Phase II trial of galiximab (anti-CD80 monoclonal antibody) plus rituximab (CALGB 50402): Follicular Lymphoma International Prognostic Index (FLIPI) score is predictive of upfront immunotherapy responsiveness.

Journal Article (Journal Article)

BACKGROUND: This phase II CALGB trial evaluated the activity and safety of an extended induction schedule of galiximab (G) plus rituximab (R) in untreated follicular lymphoma (FL). PATIENTS AND METHODS: Patients with previously untreated FL (grades 1, 2, 3a) received 4 weekly infusions of G+R, followed by an additional dose every 2 months four times. International Workshop Response Criteria were used to evaluate response. RESULTS: Sixty-one patients were treated and antibody infusions were well tolerated. The overall response rate (ORR) is 72.1% (95% confidence interval 59.2% to 82.9%): 47.6% complete response (CR)/unconfirmed complete response (CRu) and 24.6% partial response. At a median follow-up time of 4.3 years (range, 0.3-5.3 years) median progression-free survival (PFS) is 2.9 years. Notably, Follicular Lymphoma International Prognostic Index (FLIPI) correlated with ORR, CR rate, and PFS, and the low-risk FLIPI group (n=12) achieved a 92% ORR, 75% CR/CRu rate, and 75% 3-year PFS. CONCLUSIONS: An extended induction schedule of G+R in previously untreated FL is well tolerated and appears particularly efficacious in those patients with low-risk FLIPI scores. In addition, this trial served as the initial platform for additional CALGB 'doublet' combination regimes of rituximab plus other novel targeted agents.

Full Text

Duke Authors

Cited Authors

  • Czuczman, MS; Leonard, JP; Jung, S; Johnson, JL; Hsi, ED; Byrd, JC; Cheson, BD

Published Date

  • September 2012

Published In

Volume / Issue

  • 23 / 9

Start / End Page

  • 2356 - 2362

PubMed ID

  • 32018710

Electronic International Standard Serial Number (EISSN)

  • 1569-8041

Digital Object Identifier (DOI)

  • 10.1093/annonc/mdr620


  • eng

Conference Location

  • England