Novocure Limited · NASDAQ:NVCR
Novocure — ASCO Investor Event 2023
30 slides from Novocure's conference presentation, Jun 6, 2023
Slide 1: ASCO Investor Event: Phase 3 LUNAR Data
novocure’ Novocure ASCO Investor Event Phase 3 LUNAR Data | June 6, 2023 patientforward”
Slide 2: Tumor Treating Fields are electric fields that exert physical forces to kill cancer cells
novocure’ Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells GRAVITATIONAL FIELDS MAGNETIC FIELDS ELECTRIC FIELDS exert force on masses exert force on iron & exert force on charges & other magnets polarized molecules cl patientforward” © 2023 Novocur
Slide 3: Versatile platform technology backed by 20 years of research
novocure versatile platform technology backed by 20 years of clinical and preclinical research IMMUNOTHERAPY Brain oo atezolizumab nl OTE pembrolizumab i an i. = nivolumab ung ; a : a NS e CHEMOTHERAPY es y \ eee Ovarian - a SS Neen carboplatin THIELDS : ees Pancreatic e won TaEATING FIELDS THERAPY
Slide 4: ASCO investor event agenda
novocure ASCO investor event | agenda |. Introduction William Doyle, Novocure Executive Chairman Il. LUNAR Presentation Dr. Ticiana Leal, M.D., Emory University lll. Panelist Q&A Session Dr. Ticiana Leal, M.D., Emory University Dr. Corey J. Langer, M.D., University of Pennsylvania Pritesh Shah, Novo
Slide 5: ASCO LUNAR phase 3 trial results presenters
ASCO LUNAR phase 3 trial results Dr. Ticiana Leal, M.D. LEAD AUTHOR Director, Thoracic Medical Oncology Winship Cancer Institute, Emory University Associate Professor, Department of Hematology & Oncology Winship Cancer Institute, Emory University Dr. Corey J. Langer, M.D. SENIOR AUTHOR Director of T
Slide 6: TTFields Therapy with SOC in Metastatic NSCLC: Phase 3 LUNAR Study
PRESENTED BY: Tumor Treating Fields (TTFields) Therapy with Standard of Care (SOC) in Metastatic Non-Small Cell Lung Cancer (mNSCLC) After Platinum-based Therapies: Randomized, Phase 3 LUNAR Study Ticiana Leal, MD, Winship Cancer Institute - Emory University Ticiana Leal1, Rupesh Kotecha2, Rodryg Ra
Slide 7: Background
PRESENTED BY: Background • Metastatic NSCLC remains largely incurable • Platinum-based chemotherapy with immune checkpoint inhibitors (ICIs) are standard first line therapy for metastatic NSCLC lacking actionable driver mutations1–3 • Unfortunately, most patients develop disease progression4–7 and 5
Slide 8: TTFields Mechanism of Action
PRESENTED BY: Tumor Treating Fields (TTFields) Mechanism of Action Dividing cancer cells TTFields Aneuploidy ER stress ICD Immune cell recruitmentAntigen presenting cell maturation HMGB1 release ATP release Calreticulin exposure (antigen uptake) Disruption of mitosis • TTFields are electric fields t
Slide 9: Preclinical Evidence
PRESENTED BY: Preclinical Evidence Ticiana Leal, MD, Winship Cancer Institute - Emory University PTX PTX + TTFields In Vitro Model1 150 100 50 0 0.01 0.1 1 10010 Paclitaxel (nM) R e la ti v e C e ll V ia b il it y ( % o f C o n tr o l) 300 0 200 100 Control + Isotype Control + Anti-PD-1 TTFields + I
Slide 10: TTFields Therapy
PRESENTED BY: TTFields Therapy • Noninvasive anticancer treatment modality • Delivered locoregionally to the chest by a wearable medical device and 2 pairs of arrays (adhesive bandages with biocompatible insulated ceramic discs covered by hydrogel)1 • Delivered to the patient’s home with 24/7 phone
