SUSTAINED CLINICAL BENEFIT OF OBINUTUZUMAB PLUS CHEMOTHERAPY VERSUS RITUXIMAB PLUS CHEMOTHERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA: UPDATED RESULTS FROM THE GALLIUM STUDY
Author(s): ,
William Townsend
Affiliations:
Cancer Research UK and UCL Cancer Trials Centre,London,United Kingdom
,
Christian Buske
Affiliations:
Universitätsklinikum Ulm,Ulm,Germany
,
Guillaume Cartron
Affiliations:
CHU de Montpellier,Montpellier,France
,
David Cunningham
Affiliations:
Royal Marsden Hospital,Sutton,United Kingdom
,
Martin JS Dyer
Affiliations:
Ernest and Helen Scott Haematological Research Institute, University of Leicester,Leicester,United Kingdom
,
John Gribben
Affiliations:
St Bartholomew's Hospital,London,United Kingdom
,
Zilu Zhang
Affiliations:
F. Hoffmann-La Roche Ltd.,Shanghai,China
,
Tina Nielsen
Affiliations:
F. Hoffmann-La Roche Ltd.,Basel,Switzerland
,
Michael Herold
Affiliations:
HELIOS-Klinikum Erfurt,Erfurt,Germany
,
Wolfgang Hiddemann
Affiliations:
Department of Medicine III,Ludwig-Maximilians-University Hospital Munich,Munich,Germany
Robert Marcus
Affiliations:
HCA Healthcare,London,United Kingdom
EHA Library. Townsend W. 06/12/20; 293659; EP1170
Dr. William Townsend
Dr. William Townsend
Contributions
Abstract

Abstract: EP1170

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
Immunochemotherapy is standard of care for patients (pts) with previously untreated advanced stage follicular lymphoma (FL). Four-year data from the Phase III GALLIUM study (NCT01332968) have previously demonstrated an improvement in investigator-assessed progression-free survival (PFS) for obinutuzumab (GA101, G) plus chemotherapy (G-chemo) vs rituximab plus chemotherapy (R-chemo) (Townsend et al. ASH 2018).

Aims
To assess whether the clinical superiority of G-chemo vs R-chemo is sustained.

Methods
Eligibility criteria: ≥18 years; advanced stage, previously untreated grade 1–3a FL; requiring treatment according to Groupe d’Etude des Lymphomes Folliculaires (GELF) criteria. Pts were randomized 1:1 to receive induction therapy of G 1000mg IV (day [D] 1, 8 and 15 of Cycle 1; D1 of each subsequent cycle) or R 375mg/m2 IV (D1 of each cycle) with CHOP, CVP, or bendamustine for 6 or 8 cycles. Pts achieving complete or partial response at end of induction received maintenance therapy with the same monoclonal antibody every 2 months for 2 years or until disease progression or withdrawal from the study. Informed consent was obtained from all pts prior to entering the study. Primary endpoint was investigator-assessed PFS. Secondary endpoints included time-to-next-treatment (TTNT), overall survival (OS) and incidence of adverse events (AEs).

Results
1202 pts (median age 59 years) were enrolled (n=601 per treatment arm). Median duration of follow-up was 76.5 months. Pts receiving G- vs R-chemo demonstrated improved PFS (hazard ratio [HR] 0.76; 95% CI: 0.62–0.92; p=0.0043; 5-year PFS: 70.5% [95% CI: 66.4–74.1] vs 63.2% [95% CI: 59.0–67.1]) (Figure 1). TTNT was greater in the G- vs R-chemo arm (HR 0.72; 95% CI: 0.57–0.90; p=0.0039; 5-year TTNT rate: 79.7% [95% CI: 76.1–82.7] vs 72.9% [95% CI: 69.1–76.4]). There was no notable difference in 5-year OS, with few events in either arm (HR 0.87; 95% CI: 0.62–1.22; p=0.41; G-chemo: 90.2% [95% CI: 87.5–92.4]; R-chemo: 89.4% [95% CI: 86.6–91.6]). Incidence of grade 3–5 AEs was 79.3% in the G-chemo arm and 71.2% in the R-chemo arm, with no difference in the incidence of fatal AEs (4.2% for both treatment arms) consistent with the primary analysis (Marcus et al. N Engl J Med 2017).

