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Bending the Curve Trial by Trial
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A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

Phase 1/2N = 155NCT03075696

Population
Adults with relapsed or refractory diffuse large B-cell lymphoma who had received at least two lines of therapy; 52 patients had previously received CAR T-cell therapy.
Design
Phase 2 part of a phase 1-2 study in relapsed or refractory DLBCL after at least two lines of therapy: 155 patients enrolled, 154 received at least one dose of any study treatment. Obinutuzumab pretreatment to mitigate cytokine release syndrome, then fixed-duration glofitamab monotherapy (12 cycles total). Primary end point: complete response assessed by independent review committee. ClinicalTrials.gov lists 940 estimated enrolment for the whole registered study.
Primary endpoint
CR rate
Arms
  • Glofitamab monotherapy (experimental, n = 154): Obinutuzumab pretreatment, then fixed-duration glofitamab (12 cycles in total)
People
Dickinson MJ, senior author Hutchings M
Show the numbers
Results reported for A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
EndpointAnalysisGlofitamab monotherapyControlEffect
CR rateEnrolled patients in the phase 2 part (155); 154 received at least one dose of any study treatmentComplete response by independent review committee (stated primary end point).primarymedian follow-up 12.6 monthsDickinson 202239% (32–48%)—Complete response in 35% of the 52 patients with prior CAR T-cell therapy. 78% of complete responses were ongoing at 12 months. Median time to complete response 42 days.
PFSEnrolled patients in the phase 2 part (155); 154 received at least one dose of any study treatmentprimarymedian follow-up 12.6 monthsDickinson 202237% at 12 mo (28–46%)—Estimated 12-month progression-free survival.
Results reported for A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
EndpointAnalysisGlofitamab monotherapyControlEffect
CR rateEnrolled patients in the phase 2 part (155); 154 received at least one dose of any study treatmentComplete response by independent review committee (stated primary end point).primarymedian follow-up 12.6 monthsDickinson 202239% (32–48%)—Complete response in 35% of the 52 patients with prior CAR T-cell therapy. 78% of complete responses were ongoing at 12 months. Median time to complete response 42 days.
PFSEnrolled patients in the phase 2 part (155); 154 received at least one dose of any study treatmentprimarymedian follow-up 12.6 monthsDickinson 202237% at 12 mo (28–46%)—Estimated 12-month progression-free survival.
Primary publication: Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;387(24):2220-2231. PubMedDOI

Appears in

Sources

  1. Dickinson MJ, Carlo-Stella C, Morschhauser F, Bachy E, Corradini P, Iacoboni G, et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022;387(24):2220-2231.

    PubMedDOI