Progression-Free Survival Improved in Melanoma Patients Treated With Elesclomol: Presented at ASCO

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Title: Progression-Free Survival Improved in Melanoma Patients Treated With Elesclomol: Presented at ASCO
URL: http://www.pslgroup.com/dg/2231F2.htm
Doctor's Guide
June 6, 2008

By Ed Susman

CHICAGO -- June 6, 2008 -- The addition of the investigative drug elesclomol to a chemotherapy regimen that includes paclitaxel appears to improve the time to disease progression among patients with stage IV metastatic melanoma.

"Metastatic melanoma is an aggressive disease, and patients currently have few treatment options," said investigator David Lawson, MD, Winship Cancer Center, Emory University School of Medicine, Atlanta, Georgia. "Identifying novel therapies like elesclomol represents the future of treating this hard-to-treat disease."

In the United States about 60,000 people each year are diagnosed with melanoma, the deadliest form of skin cancer.

In a poster presentation on May 31 here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting, Dr. Lawson reported that treatment with a combination of paclitaxel and elesclomol resulted in a 7.1-month progression-free survival (PFS), while paclitaxel alone resulted in a 1.8-month interval without disease progression (P = .020).

Overall, the researchers evaluated 81 patients. Patients who were randomised to the combination treatment received elesclomol 213 mg/m² co-infused with paclitaxel 80 mg/m² or were assigned to receive paclitaxel 80 mg/m² alone, in 4-week cycles. Patients were dosed for 3 consecutive weeks and then were allowed 1 week's rest until disease progression.

When the researchers looked at responses among patients who had not previously received chemotherapy, they observed a statistically significant improvement in PFS in the 24 patients treated with elesclomol and paclitaxel compared with the 8 patients who received paclitaxel alone.

Patients who received elesclomol plus paclitaxel also achieved a 69% reduction in the risk of progression or death, and lived 15.9 months compared with 10.0 months for patients treated with paclitaxel alone.

Data for patients on the elesclomol plus paclitaxel arm who had 1 prior course of chemotherapy showed a trend toward results similar to patients who had received no prior chemotherapy. However, these data were not statistically significant, Dr. Lawson reported. Among these patients, overall survival was 9 months for those on elesclomol plus paclitaxel compared with 7.8 months for patients on paclitaxel alone.

Regardless of prior chemotherapy, the most common adverse events in the elesclomol plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhoea, and anaemia. The most serious adverse events (grade 3 or higher) for the combination arm were similar to those seen in the paclitaxel-only arm and included neutropenia, back pain, fatigue, and neuropathy.

Elesclomol is a novel, injectable, investigational drug candidate that triggers apoptosis in cancer cells. This mechanism of action, called oxidative stress induction, represents a novel way of selectively targeting and killing cancer cells, Dr. Lawson explained in his presentation.

Funding for this study was provided by GlaxoSmithKline and Synta Pharmaceuticals Corp. Elesclomol is not yet approved for any indication in any market. The drug is currently in phase 3 trials.

[Presentation title: Phase II Trial of Elesclomol (Formerly STA-4783) and Paclitaxel in Stage IV Metastatic Melanoma (MM): Subgroup Analysis by Prior Chemotherapy. Abstract 9036]

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