount Sinai This presentation is for investor relation
Slide 6: CARTITUDE-4
CARTITUDE-4 Phase 3 Results: Cilta-cel Versus Standard of Care (PVd or DPd) in Lenalidomide-Refractory Multiple Myeloma This presentation is for investor relations purposes only - Not for product promotional purposes 6
Slide 7: CARTITUDE-4: Introduction
CARTITUDE-4: Introduction • Cilta-cel is a dual-binding, BCMA-directed CAR-T therapy CARTITUDE-1 (median follow-up, 33.4 months) • The phase 1b/2 CARTITUDE-1 study has shown a median 100 PFS of ~3 years in heavily pretreated patients with MM with ≥3 prior LOT 80 Survival probability, % • We aimed to
Slide 8: CARTITUDE-4 Study Design and Endpoints
CARTITUDE-4 Study Design and Endpoints Screening • Primary endpoint Randomization SOC arm Key inclusion criteria: - PFSc PVd or DPda,b • Age ≥18 years 1:1 with MM randomization • 1–3 prior LOT Day 1: Day 1–112: Bridging (including PI + IMiD) Cilta-cel Collect safety, PVd or Follow-up • Len refractor
Slide 9: CARTITUDE-4: Patient Population and Follow-Up
CARTITUDE-4: Patient Population and Follow-Up 516 patients screened - At November 1, 2022 data cut-off, median follow-up was 15.9 months (range, 0.1–27) 97 screen failures - First patient randomized on July 10, 2020 and last patient randomized on November 17, 2021 - Median time from first apheresis
Slide 10: CARTITUDE-4: Baseline Demographics and Disease Characteristics
CARTITUDE-4 : Baseline Demographics and Disease Characteristics ITT population ITT population Baseline characteristic Baseline characteristic Cilta-cel SOC Cilta-cel SOC (n=208) (n=211) (n=208) (n=211) Cytogenetic high risk, n (%)e 123 (59.4) 132 (62.9) Age, median (range), years 61.5 (27–78) 61.0 (
Slide 11: CARTITUDE-4: Primary Endpoint – PFS (ITT Population)
CARTITUDE-4:Primary Endpoint – PFS (ITT Population) Bridging phase, patients in cilta-cel arm were Cilta-cel vs SOC receiving the same treatment as the SOC arm Week 8 • 12-month PFS rate: 100 Hazard ratio, 0.26 (95% CI, 0.18–0.38); P<0.0001b,c 76% vs 49% Patients progression free and alive, % • SOC
Slide 12: CARTITUDE-4: Key Subgroup Analysis (ITT)
CARTITUDE-4: Key Subgroup Analysis (ITT) Hazard ratioa Hazard ratioa Hazard ratio and 95% CI (95% CI) Hazard ratio and 95% CI (95% CI) Favor cilta-cel arm Favor SOC arm Favor cilta-cel arm Favor SOC arm Number of lines of prior therapy Cytogenetic risk at study entry 1 0.35 (0.19, 0.66) High r
Slide 13: CARTITUDE-4: PFS by Prior Line of Therapy
CARTITUDE-4: PFS by Prior Line of Therapy • Cilta-cel improved PFS vs SOC whether patients had 1 or 2–3 prior LOT cilta-cel, ciltacabtagene autoleucel; HR, hazard ratio; ITT, intent-to-treat; LOT, line of therapy; PFS, progression-free survival; SOC, standard of care. 13 Dhakal et al. ASCO Annual Me
Slide 14: CARTITUDE-4: Secondary Endpoint (ITT) – Response
CARTITUDE-4: Secondary Endpoint (ITT) – Response Cilta-cel had higher ORR vs SOC Cilta-cel SOC Outcome (N=208) (N=211) 12-month DOR 84.7 63.0 rate, % (95% CI) (78.1–89.4) (54.2–70.6) Duration of 16.6 response, months NR (12.9–NE) median (95% CI) aAssessed using a validated computerized algorithm; OR
Slide 15: CARTITUDE-4: Secondary Endpoints – MRD and OS
CARTITUDE-4: Secondary Endpoints – MRD and OS Cilta-cel improved rates of overall MRD OS was immature with 39 deaths in cilta-cel arm negativitya,b at 10-5 vs SOC vs 47e deaths in SOC arm: • HR, 0.78; 95% CI, 0.5–1.2, P=0.26 MRD negativityb 100 OR: 8.7c 87.5 P<0.0001d 80 60.6 Patients, % 60 40 32.7
Slide 16: CARTITUDE-4: Patients Treated With Cilta-cel as Study Treatment
CARTITUDE-4: Patients Treated With Cilta-cel as Study Treatment (As-Treated Population) • For the as-treated population (n=176): ⁻ 99% ORR, with 86% ≥CR ⁻ 72% MRD negative at 10-5 (n=126/176) ⁻ 90% PFS rate (from apheresis) at 12 months aAssessed using a validated computerized algorithm; ORR is defi
Slide 17: CARTITUDE-4: PFS Versus CARTITUDE-1
CARTITUDE-4: PFS Versus CARTITUDE-1 Rate of PFS in CARTITUDE-4 numerically better than in 18-month follow-up of CARTITUDE-11 CARTITUDE-4 CARTITUDE-11 Outcome, % 16-month median 18-month median follow-up follow-up 12-month PFS rate (from cilta-cel 85a 76 infusion) ≥CR or better rate 86 80 MRD negativ
Slide 18: CARTITUDE-4: TEAEs
CARTITUDE-4: TEAEs Safety population • Hematologic TEAEs most common Select TEAE ≥15%, n (%) Cilta-cel (n=208) SOC (n=208) ⁻ 85–90% neutropenia, almost all grade 3/4 Any grade Grade 3/4 Any grade Grade 3/4 ⁻ Most high-grade cytopenias resolved to Any AE 208 (100) 201 (96.6) 208 (100) 196 (94.2) grad
Slide 19: CARTITUDE-4: CRS and CAR-T Cell-Related Neurotoxicity
