Investor Meetings October 2018
|
|
- Gertrude Floyd
- 5 years ago
- Views:
Transcription
1 Investor Meetings October 2018
2 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this presentation include, among others, statements regarding the potential size of the current and future market opportunities for our various products and product candidates and our various assumptions related thereto, our lung cancer strategy, the design and expected timing of initiation, completion, and data readouts from our various ongoing and planned niraparib, TSR-042, TSR-033, TSR-022, and combination studies, the expected timing of various regulatory filings, and potential indications for our products and product candidates. Forward-looking statements in this presentation involve substantial risks and uncertainties that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks related to competition, the uncertainties inherent in the execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from clinical trials, uncertainties surrounding our ongoing discussions with and potential actions by regulatory authorities, risks related to manufacturing and supply, risks related to intellectual property, uncertainties related to our projected expenses, and other matters that could affect the availability or commercial potential of our products and product candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended June 30,
3 Building a Leading Oncology Company Robust Oncology Portfolio Led by ZEJULA ZEJULA PARP Inhibitor Approved in U.S. and Europe Development programs ongoing with monotherapy and combinations in gynecologic and lung cancers TSR-042 anti-pd-1 TSR-022 anti-tim-3 TSR-033 anti-lag-3 Registration trial ongoing; BLA on track for 2H 2019 Enables strategic development and commercial flexibility in combination with ZEJULA, TSR-022, TSR-033 TSR-042 combination trial ongoing Anti-PD-1 experienced NSCLC patients TSR-042 combination trial ongoing Multiple tumor types TSR-075 anti-pd-1/lag-3 bispecific IND-enabling studies Multiple tumor types NSCLC: Non-small Cell Lung Cancer 3
4 Development Strategy Focused on Gynecologic and Lung Cancers Gynecologic Cancers: Ovarian, Endometrial Lung Cancer Ovarian Expand current ZEJULA label to treatment setting Move into front line Endometrial No approved drug in 2L endometrial Current agents provide 10-14% ORR Lung cancer Despite the availability of anti-pd-1 therapy, a large number of patients do not respond in the front-line setting anti-pd-1 monotherapy is now standard of care in patients with TPS >50% 2 nd /3 rd line PD-1 experienced market opportunity is growing rapidly ZEJULA (PARP) TSR-042 (PD-1) ZEJULA and TSR-042 Partnerships & Collaborations (Prostate, Bladder, Breast, Pancreatic) TPS: Tumor Proportion Score 4
5 ZEJULA Strategy to Expand PARPi Maintenance Use Aligned with KOLs to Drive Awareness to Providers & Patients Leverage KOL Awareness and Support Engagement of Providers Activation of Patients Collaborations in place with ovarian cancer thought leaders to raise awareness through several new initiatives: Publication of real-world evidence NCCN engagement to better reflect the importance of PARPi maintenance KOL position papers supporting maintenance treatment Launching unbranded peer-to-peer programs to engage community oncologists Engaging with EMR vendors and provider organizations to develop workflow and care plan enhancements that facilitate maintenance therapy decisions Expanded investment in Continuing Medical Education (CME) Launching new PR campaign to inform and educate patients & families Partnering with advocacy groups to encourage dialogue with physicians EU ZEJULA launch experience supports growth opportunity for U.S. PARPi adoption. 5
6 ZEJULA New Indications Would Address Every Stage of a Women s Journey with Ovarian Cancer OVARIAN CANCER PATIENT JOURNEY 1 st Line 2 nd Line 3 rd Line 4 th, 5 th, 6 th Line+ Treatment Maintenance Treatment Recurrent Maintenance Treatment Recurrent Maintenance Treatment Recurrent Maintenance ZEJULA clinical trials FIRST PRIMA OVARIO NOVA NOVA QUADRA NOVA AVANOVA AVANOVA AVANOVA TOPACIO Follow-on Study: Platinum Resistant Ovarian Cancer (ZEJULA +TSR-042) Women who respond to platinum for <6 months are considered platinum-resistant Current ZEJULA indication Fully enrolled / completed trials Enrolling / expected to enroll patients by year-end TSR-042: anti-pd-1 antibody; AVANOVA trial in collaboration with ENGOT 6