Slide 11: LUNAR Phase 3 Study Design
PRESENTED BY: LUNAR Phase 3 Study Design Key eligibility criteria • ≥22 years of age • Metastatic NSCLC • Progression on/after platinum-based therapy • ECOG PS 0–2 Randomized (1:1) TTFields therapy* and SOC (Investigator’s choice ICI† or docetaxel) SOC (Investigator’s choice ICI† or docetaxel) Basel
Slide 12: LUNAR Study Endpoints and Statistical Analysis
PRESENTED BY: LUNAR Study Endpoints and Statistical Analysis Statistical Analysis • Targeted hazard ratio <0.75 using 2-sided proportional hazards testing (α=0.05) with 80% power, stratified by SOC treatment and histology • Key secondary endpoints were tested hierarchically if the primary endpoint w
Slide 13: Baseline Demographics and Characteristics
PRESENTED BY: TTFields + SOC (n=137) SOC (n=139) TTFields + ICI (n=66) ICI (n=68) TTFields + DTX (n=71) DTX (n=71) Age, yr - median (range) 63 (36–85) 65 (22–86) 64 (36–85) 65 (23–86) 63 (43–81) 65 (22–81) Sex, male 66% 63% 67% 66% 66% 59% Race White 81% 80% 82% 78% 80% 82% Asian 12% 9% 11% 7% 13% 1
Slide 14: Baseline Disease Characteristics
PRESENTED BY: Baseline Disease Characteristics TTFields + SOC (n=137) SOC (n=139) TTFields + ICI (n=66) ICI (n=68) TTFields + DTX (n=71) DTX (n=71) Histology Non-squamous/squamous 58%/42% 55%/45% 56%/44% 54%/46% 59%/41% 56%/44% PD-L1 <1% 17% 17% 18% 24% 16% 10% 1–49% 27% 29% 26% 27% 28% 31% ≥50% 7%
Slide 15: Overall Survival in the ITT Population
PRESENTED BY: Ticiana Leal, MD, Winship Cancer Institute - Emory University Overall Survival in the ITT Population TTFields + SOC (n=137) SOC (n=139) Median OS (95% CI), months 13.2 (10.3–15.5) 9.9 (8.1–11.5) 1-year survival (95% CI) 53% (44–61) 42% (34–50) 3-year survival (95% CI) 18% (11–27) 7% (2
Slide 16: Overall Survival in ICI-Treated Patients
PRESENTED BY: Ticiana Leal, MD, Winship Cancer Institute - Emory University Overall Survival in ICI-Treated Patients No. at Risk: TTFields + ICI 66 50 35 24 16 12 8 6 2 1 ICI 68 49 29 21 11 6 3 0 0 0 1.0 P ro b a b il it y o f O v e ra ll S u rv iv a l 0.8 0.6 0.4 0.2 0 0.9 0.7 0.5 0.3 0.1 0 6 12 48
Slide 17: Overall Survival in DTX-Treated Patients
PRESENTED BY: 1.0 0.8 0.6 0.4 0.2 0 0.9 0.7 0.5 0.3 0.1 0 6 12 48 544236302418 TTFields + DTX DTX Follow-up (Months) No. at Risk: TTFields + DTX 71 50 27 12 6 4 3 3 3 2 DTX 71 47 25 11 5 1 0 0 0 0 Ticiana Leal, MD, Winship Cancer Institute - Emory University Overall Survival in DTX-Treated Patients
Slide 18: Overall Survival by Histology Subgroups
PRESENTED BY: TTFields + SOC SOC 1.0 0.9 0.3 0.4 0.5 0.6 0.7 0.8 0.2 0.1 0.0 6 12 18 24 30 36 42 48 54 46 43 28 15 11 9 7 5 2 158 62 23 13 4 1 1 Months TTFields + SOC SOC No. at Risk 000SOC TTFields + SOC No. at Risk TTFields + SOC SOC 1.0 0.9 0.3 0.4 0.5 0.6 0.7 0.8 0.2 0.1 0.0 Months 6 12 18 24 30
Slide 19: Progression-free Survival in the ITT Population
PRESENTED BY: No. at risk: TTFields + SOC 137 44 17 9 SOC 139 40 21 9 Follow-up (Months) TTFields + SOC SOC 0 0 18126 1.0 P ro b a b il it y o f P ro g re s s io n -f re e S u rv iv a l 0.8 0.6 0.4 0.2 0.9 0.7 0.5 0.3 0.1 TTFields + SOC (n=137) SOC (n=139) Median PFS (95% CI), months 4.8 (4.1–5.7) 4
