Sustained response in the cGVHD trial (Study 1129)

Almost half of patients had a sustained response1

Sustained response rate is defined as the proportion of patients who achieved a CR or PR that was sustained for at least 20 weeks1

Responses observed across all organs evaluated1,2,4

  • Responses were observed across multiple organs, which were skin, mouth, gastrointestinal tract, and liver. Although lung was included in the trial, it was only evaluable for progression, not for response, based on the 2005 NIH Response Criteria

ORR was supported by an exploratory analysis of patient-reported symptom bother1

  • 24% of patients (10/42) experienced a clinically meaningful decrease in Lee Symptom Scale Score, defined as a ≥7-point decrease in overall summary score, on 2 or more consecutive visits1
    • The Lee Symptom Scale assesses the severity of cGVHD by directly measuring patient symptom burden based on manifestations of the disease (skin, energy, lung, nutritional status, psychological functioning, eye, and mouth)3

cGVHD=chronic graft versus host disease, CR=complete response, NIH=National Institutes of Health, ORR=overall response rate, PR=partial response.

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2Jaglowski SM, Blazar BR. How ibrutinib, a B-cell malignancy drug, became an FDA-approved second-line therapy for steroid-resistant chronic GVHD. Blood Adv. 2018;2(15):2012-2019.  3Lee SJ, Klein JP, Barrett AJ, et al. Severity of chronic graft-versus-host disease: association with treatment-related mortality and relapse. Blood. 2002;100(92);406-414. 4Data on file.