7 ZEJULA NOVA Study Primary Endpoint PFS Results 42% of patients estimated without progression or death 24 months following the start of chemotherapy gbrcamut Cohort 27% of patients estimated without progression or death 24 months following the start of chemotherapy Non-gBRCAmut Cohort Progression free Survival (%) Niraparib Placebo Progression free Survival (%) Niraparib Placebo Time Since Randomization (months) Time Since Randomization (months) Treatment Niraparib (N=138) Placebo (N=65) PFS Median (95% CI) (Months) Hazard Ratio (95% CI) p-value 21.0 (12.9, NR) (3.8, 7.2) (0.173, 0.410) p< % of Patients without Progression or Death 12 mo 18 mo 62% 50% 16% 16% Treatment Niraparib (N=234) Placebo (N=116) PFS Median (95% CI) (Months) Hazard Ratio (95% CI) p-value 9.3 (7.2, 11.2) (3.7, 5.5) (0.338, 0.607) p< % of Patients without Progression or Death 12 mo 18 mo 41% 30% 14% 12% Overall Survival (<20% patient deaths) HR 0.73 (95% CI, to 1.125; p=0.1545) PFS was analyzed using a 2-sided log-rank test using randomization stratification factors, and summarized using the Kaplan-Meier 7 methodology; Hazard ratios with 2-sided 95% confidence intervals were estimated using a stratified Cox proportional hazards model, with the stratification factors used in randomization
8 ZEJULA Moving to 1 st Line with PRIMA Ovarian Cancer With High Risk for Progression, Stage 3 or 4 (N=733) CR or PR Following Platinum Based Chemotherapy Enrolled 1 st line patients regardless of BRCA status Stratify on HRD (2:1 randomization) Niraparib 200 mg Daily Treatment 1 Placebo Daily Treatment 200 mg starting dose for most patients based on body weight & platelet count Blinded, pooled interim safety data at ESMO Primary Endpoint Endpoint Assessment Progression-free Survival (PFS) Top-line data expected in late 2019 Secondary Endpoints OS PFS2 Patient reported outcomes Safety & Tolerability Time to CA-125 progression 1 Trial was amended to incorporate a starting dose of 300 mg for patients 77 kg (170 lbs) and platelets 150K/uL, with a 200mg starting dose for all others 8
9 ZEJULA AVANOVA: Niraparib + Bevacizumab Recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer w/high-grade serous/endometrioid histology Phase 1, N = 12 Phase 2, N=94 Stratify on HRD and PFI (>6-12 months or 12+ months) Objectives Phase 1/2 AVANOVA Trial Niraparib + Bevacizumab Niraparib: 300mg Bevacizumab: 15mg/kg Niraparib: 300mg Phase 1: Safety and tolerability of bevacizumabniraparib combination Phase 2: Progression-Free Survival (PFS) in niraparib vs. niraparib + bevacizumab Potentially synergistic activity via simultaneous inhibition of antiangiogenesis and DNA repair Chemotherapy free treatment regimen Goal to improve PFS with bevacizumab or niraparib monotherapy Supported by VEGFi + PARPi exploratory work (Avastin and others) Promising initial combination activity observed in AVANOVA Update of Phase 1 data at ESMO 2017 Disease control rate of 92% 6/12 (50%) ORR, including 1 CR and 5 PRs Median progression-free survival (PFS) was 49 weeks Phase 2 is ongoing 80% power for HR 0.57 (8 vs. 14 months) Phase 2 data in 1H 2019 Initial data presented at ASCO 2016, abstract 5555 AVANOVA is an Investigator Sponsored Trial (IST) SD: Stable disease CRC: Colorectal cancer HR: Hazard ratio GBM: Glioblastoma multiforme 9
10 TSR-042 Registration Strategies Focuses on Endometrial Cancers Accelerated Approval (U.S.) Population Endometrial Cancer 2L/3L Endometrial Cancer (GARNET) Includes MSS (70-75%) and MSI-H (25-30%) endometrial cancer ~7,600 patients treated in U.S ~7,600 patients treated in EU MSI-H Endometrial, MSI-H Colorectal and other MSI-H Tumors (GARNET) 2L/3L MSI-H Endometrial 2 MSI-H Cancers 3L/4L MSI-H Colorectal & Other MSI-H Tumors Phase 3 Randomized 1L Endometrial Cancer MSI-H Endometrial, MSI-H Colorectal and other MSI-H Tumors Full Approval Populations Includes MSS and MSI-H patients ~11,000 patients treated in U.S. ~11,000 patients treated in EU 2L/3L MSI-H Endometrial 2 3L/4L MSI-H Colorectal & Other MSI-H Tumors U.S. Market Opportunity: 1 $500M (2L/3L) to $1.5B (1L) Endometrial Cancer is an Area of High Unmet Need with No FDA Approved Therapies in 2L Endometrial 1 Based on market pricing of FDA approved anti-pd-1 therapies; 2 MSI-H Endometrial accounts for ~50% of MSI-H tumors Kantar Health estimated 2018 epidemiology numbers MSI-H: microsatellite instability-high 10
11 TSR-042 is the Foundation of our Lung Strategy PARP PD-1 TIM-3 Niraparib TSR-042 TSR-022 ZEJULA+ TSR-042 in 1L (JASPER) Data 1H 19 GARNET: 2L NSCLC n=65 Data Q4 18 P2 TSR-042 vs. SOC in 1L NSCLC FPI Q1 19 2/3L TSR TSR-022 in PD-1 experienced (AMBER) Data Q4 18 & 1H 19 Data to Guide Potential Registration Opportunities >450 patients, including >120 lung cancer patients have been treated with TSR
