DYNAMO: A PHASE 2 STUDY OF DUVELISIB IN PATIENTS WITH REFRACTORY INDOLENT NON HODGKIN LYMPHOMA
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1 DYNAMO: A PHASE 2 STUDY OF DUVELISIB IN PATIENTS WITH REFRACTORY INDOLENT NON HODGKIN LYMPHOMA Ian Flinn, CB Miller, KM Ardeshna, S Tetreault, SE Assouline, PL Zinzani, J Mayer, M Merli, SD Lunin, AR Pettitt, Z Nagy, O Tournilhac, KE Abou Nassar, M Crump, ED Jacobsen, S de Vos, P Santabarbara, W Shi, L Steelman, ND Wagner Johnston
2 DUVELISIB IS AN ORAL PI3K δ,γ INHIBITOR Expression PI3K-δ Primarily Leukocytes PI3K-γ Primarily Leukocytes Biochemical Activity (K D ) 23 pm 243 pm Whole Blood Assay (IC 50 ) 96 nm Anti-FcƐR nm fmlp duvelisib Selective for PI3Ks over other protein and lipid kinases Impairs malignant B and malignant T cell survival Direct antitumor effects Disrupts tumor cell interactions within the microenvironment Duvelisib showed clinical activity in a phase 1 study in pts with advanced hematologic malignancies (Flinn ASH 2015; O Brien ASH 2015; Horwitz ASH 2015)
3 Accrual Complete; Analysis as of April 2016 (last pt enrolled + 6 mo.) STUDY OVERVIEW Phase 2, Single arm, n=129 Duvelisib 25 mg BID Continuously Treatment until progression or unacceptable toxicity Response Assessments Baseline, Cycles 3, 5, 7, 10 (cycle = 28 days) Every 4 cycles thereafter Responses per revised IWG criteria (Cheson 2007) by independent review committee (IRC) Primary Endpoint ORR (best response of CR or PR per IWG criteria) per IRC Key Secondary Endpoints Duration of response (DOR) Progression-free survival (PFS) Overall survival (OS) Safety
4 KEY ELIGIBILITY CRITERIA 3 inhl disease subtypes: follicular lymphoma (FL) small lymphocytic lymphoma (SLL) marginal zone lymphoma (MZL) Pts were double refractory to rituximab (monotherapy or in combination) and to chemotherapy* or radioimmunotherapy - Refractory = no CR or PR, or PD within 6 mo. of last dose of prior therapy No eligibility restrictions for cytopenias * Chemotherapy = alkylating agent or purine analogue
5 STUDY ENROLLMENT BY REGION / COUNTRY NORTH AMERICA United States 46 Canada 9 WESTERN EUROPE Italy 21 United Kingdom 11 France 6 Belgium 2 Spain 2 EASTERN EUROPE Belarus 10 Czech Republic 9 Hungary 7 Bulgaria 5 Georgia 1
6 BASELINE CHARACTERISTICS CATEGORY OVERALL N = 129 FL N = 83 SLL N = 28 MZL N = 18 Age, median (range) 65 (30, 90) 64 (30, 82) 63 (48, 83) 67 (41, 90) Male, % ECOG 0/1/2, % 47 / 48 / 5 51 /42/ 7 43 / 54 / 4 33 / 67 / 0 Years since diagnosis, median (range) 5 (0.3 27) 4 (0.3 27) 6 (0.9 17) 2 (0.8 10) Bulky Disease ( 5 cm), % Elevated LDH, % High FLIPI (3 5 factors), % N/A 34 N/A N/A
7 PRIOR ANTI CANCER TREATMENT CATEGORY OVERALL N = 129 FL N = 83 SLL N = 28 MZL N = 18 Number of Prior Anticancer Regimens Median Min, Max 1, 18 1, 10 1, 18 1, 8 2, % > 2, % Time since completion of last therapy (months) Median Min, Max 0, 121 0, 121 1, 74 1, 58 Median PFS on last anticancer therapy was 6.0 months per investigator assessment
8 PATIENTS REFRACTORY TO SELECT PRIOR ANTI CANCER THERAPY CATEGORY Overall N=129 % FL N=83 % SLL N=28 % MZL N=18 % Refractory to last therapy Refractory to at least 2 therapies Rituximab Alkylating Agent and/or Purine Analogue Rituximab + Alkylating Agent Bendamustine + rituximab R CHOP R CVP
