Verastem, Inc. · NASDAQ:VSTM
Verastem — Corporate Update (September 2018)
29 slides from Verastem's corporate update, Sep 24, 2018
Slide 1: We Stand United for Blood Cancer Awareness
PROPERTY OF VERASTEM, INC. – NOT FOR DISTRIBUTION OR DISSEMINATION WE STAND UNITED FOR BLOOD CANCER Conference call to discuss FDA AWARENESS approval of COPIKTRA™ (duvelisib) September 24, 2018 MONTH
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation includes forward-looking statements about, among other things, Verastem Oncology’s products and product candidates, including anticipated regulatory submissions, approvals, performance and potential benefits of Verastem Oncology products and product can
Slide 3: Introduction
3 Introduction Robert Forrester Chief Executive Officer PROPERTY OF VERASTEM, INC. – NOT FOR DISTRIBUTION OR DISSEMINATION
Slide 4: Now Available: first approved dual PI3K delta and gamma inhibitor
The first approved dual inhibitor of PI3K delta and gamma is NOW AVAILABLE COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Relapsed
Slide 5: Selected Important Safety Information
Selected Important Safety Information WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infecti
Slide 6: COPIKTRA (duvelisib) capsules
6 COPIKTRA™ (duvelisib) capsules Dan Paterson Chief Operating Officer PROPERTY OF VERASTEM, INC. – NOT FOR DISTRIBUTION OR DISSEMINATION
Slide 7: Duvelisib clinical development as a monotherapy
Duvelisib clinical development as a monotherapy 7 SCIENTIFIC HYPOTHESIS UNMET NEED Unique dual PI3K inhibition results in For patients with chronic indolent monotherapy efficacy with a lymphoma progressing on treatment, consistent safety profile additional therapy options are needed δ & γ (gamma) 1
Slide 8: Pivotal trials for duvelisib monotherapy in indolent NHL
Pivotal trials for duvelisib monotherapy in indolent NHL 8 A phase 2 study of duvelisib monotherapy in A phase 3 randomized study of duvelisib double refractory* iNHL populations monotherapy in relapsed/refractory CLL/SLL *Refractory to both rituximab and a chemotherapy Randomized vs. ofatumumab, wi
Slide 9: DYNAMO
DYNAMO™ 9 A phase 2 study of duvelisib monotherapy in double refractory iNHL populations PHASE 2 STUDY, FINAL ANALYSIS COMPLETED Study Endpoints Primary: Overall response rate (ORR) by Independent Review Committee (IRC) Double refractory* Duvelisib iNHL patients 25 mg BID Key secondary: N=129 • Safe
Slide 10: Phase 2 study results
Phase 2 study results 10 Met primary endpoint of Overall Response Rate (ORR) assessed by IRC Patient population: ORR per IRC at mature follow up 80% Patients with iNHL that is refractory to 68% 70% both rituximab and a chemotherapy or 60% radioimmunotherapy regimen 47% 43% 50% Primary endpoint: 40%
Slide 11: Data supporting FL accelerated approval
Data supporting FL accelerated approval 11 Overall Response Rate (ORR) assessed by IRC Efficacy in Patients with Relapsed or Refractory FL Endpoint FL N = 83 ORR, n (%) a 35 (42%) 95% CI (31, 54) CR, n (%) 1 (1%) PR, n (%) 34 (41%) Duration of response Range, months 0.0+ to 41.9+ Patients maintainin
Slide 12: DUO: phase 3 randomized study in relapsed/refractory CLL/SLL
DUO™ 12 A phase 3 randomized study in relapsed/refractory CLL/SLL Optional Crossover Study Disease Progression Duvelisib (DUV) Ofatumumab IV 25 mg BID continuously * Administration same as DUO Relapsed or Refractory N=160 N=8 CLL/SLL patients 319 patients Randomized 1:1 Ofatumumab IV (OFA) Duvelisib
Slide 13: Phase 3 study results
Phase 3 study results 13 Met primary endpoint of PFS by IRC, with significant improvements in ORR and LNRR Progression Free Survival (PFS) by IRC Overall Response Rate Lymph Node (ORR) Response Rate 90 80 85.0% 70 73.5% 60 50 40 45.3% 30 20 10 15.5% 0 Duvelisib Ofatumumab Duvelisib Ofatumumab Duveli
Slide 14: Efficacy supporting full approval in CLL/SLL
Efficacy supporting full approval in CLL/SLL 14 Greater benefit/risk for patients receiving two or more prior therapies Efficacy in CLL or SLL After at Least Two Prior Therapies Kaplan-Meier Curve of PFS per IRC In Patients with at Least 2 Prior Therapies COPIKTRA Ofatumumab Outcome per IRC N = 95 N
Slide 15: Consistent safety and tolerability profile across B-cell malignancies
Consistent safety and tolerability profile across B-cell malignancies 15 Pneumonitis Groupings of preferred terms Colitis Rash Transaminitis Serious opportunistic infections < 4%: PCP (unconfirmed) (n=1); Pneumonia Diarrhea CMV (n=2); fungal pneumonia (n=2) Infection Deaths attributed to treatme
