GALLIUM Compared the GAZYVA Based Regimen* and the rituximab-based Regimen* Across Multiple Measures in Previously Untreated FL

For stage II bulky, III, and IV patients

Additional endpoints 1

  • CT-assessed response rates at the end of induction (IRC-assessed) were similar between arms
    • CT-assessed overall response rates at the end of induction (IRC-assessed) were 91% for the GAZYVA based regimen and 88% for the rituximab-based regimen
    • CT-assessed complete response rates at the end of induction (IRC-assessed) were 28% for the GAZYVA based regimen and 27% for the rituximab-based regimen

Additional exploratory analyses 6,†

Response rates by PET-CT were not controlled for type I error, and the analyses were not powered to demonstrate statistically significant differences between treatment arms

  • In an exploratory analysis, PET-CT response rates at the end of induction (IRC-assessed) were evaluated in 297 patients for the GAZYVA based regimen and 298 patients for the rituximab-based regimen
    • PET-CT assessed overall response rates at the end of induction (IRC-assessed) were 89% for the GAZYVA based regimen and 85% for the rituximab-based regimen (3.3% difference; 95% CI, –2.3 to 8.9)
    • PET-CT assessed complete response rates at the end of induction (IRC-assessed) were 71% for the GAZYVA based regimen and 60% for the rituximab-based regimen (11% difference; 95% CI, 3.9 to 19.4)

These analyses are descriptive only. In the GALLIUM trial, PET results were treated as exploratory data and were not used for study treatment decisions.

*GAZYVA and rituximab were each combined with bendamustine, CHOP, or CVP, and followed by GAZYVA or rituximab monotherapy, respectively, in patients who responded.