DaunoXome an "Active Agent" in Patients with Relapsed or Refractory NHL, Say Independent Investigators

NeXstar Pharmaceuticals announced that a team of independent investigatorshas reported the findings of a phase II study in which DaunoXome(liposomal daunorubicin citrate for injection) was evaluated asa treatment for low- and intermediate-grade non-Hodgkin's lymphoma(NHL). The data, presented November 7, 1996, at the 16th ChemotherapyFoundation Symposium in New York City, included 14 patients whosedisease was resistant to conventional chemotherapy or who hadrelapsed after prior therapy. DaunoXome is NeXstar's proprietaryliposomal formulation of the anthracycline chemotherapy agentdaunorubicin.

Patients included in this study received 100 mg/m² of DaunoXomeevery 3 weeks. Of the 14 patients treated, 11 (79%) had stageIV disease with bone marrow involvement. Eight patients (57%)had not responded to two or more prior chemotherapy regimens,and the remaining six had failed to respond to one prior regimen.The data were presented by Anil Tulpule, md, assistant professorof clinical medicine in the Division of Hematology at the Universityof Southern California School of Medicine. Dr. Tulpule is coprincipalinvestigator of this study.

Dr. Tulpule stated that following treatment with DaunoXome, sixpatients (43%) had a partial response, defined as a greater than50% reduction in tumor mass. Three of these patients had receivedprior anthracycline chemotherapy. An additional three patients(21%) achieved stable disease status, defined as stable tumormass or an increase in existing disease without the appearanceof any new lesions. Of these patients, one had received previousanthracycline therapy. Two of the five patients who did not responddied of their disease before receiving a second cycle of therapybut were included in the intention-to-treat analysis.

Dr. Tulpule also stated that "there were no grade 3 or grade4 non-hematological toxicities, and though there were some instancesof grade 3 or grade 4 neutropenia, none of was long-lasting."Dr. Tulpule also stated that, "to date, none of the patientsshowing response or stable disease have started progressing."

Other sites participating in this ongoing study include NorthwestKaiser Permanente in Portland, Oregon; North Shore UniversityHospital in Manhasset, New York; Scripps Memorial Hospital inLa Jolla, California; Northwestern University Medical School inChicago; and the Denver Medical Health Center.

DaunoXome is currently approved as a primary therapy for advancedHIV-associated Kaposi's sarcoma in the United States, Canada,and 13 European countries. NeXstar is currently conducting clinicaltrials in NHL and various other forms of cancer, including breastcancer, glioma and HIV-associated lymphoma.