12 NSCLC Treatment Landscape Patients Treated Annually 1 TPS <49% 2/3 of 1L patients TPS 50% ~1/3 of 1L patients PD-1 Monotherapy PD-1 + Chemo First Line 110,000 (US) 135,000 (EU5) Platinum Containing Chemo Regimen PD-1 + Platinum Containing Chemo Regimen PD-1 Monotherapy TPS 50% KEYNOTE 024 (n=305) KEYNOTE 042 (n=1,274) KEYNOTE 189 (n=616) 2nd / 3rd Line 115,000 (US) 110,000 (EU5) PD-1 Monotherapy Platinum Containing Chemo Regimen ORR 45% 39.5% 61.4% mpfs 10.3 months 7.1 months 9.4 months Single-agent Chemo (e.g. docetaxel) PD-1 Experienced Efficacy Benchmarks ORR Single-agent Chemo (docetaxel) 3 ~10% Market research with KOLs and community oncologists support physician preference for PD-1 monotherapy in majority of first-line TPS 50% patients 2 Entinostat (HDACi) + pembrolizumab 4 10% (7/72) Durvalumab + tremelimumab 5 5% (4/78) Sitravatinib (TKI) + nivolumab 6 26% (6/23) mpfs: median PFS; NSCLC: Non-small cell lung cancer; TPS: Tumor Proportion Score 1 Stage IIIb and IV NSCLC excluding ALK/EGFRm patients, Kantar Health estimated 2018 epidemiology numbers; 2 IPSOS Oncology Monitor NSCLC, primary market research studies, external market research; 3 docetaxel PI studies TA317 and TAX320; 4 Hellmann et al.,wclc 2018; 5 Garon et al., ASCO 2018; 6 Mirati corp. presentation, includes unconfirmed responses; KEYNOTE 024, 042: squamous + non-squamous; KEYNOTE 189: non-squamous only 12
13 GARNET Data: 2/3L Lung Results by TPS Status Best Percent Change in Sum of Target Lesion Dimensions from Baseline (AACR 2018) 2L+ NSCLC GARNET TSR-042 TPS 0 TPS 1 49% TPS >50% and NA 50% 30% PD PD Ongoing Treatment Discontinued N 2/7 2/8 3/6 ORR [1,2] (%) 29% 25% 50% Percent Change 10% -10% -30% -50% -70% -90% SD SD PD SD SD SD PD SD 1 Opdivo USPI 2 Keytruda USPI 3 ASCO 2016; Abs # 9015 PD = progressive disease; PR = partial response; SD = stable disease; TPS: Tumor Proportion Score MSI-H EC = microsatellite instability-high endometrial cancer; R2PD = recommended phase 2 dose. SD SD SD SD PR PR PR Reference Data: Previously treated NSCLC ORR 20% (Checkmate - 017, squamous) 1 ORR 19% (Checkmate non-squamous) 1 ORR 18% (KN-010, TPS >1%, 2mg/kg) 2 PR PR PR PR 30% Decrease 2L+ NSCLC Keynote -010 Pembrolizumab TPS 0 TPS 1 49% TPS >50% ORR 3 (%) NA ~9 16% ~23 34% NSCLC irorr of ~29% [2,3] is similar ORR of approved anti-pd-1s; but is largely from a PD-L1 TPS < 50% population, demonstrating response rate not driven by PD-L1 status Data as of February 22, 2018 [1] Excludes patients that were not evaluable for tumor response [2] Includes both confirmed and unconfirmed responses [3] Patients who had at least 1 tumor assessment or did not have any tumor assessment but discontinued treatment NA = TPS status not available 13
14 Mechanisms by Which ZEJULA Could Potentiate an Immune Response DNA Repair Immunologically COLD Tumor PARP Inhibition Niraparib PARP Inhibition PD-1 Blockade TSR-042 Immune System Evasion Immunologically HOT Tumor Limited or no presence of activated anti-tumor immune cells in the tumor and a suppressive TME Presence of activated anti-tumor lymphocytes in the tumor and a supportive TME TME: tumor microenvironment *Brown, BJC
15 ZEJULA Rationale in Lung Cancer Effective in platinum responsive ovarian cancer (OC); lung cancer is a platinum responsive disease Both ovarian and lung cancers have high rates of HRD that infer platinum and PARPi sensitivity 1 Demonstrated activity in preclinical lung cancer models and 2 of 2 NSCLC patients in Phase 1 had tumor regression, even at low dose of niraparib (40mg, 316d; 110mg 175d) 2 Demonstrated positive effect on immune system and combination activity with anti-pd-1 in non-clinical models shows activity TOPACIO data indicative of potential positive clinical benefit from PARP + anti-pd-1 combination Phase 2 JASPER Trial 1L NSCLC Goal: Evaluate Safety and Efficacy of Niraparib + PD-1 PD-L1 TPS 50% Niraparib + anti-pd-1 mab Expression Frequency Low BRCA1/2 a 69% Low ERCC1 b 50% ATM loss c 40% PTEN loss d 20-30% Low MSH2 b 18-38% FA methylation e 14% ERCC1 low NSCLC further sensitized to niraparib 1. Marquard et al, Postel-Vinay Nature Rev Clin Onc 9: ; Postel-Vinay Oncogene , Lee et al Clin Can Res 13:832; 2. Sandhu et al Lancet Onc 2013; a. Clin Cancer Res ; b. Nat Rev Clin Onc 9: , c, oncotarget 2016 Villaruz et al, d, Rehman et al Nat Rev Clin Onc 7: , e, Oncogene 23:
16 JASPER Study: Preliminary Stage 1 Data for Niraparib in Combination with Anti-PD-1 in 1L NSCLC in Patients with TPS 50% Best Percent Change in Sum of Target Lesion from Baseline Objective responses by RECIST criteria following treatment with niraparib + pembrolizumab 16
