IMBRUVICA® Monotherapy:
Monotherapy Response Rate

MONOTHERAPY RESPONSE RATE

IMBRUVICA® is the only BTKi with up to 5 years of long-term follow-up data in monotherapy for WM1-3

Study designs and baseline characteristics

The efficacy and safety of IMBRUVICA® as a monotherapy for previously treated WM was evaluated in 2 single-arm trials1,3,4

iNNOVATE™ arm C was a substudy, single-arm, open-label trial designed to assess the efficacy and safety of single-agent
ibrutinib in patient who had failed (ie, relapse, after <12 months or failure to achieve at least a minor response) prior rituximab-containing therapy (N=31). Response rate was a secondary endpoint.1,3

  • WM IPSS; low, 23%; intermediate, 35%; high, 42%5

  • Prior systematic treatments: 1-2, 29%; 3-4, 32%; ≥5, 39%5

  • ECOG performance status; 0-1, 81%; 2, 19%1

PCYC-1118 was a phase 2, open-label, single-arm, multicenter trial of patients who received once-daily ibrutinib at 420 mg until disease progression or intolerance, with a primary endpoint of overall response rate, for up to 40 4-week cycles (N=63).1,4

  • WM IPSS; low, 22%; intermediate, 43%; high, 35%4

  • Prior systematic treatments; median, 2; range, 1-9; 0-2, 57%; ≥3, 43%2

  • ECOG performance status; 0, 75%; ≥1, 25%4

Monotherapy responses consistently observed in WM patients

Exploratory analysis: Sustained hemoglobin improvement3,8

iNNOVATE™ arm C
n/N (20/31)

  • Hemoglobin was prospectively collected in iNNOVATE™. An exploratory analysis was conducted to calculate a sustained hemoglobin improvement defined as an increase of ≥2 g/dL over baseline for at least 8 weeks without blood transfusions or growth factor support3,8

These data have not been reviewed by the FDA and are not included in the Prescribing Information for IMBRUVICA®.

Abbreviations

BTKi=Bruton’s tyrosine kinase inhibitor, CR=complete response, ECOG=Eastern Cooperative Oncology Group, FDA=US Food and Drug Administration, Hgb=hemoglobin, INV=investigator, IPSS=International Prognostic Scoring System, IRC=independent review committee, LTFU=long-term follow-up, PR=partial response, RR=response rate, VGPR=very good partial response, WM=Waldenström's macroglobulinemia.

References

1. IMBRUVICA® (ibrutinib) Prescribing Information. 2. Treon SP, Meid K, Gustine J. Long-term follow-up of ibrutinib monotherapy in symptomatic, previously treated patients with Waldenstrom macroglobulinemia. J Clin Oncol. 2021;39:565-575. doi:10.1200/JCO.20.00555 3. Trotman J, Buske C, Tedeschi A. Single-agent ibrutinib for rituximab-refractory Waldenstrom macroglobulinemia: final analysis of the substudy of the phase Ill iNNOVATE™ trial. Clin Cancer Res. 2021;27:5793-800. doi:10.1158/1078-0432.CCR-21-1497 4. Treon SP, Tripsas CK, Meid K. lbrutinib in previously treated Waldenstrom's macroglobulinemia. N Engl J Med. 2015;372:1430-1440. doi: 10.1056/NEJMoal501548 5. Dimopoulos MA, Trotman J, Tedeschi A, et al. Ibrutinib for patients with rituximab-refractory Waldenström's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017;18(2):241-250. doi:10.1016/S1470-2045(16)30632-5 6. Data on file ABVRRTI78596 7. Data on file ABVRRTI78382 8. Data on file ABVRRTI78387