Slide 20: Response Rates in the ITT Population
PRESENTED BY: Response Rates in the ITT Population TTFields + SOC (n=137) SOC (n=139) Patients with a follow-up scan n=122 n=127 ORR, % (95% CI) 20% (14–28) 17% (11–25) Difference in ORR, % (95% CI) 3% (-8.5–15.0) P=0.5 Best overall response, % Complete response 3% 1% Partial response 18% 17% Stable
Slide 21: Safety and Tolerability
PRESENTED BY: Ticiana Leal, MD, Winship Cancer Institute - Emory University Safety and Tolerability TTFields + SOC (n=133) SOC (n=134) All grades Grade ≥3 All grades Grade ≥3 Any AE* 97% 59% 91% 56% Most frequent AEs Dermatitis 43% 2% 2% 0% Fatigue 28% 4% 37% 8% Musculoskeletal pain 36% 3% 27% 4% Dy
Slide 22: TTFields Adverse Device Effects (ADEs)
PRESENTED BY: Ticiana Leal, MD, Winship Cancer Institute - Emory University TTFields Adverse Device Effects (ADEs) Preferred term TTFields + ICI (n=67) TTFields + DTX (n=66) Any ADE* 73.1% 69.7% ADEs grade ≥3 4.5% 7.6% Dermatitis 1.5% 3.0% Pruritus 0 1.5% Skin ulcer 0 1.5% Pain 1.5% 0% Skin infectio
Slide 23: Conclusions
PRESENTED BY: Conclusions • Pivotal, phase 3 LUNAR study met its primary endpoint • TTFields therapy with SOC provided a statistically significant and clinically meaningful 3-month improvement in median OS vs SOC (HR: 0.74, P=0.035) with no added systemic toxicities Statistically significant ~8-mont
Slide 24: LUNAR study investigators and sites
PRESENTED BY: Austria: Medical University Salzburg; Belgium: Institut Jules Bordet, Hospital AZ Sint Maarten; Canada: McGill University Health Centre, Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS), Allan Blair Cancer Centre; Czech Republic: Thomayer Hospital, General University Hospital in
Slide 25: Phase 3 LUNAR Trial of TTFields with Standard of Care for Metastatic NSCLC
Phase 3 Trial of TTFields with Standard of Care for Metastatic Non-Small Cell Lung Cancer orward
Slide 26: Laying the foundation for NSCLC commercial launch
novocure laying the foundation for NSCLC commercial launch . 2024 2025 L COMMERCIAL LAUNCH * Activate physician and REGULATORY PATHWAY . , patient education CLINICAL DATA v UTES pre-PMA discussions programs y : with FDA * Treat on-protocol patients Announced topline results * Submit PMA & CE mark in
Slide 27: Label-expanding series of NSCLC trials enabled by TTFields platform
novocure label-expanding series of NSCLC trials, enabled by TTFields platform technology LOCALLY ADVANCED, UNRESECTABLE FIRST LINE i METASTATIC. KEYNOTE B36 Fields + \issdagocas pembrolizumab FIRST LINE LUNAR-2 TTFields + ICI + ‘ Lung Cancer chemotherapy ‘A i LUNAR-3_ TTFields + ICI, following x ' c
Slide 28: Numerous phase 3 trials set to readout by year-end 2024
novocure numerous phase S trials set to readout by year-end 2024 with opportunity to drive further clinical expansion LUNAR Lung Cancer METIS Brain Metastasis ENGOT-ov50/ INNOVATE-3 Ovarian Cancer pat entforward” © 2023 Novocure GmbH 29 PANOVA-3 Pancreatic Cancer
Slide 29: Together with our patients, we strive to extend survival
ther with our nat SUL IR LUE OU VOUS we strive to extend survim in some of the most da © 2023NoveeureGMb 30
Slide 30: ASCO Investor Event: Phase 3 LUNAR Data
novocure’ Novocure ASCO Investor Event Phase 3 LUNAR Data | June 6, 2023 patientforward’