9 PATIENT DISPOSITION CATEGORY OVERALL N = 129 FL N = 83 SLL N = 28 MZL N = 18 Median mo. on study (95% CI) 12 (10, 14) 11 (10, 13) 17 (11, 23) 10 (6, 14) Median mo. on duvelisib (range) 6 (0.4,24) 5 (0.4, 24) 9 (0.7, 16) 6 (0.9, 15) 12 mo., % Discontinued Treatment, % Disease Progression, % Adverse Event, % Investigator Decision, % Death, % Patient Withdrawal, % Noncompliance, %
10 OVERALL RESPONSE RATE OVERALL N = 129 FL N = 83 SLL N = 28 MZL N = 18 ORR per IRC, % P value p=0.0001* 95% CI (37 55) Complete Response Partial Response ORR per Investigator, % Complete Response Partial Response * The study met the primary endpoint (p= against null hypothesis that ORR was 30% per IRC)
11 PERCENT CHANGE IN NODAL TARGET LESIONS 83% of pts had reduction in target lymph nodes (per IRC)
12 OVERALL RESPONSE RATE BY SUBGROUP
13 DURATION OF RESPONSE PER IRC
14 PROGRESSION FREE SURVIVAL PER IRC 6 month median PFS (per investigator) on last previous anticancer therapy
15 OVERALL SURVIVAL
16 MOST COMMON AEs (N=129) Preferred Term All Grades Gr 3 Gr 4 * Gr 3 AE occurring 5% of pts % % % Diarrhea * Neutropenia * Nausea Cough Fatigue * Anemia * Thrombocytopenia * Pyrexia Rash Vomiting Peripheral edema Decreased appetite Headache Other Common Gr 3 AEs ( 5% of pts) Febrile neutropenia Lipase increased ALT increased
17 OTHER SIGNIFICANT AEs AEs Leading to Discontinuation of Duvelisib ( 2 pts) N=129 Preferred Term No. pts Pneumonitis 3 Pneumonia 2 Rash (generalized) 2 Serious opportunistic infections < 5% (none fatal) Pneumocystis (suspected PJP) 1 pt (0.8%) CMV 3 pts (2.3%), with 2 pts continuing duvelisib 4 treatment related AEs had outcome of death * AEs of Special Interest N=129 Any Gr Gr 3/4 Preferred Term % % Infection Diarrhea Neutropenia Rash 29 7 Anemia Thrombocytopenia Pneumonia 18 9 Hepatoxicity 16 8 Colitis 7 5 Pneumonitis 4 2 * 1 septic shock; 1 viral infection; 1 drug reaction/eosinophilia/ systemic symptoms, 1 toxic epidermic necrolysis/sepsis syndrome
18 CONCLUSIONS Duvelisib monotherapy is clinically active in double refractory inhl ORR of 46% per IRC (p=0.0001) 83% of pts had tumor reduction Responses were durable (median 10 months) Duvelisib is generally well tolerated, with a manageable safety profile with appropriate risk mitigation The DYNAMO study showed that duvelisib monotherapy has a favorable benefit risk profile in refractory inhl pts, and may represent an important treatment option in this population
19 The Investigators and Sponsor wish to thank all of the study team members, and most importantly, our patients and their families for their participation in this study. 19
20 THANK YOU
DYNAMO: A PHASE 2 STUDY DEMONSTRATING THE CLINICAL ACTIVITY OF DUVELISIB IN PATIENTS WITH DOUBLE-REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA
DYNAMO: A PHASE 2 STUDY DEMONSTRATING THE CLINICAL ACTIVITY OF DUVELISIB IN PATIENTS WITH DOUBLE-REFRACTORY INDOLENT NON-HODGKIN LYMPHOMA Presented at 14-ICML, 14 June 2017, Lugano Switzerland Authors
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