AU-003 study Chronic Lymphocytic Leukaemia (CLL)

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Study design

AU-003 was a phase 1/2, open-label, multicentre study of BRUKINSA®▼ in patients with B-cell malignancies, including one cohort of patients with CLL/SLL.1,2

The study included two parts as shown in Figure 1.1,2

Figure 1. AU-003 study design.1,2

RP2D, recommended phase 2 dose.

Patients

Patients in the CLL/SLL cohort were ≥18 years and had either treatment-naïve or R/R CLL/SLL.1,2

Key baseline characteristics

The key baseline characteristics for the AU-003 study are summarised in Table 1.

Table 1. AU-003: baseline characteristics.2

CharacteristicTreatment-naive (n=22)R/R (n=101)
Age, years, median (range)
≥75 years, n (%)
69.5 (48–87)
4 (18.2)
66.0 (24–87)
17 (16.8)
Prior no. of anti-cancer therapies, median (range)0 (0)2 (1–10)
Rai stage for CLL, n (%)
Low risk (Stage 0)2 (9.1)9 (8.9)
Intermediate risk (Stages I–II)10 (45.5)31 (30.7)
High risk (Stages ≥III)7 (31.8)42 (41.6)
No staging1 (4.5)16 (15.8)
Bulky disease, n (%)
Any TL LDi ≥5 cm7 (31.8)40 (39.6)
Any TL LDi ≥10 cm1 (4.5)4 (4.0)
Mutational status, n/N (%)
del(13q)8/18 (44.4)37/80 (46.3)
del(11q)0/18 (0)23/80 (22.8)
del(17p)3/18 (16.7)13/81 (16.0)
Trisomy 123/18 (16.7)12/79 (15.2)
TP53 mutated3/18 (37.5)11/35 (31.4)
del(17p) and TP53 mutated1/18 (5.6)5/83 (6.0)
IGHV unmutated2/5 (40.0)27/37 (73.0)
ALC, x 109/L, median76.926.4
Haemoglobin, g/L, median122.5124.0
Platelet count, x109/L, median136.0124.0
ALC, absolute lymphocyte count; TL, target lesion; LDi, diameter of largest lymph node. Adapted from Cull G, et al. Br J Haematol. 2022.2

Key results for the CLL/SLL cohort

Among 94 patients with CLL/SLL, 78 patients (22 previously untreated patients and 56 R/R patients) were evaluable for efficacy.1

At a median follow-up of 13.7 months, the overall response rate (ORR) was 96.2% (95% CI: 89.2, 99.2) for the total population (100% [95% CI: 84.6, 100] for previously untreated patients and 94.6% [95% CI: 85.1, 98.9] for R/R patients).1 All evaluable patients with del(17p) or mutated TP53 (n=16) responded to treatment (ORR=100% [95% CI: 79.4, 100).1

Treatment was well tolerated, and the majority of adverse events were Grade 1 or 2. Grade 3 or 4 adverse events reported by more than one patient included neutropenia (n=6), anaemia (n=2), pneumonia (n=2), and hypertension (n=2).1 One patient experienced Grade 3 subcutaneous haemorrhage.1

Long-term follow-Up

The long-term safety and efficacy analysis of AU-003 reported results for a cohort of 123 patients with CLL.2

After a median follow-up of 47.2 months, the ORR was 95.9% in the total population (100% [95% CI: 84.6, 100] for previously untreated patients and 95% [95% CI: 88.8–98.4] for R/R patients).2 Rates of complete response (CR) were 22.7% in previously untreated patients and 17.8% in R/R patients.2

The estimated rate of progression-free survival (PFS) was 96% (95% CI: 90, 98) at 12 months, 90% (95% CI: 83, 95) at 24 months, and 83% (95% CI: 74, 89) at 36 months.2

The most reported Grade ≥3 adverse events were neutropenia (15.4%), pneumonia (9.8%), hypertension (8.9%) and anaemia (6.5%).2

Based on the results of this study, BRUKINSA demonstrates clinically meaningful and durable response and long-term tolerability with ~4 years of treatment in patients with CLL.2

Abbreviations: CI, confidence interval; CLL, chronic lymphocytic leukaemia; R/R, relapsed/refractory; SLL, small lymphocytic lymphoma.

Adverse events should be reported

United Kingdom (incl. Northern Ireland): Healthcare Professionals are asked to report any suspected adverse reactions via Yellow Card Scheme found at www.mhra.gov.uk/yellowcard.
Ireland: Healthcare Professionals are asked to report any suspected adverse reactions via HPRA.

All adverse events (UK and Ireland) should also be reported to BeiGene at [email protected]; (UK: 08009176799; Ireland: 1800812061).

For medical information, please contact: UK: 08004320266, Ireland: 1800946589 or email: [email protected]

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

September 2023 [0823-BRU-PRC-183]

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