Conference Call L-MIND data

Transcription

1 DECEMBER 12, 2017 Conference Call L-MIND data MorphoSys AG

2 Today on the Call Dr. Simon Moroney Dr. Malte Peters Jens Holstein Anke Linnartz CEO CDO CFO Head of Corporate Communications & IR MorphoSys AG, Investor and Analyst Call after ASH

3 This presentation includes forward-looking statements. Actual results could differ materially from those included in the forwardlooking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing. These and other risks and uncertainties are detailed in the Company s Annual Report. The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority. MorphoSys AG, Investor and Analyst Call after ASH

4 Agenda 1. INTRODUCTION 2. MOR208 THE DRUG CANDIDATE 3. L-MIND TRIAL DATA 4. Q&A 5. TAKE AWAY MESSAGES MorphoSys AG, Investor and Analyst Call after ASH

5 Dr. Simon Moroney Introduction MorphoSys AG, Investor and Analyst Call after ASH

6 Dr. Malte Peters MOR208 MorphoSys AG, Investor and Analyst Call after ASH

7 MOR208: Anti-CD19 studied in Hematological Cancers An Investigational Antibody Program for B Cell Malignancies BACKGROUND IgG1k antibody In-licensed from Xencor Humanized and affinity optimized with Xencor technology Fc-engineered for enhanced ADCC & phagocytosis MOR208 direct cytotoxicity ADCC MODE OF ACTION ADCC, phagocytosis, direct cytotoxicity STRONG PRECLINICAL PACKAGE Highly active as single agent in vitro and in vivo Strong rationale for multiple combination therapies Fc-enhancement ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity ADCP: Antibody-Dependent Cell-Mediated Phagocytosis ADCP W Jurczak et al.; ASH 2016 MorphoSys AG, Investor and Analyst Call after ASH

8 MOR208: Development Plan Opportunity Across Spectrum of B Cell Malignancies INDICATION TRIAL / PHASE DESIGN TIMELINE DLBCL L-MIND Phase 2 Lenalidomide + MOR208 (12mg/kg) in relapsed or refractory DLBCL pts ineligible for HDCT and ASCT; N=80 Under discussion with FDA (Q1 2018) B-MIND Phase 2/3 Bendamustine + MOR208 (12mg/kg) vs. bendamustine + rituximab in relapsed or refractory DLBCL pts ineligible for HDCT and ASCT; N~330 Primary endpoint: Q CLL COSMOS Phase 2 MOR208 (12mg/kg) + idelalisib in relapsed or refractory CLL BTKi-failures Updates at medical conferences 2018 MOR208 (12mg/kg) + venetoclax in relapsed or refractory CLL BTKi-failures DLBCL Front line Under evaluation Indolent lymphomas Under evaluation MorphoSys AG, Investor and Analyst Call after ASH

9 Lenalidomide with MOR208: Phase 2 in R/R DLBCL Official Title: A Phase 2, single-arm, open-label, multicentre study to evaluate the safety and efficacy of lenalidomide combined with MOR208 in patients with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL) MorphoSys AG, Investor and Analyst Call after ASH

10 L-MIND Study Design PATIENTS WITH R/R DLBCL: have received 1-3 prior regimens are not eligible for HDCT and ASCT Cycle 1-3 Cycle 4-12 MOR208 12mg/kg IV Days 1,8,15,22 Lenalidomide MOR208 12mg/kg IV Days 1,15 Disease control ( SD) Additional antibody treatment phase MOR208 12mg/kg IV Days 1,15 Survival follow-up 25mg PO Days 1-21 Response assessment after cycles 2, 4, 6 and 12, thereafter every 3 cycles. ASCT, autologous stem cell transplant; HDCT, high-dose chemotherapy; R/R DLBCL, relapsed or refractory diffuse large B cell lymphoma; SD, stable disease, IV, intravenous; PO, per os. MorphoSys AG, Investor and Analyst Call after ASH

11 L-MIND Baseline Characteristics CHARACTERISTIC N (%) N=51 Age, years Median (range) 73.5 (47-82) Sex Female/Male 27 (53) /24 (47) Ann-Arbor III-IV 30 (59) ECOG-PS (92) 2 3 (6) Currently unknown 1 (2) R-IPI Intermediate (1-2) 21 (41) Poor (3-5) 24 (47) Currently unknown 6 (12) Prior therapies 1 26 (51) 2 24 (47) Currently unknown 1 (2) LDH level Elevated 28 (55) Not elevated 18 (35) Currently unknown 5 (10) Refractory to rituximab Yes 18 (27) Currently unknown 3 (6) Refractory to last prior line Yes 20 (39) Currently unknown 3 (6) Prior ASCT Yes 2 (5) First relapse post diagnosis <12 months 8 (16) >12 months 30 (59) Currently unknown 13 (25) MorphoSys AG, Investor and Analyst Call after ASH

12 Best Overall Response (%)** L-MIND Response Rates MOR208 + Lenalidomide: ORR of 52% in a Phase 2 Study in R/R DLBCL* Patients 100 n=44 NE: 14% (n=6) 80 PD: 21% (n=9) 60 SD: 14% (n=6) 40 PR: 20% (n=9) 20 : 32% (n=14) Objective response rate (ORR): 52% 0 *R/R= relapsed/refractory; DLBCL = Diffuse Large B-cell Lymphoma. ** Differences due to rounding, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease. Single-Arm phase 2 study of MOR208 combined with lenalidomide in patients with R/R DLBCL: L-MIND, ASH Abstract 2017 as of November 1, 2017 MorphoSys AG, Investor and Analyst Call after ASH

