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Nab-paclitaxel Development in Gynecologic Malignancies

Nab-paclitaxel Development in Gynecologic Malignancies. Robert Coleman, MD, FACOG, FACS Director of Clinical Research Department of Gynecologic Oncology MD Anderson Cancer Center. Nab-paclitaxel Gynecologic Malignancy Trials with Enrollment Complete.

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Nab-paclitaxel Development in Gynecologic Malignancies

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  1. Nab-paclitaxel Development in Gynecologic Malignancies Robert Coleman, MD, FACOG, FACS Director of Clinical Research Department of Gynecologic Oncology MD Anderson Cancer Center

  2. Nab-paclitaxel Gynecologic Malignancy Trials with Enrollment Complete

  3. Phase II Evaluation of Nab-paclitaxel in Platinum-Sensitive Patients with Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer • Key Eligibility • Measurable disease by RECIST or elevated CA-125 ( > 70 U/mL) • Prior platinum-based chemotherapy • Platinum treatment-free interval >6 months • n=47 nab-paclitaxel 260 mg/m2 on Day 1 q Q3W x 6 cycles or 8 cycles if patient achieved CR Primary endpoints: Response Rate Secondary endpoints: Progression Free and Overall Survival, Quality of Life, Safety Teneriello, JCO 2009

  4. Patient Characteristics Teneriello JCO 2009

  5. Efficacy Data64% Response Rate with Nab-paclitaxel Monotherapy Teneriello JCO 2009

  6. Safety Data: Adverse Events Teneriello JCO 2009

  7. Phase II Study of nab-paclitaxel Plus Carboplatin in Patients with Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer • Key Eligibility • Recurrent ovarian or primary peritoneal cancer • Platinum-sensitive • Measurable disease • n = 41 nab-paclitaxel 100 mg/m2 Days 1, 8, 15 q 28 days + Carboplatin AUC 5 or 6 Day 1 q 28 days x 6 cycles Continue nab-paclitaxel until progressive disease or PI-PT discretion Primary endpoints: Antitumor activity and safety Secondary endpoints: Progression-free survival and overall survival Benigno

  8. Patient Characteristics Benigno

  9. Dosing Information • Carboplatin dose AUC 6 administered to first 9 patients • After Grade 4 neutropenia in 3 patients, reduced carboplatin to AUC 5 • 20 patients discontinued treatment for reasons other than toxicity or disease progression Benigno

  10. Safety Data: Adverse Events Benigno

  11. Efficacy Data: SurvivalOver 50% of patients alive at 1-year • Until 9/18/2009, there are 18 patients alive, 21 are dead and one is UNK due to lost of FU, one still active on cycle 44 Benigno

  12. Phase II Evaluation of nab-paclitaxelin Recurrent or Persistent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer • Key Eligibility • Recurrent or persistent ovarian, peritoneal, fallopian tube carcinoma • Platinum-resistant or refractory • Paclitaxel-resistant or refractory • Measurable disease • n = 49 nab-paclitaxel 100 mg/m2 on Days 1, 8, 15 q 28 Treatment until disease progression or unacceptable toxicity Primary endpoints: Antitumor activity and safety Secondary endpoints: Progression Free and Overall Survival R.Coleman

  13. Patient Characteristics • Age: • 50-59 15 (36.6%) • 60-69 14 (34.1%) • 30-49 7 (17 %) • 70-79 5 (12.2%) • Performance Status: • 0 28 (68.3%) • 1 12 (29.3%) • 2 1 ( 2.4%) • Prior Therapy • 1 Reg. 41 (100%) • Immunoth 1 • Hormonal 2 • Race: • White 30 (73.2%) • African American 8 (19.5%) • Hispanic 2 ( 4.9%) • Am Indian 1 ( 2.4%) • Site of Disease • Ovary 35 (85.4%) • Fallopian Tube 1 ( 2.4%) • Peritoneum 5 (12.2%) • Grade • 1 5 (12.2%) • 2 2 ( 4.9%) • 3 34 (82.9%) • Cell Type: • Serous Adeno 29 (72%) R.Coleman

  14. Efficacy Data23% Response Rate with nab-paclitaxel Monotherapy Responses reported in 41 of 49 patients: • 8 patients still to be evaluated R.Coleman

  15. Status of Patients by Cycles Completed55% of patients received more than 3 cycles R.Coleman

  16. Efficacy Data: Overall Survival and Progression-free Survival • Progression-free Survival, median: 4.5 months • Overall survival, median: 18.5 months R.Coleman

  17. Safety Data: Adverse Events • No grade 4 toxicities • Only 1 patient grade 3 neurosensory toxicity AE, adverse event R.Coleman

  18. GOG Phase II Trials in Platinum-Resistant Ovarian Cancer: Active Agents (126 Queue)

  19. Phase II Study of Nab-paclitaxel with Bevacizumab in Patients with Recurrent Platinum-Resistant Primary Epithelial Ovarian or Primary Peritoneal Cancer • Key Eligibility • Recurrent or persistent ovarian, peritoneal cancer • Platinum-resistant within 6 months • Measurable disease • n = 48 Nab-paclitaxel 100 mg/m2 on Days 1, 8, 15 + Bevacizumab 10mg/kg Days 1, 15 Q28d Treatment until disease progression or unacceptable toxicity Primary endpoints: Duration of objective response, safety Secondary endpoints: Duration of progression-free survival, overall survival, quality of life Tillmans

  20. Efficacy Data48% response rate with Nab-paclitaxel + Bevacizumab • Response rate: 48% • Stable Disease: 25% Tillmanns

  21. Efficacy: Progression-free Survival • Median Progression-free Survival: 8.26 months Tillmanns

  22. Safety Data: Grade 3 / 4 Adverse Events* * One Death, NOS Tillmanns

  23. Phase II Single Agent Bevacizumab Efficacy and Safety *Trial terminated prematurely due to incidence of GI perforation. Burger RA, et al. J Clin Oncol. 2007;25(33):5165-5167; Cannistra SA, et al. J Clin Oncol. 2007;25(33):5180-5186.

  24. Nab-paclitaxel Gynecologic Malignancy Trials Ongoing

  25. Ovarian Cancer Treatment ParadigmWhere does nab-paclitaxel fit into this treatment paradigm? #2 #3 1st relapsed Platinum-based regimen Non-platinum-based regimens Platinum-sensitive • Carbo + Taxol ± Avastin • Carbo + Gemzar ± Avastin • Carbo + Doxil • Doxil + Trabectedin • Doxil • Hycamtin #1 Surgery Front-line Platinum-based regimen • Carbo + Taxol ± Avastin #3 Non-platinum-based regimen Platinum-resistant • Doxil • Hycamtin Platinum-sensitive = >6 months before recurrence after front-line platinum-based chemo Platinum-resistant = <6 months before recurrence after platinum-based chemo

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