Genasense data released

In briefing documents released in advance of Monday's meeting of the Oncologic Drugs Advisory Committee, FDA said that approval of Genasense oblimersen from Genta would require the agency to change its standards for assessing the clinical efficacy of metastatic melanoma therapies. While both GNTA and the agency agree that Genasense plus dacarbazine (DTIC) did not achieve significance versus DTIC alone on survival, the primary endpoint, they disagree about the analysis and importance of two secondary endpoints, progression-free survival and overall response rate.

GNTA filed based on a single open-label Phase III trial of Genasense plus DTIC versus DTIC alone as first-line therapy for metastatic melanoma. While there was no significant difference in survival between the two arms, GNTA asserts that there was a statistically significant 25-day benefit in progression-free survival (p=0.0003). It also reported an 11.7% overall response rate in the Genasense arm compared to 6.8% in the control arm (p=0.019). ...