17 TIM-3 is a Key Immune Checkpoint and a Next Generation Cancer Immunotherapy Target TIM-3 biology has been Implicated in T Cell Exhaustion AND Immune Suppression Mediated by Regulatory T Cells and Myeloid Cells CD4/8+ T Cell Exhaustion Myeloid Cells TIM-3 is expressed on macrophages and can also influence MDSC activity in TME* Dendritic Cells Regulatory T Cells T-cell TIM-3 negatively regulates T cell activation and is a marker of exhausted T cells TIM-3 is expressed on regulatory T cells and promotes survival and suppressive activity TIM-3 is expressed on tumor associated dendritic cells and may negatively regulate DC activation *TME = tumor microenvironment. Adapted from Anderson, A. Cancer Immunology Research
18 NSCLC Post-PD-1 Patient Case TSR anti-pd-1 combination dose escalation 63 year-old female diagnosed with Stage IV NSCLC Prior treatment included 1L chemotherapy, 2L anti-pd-1, 3L Tarceva TSR-022 (1 mg/kg) + anti-pd-1 >>> 72% shrinkage Feb Apr
19 AMBER Study: TSR-022 (anti-tim-3) + TSR-042 (anti-pd-1) in Post-PD-1 NSCLC Patients Part 1 TSR TSR-042 (500 mg) 300 mg 900 mg 100 mg Post-PD-1 NSCLC Data presentation at SITC Part 2 TSR TSR-042 (500 mg) Expansion Cohorts 100 mg 300 mg 900 mg = complete = enrolling *enrolled patients Patients must have progressed following treatment with an anti-pd(l)-1 antibody as assessed by the investigator Patients had median of 5 prior lines of therapy Biomarker Analysis: PD-L1, TIM-3, TMB 19
20 Several Key Milestones & Data Readouts Approaching 2H Gynecologic Lung Gynecologic Lung ESMO Congress: GARNET: MSI-H endometrial data with TSR- 042 PRIMA: blinded pooled interim safety data associated with a 200 milligram starting dose based upon baseline weight and platelet count SITC Annual Meeting: GARNET: TSR-042 data in NSCLC patients AMBER: TSR-022 plus TSR-042 combination initial data in post-pd-1 NSCLC CITRINO: TSR-033 monotherapy data QUADRA snda regulatory decision GARNET: TSR-042 data in MSS Endometrial patients submitted to SGO (Mar) AVANOVA P2 data of niraparib vs niraparib + bevacizumab in 1H 2019 PRIMA top-line data of niraparib in 1L OC in late 2019 BLA submission for TSR- 042 in 2H 2019 OVARIO top-line data of niraparib + bevacizumab in 1L OC in late 2019 Initial Phase 2 JASPER lung data with ZEJULA + TSR-042 in 1H 2019 Initiate Phase 2 registration enabling trial of TSR-042 versus standard of care in first-line NSCLC in early 2019 GARNET: final data for TSR-042 MSI-H and 2L Endometrial and NSCLC AMBER data for TSR TSR-042 CITRINO data TSR TSR-042 TSR-042: anti-pd-1; TSR-022: anti-tim-3; TSR-033: anti-lag-3 SITC: Society for the Immunotherapy of Cancers; BLA: Biologics License Application 20
21 Investor Meetings October 2018
Wells Fargo Healthcare Conference September 6, 2018
Wells Fargo Healthcare Conference September 6, 2018 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they are
More informationCiti s 13 th Annual Biotech Conference September 5, 2018
Citi s 13 th Annual Biotech Conference September 5, 2018 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they
More informationInvestor Call. May 19, Nasdaq: IMGN
Investor Call May 19, 2017 Nasdaq: IMGN Forward-Looking Statements This presentation includes forward-looking statements based on management's current expectations. These statements include, but are not
More informationEvercore ISI Conference November 29, 2017
Evercore ISI Conference November 29, 2017 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they are forward-looking
More informationDetermined to realize a future in which people with cancer live longer and better than ever before
Determined to realize a future in which people with cancer live longer and better than ever before 3Q 2018 EARNINGS PRESENTATION NOVEMBER 2018 1 Forward-looking statements disclosure This presentation
More informationLeerink Immuno-Oncology Roundtable Conference
Leerink Immuno-Oncology Roundtable Conference September 28, 2017 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private
More informationMerck ASCO 2015 Investor Briefing
Merck ASCO 2015 Investor Briefing Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation
More informationInvestor Webcast: Initial Data from Phase 1a/1b Trial of Cabiralizumab/OPDIVO and Early Efficacy Signal in Pancreatic Cancer.
Investor Webcast: Initial Data from Phase 1a/1b Trial of Cabiralizumab/OPDIVO and Early Efficacy Signal in Pancreatic Cancer November 8, 2017 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation
More informationMERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018
MERCK ONCOLOGY OVERVIEW ASCO 218 JUNE 4, 218 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes forward
More information33 rd Annual J.P. Morgan Healthcare Conference. January 2015
33 rd Annual J.P. Morgan Healthcare Conference January 2015 Forward-looking Statements This presentation contains forward-looking statements, which express the current beliefs and expectations of management.