Slide 16: Pooled analysis of safety supporting approval
Pooled analysis of safety supporting approval 16 442 patients with previously treated hematologic malignancies Most Common Adverse Reactions (≥ 10% Grade ≥ 3 or ≥ 20% Any Grade) in Patients with B-cell Malignancies Receiving COPIKTRA COPIKTRA 25 mg BID (N = 442) Adverse Reactions Serious adverse rea
Slide 17: Selected Important Safety Information
Selected Important Safety Information WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infecti
Slide 18: Commercial launch
18 Commercial launch Joe Lobacki Chief Commercial Officer PROPERTY OF VERASTEM, INC. – NOT FOR DISTRIBUTION OR DISSEMINATION
Slide 19: Additional therapy options are needed for chronic iNHL patients
Additional therapy options are needed for chronic iNHL patients 19 1ST LINE TREATABLE 22,205 PATIENTS/YEAR (AVG.)1 Increasing Elderly At-Risk Patient Population 13,500 65-75 AGING BABY BOOMER POPULATION CLL/SLL AGE AT DIAGNOSIS2 INCREASED DIAGNOSES US PREVALENCE 20181 197,000 FL US PREVALENCE 20181
Slide 20: COPIKTRA opportunity in relapsed or refractory FL
The COPIKTRA™ opportunity in relapsed or refractory FL after two prior systemic therapies 20 COPIKTRA provides a targeted therapy option after chemo-immunotherapy > 8 0 % o f 2 nd l i n e treated FL For F O L L I C U L A R LY M P H O M A patients are still patients considering their next therapy ● ●
Slide 21: COPIKTRA opportunity in relapsed or refractory CLL/SLL
The COPIKTRA™ opportunity in relapsed or refractory CLL/SLL after two prior therapies 21 COPIKTRA expands oral monotherapy opportunities For C H R O N I C LY M P H O C Y T I C L E U K E M I A / 70% Po rr ea fl etraerng ceet efdo r S M A L L LY M P H O C Y T I C LY M P H O M A patients considering th
Slide 22: Making COPIKTRA available
Making COPIKTRA available 22 Experienced senior commercial and medical affairs leadership, with a focused field force providing One Voice to the customer Senior leadership has an average of 24+ years industry experience and participation in over 30 drug launches 50 person Oncology sales team D
Slide 23: COPIKTRA value
COPIKTRA value 23 CLINICAL OUTCOMES AND NEED COPIKTRA patients can PATIENT maintain flexibility in daily BENEFIT life with at-home dosing COPIKTRA is an effective oral monotherapy regimen with a consistent safety profile Copiktra has been granted full approval for the treatment of adult patients wit
Slide 24: VerastemCares: Go beyond the expected
VerastemCares: Go beyond the expected 24 ACCESS Cancer is hard enough – let’s keep it simple. For the majority of patients and their healthcare providers, stay with the system that already works for you ASSISTANCE Patients prescribed COPIKTRA should have access to therapy. Bridge Program provides
Slide 25: Future Potential of COPIKTRA
Future Potential of COPIKTRA 25 MAXIMIZE POTENTIAL Combinations with novel BOLD STEPS agents and CAR-T TODAY: BROADEN REACH Combinations with I-O and SOC in aggressive NHL, Myeloma, Solid Tumors† Expand in FL and CLL/SLL NHL subtypes ANCHOR Expand into PTCL† DLBCL, MCL, Richter’s, Approved in the US
Slide 26: Now Available: first approved dual PI3K delta and gamma inhibitor
The first approved dual inhibitor of PI3K delta and gamma is NOW AVAILABLE COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Relapsed
Slide 27: Indications and Usage; Important Safety Information
INDICATIONS AND USAGE 27 COPIKTRA™ (duvelisib) is indicated for: The treatment of adult patients with relapsed or refractory CLL or SLL after at least two prior therapies; and The treatment of adult patients with relapsed or refractory FL after at least two prior systemic therapies. This indication
Slide 28: Important Safety Information (continued)
28 IMPORTANT SAFETY INFORMATION (continued) Cutaneous Reactions: Serious, including fatal (2/442; <1%), cutaneous reactions occurred in 5% of patients receiving COPIKTRA 25 mg BID (N= 442). Fatal cases included drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necroly
Slide 29: Important Safety Information (continued): Adverse Reactions
29 IMPORTANT SAFETY INFORMATION (continued) ADVERSE REACTIONS B-cell Malignancies Summary Fatal adverse reactions within 30 days of the last dose occurred in 8% (36/442) of patients treated with COPIKTRA 25 mg BID. Serious adverse reactions were reported in 289 patients (65%). The most frequent seri