Study 206 (NCT03206970) is a Phase 2, single-arm, open-label study that investigated the efficacy and safety of BRUKINSA in patients with relapsed or refractory mantle cell lymphoma in China.3
Study 206
Indication
BRUKINSA as monotherapy is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1
At 18.4 months median follow-up, the IRC-assessed overall response rate was 84% (95% CI: 74.2, 90.8%), with 69% of patients achieving a complete response3
Primary endpoint: IRC-assessed response rates3
Median follow-up: 18.4 months
Figure adapted from Song Y, et al. 2020.3
Secondary endpoint: PFS4
Median follow-up: 33.3 months
Figure adapted from Song Y, et al. 2022.4
- High response rates were observed consistently, including in patients with TP53 mutation (ORR: 80%, n=12/15) and refractory disease (ORR: 84%, n=38/45)3,4
- Median time to response was 2.7 months (range 2.5–3.0)4
- At a median follow-up of 30.6 months, the median DoR had not been reached4
- The 36-month OS rate was 75%4
TEAEs in ≥10% of patients (N=86; median follow-up: 35.3 months)†4
Adapted from Song Y, et al. 20224
Select AEs of special interest
Median treatment duration 27.6 months, N=864
- Low rate of treatment discontinuations due to AEs: 9%3
- No dose reductions due to AEs during the extension period4
- Most AEs occurred early during BRUKINSA treatment and no new safety signals were observed with extended follow-up4
- No patients experienced atrial fibrillation or flutter, grade ≥3 cardiac AEs, second primary malignancies or tumour lysis syndrome4