Synta Pharmaceuticals’ STA-4783 Passed Phase 2 Trial in Metastatic Melanoma

The Phase 2b study in metastatic melanoma of Synta Pharmaceuticals Corp. (Nasdaq: SNTA)’s STA-4783, revealed positive data.

The said Phase 2b study was a randomized, controlled trial in patients with Stage IV metastatic melanoma where STA-4783 plus paclitaxel doubled progression-free survival (PFS), as compared to paclitaxel alone.

Steven O’Day, MD, Chief of Research and Director of Melanoma at The Angeles Clinic and Research Institute in Los Angeles and Principal Investigator for the study, stated:

“These positive Phase 2b results in metastatic melanoma, a devastating cancer with an extremely poor prognosis and limited treatment options, are very encouraging. Metastatic melanoma has proven resistant to many therapeutic approaches and pharmaceutical agents.

To my knowledge, this study is the first in metastatic melanoma to demonstrate increased progression-free survival by a small molecule in a double-blind, randomized, controlled trial.”

The Phase 2b study of STA-4783 was conducted at 21 U.S. clinical sites where STA-4783 was well-tolerated, with adverse events typical of those expected for paclitaxel alone.

Melanoma is the most deadly form of skin cancer that arises from melanocytes (the pigment producing cells of the skin) while STA-4783 is an investigational first-in-class heat shock protein 70 (Hsp70) inducer that activates natural killer (NK) cell-mediated tumor killing.

If diagnosed and surgically removed while localized in the outermost skin layer, melanoma is potentially curable; however, for patients with deeper lesions or metastatic disease, the prognosis is poor, with limited available treatments and an expected survival of only six to nine months.

The incidence of melanoma has increased more rapidly than any other cancer during the past ten years. The last novel, small-molecule drug to treat patients with this disease was approved by the FDA over 30 years ago.

STA-4783 acts synergistically with taxanes (a commonly used chemotherapeutic class) and in preclinical studies has shown (combined with taxanes) activity against a range of cancers, including breast, lung, colon, lymphoma, and melanoma.

Find more details from the Synta Pharma press release.