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Slide 1 - Clofarabine ODAC Presentation Pediatric Acute Leukemia December 1, 2004
Slide 2 - Clofarabine ODAC Presentation Steve Weitman, MD, PhD Chief Medical Officer ILEX Oncology, Inc.
Slide 3 - 3 Clofarabine ODAC Consultants Sima Jeha, MD St. Jude Children’s Research Hospital Ka Wah Chan, MD M.D. Anderson Cancer Center Laurel Steinherz, MD Memorial Sloan-Kettering Cancer Center Robert Arceci, MD, PhD Sidney Kimmel CCC at Johns Hopkins Peter Steinherz, MD Memorial Sloan-Kettering Cancer Center Stephen Sallan, MD Dana-Farber Cancer Institute Varsha Gandhi, PhD M.D. Anderson Cancer Center Eric Sandler, MD Nemours Children’s Clinic Peter Adamson, MD Children’s Hospital of Philadelphia
Slide 4 - 4 Agenda Introduction Steve Weitman, MD, PhD Pediatric Leukemia: Robert Arceci, MD, PhD Need for New Treatment Options Sidney Kimmel CCC at Johns Hopkins Clofarabine Pivotal Studies Steve Weitman, MD, PhD Clinician’s Perspective Stephen Sallan, MD Dana-Farber Cancer Institute Clofarabine Development Plan Steve Weitman, MD, PhD
Slide 5 - The Challenge Robert Arceci, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsDepartments of Oncology and Pediatrics Pediatric Leukemia:Need for New Treatment Options
Slide 6 - 6 Treatment of Patients with Pediatric Leukemias Treatments for newly diagnosed patients with ALL & AML use aggressive multi-drug regimens Overall survival for pediatric ALL and AML has improved, but is approaching a plateau 20% ALL and 50% AML have disease recurrence
Slide 7 - 7 Common Pediatric Cancers De Novo ALL & AML CNS Source: SEER Pediatric Monograph Assumes: 75% ALL cases cured and 50% AML cases cured Relapsed/ Refractory ALL & AML
Slide 8 - 8 Challenges in Pediatric Relapsed & Refractory Leukemias Heterogeneous population Multi-drug resistance is common in leukemia cells, particularly at relapse Dose intensification with combination therapies has resulted in significant co-morbidities and organ dysfunction Transplant is the best curative option but requires disease control and time to identify donor
Slide 9 - 9 Survival in Relapsed/ Refractory Pediatric Leukemia Weitman, et. al. J Pediatr Hematol Oncol. 1997;17:197-207 Acute Lymphoid Leukemia Acute Myeloid Leukemia
Slide 10 - 10 New Agents Needed for Remission Induction in Relapsed/ Refractory Patients Few agents have been approved for pediatric leukemia Most commonly used agents approved many years ago Methotrexate (1953) 6-Mercaptopurine (1953) Vincristine (1963) Ara-C (1969) Doxorubicin (1974) Development of new pediatric oncology agents has lagged behind adult oncology drug development
Slide 11 - 11 Conclusions Relapsed leukemia is the third most common childhood cancer Successful treatment of relapsed and refractory pediatric leukemias remains a major challenge Patients with multi-drug resistant leukemia are refractory to chemotherapy and have accumulated organ toxicities New, well tolerated and effective agents are urgently needed
Slide 12 - Clofarabine NDA Steve Weitman, MD, PhD Development OverviewClinical Study Results ILEX Oncology, Inc.
