NHL: polatuzumab vedotin + rituximab favored in final analysis

  • Morschhauser F & al.
  • Lancet Haematol
  • 29 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • Pinatuzumab vedotin or polatuzumab vedotin plus rituximab (R-pina, R-pola) are viable regimens for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
  • R-pola was selected for continued study in non-Hodgkin lymphoma (NHL).

Why this matters

  • The antibody-drug conjugates previously demonstrated activity in phase 1 trials.

Study design

  • Randomized phase 2 ROMULUS study of R-pola vs R-pina in 81 patients with DLBCL and 41 patients with FL. 
  • Treatment was administered every 21 days until disease progression or unacceptable toxicity, up to 1 year. 
  • Funding: F Hoffman-La Roche. 

Key results

  • Objective response rates (ORRs):
    • DLBCL: R-pina, 60% (95% CI, 43%-74%) vs R-pola, 54% (95% CI, 37%-70%).
    • FL: R-pina, 62% (95% CI, 38%-82%) vs R-pola, 70% (95% CI, 46%-88%).
  • Complete response (CR):
    • DLBCL: R-pina, 26% (95% CI, 14%-42%) vs R-pola, 21% (95% CI, 9%-36%).
    • FL: R-pina, 5% (95% CI, 0.1%-24%) vs R-pola, 45% (95% CI, 23%-68%).
  • Duration of response (months):
    • DLBCL: R-pina, 4.0 (95% CI, 2.8-11.5) vs R-pola, 13.4 (95% CI, 3.0-21.2).
    • FL: R-pina, 8.3 (95% CI, 6.0-11.1) vs R-pola, 9.4 (95% CI, 5.6-not estimable).
  • Grade 3-5 adverse events:
    • DLBCL: R-pina, 78.6% vs R-pola, 76.9%.
    • FL: R-pina, 61.9% vs R-pola, 50.0%.

Limitations

  • No assessment for double-/triple-hit lymphomas.

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