Obinutuzumab Plus Bendamustine Prolongs PFS in Rituximab-Refractory Non-Hodgkin Lymphoma

Share this content:
Previous findings showed that patients obinutuzumab plus bendamustine prolonged progression-free survival, but data was immature at the time of analysis.
Previous findings showed that patients obinutuzumab plus bendamustine prolonged progression-free survival, but data was immature at the time of analysis.

Obinutuzumab plus bendamustine (G-B) significantly prolongs progression-free survival (PFS) among patients with indolent non-Hodgkin lymphoma (iNHL) compared with bendamustine alone, according to a study published in the Journal of Clinical Oncology.1

For the phase 3 GADOLIN study (ClinicalTrials.gov Identifier: NCT01059630), researchers randomly assigned 413 patients with rituximab-refractory iNHL — of whom 335 had follicular lymphoma (FL) — to undergo induction therapy with obinutuzumab 1000 mg plus bendamustine 90 mg/m2/day or bendamustine 120 mg/m2/day alone; patients who did not experience disease progression in the G-B arm received obinutuzumab 1000 mg maintenance therapy every 2 months. Patients in the G-B arm had a significantly reduced risk of progression of death but did not reach PFS at the time of the primary analysis and data was immature for other clinical endpoints.

The median follow-up for the current analysis was 31.8 months, approximately 11 months longer compared with the former report.

Patients in the G-B arm had a median PFS of 25.8 months compared with 14.1 months among patients in the bendamustine alone arm (hazard ratio [HR], 0.57; 95% CI, 0.44-0.73; P < .001) and overall survival (OS) was improved in the G-B arm as well (HR, 0.67; 95% CI, 0.47-0.96; P = .027). Patients with FL experienced a similar benefit for PFS and OS.

Time to new antilymphoma treatment (TTNT) in the G-B arm (41 months) was more than double the time in the bendamustine alone arm (19 months). 

Grade 3 to 5 adverse events (AEs) were reported by 72.5% (148) of patients in the G-B arm and 65.5% (133) of patients in the bendamustine alone group; the most frequently reported AEs included neutropenia, thrombocytopenia, anemia, and infusion-related reactions. Serious AEs occurred in 43.6% (89) compared with 36.9% (75) of patients in the G-B arm and bendamustine alone arm, respectively, and 7.8% (16) and 6.4% (13) of patients died due to fatal AEs, respectively.

The updated results confirm the earlier findings from the GADOLIN study. The authors concluded that “because G-B prolonged OS, PFS, and TTNT compared with [bendamustine] monotherapy in rituximab-refractory FL, this supports the conclusion that G-B is the preferred option in the treatment of these patients.”

Reference

  1. Cheson BD, Chua N, Mayer J, et al. Overall survival benefit in patients with rituximab-refractory indolent non-Hodgkin lymphoma who received obinutuzumab plus bendamustine induction and obinutuzumab maintenance in the GADOLIN study [published online March 27, 2018]. J Clin Oncol. doi: 10.1200/JCO.2017.76.3656

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs