The MAGNOLIA study (NCT03846427) is a global, Phase 2, single-arm, open-label study that investigated the efficacy and safety of BRUKINSA in patients with relapsed or refractory marginal zone lymphoma.2
MAGNOLIA study
Indication
BRUKINSA as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.1
After 28 months of follow-up, the overall response rate was 68% (95% CI: 55.6, 79.1), with 26% of patients achieving a complete response3
Primary endpoint: IRC-assessed response rates‡3
Secondary endpoint: IRC-assessed PFS3
Figures adapted from Opat S, et al. 2023.3
- Responses were consistent across MZL subtypes. The ORR was 64.0% in extranodal (40% CR, n=10/25), 76.0% in nodal (20% CR, n=5/25) and 66.7% in splenic MZL (8.3% CR, n=1/12)¶3
- High response rates were observed in patient subgroups who traditionally respond poorly to treatment: ≥75 years of age: 94%; target lesion >5 cm: 79%; refractory disease: 67%2
- Median time to response was 2.8 months (range 1.7–11.1)1
Summary of AEs that occurred during treatment3
| Event | n (%) (N=68) |
|---|---|
| ≥1 AE | 68 (100) |
| Grade≥3 AEs | 33 (48.5) |
| Serious AEs | 30 (44.1) |
| AE leading to dose interruption | 25 (36.8) |
| AE leading to dose reduction | 0 (0) |
| AE leading to discontinuation | 5 (7.4) |
| AE leading to death | 5 (7.4) |
- The safety profile of BRUKINSA during the MAGNOLIA study was consistent with other clinical trials1–3
- The rates of treatment discontinuation and dose reduction due to AEs were low (7.4% and 0%)3
- Discontinuations included two patients who died from COVID-19 pneumonia§3
Common treatment-emergent AEs;
Median treatment duration 24.2 months, N=683
AEs of special interest; N=683
Figures adapted from Opat S, et al. 2023.3
- Low rates of cardiovascular AEs were observed. Hypertension occurred in 3 (4.4%) patients, atrial fibrillation and atrial flutter in 1 (1.5%) patient each and none led to treatment withdrawal3