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GO29365

A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Phase 1/2N = 80NCT02257567

Population
Transplantation-ineligible relapsed or refractory diffuse large B-cell lymphoma; randomised cohort median age 71 years (BR) versus 67 years (pola-BR); median number of prior lines of therapy 2.
Design
International, multicentre, open-label phase Ib/II trial in transplantation-ineligible relapsed or refractory DLBCL (including patients with failure of prior autologous transplantation). Polatuzumab vedotin with bendamustine and obinutuzumab (pola-BG) was evaluated in a single-arm cohort of 27 patients; polatuzumab vedotin with bendamustine and rituximab (pola-BR) was compared with BR in a randomly assigned cohort of 80 patients (40 per arm). Primary end point of the randomised cohort: complete response rate at the end of treatment assessed by independent review committee. The authors name the phase II design and modest sample size as potential limitations. A follicular lymphoma cohort is reported separately.
Primary endpoint
CR rate
Arms
  • Bendamustine and rituximab (control, n = 40): Bendamustine and rituximab (BR)
  • Pola-BR (experimental, n = 40): Polatuzumab vedotin with bendamustine and rituximab
  • Pola-BG (single-arm cohort) (experimental, n = 27): Polatuzumab vedotin with bendamustine and obinutuzumab
People
Sehn LH, senior author Matasar MJ
Δ CR rate+22.5 pointsPFSHR 0.36 (95% CI 0.21–0.63)Δ median PFS+5.8 monthsOSHR 0.42 (95% CI 0.24–0.75)Δ median OS+7.7 months
Show the numbers
Results reported for GO29365
EndpointAnalysisPola-BR / Pola-BG (single-arm cohort)Bendamustine and rituximabEffect
CR rateRandomly assigned cohort (80 patients; 40 per arm)Complete response rate at the end of treatment assessed by independent review committee (stated primary end point of the randomised cohort).primarySehn 202040%17.5%P=.026
PFSRandomly assigned cohort (80 patients; 40 per arm)Independent review committee-assessed progression-free survival (not the primary end point).primarySehn 2020median 9.5 monthsmedian 3.7 monthsHR 0.36 (95% CI 0.21–0.63)P<.001
OSRandomly assigned cohort (80 patients; 40 per arm)Overall survival (not the primary end point).primarymedian follow-up 22.3 monthsSehn 2020median 12.4 monthsmedian 4.7 monthsHR 0.42 (95% CI 0.24–0.75)P=.002
CR ratePhase Ib/II pola-BG single-arm cohort (27 patients)primarySehn 202029.6%——
OSPhase Ib/II pola-BG single-arm cohort (27 patients)primarymedian follow-up 27 monthsSehn 2020median 10.8 months——
Results reported for GO29365
EndpointAnalysisPola-BR / Pola-BG (single-arm cohort)Bendamustine and rituximabEffect
CR rateRandomly assigned cohort (80 patients; 40 per arm)Complete response rate at the end of treatment assessed by independent review committee (stated primary end point of the randomised cohort).primarySehn 202040%17.5%P=.026
PFSRandomly assigned cohort (80 patients; 40 per arm)Independent review committee-assessed progression-free survival (not the primary end point).primarySehn 2020median 9.5 monthsmedian 3.7 monthsHR 0.36 (95% CI 0.21–0.63)P<.001
OSRandomly assigned cohort (80 patients; 40 per arm)Overall survival (not the primary end point).primarymedian follow-up 22.3 monthsSehn 2020median 12.4 monthsmedian 4.7 monthsHR 0.42 (95% CI 0.24–0.75)P=.002
CR ratePhase Ib/II pola-BG single-arm cohort (27 patients)primarySehn 202029.6%——
OSPhase Ib/II pola-BG single-arm cohort (27 patients)primarymedian follow-up 27 monthsSehn 2020median 10.8 months——
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.360.21–0.63
OS0.420.24–0.75
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Bendamustine and rituximab (control)
  • Pola-BR (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsBendamustine and rituximabPola-BR
0100.0%100.0%
632.5%64.5%
1210.6%41.7%
183.4%26.9%
241.1%17.4%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015202530Months (modelled)
  • Bendamustine and rituximab (control)
  • Pola-BR (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsBendamustine and rituximabPola-BR
0100.0%100.0%
830.7%63.9%
169.4%40.9%
233.4%27.6%
311.0%17.7%
Primary publication: Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020;38(2):155-165. PubMedDOI

Appears in

Sources

  1. Sehn LH, Herrera AF, Flowers CR, Kamdar MK, McMillan A, Hertzberg M, et al. Polatuzumab Vedotin in Relapsed or Refractory Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2020;38(2):155-165.

    PubMedDOI