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Study design

Study 201: A single-arm, open-label, Phase 1/2 trial of BEQALZI in R/R MCL1,2

KEY ELIGIBILITY CRITERIA1,3

  • Age ≥ 18 years
  • Relapsed/refractory MCL
  • Prior treatment with an anti-CD20–based therapy and at least one BTKi
  • No known central nervous system involvement by lymphoma
  • No prior exposure to a BCL-2i

BEQALZI 320 mg QD target dose after ramp-up; treatment until disease progression or unacceptable toxicity1

PRIMARY ENDPOINT1,2

  • ORR determined by IRC (N=103)*

SELECT SECONDARY ENDPOINTS1-3

  • DOR and TTR determined by IRC and investigator (N=103)
  • Safety (N=115)†

*Assessed per 2014 Lugano criteria.1

†The safety analysis included 12 patients from the dose-expansion cohort and 103 patients from the efficacy-expansion cohort who received BEQALZI 320 mg once daily.2

Baseline patient characteristics

Demographics and baseline characteristics2 N=115
Median age, years (range) 68 (39, 85)
Male, n (%) 87 (76)
ECOG performance status, n (%)
0 34 (30)
1 74 (64)
2 7 (6)
Histology classification, n/N with known status (%)
Classic 52/79 (66)
Pleomorphic 5/79 (6)
Blastoid 21/79 (27)
Mixed blastoid/pleomorphic features 1/79 (1.3)
Bulky disease status, n (%)
LDi ≥5 cm 46 (40)
LDi ≥10 cm 12 (10)
sMIPI, n (%)
High 35 (30)
Intermediate 41 (36)
Low 39 (34)
Ki-67 ≥30%, n/N with known status (%) 41/98 (42)
TP53 mutation, n/N with known status (%) 27/78 (35)
Median prior lines of therapy (range) 3 (1, 8)
Most common prior regimens, n (%)
BTKi 115 (100)
Anti-CD20–based 115 (100)
ASCT 17 (15)
Patients with refractory disease to last line of therapy, n (%) 100 (87)
Reasons for discontinuation of last line of anticancer drug therapy, n (%)
Progressive disease 79 (69)
Treatment completed 17 (15)
Toxicity 12 (10)
Other 7 (6)

ASCT=autologous stem cell transplant; BCL-2i=B-cell lymphoma 2 inhibitor; BTKi=Bruton’s tyrosine kinase inhibitor; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; IRC=independent review committee; LDi=longest diameter; ORR=overall response rate; QD=once daily; sMIPI=simplified Mantle cell lymphoma International Prognosis Index score; TTR=time to response.

About BEQALZI Efficacy

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome (TLS).

WARNINGS & PRECAUTIONS

Tumor Lysis Syndrome (TLS):

BEQALZI can cause rapid tumor reduction and changes in blood chemistries consistent with TLS, which may be serious or life-threatening and require prompt management. TLS may occur as early as 4 hours after the first dose, with dose increases, or upon reinitiation following treatment interruption. Laboratory or clinical TLS occurred in 7% of patients who followed the recommended dose ramp-up. Assess all patients for TLS risk and initiate prophylaxis, including adequate hydration and antihyperuricemics. For patients at high risk of TLS, consider hospitalization with intravenous hydration and employ frequent monitoring. Monitor blood chemistries closely and manage abnormalities promptly. Interrupt BEQALZI for TLS; upon reinitiation, follow dose modification guidance in the Prescribing Information.

Serious Infections:

BEQALZI can cause fatal or serious infections. Serious infections occurred in 14% of patients; Grade 3-4 occurred in 17% (fatal: 2.6%). The most common Grade 3 or greater infection was pneumonia (10%). Monitor for signs and symptoms of infection and treat appropriately. Consider prophylactic antimicrobials and immunoglobulins. Interrupt, reduce dose, or permanently discontinue BEQALZI based on severity.

Neutropenia:

BEQALZI can cause serious or severe cytopenias, including neutropenia. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%); febrile neutropenia occurred in 1.7% of all patients. Monitor complete blood counts throughout treatment. Interrupt treatment, reduce the dose, or permanently discontinue BEQALZI based on severity.

Embryo-Fetal Toxicity:

BEQALZI can cause fetal harm when administered to pregnant women. Advise patients of the potential risk to a fetus. Verify pregnancy status prior to initiation. Advise females to use effective contraception and males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions (≥15%) are pneumonia (16%) and fatigue (16%). The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes (29%) and neutrophils (18%).

DRUG INTERACTIONS

Strong or Moderate CYP3A Inhibitors:

Concomitant use increases BEQALZI exposure. Avoid use of strong CYP3A inhibitors during BEQALZI initiation and ramp-up. Avoid use of moderate CYP3A inhibitors at the 1 mg and 2 mg doses; for all other doses, reduce the BEQALZI dose with concomitant use. See approved labeling for dose modifications.

Strong or Moderate CYP3A Inducers:

Concomitant use decreases BEQALZI exposure. Avoid use.

SPECIAL POPULATIONS

Lactation: Advise women not to breastfeed during treatment with BEQALZI and for 1 week after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact BeOne Medicines at 1-877-828-5596 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

INDICATION

BEQALZI™ (sonrotoclax) is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information.

References: 1. BEQALZI. Prescribing Information. BeOne Medicines USA, Inc.; 2026. 2. Eyre TA, Song Y, Hermine O, et al. Phase I/II study of sonrotoclax (BGB-11417) monotherapy in patients with mantle cell lymphoma previously treated with anti-CD20 therapy and a Bruton tyrosine kinase inhibitor. J Clin Oncol. Published online July 1, 2026. doi:10.1200/JCO-26-00550 3. BeiGene. Study of BGB-11417 monotherapy in participants with relapsed or refractory mantle cell lymphoma. ClinicalTrials.gov website. NCT05471843. Last updated September 9, 2025. Accessed September 3, 2026. https://clinicaltrials.gov/study/NCT05471843

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