Abstract
6611 Background: Oblimersen sodium (Genasense;GNS) is an 18-mer oligonucleotide that targets the mRNA of Bcl-2, a protein that inhibits apoptosis and confers treatment resistance. GNS has shown marked activity in xenograft models of non-Hodgkin’s lymphoma (NHL) and enhances the antitumor activity of rituximab (RIT). We are conducting a phase II study to determine the efficacy and toxicity of GNS + RIT in patients (pts) with recurrent B-cell NHL. Methods: GNS (3mg/kg/d) was administered as continuous IV infusion for seven days in weeks 1,3, and 5 (d1–7,15–21,29–35). RIT (375 mg/m2) was given weekly for 6 doses (d3,8,15,22,29,36). Patients whose disease did not progress were allowed to receive one additional cycle. Prior exposure to rituximab was permitted. Results: To date 29 have been enrolled. Thirteen pts had follicular lymphoma (FL), 5 large cell lymphoma (LCL), 5 small lymphocytic lymphoma (SLL), 3 mantle cell lymphoma (MCL), 2 mucosa-associated lymphoid tissue (MALT) lymphoma, and one B-cell lymphoma not further classified (NOS). Median number of prior treatments was 2 (range 1–3). Twenty-one pts are evaluable for response and toxicity. Eight pts (38%) responded to the combination therapy, 2 pts achieved a CR (1 MALT, 1 FL), 1 pt achieved an unconfirmed CR (FL), 5 pts achieved a PR (1 MCL, 2 FLCL, 1 SLL, 1FL). Two of the responses (1 CR,1 PR) were observed in rituximab-refractory pts. Common grade 3–4 toxicities included: reversible neutropenia in 7 pts (33%), thrombocytopenia in 2 pts (9%), non-neutropenic fever in 4 pts (19%). Conclusions: GNS can be safely combined with RIT and appears to be an active combination in recurrent B-cell lymphomas. Patients accrual is ongoing. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech Genentech
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