CARTITUDE-4: CRS and CAR-T Cell-Related Neurotoxicity In the cilta-cel as-treated population: As-treated patients (n=176) • 30 patients had non-ICANS neurotoxicitiesc Median AEs, n (%) Any Grade time to Median Resolved, ⁻ 16 cranial nerve palsies (14 recovered) duration, grade 3/4 onset, days n ⁻ 5
Slide 20: CARTITUDE-4: Conclusions
CARTITUDE-4: Conclusions • Cilta-cel significantly prolonged PFS vs SOC (HR, 0.26; P<0.0001) in patients with lenalidomide- refractory MM and 1–3 prior LOT ⁻ PFS benefit was seen across all subgroups, including patients with high-risk cytogenetics (including in patients with 2 or more high-risk feat
Slide 21: CARTITUDE-1 End of Study Results
CARTITUDE-1 End of Study Results (~3-year Follow-up) Primary Efficacy and Safety This presentation is for investor relations purposes only - Not for product promotional purposes 21
Slide 22: CARTITUDE-1 Final Results: Introduction
CARTITUDE-1 Final Results: Introduction (~3-Year Follow-Up) • Ciltacabtagene autoleucel (cilta-cel) is a dual-binding, BCMA, CAR-T cell therapy for the treatment of patients with RRMM1,2 ⁻ Heavily pretreated patients with RRMM who are treated with standard-of-care therapy have a median OS of ~9–12 m
Slide 23: CARTITUDE-1 Final Results: Study Population and Endpoints
CARTITUDE-1 Final Results: Study Population and Endpoints (~3-Year Follow-Up) Study population • As of October 14, 2022, 97 patients were treated Time-to-event outcomes with cilta-cel, with a median follow-up of 33.4 A PFS 100 months (range, 1.5–45.2) Survival probability, % 80 • Patient demographic
Slide 24: CARTITUDE-1 Final Results: MRD Results
CARTITUDE-1 Final Results: MRD Results (~3-Year Follow-Up) • 62 patients had samples evaluable PFS by CR and sustained MRD negativity for MRD at any time, and 49 patients had samples evaluable for 12-month mPFS (95% CI), 30-mo 36-mo sustained MRD Subgroups mo PFS rate PFS rate ⁻ Of these 49 evaluabl
Slide 25: CARTITUDE-1 Final Results: Safety
CARTITUDE-1 Final Results: Safety (~3-Year Follow-Up) • No new neurotoxicity events were reported TABLE: Study deaths since the 27.7-month median follow-up1 Patients Time of death post (N=97) cilta-cel infusion, days • A total of 26 SPMs were reported in 20 Total deaths during the study 35 45–980 pa
Slide 26: CARTITUDE-1 Final Results: Conclusions
CARTITUDE-1 Final Results: Conclusions (~3-Year Follow-Up) • At 3-year follow-up: – An estimated 62.9% of patients were alive – There were no new neurotoxicity events • Achieving CR and/or sustained MRD negativity was associated with prolonged PFS • Patients continue to be followed for safety and su
Slide 27: LEGEND-2 ≥5-Year Follow-Up
LEGEND-2 ≥5-Year Follow-Up This presentation is for investor relations purposes only - Not for product promotional purposes 27
Slide 28: LEGEND-2 5-Year Results: Introduction
LEGEND-2 5-Year Results: Introduction • LCAR-B38M CAR T cells express a structurally differentiated CAR construct containing a 4-1BB costimulatory domain and 2 BCMA-targeting, single-domain antibodies to confer avidity1 • LEGEND-2 was a first-in-human phase 1 study of LCAR-B38M conducted at 4 sites
Slide 29: LEGEND-2 5-Year Results: Efficacy
LEGEND-2 5-Year Results: Efficacy • As of November 2022, 74 patients were treated with LCAR-B38M with a median follow-up of 65.4 months (range, 0.4– 78.8), 5 years after the last patient was dosed • ORR was mature at 87.8% (95% CI, 78.294.3) and unchanged since 48-month follow-up ⁻ Median DOR was 2
Slide 30: LEGEND-2 5-Year Results: Efficacy (cont'd)
LEGEND-2 5-Year Results: Efficacy (cont’d) Time-to-event outcomes A 100 • Median PFS was 18.0 months PFS (95% CI, 10.626.6) 80 Survival probability, % 60 • Median OS was reached with this 5-year PFS rate: 21.70% (95% CI, 12.95–31.92) data cut and was 55.8 months 40 (95% CI, 24.4not evaluable) 20 •
Slide 31: LEGEND-2 5-Year Results: Conclusions
LEGEND-2 5-Year Results: Conclusions • At 65.4 months follow-up in LEGEND-2, 16% of patients remained disease free and alive for ≥5 years; median OS was 55.8 months, and 45% were still alive, suggesting long-term OS benefit even for patients who progressed • No new safety signals were reported at th
Slide 32: Q&A
Q&A Binod Dhakal, M.D. Shambavi Richard, M.D. Associate Professor Associate Professor of Medicine Cancer Center - Froedtert Hospital (Hematology & Medical Oncology) Medical College of Wisconsin Center of Excellence for Multiple Myeloma, Mount Sinai Steve Gavel Ying Huang, Ph.D. Nitin Patel Head of C
Slide 33: Thank You
THANK YOU This presentation is for investor relations purposes only - Not for product promotional purposes 33