Phase I/II study of galiximab, an anti-CD80 antibody, for relapsed or refractory follicular lymphoma.
OBJECTIVE
This multicenter, dose-escalation study evaluates the safety, pharmacokinetics, and efficacy of galiximab (anti-CD80 monoclonal antibody) in patients with relapsed or refractory follicular lymphoma.


METHODS
Patients had follicular lymphoma that had relapsed or failed to respond to primary therapy; the majority (90%) presented with stage III or IV disease. Four weekly intravenous infusions of galiximab were administered at doses of 125, 250, 375, or 500 mg/m2.


RESULTS
Thirty-seven patients received galiximab treatment and were evaluated for safety; 35 were assessable for response. Antibody infusions were safe and well tolerated with no dose-limiting toxicities. A total of 22 (60%) of 37 patients experienced adverse events related to galiximab. All but one of the events were grade 1 or 2; the most common were fatigue, nausea, and headache. Cytopenias were rare; only one patient experienced anemia and febrile neutropenia, which were unrelated to galiximab and resolved after treatment. No patient developed antigaliximab antibody formation. The mean serum half-life ranged from 13 to 24 days. The overall response rate was 11% (two complete responses and two partial responses). Time to best response was delayed (months 3, 6, 9, and 12). Twelve patients (34%) maintained stable disease. Nearly half of all patients (49%) had a decrease in indicator lesions. Two responders remain on study without progression (22 and 24.4 months).


CONCLUSIONS
The favorable safety profile of galiximab and evidence of single-agent biologic activity and dose-dependent pharmacokinetics support further evaluation of galiximab as a treatment for follicular lymphoma, possibly in combination with other lymphoma therapies.
Czuczman
Myron S
MS
Roswell Park Cancer Institute, Elm and Carlton St, Buffalo, NY 14263-0001, USA. Myron.Czuczman@RoswellPark.org
Thall
Aron
A
Witzig
Thomas E
TE
Vose
Julie M
JM
Younes
Anas
A
Emmanouilides
Christos
C
Miller
Thomas P
TP
Moore
Joseph O
JO
Leonard
John P
JP
Gordon
Leo I
LI
Sweetenham
John
J
Alkuzweny
Baha
B
Finucane
Deborah M
DM
Leigh
Bryan R
BR
D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018122:B7-1 Antigen / Q000276:immunology*; D005260:Female; D006801:Humans; D007239:Infections / Q000150:complications; D008224:Lymphoma, Follicular / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local
D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D018122:B7-1 Antigen; C437823:galiximab