Slide 13 - 13 Clofarabine Development Overview Adult Phase I studies started in 1999 Pediatric Phase I studies started in 2000 Striking activity in heavily pretreated population with acceptable toxicity profile Compelling results in pediatric patients with an unmet medical need Propelled development in pediatrics at a faster rate than adults Increased the request for expanded access due to lack of alternative studies
Slide 14 - 14 Clofarabine Development Timeline Adult Studies Pediatric Studies Phase II/ III CLO/ ARA-C AML In Development 1999 2000 2001 2002 2003 2004 2005 COG Phase II CLO/ ARA-C AML, ALL In Development
Slide 15 - 15 Phase I Pediatric ALL & AML Twenty-five patients Dose levels from 11-70 mg/m2/day x 5 MTD 52 mg/m2/day IV DLT was reversible increases in bilirubin and skin rash Response CR 5/25 (20%) PR 3/25 (12%) 7 of 25 patients went to transplant Jeha, et. al. Blood. 2004;103:784-789
Slide 16 - 16 Pivotal Pediatric ALL & AML Planned Study Design Primary Endpoint is Overall Response Rate (CR+CRp) Fleming 2 stage design - (40% response rate of interest was based on 1 to 2 prior regimens) Current Clinical Practice Population was heavily pretreated, having highly resistant leukemia (up to 6 prior regimens) Patients went to transplant before count recovery The study size was expanded in collaboration with FDA to understand the true response rate
Slide 17 - 17 Pivotal Pediatric ALL Number of Unique Prior Agents Number of Agents Patients
Slide 18 - 18 Pivotal Pediatric AMLNumber of Unique Prior Agents Number of Agents Patients
Slide 19 - 4 Year Old AML Patient
Slide 20 - Safety and EfficacyPediatric Leukemia ALL & AML
Slide 21 - 21 NDA Efficacy/ Safety Population Efficacy data base N=84 Integrated safety data base N=113
Slide 22 - 22 Pivotal Study Endpoints Key Efficacy Endpoints: Independent Response Review Panel (IRRP) determined response: CR, CRp, PR Duration of remission Post-treatment transplants Survival Safety
Slide 23 - Pivotal Pediatric ALL Efficacy
Slide 24 - 24 Pivotal Pediatric ALL Characteristics of Study Group
Slide 25 - 25 Pivotal Pediatric ALLIRRP Determined Best Objective Response
Slide 26 - 26 Pivotal Pediatric ALLDuration of Remission CR + CRp (N=10) Median 20.2 wks CR + CRp + PR (N=15) Median 9.7 wks
Slide 27 - 27 Pivotal Pediatric ALLPost-Clofarabine Transplants 14% of patients went to transplant (7/49) 2 CR, 2 CRp, 2 PR, 1 NE Median time to transplant was 32 days (range 16 - 77) Median number cycles was 2 (range 2 - 3) 5 of 7 patients alive post-transplant
Slide 28 - 28 Pivotal Pediatric ALLOverall Survival CR + CRp (N=10) Median 58.6 wks CR + CRp + PR (N=15) Median 42 wks All Pts (N=49) Median 11.7 wks
Slide 29 - Pivotal Pediatric AML Efficacy
Slide 30 - 30 Pivotal Pediatric AML Characteristics of Study Group
Slide 31 - 31 Pivotal Pediatric AML IRRP Determined Best Objective Response
Slide 32 - 32 Pivotal Pediatric AMLDuration of Remission CR + CRp + PR (N=9) Median 16.2 wks
Slide 33 - 33 Pivotal Pediatric AMLPost-Clofarabine Transplants 34% of patients went to transplant (12/35) 1 CRp, 6 PR, 3 NE, 2 TF Median time to transplant was 38 days (range 21 - 75) Median number of cycles was 2 (range 1 - 5) 7 of 12 patients alive post-transplant
Slide 34 - 34 Pivotal Pediatric AMLOverall Survival CR + CRp + PR (N=9) Median 39 wks All Pts (N=35) Median 21 wks
Slide 35 - 35 Pivotal ALL & AML Efficacy Summary Recurrent pediatric acute leukemia is a substantial unmet medical need, especially for patients with AML Impressive response rates with Clofarabine for pediatric patients with ALL and AML that has become cross-resistant to most currently available agents The duration of remission was more than sufficient to allow patients with donors the opportunity to proceed to transplant Long-term survival was observed in patients with ALL and AML who responded to Clofarabine
