title: Obinutuzumab (GA101) in patients with relapsed/refractory indolent non-Hodgkin lymphoma: results from the phase II GAUGUIN study.
abstract: OBJECTIVE
  The phase II part of the phase I/II GAUGUIN study evaluated the efficacy and safety of two different doses of obinutuzumab (GA101), a type II, glycoengineered, humanized anti-CD20 monoclonal antibody, in patients with relapsed/refractory indolent non-Hodgkin lymphoma.
  
  
  METHODS
  Patients were randomly assigned to receive eight cycles of obinutuzumab (GA101) as a flat dose of 400 mg on days 1 and 8 of cycle 1 and also on day 1 of cycles 2 to 8 (400/400 mg) or 1,600 mg on days 1 and 8 of cycle 1 and 800 mg on day 1 of cycles 2 to 8 (1,600/800 mg).
  
  
  RESULTS
  Forty patients were enrolled, including 34 with follicular lymphoma; 38 of 40 patients had previously received rituximab and 22 of 40 were rituximab refractory. The overall response rate at the end of treatment was 55% (95% CI, 32% to 76%) in the 1,600/800-mg group (9% complete responders) and 17% (95% CI, 4% to 41%) in the 400/400-mg group (no complete responders). Five of 10 rituximab-refractory patients had an end-of-treatment response in the 1,600/800-mg group versus one of 12 in the 400/400-mg group. Median progression-free survival was 11.9 months in the 1,600/800-mg group (range, 1.8 to 33.9+ months) and 6.0 months in the 400/400-mg group (range, 1.0 to 33.9+ months). The most common adverse events were infusion-related reactions (IRRs) seen in 73% of patients, but only two patients had grade 3 to 4 IRRs (both in the 1,600/800-mg group). No IRRs were considered serious, and no patients withdrew for IRRs.
  
  
  CONCLUSIONS
  The 1,600/800-mg dose schedule of obinutuzumab (GA101) has encouraging activity with an acceptable safety profile in relapsed/refractory indolent non-Hodgkin lymphoma.
authors.affiliation: Hospices Civils de Lyon-Université de Lyon, 165 Chemin du Grand Revoyet, 69495 Pierre-Bénite cedex, France. gilles.salles@chu-lyon.fr
authors.forename: Gilles A
authors.initials: GA
authors.lastname: Salles
authors.forename: Franck
authors.initials: F
authors.lastname: Morschhauser
authors.forename: Philippe
authors.initials: P
authors.lastname: Solal-Céligny
authors.forename: Catherine
authors.initials: C
authors.lastname: Thieblemont
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
authors.forename: Hervé
authors.initials: H
authors.lastname: Tilly
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Gyan
authors.forename: Guiyuan
authors.initials: G
authors.lastname: Lei
authors.forename: Michael
authors.initials: M
authors.lastname: Wenger
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Wassner-Fritsch
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cartron
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000378:metabolism; D008875:Middle Aged
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C543332:obinutuzumab