Genta’s Genasense Achieves High Response Rates In Patients With Advanced Melanoma

Genta has declared preliminary results showing a high objective response rate and potentially extended survival in an ongoing pilot study. The trial incorporates the company’s lead oncology product, Genasense (oblimersen sodium) Injection, in a chemotherapy program for patients with advanced melanoma.

Based on preclinical evidence of synergy, Genasense was combined with temozolomide (Temodar), the most commonly used anticancer drug for melanoma, plus Abraxane for Injectable Suspension .

To date, 18 patients have been accrued, all of whom had unresectable stage 4 melanoma. None had previously received chemotherapy, and their baseline LDH did not exceed 1.1 times the upper limit of normal. (LDH is a tumor-derived biomarker that has been associated with outcome in melanoma and other diseases).

Additionally, 7 patients (39%) have achieved major objective responses: one with complete response (CR) after 6 cycles of treatment, and 6 with at least a partial response after a minimum of 2 treatment cycles. Five patients have maintained stable disease (SD) after at least 3 treatment cycles (24 weeks), for an overall disease control rate (CR+PR+SD) of 68%.

The most commonly observed side-effects were similar to those associated with the chemotherapy drugs used alone, including leukopenia, thrombocytopenia, neuropathy, and hair loss.

Overall median survival for all patients irrespective of response was 14.7 months, and 50% of patients have survived greater than 1 year. The patient who achieved a complete response has stopped all therapy and remains without recurrence for 20+ months.

These data compare very favorably with median survival reported in the randomized Phase 3 trial of patients with advanced melanoma and similar LDH criteria using dacarbazine alone or dacarbazine plus Genasense .