1 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Studies of DOXIL for AIDS-related KS (Pre-HAART) Study No.Design No. of pts.Objective Response Rate/Results.

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Presentation transcript:

1 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Studies of DOXIL for AIDS-related KS (Pre-HAART) Study No.Design No. of pts.Objective Response Rate/Results 30-10Phase 3 comparison to ABV 258DOXIL (46.2%) vs. ABV (25.6%) 30-11Phase 3 comparison to BV241DOXIL (58.7%) vs. BV (23.3%) 30-12Open-label, non-comparative extension 871DOXIL (65.9%) (n = 41 patients w/prior therapy) 30-14Randomized, crossover, PK and tumor localization 43DOXIL selectively accumulates into KS lesions No significant differences in PK parameters b/w doses 30-21Phase 1/2, cardiac biopsy data; comparison to cardiac damage 10Less myocardial damage observed in patients treated with DOXIL compared to their matched doxorubicin controls Note: A total of 10 DOXIL studies of varying design were completed for AIDS related KS

2 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Publications of DOXIL for AIDS-related KS (HAART Era) Study No.Design DOXIL Treatment (mg/m 2 ) No. of pts.Results NunezProspective, non-comparative, multicenter DOXIL + HAART7979% response rate Median time to response ~ 42 days Martin- Carbonero Randomized, open-label, multicenter DOXIL 20mg/m 2 every 3-weeks 2820% HAART (N = 15) 76% HAART + DOXIL (N = 13) LichterfeldUncontrolled, multicenter, observational study with matched controls DOXIL + HAART % response rate Recovery of CD4 counts not impaired by combination therapy HernandezProspective, single arm, open-label, single center DOXIL 20 mg/m 2 every 3-weeks for 6 cycles 15100% - GI response rate 53% Cutaneous response rate

3 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Results of Randomized Studies of Liposomal Anthracyclines NOTE: # = number; eval. = evaluable; A = Adriamycin (doxorubicin); B = bleomycin; V = vincristine; NS = not significant; NR = not reported. * includes complete and partial responses † this study reported mean survival times of 239 days for DOXIL, versus 160 days for bleomycin and vincristine. ReferenceTreatment # entered (# eval) Objective Response Rate (%)* Time-to-treatment failure (days) Gill et al, 1996 DaunoXome117 (116)25% p=NS 115 p=0.13 ABV115 (111)28%99 Northfelt et al, 1998 DOXIL (2 Weeks) 133 (133)46% p< p=0.26 ABV125 (125)25%128 Stewart, et al, 1998 † DOXIL (3 Weeks) 121 (116)59% p< p=NR BV120 (102)23%157

4 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Documentation for ACTG Criteria Biopsy Cutaneous lesions – – Number – – Character (flat or raised) Tumor-associated edema 3-5 marker lesions – – Bi-dimensional measurement Visceral lesions – – Radiographic evaluation – – Bronchoscopy and endoscopy

5 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Clinical Presentation of Patients Treated with DOXIL Advanced KS with: – –No prior HAART – –HAART intolerant or failure – –Virologic and immunologic response to HAART Rapid KS progression on starting HAART (IRIS)

6 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Response of Kaposi’s Sarcoma to DOXIL

7 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Response of Kaposi’s Sarcoma to DOXIL

8 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Response of Kaposi’s Sarcoma to DOXIL

9 8 November 2005 ODAC: DOXIL ®, AIDS-related KS Kaposi Sarcoma Incidence Study Source: SEER Cancer Statistics Review, AIDS-related KS approval