More informationAccelerating our priorities and building our capabilities in Oncology GSK to acquire TESARO
Accelerating our priorities and building our capabilities in Oncology GSK to acquire TESARO 3 December 2018 Cautionary statements This presentation may contain forward-looking statements. Forward-looking
More informationDetermined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION JUNE 2017
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION JUNE 2017 1 Forward-looking statements disclosure This presentation contains forward-looking
More informationMERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018
MERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes
More informationDetermined to realize a future in which people with cancer live longer and better than ever before
Determined to realize a future in which people with cancer live longer and better than ever before 4Q 2016 EARNINGS PRESENTATION MARCH 2017 1 Forward-looking statements disclosure This presentation contains
More informationDetermined to realize a future in which people with cancer live longer and better than ever before Q Conference Call
Reimagining Cancer Treatment Determined to realize a future in which people with cancer live longer and better than ever before Q1 2016 Conference Call 1 Forward-Looking Statements Disclosure This presentation
More informationDetermined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017 1 Forward-looking statements disclosure This presentation contains
More informationInhibidores de PARP en cáncer de ovario
Inhibidores de PARP en cáncer de ovario Ma Pilar Barretina Ginesta Servicio Oncología Médica Hospital Universitari Dr. J. Trueta Institut Català d Oncologia Coordinación científica: Dr. Fernando Rivera
More informationCombining HS-110 and anti-pd-1 in NSCLC. September 1, 2015
Combining HS-110 and anti-pd-1 in NSCLC September 1, 2015 Forward Looking Statements This presentation includes statements that are, or may be deemed, forward-looking statements. In some cases, these forward-looking
More informationESMO PRECEPTORSHIP IN IMMUNO-ONCOLOGY
ESMO PRECEPTORSHIP IN IMMUNO-ONCOLOGY LUGANO, MAY 4-5, 2018 Clinical development in ovarian cancer C. Sessa, CH CONTENT Rationale for immunotherapy in ovarian cancer Clinical data with single agent immune
More informationCONSIDERATIONS IN DEVELOPMENT OF PEMBROLIZUMAB IN MSI-H CANCERS
CONSIDERATIONS IN DEVELOPMENT OF PEMBROLIZUMAB IN MSI-H CANCERS December 2017 Christine K. Gause, Ph.D Executive Director, Biostatistics. 2 Microsatellite Instability-High Cancer - USPI KEYTRUDA is indicated
More informationDawson James Conference
Dawson James Conference October 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV s current expectations regarding
More informationThird Quarter 2015 Earnings Call. November 9, 2015
Third Quarter 2015 Earnings Call November 9, 2015 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements
More informationNational Bank 8th Annual Quebec Conference TSX: IMV. May 30, IMV Inc. All rights reserved.
National Bank 8th Annual Quebec Conference TSX: IMV May 30, 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV Inc.
More informationAnalyst/Investor Call
Analyst/Investor Call November 20 th, 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV s current expectations
More informationRecurrent Ovarian Cancer Phase 1b Results
Recurrent Ovarian Cancer Phase 1b Results December 5 th, 2017 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect Immunovaccine
More informationMore cancer patients are being treated with immunotherapy, but
Bristol-Myers Squibb and Five Prime Present Phase 1a/1b Data Evaluating Cabiralizumab (anti-csf-1 receptor antibody) with Opdivo (nivolumab) in Patients with Advanced Solid Tumors PRINCETON, N.J. & SOUTH
More informationLonnie Moulder, CEO Leerink Global Healthcare Conference February 12, 2015
Lonnie Moulder, CEO Leerink Global Healthcare Conference February 12, 2015 Safe Harbor Statement Statements made in this presentation about TESARO, Inc. that are not descriptions of historical facts are
More informationSyndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab)
Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA (pembrolizumab) Ongoing ENCORE 601 biomarker analyses suggest enhanced clinical benefit in subpopulation
More informationClovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET
Clovis Oncology Announces Q3 2016 Operating Results and Corporate Update November 3, 2016 4:05 PM ET Rucaparib New Drug Application (NDA) accepted for Priority Review in the treatment of advanced BRCA-mutant
More informationFORWARD II PROGRAM UPDATE
FORWARD II PROGRAM UPDATE NASDAQ: IMGN May 17, 2018 FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements based on management's current expectations. These statements include,
More informationCorporate Presentation
Corporate Presentation Leerink Global Healthcare Conference February 14 th -15 th, 2018 C O N F I D E N T I A L a n d P R O P R I E T A R Y Forward Looking Statements / Safe Harbor This presentation contains
More informationPractical Guidance and Strategies for PARP Inhibition. Nicoletta Colombo, MD University of Milan-Bicocca European Institute of Oncology Milan, Italy
Practical Guidance and Strategies for PARP Inhibition Nicoletta Colombo, MD University of Milan-Bicocca European Institute of Oncology Milan, Italy Clinical Data Maintenance therapy : BRCA-mutated or all
More informationUse of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories
Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies Eric H. Rubin, MD Merck Research Laboratories Outline Pembrolizumab P001 study - example of multiple expansion
More informationCORPORATE PRESENTATION
CORPORATE PRESENTATION June 2017 FORWARD LOOKING SAFE HARBOR STATEMENT This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
More informationCorporate Presentation October 2018 Nasdaq: ADXS
Innovations in Immuno-Oncology Corporate Presentation October 2018 Nasdaq: ADXS Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements
More informationClovis Oncology Announces First Quarter 2017 Operating Results. May 3, :06 PM ET
Clovis Oncology Announces First Quarter 2017 Operating Results May 3, 2017 4:06 PM ET Strong Q1 launch quarter for Rubraca (rucaparib) in U.S. with $7M reported in net sales Clovis notified that ARIEL3
More informationJuly, ArQule, Inc.
