Hematology Today—December 15, 2025

In Today’s Newsletter

🧬 TECVAYLI + DARZALEX FASPRO Phase 3 in RRMM shows OS and PFS gains [1] [US • 09 Dec 2025]

https://www.jnj.com/media-center/press-releases/unprecedented-results-from-the-phase-3-majestec-3-study-support-tecvayli-plus-darzalex-faspro-as-a-potential-standard-of-care-as-early-as-second-line-for-patients-with-relapsed-refractory-multiple-myeloma

Context: Phase 3 MajesTEC-3 vs DPd/DVd in RRMM, 1–3 prior lines, ~3-year follow-up; ASH late-breaker with NEJM.

Key point: 83% PFS risk reduction (HR 0.17); OS benefit (HR 0.46); higher ≥CR and MRD-negativity; CRS mostly Grade 1–2, infections common.

Implication: May influence prescriber choice and payer reviews pending full data.

💊 Ziftomenib + venetoclax/azacitidine shows broad AML activity [2] [US/JP • 08 Dec 2025]

https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-report-combination-data-komziftitm

Context: KOMET-007 Phase 1a/1b in newly diagnosed chemo-ineligible and R/R AML with NPM1-m or KMT2A-r; ASH orals.

Key point: ND NPM1-m CRc 86% (CR 73%), 68% MRD-neg; R/R NPM1-m ORR 65% (83% ven-naïve); R/R KMT2A-r ORR 41% (70% ven-naïve); tolerability consistent with ven/aza.

Implication: May influence prescriber choice and payer reviews pending full data.

🧠 RMAT granted to SENTI-202 logic-gated CAR-NK for R/R AML [3] [US • 09 Dec 2025]

https://investors.sentibio.com/news-releases/news-release-details/senti-bio-receives-fda-regenerative-medicine-advanced-therapy

Context: RMAT based on ongoing Phase 1 in CD33 and/or FLT3 expressing malignancies; ASH oral + poster.

Key point: At RP2D, ORR 50% and CR/CRh 42%, median 7.6-month composite CR duration across patients; safety described as well tolerated.

Implication: Signals pipeline investment and modality expansion.

🔗 Pirtobrutinib beats BR in front-line CLL/SLL without del(17p) [4] [09 Dec 2025]

https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-significantly-improved-progression

Context: Phase 3 BRUIN CLL-313, 282 TN CLL/SLL randomized to pirtobrutinib vs bendamustine/rituximab.

Key point: 80% PFS risk reduction (HR 0.20; p<0.0001); early OS trend despite 53% crossover; fewer Grade ≥3 TEAEs vs BR.

Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Epcoritamab shows activity in Richter transformation [5] [DK • 08 Dec 2025]

https://ir.genmab.com/news-releases/news-release-details/genmab-announces-new-data-phase-1b2-epcorer-cll-1-highlighting

Context: EPCORE CLL-1 Arms 2A–2C, RT monotherapy and combos; ASH orals; Arm 2A in Lancet Haematology.

Key point: Mono 1L RT ORR 57% with CR 52% and median OS 27.5 months; combos ORR 77–82% with CR 63–73%; CRS mostly low grade, some Grade 5 events in combos.

Implication: May influence prescriber choice and payer reviews pending full data.

🧩 Lunsumio combos in FL and LBCL highlight outpatient potential [6] [CH • 08 Dec 2025]

https://www.roche.com/media/releases/med-cor-2025-12-08b

Context: CELESTIMO US extension 2L+ FL, and SC Lunsumio + Polivy in R/R LBCL; long-term mono follow-up.

Key point: FL len combo CR 87% in single-arm cohort; LBCL SC Lunsumio + Polivy ORR 77.5% vs 50% with R+Polivy and longer PFS; safety consistent.

Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🛡️ FDA Priority Review for Opdivo + AVD in advanced cHL [7] [US • 08 Dec 2025]

https://news.bms.com/news/corporate-financial/2025/U-S–Food-and-Drug-Administration-FDA-Grants-Priority-Review-to-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-Plus-Chemotherapy-Combination-for-Classical-Hodgkin-Lymphoma/default.aspx

Context: sBLA for adults and adolescents ≥12 with untreated Stage III–IV cHL; PDUFA 08 Apr 2026; based on SWOG S1826.

