Hematology Today—July 6, 2026

This week’s Hematology update highlights regulatory progress, positive late-stage clinical data, advancing cell and gene therapies, strategic acquisitions, and continued momentum across hematologic malignancies and rare blood disorders.

In Today’s Newsletter

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💊 Epcoritamab plus lenalidomide improves PFS in R/R DLBCL [1] [Denmark • 29 Jun 2026]

https://ir.genmab.com/news-releases/news-release-details/genmab-announces-positive-phase-3-results-epcoritamab-plus
Context: Genmab evaluated fixed-duration epcoritamab plus lenalidomide versus R-GemOx in Phase 3 EPCORE DLBCL-4.
Key point: The study met its primary PFS objective, with reported risk reductions of 60% under US censoring rules and 56% outside the US.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Exa-cel pediatric data published in NEJM [2] [US • 29 Jun 2026]

https://investor.hcahealthcare.com/news/news-details/2026/HCA-Healthcare-Announces-New-England-Journal-of-Medicine-Study-Highlighting-Advances-in-CRISPR-based-Therapy-for-Children/default.aspx
Context: HCA Healthcare highlighted NEJM data from two Phase 3 studies of exa-cel in 26 children ages 5–11.
Key point: Among evaluable children, eight with beta thalassemia achieved 12-month transfusion independence and eight with SCD had no severe vaso-occlusive crises for 12 months.
Implication: May expand screening, initiation, and follow-up at scale.

🩸 AB8939 plus venetoclax shows early R/R AML activity [3] [France • 29 Jun 2026]

https://www.globenewswire.com/news-release/2026/06/29/3318659/0/en/ab-science-reports-completion-of-the-step-3-of-phase-1-evaluating-the-combination-of-ab8939-with-venetoclax-for-the-treatment-of-refractory-or-relapsed-aml.html
Context: AB Science completed Step 3 of Phase 1 AB8939 plus venetoclax in six R/R AML patients with adverse genetics.
Key point: The company reported 67% ORR, 100% disease control and no dose-limiting toxicities after one 14-day cycle.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Ipsen to acquire Kartos Therapeutics [4] [France–US • 29 Jun 2026]

https://www.ipsen.com/press-release/ipsen-to-acquire-kartos-therapeutics-expanding-hemato-oncology-late-stage-pipeline-3318643/
Context: Ipsen agreed to acquire Kartos Therapeutics, adding navtemadlin, an oral MDM2 inhibitor in Phase 3 POIESIS.
Key point: The deal includes $450 million upfront and up to $1.3 billion in milestones, with POIESIS top-line data expected in 2027.
Implication: Signals pipeline investment and modality expansion.

🎯 LOTIS-7 ZYNLONTA plus glofitamab enrollment complete [5] [Switzerland • 30 Jun 2026]

https://ir.adctherapeutics.com/2026-06-30-ADC-Therapeutics-Announces-Completion-of-Enrollment-in-LOTIS-7-Phase-1b-ZYNLONTA-R-Combination-Trial
Context: ADC Therapeutics completed enrollment in LOTIS-7, a Phase 1b study of ZYNLONTA plus glofitamab in r/r DLBCL.
Key point: 100 patients received the selected 150 µg/kg ZYNLONTA dose, with full data expected in Q4 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🔥 Annamycin MIRACLE interim data in R/R AML [6] [US • 30 Jun 2026]

https://moleculin.com/moleculin-reports-positive-phase-2-3-miracle-interim-results-with-annamycin-complete-remission-rates-3-fold-greater-than-control/
Context: Moleculin reported preliminary unblinded Part A MIRACLE data from 45 ITT patients with R/R AML.
Key point: CR was 43% and 36% in Annamycin plus HiDAC arms versus 12% control, while CRc was 50% and 57% versus 29%.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 BRUKINSA Phase 3 frontline MCL update [7] [30 Jun 2026]

https://ir.beonemedicines.com/news/beone-medicines-announces-positive-phase-3-results-for-brukinsa-in-frontline-mantle-cell-lymphoma/44597eac-a44b-451f-a021-48d345cdb85e
Context: BeOne Medicines reported Phase 3 data for BRUKINSA in frontline mantle-cell lymphoma.
Key point: The company announced positive results for BRUKINSA in the frontline MCL setting.
Implication: May influence prescriber choice and payer reviews pending full data.

📄 Cogent submits bezuclastinib NDA in nonadvanced systemic mastocytosis [8] [US • 30 Jun 2026]

https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-announces-submission-new-drug-application-nda
Context: Cogent Biosciences submitted a New Drug Application for bezuclastinib in adults with nonadvanced systemic mastocytosis.
Key point: The filing moves bezuclastinib into FDA review as a potential targeted treatment for nonadvanced systemic mastocytosis.
Implication: Introduces competition that may affect pricing and formulary access.