July, 2012 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical
More informationCorporate Presentation September Nasdaq: ADXS
Corporate Presentation September 2018 Nasdaq: ADXS Forward-Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the ability and
More informationVAL-083: Validated DNA-targeting Agent for Underserved Cancer Patients. September 2018
VAL-083: Validated DNA-targeting Agent for Underserved Cancer Patients September 2018 Forward-Looking Statements Any statements contained in this presentation that do not describe historical facts may
More informationCORPORATE PRESENTATION. March 2017
CORPORATE PRESENTATION March 2017 Safe Harbor Statement To the extent that statements contained in this presentation are not descriptions of historical facts regarding TESARO, they are forward-looking
More informationFive Prime Therapeutics, Inc. Corporate Overview
Five Prime Therapeutics, Inc. Corporate Overview June 2015 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities
More informationTargeting the genetic and immunological drivers of cancer
NASDAQ: MRTX Targeting the genetic and immunological drivers of cancer Corporate Presentation April 2019 1 Safe Harbor Statement Certain statements contained in this presentation, other than statements
More informationGSK Oncology R&D Update
GSK Oncology R&D Update Axel Hoos, MD Senior Vice President, Oncology R&D February 2019 Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements.
More informationReimagining Cancer Treatment. Determined to realize a future in which people with cancer live longer and better than ever before
Reimagining Cancer Treatment Determined to realize a future in which people with cancer live longer and better than ever before Cantor Fitzgerald 2nd Annual Healthcare Conference July 13, 2016 Forward-Looking
More informationASCO Investor & Analyst Briefing. June 3, 2017
ASCO Investor & Analyst Briefing June 3, 2017 Safe Harbor Statement To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking
More informationNewLink Genetics Corporation
Cantor Fitzgerald 2018 Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK October 3, 2018 Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking
More informationFirst Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor
September 30, 2014 Positive Phase 3 Data for Opdivo (nivolumab) in Advanced Melanoma Patients Previously Treated with Yervoy @ (ipilimumab) Presented at the ESMO 2014 Congress First Phase 3 Results Presented
More informationNASDAQ & TSX: IMV. BIO Investor Forum. October IMV Inc. All rights reserved.
NASDAQ & TSX: IMV BIO Investor Forum October 2018 Forward-looking Statements Except for historical information, this presentation contains forward-looking statements, which reflect IMV s current expectations
More informationTARGET A BETTER NOW FORWARD-LOOKING STATEMENTS NASDAQ: IMGN. Current as of January 2018
NASDAQ: IMGN TARGET A BETTER NOW Current as of January 2018 FORWARD-LOOKING STATEMENTS This presentation includes forward looking statements based on management's current expectations. These statements
More informationAACR 2018 Investor Meeting
AACR 218 Investor Meeting April 16, 218 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute forward-looking statements for
More informationNewLink Genetics Corporation
Cantor Fitzgerald Global Healthcare Conference NewLink Genetics Corporation NASDAQ: NLNK September 25, 2017 Forward-Looking Disclaimer This presentation contains forward-looking statements of NewLink that
More informationDetermined to realize a future in which people with cancer live longer and better than ever before
Determined to realize a future in which people with cancer live longer and better than ever before 4Q 2017 EARNINGS PRESENTATION MARCH 2018 1 Forward-looking statements disclosure This presentation contains
More informationUpdate on PARP inhibitors: opportunities and challenges in cancer therapy
Update on PARP inhibitors: opportunities and challenges in cancer therapy Vanda Salutari Unità di Ginecologia Oncologica Fondazione Policlinico Universitario A. Gemelli vanda.salutari@policlinicogemelli.it
More informationDetermined to realize a future in which people with cancer live longer and better than ever before
Determined to realize a future in which people with cancer live longer and better than ever before 1Q 2018 EARNINGS PRESENTATION MAY 2018 1 Forward-looking statements disclosure This presentation contains
More informationPLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective
PLENARY SESSION 1: CLINICAL TRIAL DESIGN IN AN ERA OF HORIZONTAL DRUG DEVELOPMENT Industry Perspective Davy Chiodin, VP - Regulatory Science, QA and Compliance, Acerta Pharma (A Member of the AstraZeneca
More informationCorporate Presentation May Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers
Corporate Presentation May 2016 Transforming Immuno-Oncology Using Next-Generation Immune Cell Engagers Forward-looking statements / safe harbor This presentation and the accompanying oral commentary contain
More informationDetermined to realize a future in which people with cancer live longer and better than ever before 4Q18 EARNINGS PRESENTATION MARCH 2019
Determined to realize a future in which people with cancer live longer and better than ever before 4Q18 EARNINGS PRESENTATION MARCH 2019 Forward-looking statements disclosure This presentation contains
More informationNSCLC: immunotherapy as a first-line treatment. Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To)