Key point: NCTN Phase 3 supports IO-chemo in frontline cHL; FDA Priority Review.

Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Hemgenix 5-year durability in hemophilia B confirmed in NEJM [8] [US • 07 Dec 2025]

https://newsroom.csl.com/2025-12-07-Data-Published-in-the-New-England-Journal-of-Medicine-Confirm-the-Long-term-Durability-and-Safety-of-HEMGENIX-R-etranacogene-dezaparvovec-drlb-Over-Five-Years

Context: Phase 3 HOPE-B 60-month analysis, 54 adults; NEJM + ASH.

Key point: 94% off continuous prophylaxis at year 5, mean FIX ~36%, ~90% ABR reduction vs lead-in, favorable safety.

Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🇨🇳 Qfitlia and Cablivi win NMPA approvals in China [9] [CN • 11 Dec 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-11-06-00-00-3203611

Context: Fitusiran prophylaxis for severe hemophilia A/B, with or without inhibitors; Caplacizumab for aTTP/iTTP.

Key point: ATLAS program supports low-frequency SC fitusiran with ABR reductions; caplacizumab adds targeted therapy with PEX and immunosuppression.

Implication: May expand screening, initiation, and follow-up at scale.

🩸 Ianalumab short-course extends ITP control vs placebo combo [10] [CH • 09 Dec 2025]

https://www.novartis.com/news/media-releases/novartis-ianalumab-significantly-extends-disease-control-patients-immune-thrombocytopenia-only-four-once-monthly-doses

Context: Phase 3 VAYHIT2, prior steroid-treated primary ITP; ianalumab + eltrombopag vs placebo + eltrombopag.

Key point: Time to treatment failure 2.8× longer; SR6 62% vs 39%; manageable AEs including mostly resolving neutropenia.

Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

• Earlier lines: bispecifics and non-covalent BTK show randomized advantages and survival signals.
• Treatment burden: short-course and outpatient regimens target durable control with less chronic therapy.
• Modalities: gene therapy and siRNA expand durable, non-factor options and global access.
• Regulatory tailwinds: RMAT and Priority Review may accelerate availability in high-need indications.

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FAQ

What exactly did MajesTEC-3 show for TECVAYLI + DARZALEX?

In RRMM with 1–3 prior lines, the combo cut PFS risk by 83% vs DPd/DVd and improved OS, with higher ≥CR and MRD-negativity; safety included mostly low-grade CRS and infections [1].

How strong are ziftomenib triplet data with ven/aza?

In ND NPM1-m AML, CRc was 86% with 68% MRD-neg; in R/R NPM1-m ORR was 65% overall, 83% ven-naïve; KMT2A-r ORR 41% overall, 70% ven-naïve, with tolerability similar to ven/aza [2].

What does RMAT mean for SENTI-202?

It enables closer FDA interaction and potential expedited pathways based on early Phase 1 signals in R/R AML, including ORR 50% and CR/CRh 42% at RP2D reported by the company [3].

Is pirtobrutinib ready for front-line CLL/SLL?

BRUIN CLL-313 showed an 80% PFS risk reduction vs BR with fewer high-grade TEAEs; OS is immature but trending positive despite crossover. Regulatory submissions have begun per company [4].

Which approvals progressed this week?

FDA Priority Review for Opdivo + AVD in Stage III–IV cHL (PDUFA 08 Apr 2026) [7]; China NMPA approved fitusiran and caplacizumab [9].

Entities / Keywords

TECVAYLI (teclistamab), DARZALEX FASPRO (daratumumab) • KOMZIFTI (ziftomenib) • SENTI-202 CAR-NK • Jaypirca (pirtobrutinib) • Epcoritamab (EPKINLY/TEPKINLY) • Lunsumio (mosunetuzumab), Polivy (polatuzumab) • Opdivo (nivolumab) + AVD • Hemgenix (etranacogene dezaparvovec) • Qfitlia (fitusiran), Cablivi (caplacizumab) • Ianalumab (VAY736), eltrombopag.

References