The novel alkylator bendamustine HCl is active in both rituximab-refractory and rituximab-sensitive relapsed indolent NHL with acceptable toxicity

• DOI: 10.1200/jco.2005.23.16_suppl.6564
• Publication Date: 2017-02-23T18:55:09Z
• Authors: P. Cohen; B. Cheson; J. Friedberg; K. S. Robinson; J. Foran; L. Fayad; A. Tulpule; A. Bessudo; R. van der Jagt; M. S. Suster; P. S. Multani
• Keywords: Bendamustine; Refractory (planetary science)

6564 Background: Treanda (bendamustine HCl) (T), a novel DNA-alkylating cytotoxic agent, has been shown to be active in vitro against variety of alkylator-resistant cell lines. Moreover, T combination with the anti-CD20 monoclonal antibody rituximab (R), enhances tumor growth inhibition Daudi lymphoma xenograft models. We have extended these observations through 2 Phase II multi-center clinical trials (SDX-105–01 and SDX-105–02). Methods: The SDX-105–01 trial enrolled patients (pts) relapsed indolent or transformed B-cell NHL who were refractory R (no response progression within 6 months). Pts received T, 120 mg/m2 IV over 30–60 min. D1–2, every 21 days for cycles. SDX-105–02 pts mantle sensitive R. R, 375 D1 90 D2–3, 28 4–6 All an additional dose 1 week prior first cycle chemotherapy 4 weeks after last cycle. Results: 32 are evaluable study (median 3.5 therapies). overall rate (ORR), median 5 cycles therapy, is 75% complete (CR) 25%. There no differences ORR CR when stratified by vs. early progression). 13 77% (23% CR) (out planned 4–6) therapy. primary toxicity both studies hematologic. Grade 3/4 neutropenia thrombocytopenia occurred 39% 19% pts, respectively, 31% 8% trial. Non-hematologic toxicities predominantly 2. Infection requiring hospitalization pt, respectively. No alopecia was observed. Conclusions: out well tolerated at schedule used demonstrates activity whose either rates 70%. Further accrual follow-up needed confirm findings determine durability responses. Author Disclosure Employment Leadership Consultant Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Salmedix