NSCLC: immunotherapy as a first-line treatment Paolo Bironzo Oncologia Polmonare AOU S. Luigi Gonzaga Orbassano (To) The 800-pound gorilla Platinum-based chemotherapy is the SOC for 1st-line therapy in
More informationASCO Investor & Analyst Briefing May 30, 2015
ASCO Investor & Analyst Briefing May 30, 2015 1 Lonnie Moulder Co-Founder & CEO 2 Safe Harbor Statement Statements made in this presentation that are not descriptions of historical facts are forwardlooking
More informationCorporate Overview. June 2018 NASDAQ:FPRX
Corporate Overview June 2018 NASDAQ:FPRX Forward-Looking Statements Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
More informationDr. Josep M. Del Campo Clínica Diagonal. Barcelona
Dr. Josep M. Del Campo Clínica Diagonal. Barcelona Nuevas Oportunidades en Cáncer de Ovario Cancer de Ovario: Es una enfermedad única? Cáncer de Ovario: Tratamiento actual Tratamiento inicial: sin cambios
More informationADAPTIMMUNE INVESTOR PRESENTATION. August 2016
ADAPTIMMUNE INVESTOR PRESENTATION August 2016 DISCLAIMER This presentation contains forward-looking statements, as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA),
More informationBuilding a Premier Oncology Biotech
Building a Premier Oncology Biotech August 208 Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within
More informationLION. Corporate Presentation June 2016 BIOTECHNOLOGIES. Leadership & Innovation in Oncology
LION BIOTECHNOLOGIES Leadership & Innovation in Oncology Corporate Presentation June 2016 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private
More informationIMMUNOMEDICS, INC. November Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases November 2017 Forward-Looking Statements This presentation, in addition to historical information, contains certain
More informationESMO 2016 * Investor Meeting October 9, *European Society of Medical Oncology, October 7-11, 2016 ESMO 2016 NOT FOR PRODUCT PROMOTIONAL USE
ESMO 2016 * Investor Meeting October 9, 2016 *European Society of Medical Oncology, October 7-11, 2016 1 Forward-Looking Information During this meeting, we will make statements about the Company s future
More informationImmunotherapy for the Treatment of Head and Neck Cancers. Robert F. Taylor, MD Aurora Health Care
Immunotherapy for the Treatment of Head and Neck Cancers Robert F. Taylor, MD Aurora Health Care Disclosures No relevant financial relationships to disclose I will be discussing non-fda approved indications
More informationCelldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity in Patients with EGFRvIII-positive Recurrent Glioblastoma at SNO
November 24, 2013 Celldex Therapeutics' Rindopepimut Demonstrates Promising Clinical Activity in Patients with EGFRvIII-positive Recurrent Glioblastoma at SNO Strong interim survival trend (12.0 vs 7.9
More informationImmunotherapy for the Treatment of Head and Neck Cancers. Barbara Burtness, MD Yale University
Immunotherapy for the Treatment of Head and Neck Cancers Barbara Burtness, MD Yale University Disclosures AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim, Bristol-Myers Squibb, Merck & Co., Inc.,
More informationMerck Oncology Overview ASCO 2017
Merck Oncology Overview ASCO 217 June 5, 217 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the company ) includes forward-looking
More informationMerck Oncology Overview ASCO 2017
Merck Oncology Overview ASCO 217 June 5, 217 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the company ) includes forward-looking
More informationAnti-IL-33 (ANB020) Program
Anti-IL-33 (ANB020) Program Phase 2a Peanut Allergy Clinical Trial Interim Data Update March 26 th 2018 NASDAQ: ANAB Safe Harbor Statement This presentation and the accompanying oral presentation contain
More informationA New String to the Bow in the Treatment of Advanced Ovarian Cancer Bradley J. Monk, MD, FACS, FACOG
A New String to the Bow in the Treatment of Advanced Ovarian Cancer Bradley J. Monk, MD, FACS, FACOG Arizona Oncology (US Oncology Network) Professor, Gynecologic Oncology University of Arizona and Creighton
More informationNordic Society of Gynaecological Oncology
Nordic Society of Gynaecological Oncology - from a Nordic interest group to a global leader in clinical trials Line Bjørge 14. mars 2017 I 1 Profile NSGO is a non-political, non-profit society Nordic platform
More informationArQule Jefferies Global Healthcare Conference June 2015
ArQule Jefferies Global Healthcare Conference June 2015 1 ArQule Corporate Update Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning
More informationASCO 2018 Investor Meeting
ASCO 2018 Investor Meeting June 4, 2018 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute forward-looking statements for
More informationInducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy
Inducing Tumor-Specific Ischemic Necrosis to Enhance the Efficacy of Checkpoint Inhibitors and Chemotherapy Company Overview, September 2018 Safe Harbor Statement This presentation contains forward-looking
More informationNOVEL CHECKPOINTS IN IMMUNO-ONCOLOGY KIR NKG2A. C5aR. NKp46 HALF-YEAR RESULTS. Tumor antigen KIR3DL2 CD39 MICA/B CD73 SEPTEMBER 18, 2017
NOVEL CHECKPOINTS IN IMMUNO-ONCOLOGY KIR NKG2A NKp46 C5aR Tumor antigen HALF-YEAR RESULTS KIR3DL2 MICA/B CD73 CD39 SEPTEMBER 18, 2017 Page 2 FORWARD LOOKING STATEMENT This document has been prepared by
More informationMerrimack Pharmaceuticals: A Refocused R&D Company January 2017
Merrimack Pharmaceuticals: A Refocused R&D Company January 2017 Forward Looking Statements This presentation contains forward-looking statements of the Company that involve substantial risks and uncertainties.
