Genta Incorporated announced that overall survival for patients treated with Genasense (oblimersen sodium) Injection plus chemotherapy in AGENDA, the company’s phase III trial of Genasense in patients with advanced melanoma, was not significantly superior compared with patients treated with chemotherapy alone.

AGENDA was a randomized, double-blind, placebo-controlled trial of dacarbazine administered with or without Genasense in patients who had not previously received chemotherapy. As defined in a prior randomized trial, AGENDA employed a biomarker to define patients who might maximally benefit from such treatment.

In the trial, median survival was 13.5 months in the Genasense group and 13.1 months in the chemotherapy-only group (P=0.73). The durable response rate (i.e., the proportion of patients who achieved a major objective response that persists at least 6 months) was 10.8% and 7.6%, respectively (P=0.32). The safety profile of Genasense in AGENDA was consistent with prior studies, as previously released.

“We are keenly disappointed in this result, which terminates our 10-year effort to achieve a clinically meaningful benefit for patients with melanoma,” said Dr Raymond P Warrell, Jr., Genta’s chief executive officer. “In view of these results, we will review the company’s pipeline portfolio and provide further guidance in the near future. Genta is grateful for the tireless dedication of our employees and for the contributions of the many physicians, patients, and families who have worked to advance Genasense for cancer treatment.”

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The company is developing tesetaxel, a novel, orally absorbed taxane that is in the same class of drugs as paclitaxel and docetaxel. As the leading oral taxane in clinical development, tesetaxel has been evaluated in a broad programme of completed or ongoing phase II a/phase II b clinical trials.