Hematology Update: Inobrodib Trial, Tecvayli Combo, Bexobrutideg Data and More
From Phase 2 enrollment milestones in multiple myeloma to CHMP’s recommendation of Lunsumio in follicular lymphoma, this week’s hematology roundup delivers major progress across myeloma, AML, CLL, and lymphoma.
In Today’s Newsletter
🔬 CellCentric completes Phase 2 MM cohort enrollment [1] [UK/US • 09 Sep 2025]
Context: Earlier escalation cohorts showed 75% ORR at the highest dose; data due 2H25.
Key point: CellCentric completed enrollment (n=60) for dose-optimization cohorts of inobrodib + pomalidomide/dexamethasone in MM.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 J&J’s Tecvayli + Darzalex Faspro shows deep NDMM responses [2] [CA • 19 Sep 2025]
Context: 49 patients treated; 85.7% achieved CR or better after induction; CRS mostly grade 1/2.
Key point: Phase 2 MajesTEC-5 trial in transplant-eligible NDMM showed 100% response and MRD negativity.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Moleculin initiates EU dosing in pivotal AML trial [3] [EU • 08 Sep 2025]
https://moleculin.com/moleculin-doses-first-eu-patient-in-phase-3-pivotal-miracle-trial-for-treatment-of-acute-myeloid-leukemia/
Context: Global trial, adaptive design; 45-patient unblinding planned for 2H25.
Key point: First EU patient dosed in MIRACLE Phase 2B/3 study of annamycin + cytarabine in R/R AML.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Akeso’s ligufalimab wins FDA Orphan Drug Designation [4] [CN • 16 Sep 2025]
https://akesobio.com/en/media/akeso-news/250916/
Context: Ligufalimab also in Phase 2 AML/MDS trials; Phase 3 in solid tumors ongoing.
Key point: FDA granted ODD to Akeso’s CD47 mAb ligufalimab for AML.
Implication: Introduces competition that may affect pricing and formulary access.
📑 Syndax’s revumenib added to NCCN AML Guidelines [5] [US • 19 Sep 2025]
https://ir.syndax.com/news-releases/news-release-details/syndaxs-revuforjr-revumenib-included-nccn-clinical-practice
Context: Based on pivotal AUGMENT-101 trial; FDA sNDA under Priority Review (PDUFA 25 Oct 2025).
Key point: NCCN now lists revumenib as category 2A for R/R NPM1-mutated AML.
Implication: May influence prescriber choice and payer reviews pending full data.
📈 Lilly’s Jaypirca boosts PFS in front-line CLL [6] [US • 08 Sep 2025]
https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-first-and-only-approved-non-0
Context: 282 patients randomized; OS trending positive but not yet mature.
Key point: Phase 3 BRUIN CLL-313 showed significant PFS benefit for pirtobrutinib vs chemoimmunotherapy in untreated CLL/SLL.
Implication: May influence prescriber choice and payer reviews pending full data.
🔄 Bexobrutideg shows strong efficacy in R/R CLL [7] [US • 09 Sep 2025]
https://www.bloodcancerstoday.com/post/novel-btk-degrader-bexobrutideg-shows-high-response-rates-in-relapsed-or-refractory-cll
Context: n=48; durable responses beyond 2.5 years; no dose-limiting toxicities reported.
Key point: Phase 1a trial of BTK degrader bexobrutideg showed ~81% ORR in heavily pretreated R/R CLL.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Roche CHMP backs SC Lunsumio in FL [8] [EU • 19 Sep 2025]
https://www.roche.com/media/releases/med-cor-2025-09-19
Context: Phase 2 GO29781 showed non-inferior PK vs IV; CR rate ~59%, durable responses.
Key point: CHMP recommended EU approval of SC Lunsumio for R/R FL after ≥2 prior lines.
Implication: Introduces competition that may affect pricing and formulary access.
Why it matters
- Expanding MM pipeline: Inobrodib and Tecvayli/Darzalex regimens highlight novel mechanisms and deeper responses in early disease.
- AML innovation: Revumenib’s NCCN inclusion, annamycin’s pivotal trial, and ligufalimab’s ODD reflect progress across genetic and immune targets.
- CLL therapy shift: Jaypirca’s PFS benefit and bexobrutideg’s efficacy suggest movement beyond covalent BTK inhibitors.
- Access evolution: Subcutaneous Lunsumio could simplify FL treatment and reduce healthcare burden.
📢 Stay Ahead in Hematology Research!
✅ Contact LucidQuest at info@lqventures.com for strategic guidance on Hematology innovations and clinical research.
FAQ
What milestone did CellCentric achieve with inobrodib?
CellCentric completed enrollment of 60 MM patients in Phase 2 dose-optimization cohorts for inobrodib + pomalidomide/dexamethasone; data expected late 2025 [1].
How effective was the Tecvayli + Darzalex Faspro induction regimen?
In Phase 2 MajesTEC-5, all evaluable NDMM patients achieved MRD negativity after induction, with 85.7% reaching CR or better [2].
What is the goal of Moleculin’s MIRACLE trial?
The Phase 2B/3 MIRACLE trial is designed to evaluate annamycin + cytarabine in R/R AML, with first efficacy unblinding at 45 patients in 2H25 [3].
Why is revumenib’s NCCN inclusion significant?
Revumenib is now a recommended option for R/R NPM1-mutated AML, supporting its FDA sNDA under Priority Review (decision due Oct 2025) [5].
How does Jaypirca compare to chemoimmunotherapy in CLL?
In treatment-naïve CLL/SLL without 17p deletions, Jaypirca significantly improved PFS versus bendamustine + rituximab in Phase 3 BRUIN CLL-313 [6].
What advantage does SC Lunsumio offer in FL?
SC Lunsumio can be administered in ~1 minute versus 2–4 hours IV, with similar efficacy and safety, potentially reducing treatment burden [8].
Entities / Keywords
CellCentric; inobrodib; multiple myeloma; Johnson & Johnson; Tecvayli (teclistamab); Darzalex Faspro (daratumumab); MajesTEC-5;Moleculin; annamycin (naxtarubicin); MIRACLE trial; AML; Akeso; ligufalimab (AK117); CD47 mAb; AML; Syndax; revumenib (Revuforj); NPM1-mutated AML; NCCN; Eli Lilly; Jaypirca (pirtobrutinib); CLL/SLL; BRUIN CLL-313; Bexobrutideg (NX-5948); BTK degrader; CLL; Roche; Lunsumio (mosunetuzumab); follicular lymphoma; CHMP
References
- https://www.cellcentric.com/press-release/cellcentric-announces-completion-of-enrollment-for-dose-optimization-cohorts-in-phase-2-study-for-multiple-myeloma/
- https://www.jnj.com/media-center/press-releases/tecvayli-and-darzalex-faspro-based-induction-treatment-demonstrates-promising-rates-and-depths-of-response-in-transplant-eligible-patients-with-newly-diagnosed-multiple-myeloma
- https://moleculin.com/moleculin-doses-first-eu-patient-in-phase-3-pivotal-miracle-trial-for-treatment-of-acute-myeloid-leukemia/
- https://akesobio.com/en/media/akeso-news/250916/
- https://ir.syndax.com/news-releases/news-release-details/syndaxs-revuforjr-revumenib-included-nccn-clinical-practice
- https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-first-and-only-approved-non-0
- https://www.bloodcancerstoday.com/post/novel-btk-degrader-bexobrutideg-shows-high-response-rates-in-relapsed-or-refractory-cll
- https://www.roche.com/media/releases/med-cor-2025-09-19