References: Published Clinical Trials in Metastatic Melanoma
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1 References: Published Clinical Trials in Metastatic Melanoma
2 Melanoma historical data summary While results from open-label, or uncontrolled, or small # center studies can vary enormously, results from published randomized, controlled studies have fallen within a tight range: PFS (Progression-Free: months (single-agent) Survival) months (combinations) Median survival: Survival at 12 months: 6 8 months (single-agent) 6 9 months (combinations) 15 35% (single-agent) 25 38% (combinations) The only result outside this range, to date in published trials, has been the biochemotherapy trial for Cisplatin + Vincristine + + IL-2 + IFNα. This five drug regimen has severe toxicities. 2
3 Historical data 1/3 Published randomized trials with single-agent control Trial N Treatment Arms PFS/TTP Median OS Overall Survival at 12 Months (%) Design 1 st /2 nd Line vs. Temozolomide Middleton, JCO TEM ~ 22% ~ 25% + Genasense vs. Bedekian, JCO Genasense ~ 38% vs. Fotemustine Avril, JCO Fotemustine ~ 15% vs. Dartmouth Regimen Chapman, JCO CCT ~ 27% ~ 22% Il-2 vs. IL-2 + Histamine Agarwala, JCO IL-2 IL-2+ Histamine ~ 38% 1 st or 2 nd line 3
4 Historical data 2/3 Published randomized trials with biochemotherapy and combination chemotherapy Trial N Treatment Arms PFS/TTP Median OS Overall Survival at 12 Months (%) Design 1 st /2 nd Line CVD vs. CVD + Interferon/IL-2 Eaton, JCO CVD CVD + Interferon/IL ~ 50% + Cisplatin + IFN vs. /CIS/ IFN/IL-2 Keilholz, JCO /CIS /CIS/ Interferon/IL st or 2 nd line CDB vs. CDB + Tamoxifen Creagan, JCO CDB CDB+ Tamoxifen ~ 25% ~ 25% Interferon/IL-2 vs. Interferon/IL-2+ Cisplatin Keilholz, JCO Interferon/IL-2 Interferon/IL-2+ CIS 1.7 ~ 32% Meta-analysis Manola, JCO ,362 Various 6.4 4
5 Historical data 3/3 Published trials with paclitaxel (randomized or single-arm) Trial N Treatment Arms PFS/TTP Median OS Overall Survival at 12 Months (%) Design 1 st /2 nd Line Paclitaxel vs. Paclitaxel/Carboplatin Zimpfer, Paclitaxel Paclitaxel/ Carboplatin ~ 20% ~ 20% <=1 Prior Paclitaxel- 90 mg/m^2/ 3 doses every 3 weeks Bedikian, Paclitaxel (nonchoroidal patients only) Reported Singlearm; low # of centers 2nd Paclitaxel- 80 mg/m^2/ weekly administration Walker, Paclitaxel Singlearm; low # of centers <=1 Prior Paclitaxel + Carboplatin Rao, ACS Paclitaxel + Carboplatin 7.8 Singlearm; low # of centers >=1 Prior 5
6 References Agarwala SS, et al: Results from a randomized phase III study comparing combined treatment with histamine dihydrochloride plus interleukin-2 versus interleukin-2 alone in patients with metastatic melanoma. J Clin Oncol 2002; 20(1): Avril MF, et al: Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol 2004; 22(6): Bedikian, AY, et al: Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma. Mel Res 2004; 14: Bedikian AY, et al: Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol 2006; 24(29): Chapman PB, et al: Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol 1999; 17(9): Creagan ET, et al: Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma. J Clin Oncol 1999; 17(6): Eton O, et al: Sequential biochemotherapy versus chemotherapy for metastatic melanoma: results from a phase III randomized trial. J Clin Oncol 2002; 20(8): Keilholz U, et al: Interferon alfa-2a and interleukin-2 with or without cisplatin in metastatic melanoma: a randomized trial of the European Organization for Research and Treatment of Cancer Melanoma Cooperative Group. J Clin Oncol 1997; 15(7): Keilholz U, et al: Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol 2005; 23(27): Manola J, et al: Prognostic factors in metastatic melanoma: a pooled analysis of Eastern Cooperative Oncology Group trials. J Clin Oncol 2000; 18(22): Middleton MR, et al: Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol 2000; 18(1): Rao RD, et al: Combination of paclitaxel and carboplatin as second-line therapy for patients with metastatic melanoma. Cancer 2006; 106(2): Walker L, et al: Phase II trial of weekly paclitaxel in patients with advanced melanoma. Mel Res 2005; 15: Zimpfer-Rechner C, et al: Randomized phase II study of weekly paclitaxel versus paclitaxel and carboplatin as second-line therapy in disseminated melanoma: a multicentre trial of the Dermatologic Co-operative Oncology Group (DeCOG). Melanoma Res 2003; 13(5):
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