Study 215 Chronic Lymphocytic Leukaemia (CLL)

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STUDY DESIGN

Study 215 was a phase 2, multicentre, open-label, single-arm trial of BRUKINSA in patients with previously treated B-cell lymphoma* who have shown intolerance to prior Bruton’s tyrosine kinase (BTK) inhibitors (Figure 1).1,2

*Study 215 enroled patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) Waldenström’s macroglobulinaemia, mantle cell lymphoma, and marginal zone lymphoma.2

Figure 1. Study 215: Study design1,2

CLL, chronic lymphocytic leukaemia; SLL, small lymphocytic lymphoma. *17/61 patients were intolerant to acalabrutinib alone, or acalabrutinib and ibrutinib.1,2

Patients

As of January 3, 2023, 61 patients with CLL/SLL were enroled and received ≥1 dose of BRUKINSA.Patients were eligible for the Study 215 if they had received ≥4 weeks of ibrutinib and/or acalabrutinib therapy.1

Stratification

Patients were stratified according to BTK inhibitor intolerance; Cohort 1 included patients intolerant to ibrutinib only, and Cohort 2 included patients intolerant to acalabrutinib alone, or acalabrutinib and ibrutinib.1,2

Key baseline characteristics

The key baseline characteristics for Cohorts 1 and 2 are summarised in Table 1.1

Table 1. Study 215: Key baseline characteristics for Cohorts 1 and 21

Characteristic
Cohort 1: Ibrutinib intolerant (n=44)Cohort 2: Acalabrutinib intolerant* (n=17)Total (n=61)
Indication, n (%)
CLL38 (86.4)15 (88.2)53 (86.9)
SLL6 (13.6)2 (11.8)8 (13.1)
Male sex, n (%)23 (52.3)9 (52.9)32 (52.5)
Age, median (range), years71.5 (49-91)71 (51-83)71 (49-91)
ECOG PS, n (%)
026 (59.1)11 (64.7)37 (60.7)
118 (40.9)4 (23.5)22 (36.1)
202 (11.8)2 (3.3)
No. of prior anticancer regimens,
median (range)
1 (1-7)2 (1-6)1 (1-7)
Duration of prior ibrutinib therapy,
median (range), months
12.9
(1.2-64.8)
6.2
(3.1-46.4)
9.5
(1.2-64.8)
Duration of prior acalabrutinib therapy,
median (range), months
NA5.1
(1.2-33.7)
5.1
(1.2-33.7)
del(17p) mutation, n (%)
Present4 (9.1)2 (11.8)6 (9.8)
Absent32 (72.7)8 (47.1)40 (65.6)
Unmutated IGHV, n (%)
Present10 (22.7)1 (5.9)11 (18.0)
Absent8 (18.2)3 (17.6)11 (18.0)
TP53 mutation, n (%)
Present11 (25.0)3 (17.6)14 (23.0)
Absent27 (61.4)6 (35.3)33 (54.1)
CLL, chronic lymphocytic leukaemia; ECOG PS, Eastern Cooperative Oncology Group Performance Status; NA, not applicable; SLL, small lymphocytic lymphoma. *Includes patients intolerant to acalabrutinib alone, or acalabrutinib and ibrutinib; Missing data not shown.1

Primary endpoint

The primary endpoint was the recurrence and change in severity of intolerance events, based on investigator-assessed adverse events.1,2

Cohort 1

At a median follow-up of 28.2 months, over 90% of ibrutinib intolerance events (87/95 events) did not recur or improved with BRUKINSA, and none recurred at a higher grade (Figure 2).1

Figure 2. Ibrutinib-intolerance events in Cohort 1 (n=44. 95 events; investigator-assessed)1,2

Fewer than 10% (n=4) of ibrutinib-intolerant patients discontinued BRUKINSA due to treatment-emergent adverse events (TEAEs).1

Cohort 2

At a median follow-up of 10.1 months, over 80% of acalabrutinib intolerance events (17/21 events) did not recur or improved with BRUKINSA, and none recurred at a higher grade (Figure 3).1

Figure 3. Acalabrutinib-intolerance events (n=17. 21 events; investigator-assessed)*1,2

*Includes patients intolerant to acalabrutinib alone, or acalabrutinib and ibrutinib.1,2

Fewer than 6% (n=1) of acalabrutinib-intolerant patients discontinued BRUKINSA due to TEAEs.1

Secondary endpoints 

Secondary endpoints in Study 215 were investigator-assessed overall response rate, duration of response, disease control rate, progression-free survival, and health-related quality of life.1,2

In 57 evaluable patients receiving BRUKINSA, 95% (n=54) maintained or improved their response rate.1 

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.

March 2024 [0324-BRU-PRC-181]

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