13 Long Duration of Response 19 (83%) of 23 responder patients still on treatment with ongoing responses Best Overall Response SD PR PR PR PR PR SD SD PR PR PR PR SD SD SD PD PD PD NE PD NE PD PD NE PD PD NE NE NE NE Time on Study (months) MorphoSys AG, Investor and Analyst Call after ASH

14 Median Progression Free Survival of 11.3 months Preliminary Analysis (Kaplan Meier) Salles et al., ASH 2017 MorphoSys AG, Investor and Analyst Call after ASH

15 Comparison of Previous Lenalidomide Approaches in R/R DLBCL Comparison to Literature Data* L-MIND MOR208 + LEN Salles et al., 2017** LEN mono Witzig et al LEN mono Czuzcman et al RTX + LEN Wang et al OBI + LEN Morschhauser et al. ASH 2016 Number of patients N=44 N=108 N=51 N=32 N=71 ORR 52% 28% 28% 28% 45% 32% 7% 10% 22% 16% median PFS, month 11.3 (preliminary) *Please note limitations of cross-trial comparisons. ** Cut-off date June 13, 2017 R/R= relapsed/refractory; DLBCL = Diffuse Large B-cell Lymphoma, LEN, lenalidomide; RTX, rituximab; OBI, obinutuzumab;, complete response;; ORR, objective response rate; PFS, progression-free survival;. MorphoSys AG, Investor and Analyst Call after ASH

16 Existing and Upcoming Approaches in R/R DLBCL Comparison to Literature Data* Parameter L-MIND Salles et al., 2017** Dang et al., 2014 Sehn et al., 2017 Scholar-1 Crump et al., 2017 Juliet Schuster et al Zuma-1 Neelapu et al., 2017 Compound(s) MOR208 + lenalidomide RTX + bendamustine Polatuzumab + RTX + bendamustine Salvage chemotherapies + radiation Tisagenlecleucel (CTL019) Axi-CEL (CD19 CAR-T) Phase II III II Retrospective study II II Evaluable patient population R/R DLBCL n=44 R/R DLBCL n=135 R/R DLBCL n=40 R/R DLBCL n=635 R/R DLBCL n=81 R/R DLBCL n=101 Objective response rate 52% 49% 70% 26% 53%/37% Best/@6M 82%/48% Best/@6M Complete response rate Median PFS, months Median overall survival, months 32% 18% 58% 8% 40%/30% Best/@6M 11.3 (preliminary) 54%/ 46% Best/@6M n/a NR**** NR NR*** *Please note limitations of cross-trial comparisons. **Cut off June 13, ***NR = not reached. MorphoSys AG, Investor and Analyst Call after ASH

17 MOR208/Lenalidomide Safety Evaluation Most commonly reported TEAEs occurring in 8% of patients; n (%) N=51. Neutropenia Anemia Thrombocytopenia Diarrhea Rashes Pyrexia Leukopenia Asthenia Cough Nausea Pneumonia Hypokalemia Bronchitis Urinary tract infection Hypotension Creatinine increased Vomiting Cramps Patients (%)* 14 Grade 1/2 Grade 3 Grade 4 Most frequently observed adverse event was neutropenia (36%) No infusion-related reactions were reported for MOR208 Addition of MOR208 did not result in increased lenalidomide toxicity Lenalidomide dose reductions were required in 45% of patients * Differences due to rounding MorphoSys AG, Investor and Analyst Call after ASH

18 Upcoming Events and Potential Newsflow MOR208 MOR208 October 2017 FDA granted Breaktrough Therapy Designation End of 2017 Recruitment for L-MIND complete (analysis ongoing) Q Update on Breakthrough Therapy designation 2018 Complete Analysis L-MIND 2018 CLL phase 2 data 2018 B-MIND Interim analysis* *Including futility analysis. No publication of data expected. MorphoSys AG, Investor and Analyst Call after ASH

19 Q&A-Session MorphoSys AG, Investor and Analyst Call after ASH

20 Dr. Simon Moroney Take-Away Messages MorphoSys AG, Investor and Analyst Call after ASH

21 Take-Away Messages MOR208 HAS THE POTENTIAL TO OFFER A NEW TREATMENT OPTION IN R/R DLBCL MOR208 combination with lenalidomide in R/R DLBCL showed an objective response rate (ORR) of 52% and a complete remission rate () of 32% The preliminary median progression-free survival mounts up to 11.3 months No unexpected toxicities were observed for the combination and no infusion-related reactions were reported for MOR208 INTENTION TO BRING MOR208 TO MARKET AS QUICKLY AS POSSIBLE Based on preliminary L-MIND data FDA granted Breakthrough Therapy Designation in Oct FDA now grants support by a senior management team and helps to streamline further development activities We are committed to develop MOR208 in close interaction with the FDA as quickly as possible MorphoSys AG, Investor and Analyst Call after ASH

22 Thank You Anke Linnartz Head of Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / investors@morphosys.com MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational drugs and have not been approved by the FDA or other ex-us regulatory agencies. HuCAL, HuCAL GOLD, HuCAL PLATINUM, CysDisplay, RapMAT, aryla, Ylanthia, 100 billion high potentials, Slonomics, Lanthio Pharma and LanthioPep are registered trademarks of the MorphoSys Group. Tremfya TM and STELARA are trademarks of Janssen Research & Development, LLC; Humira is a trademark of Abbvie Inc.; Cosentyx is a trademark of Novartis AG; Dupixent is a trademark of Sanofi Biotechnology; Cimzia is a trademark of UCB Pharma, S.A.; Enbrel is a trademark of Immunex Corporation/Wyeth LLC; Remicade is a trademark of Janssen Biotech, Inc./Centocor Inc.; Simponi is a trademark of Johnson & Johnson; Siliq is a trademark of Amgen Inc.; Taltz is a trademark of Eli Lilly and Company. MorphoSys AG, Investor and Analyst Call after ASH