Slide 36 - Integrated Safety Analysis
Slide 37 - 37 All Grade 3 & 4 Adverse Events in > 10% of Pediatric Patients (N=113) Integrated Safety
Slide 38 - 38 Drug-Related Grade 3 & 4 Adverse Events in > 5% of Pediatric Patients (N=113) Integrated Safety
Slide 39 - 39 All Grade 3 & 4 Hepato-Biliary/ Renal Lab Abnormalities
Slide 40 - 40 Deaths During Study Includes deaths within 30 days of last dose of study drug
Slide 41 - 41 Integrated Safety Summary Heavily pretreated population Many adverse events were consistent with underlying leukemia Events are not unexpected for a cytotoxic agent Most adverse events were reversible
Slide 42 - Stephen Sallan, MD Clinician’s Perspective Dana-Farber Cancer Institute
Slide 43 - 43 Childhood Leukemia ALL 75 - 80% cured with multi-drug chemotherapy AML 40 - 50% are cured Successful treatment of relapsed and refractory pediatric leukemias remains a major challenge
Slide 44 - 44 Survival in Pediatric Leukemias Year Five Year Relative Survival Rates Kersey, Blood. 1997; 90(11):4243-4251 ALL AML
Slide 45 - 45 CR After Single Agents in Childhood ALL Adapted from Holland and Frei Cancer Medicine 1974
Slide 46 - 46 What Impresses Me As A Clinician ALL Clofarabine results 1 in 5 children with multi-drug resistant ALL achieved a CR, affording them a transplant option AML Clofarabine results 1 in 3 children with multi-drug resistant AML went to transplant Transplant is the curative therapeutic option in drug-resistant childhood ALL and AML
Slide 47 - 47 What Impresses Me As A Clinician Clofarabine is Well Tolerated No overlapping toxicities Clofarabine provides Clinical Benefit In a heterogeneous population No meaningful Alternatives
Slide 48 - Commitment to Pediatric Clinical Development Steve Weitman, MD, PhD ILEX Oncology, Inc.
Slide 49 - 49 Commitment to Pediatric Clinical Development This represents a new paradigm in pediatric drug development The sponsor commits to further develop this drug in children: Continue survival follow-up on pivotal studies Moving to less heavily pretreated ALL and AML patients Proceed to a randomized study in pediatric patients Our commitment includes working closely with the Children’s Oncology Group and CTEP
Slide 50 - 50 Commitment to Pediatric Clinical Development Children’s Oncology Group (COG)/ CTEP AML Ara-C/Clofarabine Combination Study First relapsed patients Study chairs: Razzouk and Cooper ALL Cytoxan/Clofarabine and Etoposide/Clofarabine Combination Study Second relapsed patients Study chair: Hijiya
Slide 51 - 51 Commitment toAdult Clinical Development Program Objectives Focused on AML and MDS Combination studies with Ara-C Interest in elderly population of patients Adult Leukemia Studies CLO-141 Phase I/II Combination Ara-C/Clofarabine in AML Randomized studies planned Phase II/III Ara-C/Clofarabine in elderly patients with De Novo AML Phase II/III Ara-C/Clofarabine in non-elderly adult patients with relapsed AML Adult Development Discussion with FDA Ongoing
Slide 52 - 52 Overall Risk/ Benefit of Clofarabine inPediatric Leukemia Acceptable safety profile in this heavily pre-treated patient population Impressive benefits Provided meaningful clinical response and cytoreduction (CR, CRp, and PR) Overall, 23% of patients proceeded to transplant (19/84) 14% of patients with ALL 34% of patients with AML Patients alive at data cutoff - ALL 22%, AML 26% (Median follow-up 29 weeks) Meets an urgent unmet medical need in highly resistant pediatric leukemia
Slide 53 - Clofarabine ODAC Presentation Pediatric Acute Leukemia December 1, 2004