BeOne Medicines has got the first US approval for its next-generation BCL2 inhibitor sonrotoclax, now branded Beqalzi. The accelerated nod, in the rare blood cancer mantle cell lymphoma, is perhaps most important for paving the way for more lucrative uses, such as first-line CLL, where the Celestial-TNCLL (301) trial is set to read out this year. But it will be a relief for BeOne, which has fielded questions about Beqalzi’s toxicity. Like AbbVie's similarly acting Venclexta, Beqalzi’s label carries warnings of tumour-lysis syndrome, serious infections and neutropenia, but no boxed warning. The label cites a 37% rate of serious adverse events in the supporting BGB-11417-201 study, and a 4% rate of fatal adverse reactions, with pneumonia being a major cause of death. This hasn’t deterred BeOne, which reckons Beqalzi is more potent than Venclexta, and has a comprehensive pivotal trial programme under way. BeOne also plans to start new studies in relapsed/refractory multiple myeloma and CLL, the latter testing a combo with its BTK degrader BGB-16673. Elsewhere in blood cancers, a Venclexta combo with Otsuka’s Inqovi has been FDA approved for first-line AML ineligible for intensive induction chemotherapy; the decision was delayed from February. Selected pivotal Beqalzi trialsTrialIndicationDesignStatusBGB-11417-201r/r MCL (post BTKi & anti-CD20 MAb)Phase 1/2 monotherapySupported US AA May 2026 in 3rd-line MCL, post-BTKiCelestial-TNCLL (301)1st-line CLLPhase 3, + Brukinsa, vs Gazyva + VenclextaMRD data expected in 2026, with potential to support AACelestial-203Waldenström’s macroglobulinemiaPhase 2 uncontrolled, monotherapy (r/r) & Brukinsa combo (1st-line)Enrolment completed Nov 2025; potentially registration enablingCelestial-RRMCLr/r MCL (post anti-CD20 MAb)Phase 3, + Brukinsa, vs BrukinsaConfirmatory study; expected completion Aug 2028 (from Mar 2029)Celestial-RRCLLr/r CLLPhase 3, + Gazyva/Rituxan, vs Venclexta + RituxanPrimary completion Sep 2029Celestial-TNCLL (304)1st-line CLLPhase 3, + Brukinsa, vs Calquence + VenclextaStarted Jan 2026; MRD data could be reported in 2029Unnamedr/r multiple myelomaPhase 3, + anti-CD38 mAb + dexamethasoneTo start H2 2026Unnamedr/r CLLPhase 3, + BGB-16673 (BTK degrader)Planned, timing unclearSource: OncologyPipeline.
BeOne Medicines has got the first US approval for its next-generation BCL2 inhibitor sonrotoclax, now branded Beqalzi. The accelerated nod, in the rare blood cancer mantle cell lymphoma, is perhaps most important for paving the way for more lucrative uses, such as first-line CLL, where the Celestial-TNCLL (301) trial is set to read out this year. But it will be a relief for BeOne, which has fielded questions about Beqalzi’s toxicity. Like AbbVie's similarly acting Venclexta, Beqalzi’s label carries warnings of tumour-lysis syndrome, serious infections and neutropenia, but no boxed warning. The label cites a 37% rate of serious adverse events in the supporting BGB-11417-201 study, and a 4% rate of fatal adverse reactions, with pneumonia being a major cause of death. This hasn’t deterred BeOne, which reckons Beqalzi is more potent than Venclexta, and has a comprehensive pivotal trial programme under way. BeOne also plans to start new studies in relapsed/refractory multiple myeloma and CLL, the latter testing a combo with its BTK degrader BGB-16673. Elsewhere in blood cancers, a Venclexta combo with Otsuka’s Inqovi has been FDA approved for first-line AML ineligible for intensive induction chemotherapy; the decision was delayed from February.
Selected pivotal Beqalzi trials
| Trial | Indication | Design | Status |
|---|
| BGB-11417-201 | r/r MCL (post BTKi & anti-CD20 MAb) | Phase 1/2 monotherapy | Supported US AA May 2026 in 3rd-line MCL, post-BTKi |
| Celestial-TNCLL (301) | 1st-line CLL | Phase 3, + Brukinsa, vs Gazyva + Venclexta | MRD data expected in 2026, with potential to support AA |
| Celestial-203 | Waldenström’s macroglobulinemia | Phase 2 uncontrolled, monotherapy (r/r) & Brukinsa combo (1st-line) | Enrolment completed Nov 2025; potentially registration enabling |
| Celestial-RRMCL | r/r MCL (post anti-CD20 MAb) | Phase 3, + Brukinsa, vs Brukinsa | Confirmatory study; expected completion Aug 2028 (from Mar 2029) |
| Celestial-RRCLL | r/r CLL | Phase 3, + Gazyva/Rituxan, vs Venclexta + Rituxan | Primary completion Sep 2029 |
| Celestial-TNCLL (304) | 1st-line CLL | Phase 3, + Brukinsa, vs Calquence + Venclexta | Started Jan 2026; MRD data could be reported in 2029 |
| Unnamed | r/r multiple myeloma | Phase 3, + anti-CD38 mAb + dexamethasone | To start H2 2026 |
| Unnamed | r/r CLL | Phase 3, + BGB-16673 (BTK degrader) | Planned, timing unclear |