✅ CASGEVY expanded-use FDA approval [9] [US • 01 Jul 2026]

https://news.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-approval-expanded-use-casgevyr-treatment
Context: Vertex announced US FDA approval expanding CASGEVY use to younger patients with sickle cell disease and transfusion-dependent beta thalassemia.
Key point: The expanded approval broadens the eligible treatment population for the CRISPR-based cell therapy.
Implication: May expand screening, initiation, and follow-up at scale.

💶 Oryzon raises €12 million and signs COFIDES financing agreement [10] [01 Jul 2026]

https://www.oryzon.com/en/news-events/news/oryzon-raises-eur12-million-and-signs-financing-agreement-cofides-strengthen-its
Context: Oryzon announced a €12 million raise and a financing agreement with COFIDES.
Key point: Oryzon raised €12 million and signed a financing agreement with COFIDES to strengthen its financing position.
Implication: Signals pipeline investment and modality expansion.

Why it matters

DLBCL remains a key proving ground for bispecific and ADC-based combinations, with Genmab and ADC Therapeutics advancing different immune-oncology strategies. [1,5]
AML updates continue to focus on hard-to-treat R/R settings, including adverse genetics, venetoclax exposure and cytarabine combinations. [3,6]
Pediatric cell and gene therapy data could support broader discussions on earlier intervention in inherited blood disorders. [2,9]
Ipsen’s Kartos deal reinforces the value of late-stage hemato-oncology assets with defined registrational timelines. [4]
Financing and regulatory submissions may shape near-term runway, label expansion and competitive positioning. [8,10]

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FAQ

What did Genmab report for epcoritamab plus lenalidomide in EPCORE DLBCL-4?

Genmab said the Phase 3 trial met its primary PFS objective in R/R DLBCL. The company reported risk reductions using both US and non-US censoring approaches. [1]

What was notable about HCA Healthcare’s exa-cel pediatric data?

The NEJM study evaluated children ages 5–11 with severe sickle cell disease or transfusion-dependent beta thalassemia. Evaluable children reached 12-month endpoint milestones in both disease groups. [2]

How should AB Science’s AB8939 plus venetoclax data be interpreted?

The signal is early and based on six Phase 1 patients with adverse-risk R/R AML. AB Science reported responses and no DLTs, but the dataset remains small. [3]

Why is Ipsen acquiring Kartos Therapeutics?

Ipsen gains navtemadlin, an oral MDM2 inhibitor in Phase 3 for myelofibrosis patients with suboptimal response to ruxolitinib. POIESIS top-line data are expected in 2027. [4]

What is the status of ADC Therapeutics’ LOTIS-7 study?

Enrollment is complete for 100 r/r DLBCL patients treated with ZYNLONTA plus glofitamab at the selected dose. Full data are expected in Q4 2026. [5]

What did Cogent and Vertex add to the week’s regulatory flow?

Cogent submitted an NDA for bezuclastinib in adults with nonadvanced systemic mastocytosis. Vertex received US FDA approval expanding CASGEVY use to younger patients with sickle cell disease and transfusion-dependent beta thalassemia. [8,9]

Entities / Keywords

Genmab, AbbVie, epcoritamab, EPKINLY, TEPKINLY, lenalidomide, EPCORE DLBCL-4, R/R DLBCL, R-GemOx
HCA Healthcare, Sarah Cannon, TriStar Centennial, exa-cel, CASGEVY, sickle cell disease, transfusion-dependent beta thalassemia
AB Science, AB8939, venetoclax, azacitidine, R/R AML, TP53, MECOM, complex karyotype
Ipsen, Kartos Therapeutics, navtemadlin, MDM2 inhibitor, p53, POIESIS, myelofibrosis, ruxolitinib
ADC Therapeutics, ZYNLONTA, loncastuximab tesirine, glofitamab, COLUMVI, LOTIS-7, r/r DLBCL
Moleculin, Annamycin, HiDAC, MIRACLE, complete remission, composite complete remission
BeOne Medicines, BRUKINSA, zanubrutinib, mantle-cell lymphoma, frontline MCL
Cogent Biosciences, bezuclastinib, nonadvanced systemic mastocytosis, New Drug Application, NDA
Vertex Pharmaceuticals, CASGEVY, exagamglogene autotemcel, CRISPR-based therapy, sickle cell disease, transfusion-dependent beta thalassemia
Oryzon, COFIDES, financing, €12 million