More informationDetermined to realize a future in which people with cancer live longer and better than ever before
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION JULY 2018 1 Forward-looking statements disclosure This presentation contains forward-looking
More information8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 Weeks
October 19, 2017 OncoSec Presents Positive Phase 2 Data for ImmunoPulse IL-12 in Combination with Pembrolizumab Demonstrating a Best Overall Response Rate (BORR) of 50% in Predicted Anti-PD-1 Non- Responder
More informationThe OReO Study. Study design & Protocol Study design Key Inclusion criteria Patient population Recruitment and retention tools
The OReO Study A Phase IIIb, Randomised, Double-blind, Placebo-controlled, multi-centre Study of Olaparib Maintenance Re-treatment in Patients with Epithelial Ovarian Cancer Previously treated with a and
More informationMetastatic NSCLC: Expanding Role of Immunotherapy. Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian
Metastatic NSCLC: Expanding Role of Immunotherapy Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian Disclosures: No relevant disclosures Please note that some of the studies reported in
More informationPost-ASCO Immunotherapy Highlights (Part 2): Biomarkers for Immunotherapy
Post-ASCO Immunotherapy Highlights (Part 2): Biomarkers for Immunotherapy Lee S. Schwartzberg, MD, FACP Chief, Division of Hematology Oncology; Professor of Medicine, The University of Tennessee; The West
More informationARQ 087 Overview. FGFR Inhibitor. March 2017
ARQ 087 Overview FGFR Inhibitor March 2017 Safe Harbor This presentation and other statements by ArQule contain forward-looking statements within the meaning of the Private Securities Litigation Reform
More informationBiomarkers in Imunotherapy: RNA Signatures as predictive biomarker
Biomarkers in Imunotherapy: RNA Signatures as predictive biomarker Joan Carles, MD PhD Director GU, CNS and Sarcoma Program Department of Medical Oncology Vall d'hebron University Hospital Outline Introduction
More informationQ Financial Update November 6, 2018 NASDAQ:FPRX
Q3 2018 Financial Update November 6, 2018 NASDAQ:FPRX 2 Forward-Looking Statements Disclaimer Forward-looking statements contained in this presentation include statements regarding (i) the timing of initiation,
More informationBuilding a Leading Oncology Franchise
ASDAQ: MEIP Building a Leading Oncology Franchise 17th Annual eedham Healthcare Conference March 27, 2018 Forward-Looking Statements This presentation contains, and our officers and representatives may
More informationIMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics
IMMUNOMEDICS, INC. Advanced Antibody-Based Therapeutics Oncology Autoimmune Diseases Rodman & Renshaw 19 th Annual Global Investment Conference Michael R. Garone, Principal Executive Officer and CFO Forward-Looking
More informationII sessione. Immunoterapia oltre la prima linea. Alessandro Tuzi ASST Sette Laghi, Varese
II sessione Immunoterapia oltre la prima linea Alessandro Tuzi ASST Sette Laghi, Varese AGENDA Immunotherapy post-chemo ( true 2/3L ) Immunotherapy in oncogene addicted NSCLC (yes/no? when?) Immunotherapy
More informationOncoSec Provides 2018 Business Outlook
January 3, 2018 OncoSec Provides 2018 Business Outlook Complete stage 1 enrollment of PISCES/KEYNOTE-695 clinical trial of ImmunoPulse IL-12 in combination with KEYTRUDA (pembrolizumab) Present preliminary
More informationCalithera Biosciences. January 2019
Calithera Biosciences January 2019 Forward-Looking Statements This presentation and the accompanying oral commentary contain forward looking statements for purposes of the safe harbor provisions of the
More informationThe Current Status of Immune Checkpoint Inhibitors: Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb
The Current Status of Immune Checkpoint Inhibitors: A Global Overview of the Field Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb Immune Checkpoint Inhibitors Conference, March
More informationFOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND BUSINESS UPDATE. Thursday, February 7, 2019
FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND BUSINESS UPDATE Thursday, February 7, 2019 Today s Speakers Overview and Key Highlights Clay Siegall, President & CEO Financial Results and Guidance
More informationSpectrum Pharmaceuticals
Spectrum Pharmaceuticals Joe Turgeon President and CEO June 2018 Investor Presentation 1 Safe Harbor Statement This presentation contains forward looking statements regarding future events and the future
More informationMerck Oncology Overview. The Development of MSI-H Cancer Therapy. Development of Anti-Cancer Drugs Forum Tokyo, Japan, 18, February 2017
Merck Oncology Overview The Development of MSI-H Cancer Therapy Development of Anti-Cancer Drugs Forum Tokyo, Japan, 18, February 217 Andrew Joe, MD Executive Director, Late Stage Oncology Merck & Co.,
More informationConversations in Oncology. November Kerry Hotel Pudong, Shanghai China
Conversations in Oncology November 12-13 Kerry Hotel Pudong, Shanghai China Immunotherapy of Lung Cancer Professor Caicun Zhou All materials are for scientific exchanges. Afatinib and nintedanib are not
More informationMOLOGEN AG. Pioneering Immune Therapy. Annual Results Analysts Call March 25, 2014
Pioneering Immune Therapy Annual Results 2013 Analysts Call March 25, 2014 Disclaimer Certain statements in this presentation contain formulations or terms referring to the future or future developments,
More informationFrédéric Triebel MD, PhD World Immunotherapy Congress Basel, October 30, 2018
Two ACTive immunotherapies in melanoma (TACTI-mel): results of a phase I trial combining a soluble LAG-3 receptor (Eftilagimod Alpha) with Pembrolizumab Frédéric Triebel MD, PhD World Immunotherapy Congress
More informationRubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer Rubraca is now indicated as maintenance treatment for women with recurrent ovarian cancer who are in a complete
More information