Conclusion
These data further demonstrate the clinically meaningful and durable benefit of treatment with G-chemo relative to R-chemo in previously untreated FL pts.

Acknowledgement: GALLIUM was sponsored by F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of William Townsend, was provided by Louise Profit and Stephanie Lacey of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd.

Session topic: 18. Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Keyword(s): Chemotherapy, Follicular lymphoma, Obinutuzumab, Phase III

Abstract: EP1170

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
Immunochemotherapy is standard of care for patients (pts) with previously untreated advanced stage follicular lymphoma (FL). Four-year data from the Phase III GALLIUM study (NCT01332968) have previously demonstrated an improvement in investigator-assessed progression-free survival (PFS) for obinutuzumab (GA101, G) plus chemotherapy (G-chemo) vs rituximab plus chemotherapy (R-chemo) (Townsend et al. ASH 2018).

Aims
To assess whether the clinical superiority of G-chemo vs R-chemo is sustained.

Methods
Eligibility criteria: ≥18 years; advanced stage, previously untreated grade 1–3a FL; requiring treatment according to Groupe d’Etude des Lymphomes Folliculaires (GELF) criteria. Pts were randomized 1:1 to receive induction therapy of G 1000mg IV (day [D] 1, 8 and 15 of Cycle 1; D1 of each subsequent cycle) or R 375mg/m2 IV (D1 of each cycle) with CHOP, CVP, or bendamustine for 6 or 8 cycles. Pts achieving complete or partial response at end of induction received maintenance therapy with the same monoclonal antibody every 2 months for 2 years or until disease progression or withdrawal from the study. Informed consent was obtained from all pts prior to entering the study. Primary endpoint was investigator-assessed PFS. Secondary endpoints included time-to-next-treatment (TTNT), overall survival (OS) and incidence of adverse events (AEs).

Results
1202 pts (median age 59 years) were enrolled (n=601 per treatment arm). Median duration of follow-up was 76.5 months. Pts receiving G- vs R-chemo demonstrated improved PFS (hazard ratio [HR] 0.76; 95% CI: 0.62–0.92; p=0.0043; 5-year PFS: 70.5% [95% CI: 66.4–74.1] vs 63.2% [95% CI: 59.0–67.1]) (Figure 1). TTNT was greater in the G- vs R-chemo arm (HR 0.72; 95% CI: 0.57–0.90; p=0.0039; 5-year TTNT rate: 79.7% [95% CI: 76.1–82.7] vs 72.9% [95% CI: 69.1–76.4]). There was no notable difference in 5-year OS, with few events in either arm (HR 0.87; 95% CI: 0.62–1.22; p=0.41; G-chemo: 90.2% [95% CI: 87.5–92.4]; R-chemo: 89.4% [95% CI: 86.6–91.6]). Incidence of grade 3–5 AEs was 79.3% in the G-chemo arm and 71.2% in the R-chemo arm, with no difference in the incidence of fatal AEs (4.2% for both treatment arms) consistent with the primary analysis (Marcus et al. N Engl J Med 2017).

Conclusion
These data further demonstrate the clinically meaningful and durable benefit of treatment with G-chemo relative to R-chemo in previously untreated FL pts.

Acknowledgement: GALLIUM was sponsored by F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of William Townsend, was provided by Louise Profit and Stephanie Lacey of Gardiner-Caldwell Communications, and was funded by F. Hoffmann-La Roche Ltd.

Session topic: 18. Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Keyword(s): Chemotherapy, Follicular lymphoma, Obinutuzumab, Phase III

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