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The latest non-approval letter came after Genta submitted results from a Phase III trial to the FDA following an appeal against a previous negative decision. The randomized trial investigated fludarabine and cyclophosphamide (FC) with or without Genasense (oblimersen) in 241 patients with relapsed/refractory chronic lymphocytic leukemia (CLL). The investigators concluded that the addition of Genasense to FC significantly increases the rate of complete response or nodular partial response (17% compared to 7%). Fludarabine-sensitive patients showed particular benefit from treatment with Genasense plus FC. The drug also led to an improvement in response duration among patients who achieved a response. The FDA has not stated a reason for rejecting Genasense although it suggested the need for an additional clinical trial.
Genasense is an antisense oligonucleotide designed to bind to the first six codons of Bcl-2 messenger ribonucleic acid (mRNA). This triggers mRNA degradation and subsequent inhibition of Bcl-2 expression. The Bcl-2 gene is overexpressed in around 80% of tumors and contributes to the development of resistance to chemotherapy, radiotherapy and immunotherapy by inhibition of apoptosis.
CLL is the most common leukemia subtype in the seven major markets ahead of acute myeloid leukemia. Datamonitor forecasts incidence of CLL in the seven major pharmaceutical markets to reach over 25,000 in 2008. Currently, FCR - fludarabine, cyclophosphamide and Rituxan (rituximab; Biogen Idec/Genentech/Roche/Zenyaku Kogyo) and Campath (alemtuzumab; Takeda/Genzyme/Bayer Schering) are commonly used for second and third-line treatment of recurrent/refractory CLL.
This setback is the most recent in a series of significant obstacles that Genasense has suffered in its development. In December 2006, the FDA rejected a rolling NDA submission for Genasense in combination with FC for CLL in patients who had previously received fludarabine therapy, as well as an appeal against the decision. This latest blow may mark the end of the line for Genasense in CLL. It is uncertain whether Genta has sufficient funds to initiate another Phase III trial in CLL, which may in any case prove to be futile. Even though the drug has other ongoing trials in different cancer types it now seems increasingly unlikely that after 13 years of clinical trials this drug will gain approval.
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