NeXstar Pharmaceuticals announced that a team of independent investigators
has reported the findings of a phase II study in which DaunoXome
(liposomal daunorubicin citrate for injection) was evaluated as
a treatment for low- and intermediate-grade non-Hodgkin's lymphoma
(NHL). The data, presented November 7, 1996, at the 16th Chemotherapy
Foundation Symposium in New York City, included 14 patients whose
disease was resistant to conventional chemotherapy or who had
relapsed after prior therapy. DaunoXome is NeXstar's proprietary
liposomal formulation of the anthracycline chemotherapy agent
Patients included in this study received 100 mg/m² of DaunoXome
every 3 weeks. Of the 14 patients treated, 11 (79%) had stage
IV 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 professor
of clinical medicine in the Division of Hematology at the University
of Southern California School of Medicine. Dr. Tulpule is coprincipal
investigator of this study.
Dr. Tulpule stated that following treatment with DaunoXome, six
patients (43%) had a partial response, defined as a greater than
50% reduction in tumor mass. Three of these patients had received
prior anthracycline chemotherapy. An additional three patients
(21%) achieved stable disease status, defined as stable tumor
mass or an increase in existing disease without the appearance
of any new lesions. Of these patients, one had received previous
anthracycline therapy. Two of the five patients who did not respond
died of their disease before receiving a second cycle of therapy
but were included in the intention-to-treat analysis.
Dr. Tulpule also stated that "there were no grade 3 or grade
4 non-hematological toxicities, and though there were some instances
of grade 3 or grade 4 neutropenia, none of was long-lasting."
Dr. Tulpule also stated that, "to date, none of the patients
showing response or stable disease have started progressing."
Other sites participating in this ongoing study include Northwest
Kaiser Permanente in Portland, Oregon; North Shore University
Hospital in Manhasset, New York; Scripps Memorial Hospital in
La Jolla, California; Northwestern University Medical School in
Chicago; and the Denver Medical Health Center.
DaunoXome is currently approved as a primary therapy for advanced
HIV-associated Kaposi's sarcoma in the United States, Canada,
and 13 European countries. NeXstar is currently conducting clinical
trials in NHL and various other forms of cancer, including breast
cancer, glioma and HIV-associated lymphoma.