Hematology Today—June 8, 2026

This week’s Hematology update highlights regulatory approvals, late-stage clinical progress, biomarker-driven research, emerging gene-editing advances, and notable development setbacks across blood cancers and rare blood disorders.

In Today’s Newsletter

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💊 Scemblix week-144 CML data [1] [01 Jun 2026]

https://www.novartis.com/news/media-releases/scemblix-continued-show-superior-efficacy-and-favorable-safety-and-tolerability-profile-week-144-newly-diagnosed-cml
Context: ASC4FIRST is a Phase III study of Scemblix (asciminib; Novartis) versus investigator-selected TKIs in newly diagnosed Ph+ CML-CP.
Key point: Week-144 MMR was 77.1% with Scemblix versus 53.4% with standard TKIs, with fewer grade ≥3 AEs than 2G TKIs.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Tapestri links CXCR4-high AML MRD to motixafortide signal [2] [Germany • 03 Jun 2026]

https://www.missionbio.com/press/mission-bio-s-tapestri-enables-single-cell-profiling-of-residual-disease-identifying-aml-patients-likely-to-benefit-from-motixafortide-in-the-multicenter-blast-trial
Context: Mission Bio, Heidelberg University Hospital and partners reported a retrospective single-cell analysis of the Phase II BLAST AML trial.
Key point: High CXCR4 expression on residual leukemic cells emerged as a candidate predictive biomarker for motixafortide benefit.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

✅ Opdivo plus AVD gains EU frontline cHL approval [3] [EU • 01 Jun 2026]

https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Opdivo-nivolumab-in-Combination-with-AVD-Receives-Expanded-EU-Label-with-Approval-in-Frontline-Advanced-Classical-Hodgkin-Lymphoma/default.aspx
Context: Bristol Myers Squibb received EC approval for Opdivo (nivolumab) plus AVD in untreated Stage III or IV classical Hodgkin lymphoma, age 12+.
Key point: Approval was based on SWOG 1826, where Opdivo plus AVD reduced risk of progression or death versus brentuximab vedotin plus AVD.
Implication: May influence prescriber choice and payer reviews pending full data.

☢️ Iopofosine I 131 shows post-BTKi WM activity [4] [US • 01 Jun 2026]

https://www.cellectar.com/investors/news-events/press-releases/detail/393/cellectar-biosciences-to-highlight-compelling-new-efficacy-data-from-phase-2b-clover-wam-study-of-iopofosine-i-131-in-rr-waldenstrm-macroglobulinemia-at-the-american-society-of-clinical-oncology-annual-meeting
Context: Cellectar reported a CLOVER WaM Phase 2 subset of r/r Waldenström macroglobulinemia patients treated immediately after BTKi therapy.
Key point: Iopofosine I 131 showed 79.2% major response rate and median duration of response of 16 months in n=24.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Oryzon starts IDEAL Phase II in essential thrombocythemia [5] [Spain • 02 Jun 2026]

https://www.oryzon.com/en/news-events/news/oryzon-initiates-patient-enrollment-ideal-phase-ii-trial-iadademstat-essential
Context: Oryzon enrolled the first patient in IDEAL, a multicenter, single-arm Phase II trial of iadademstat in hydroxyurea-resistant or intolerant ET.
Key point: The study will assess safety, tolerability and clinical activity, including effects on abnormal platelet counts.
Implication: Signals pipeline investment and modality expansion.

🩸 DISC-0974 updates anemia data in myelofibrosis [6] [US • 02 Jun 2026]

https://www.biospace.com/press-releases/disc-medicine-presents-updated-positive-data-from-rally-mf-phase-2-trial-in-patients-with-myelofibrosis-mf-and-anemia-at-the-2026-american-society-of-clinical-oncology-asco-annual-meeting
Context: Disc Medicine reported updated open-label Phase 2 RALLY-MF data in 61 adults with myelofibrosis and anemia.
Key point: DISC-0974 reduced hepcidin and showed anemia responses across transfusion groups, including patients on JAK inhibitors.
Implication: May influence prescriber choice and payer reviews pending full data.

🎯 Ziftomenib triplet published in Blood for R/R NPM1-mutated AML [7] [US/Japan • 02 Jun 2026]

https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-announce-publication-blood
Context: Kura Oncology and Kyowa Kirin published KOMET-007 Phase 1a/b data for ziftomenib plus venetoclax/azacitidine in R/R NPM1-mutated AML.
Key point: At 600 mg, venetoclax-naïve patients had 87% ORR and 70% CRc; venetoclax-experienced patients had 48% ORR and 24% CRc.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Taiho all-oral AML regimen published in NEJM [8] [03 Jun 2026]

https://www.taihooncology.com/us/news/taiho-oncology-announces-new-england-journal-of-medicine-publication-of-first-all-oral-regimen-in-newly-diagnosed-acute-myeloid-leukemia/
Context: Taiho Oncology announced NEJM publication of ASCERTAIN-V, testing oral decitabine-cedazuridine plus venetoclax in newly diagnosed AML patients ineligible for intensive induction.
Key point: Phase 2b CR was 47%, CR/CRi was 63%, and median OS was 15.5 months, with expected myelosuppressive toxicity.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

⛔ Fulcrum stops pociredir in sickle cell disease [9] [US • 01 Jun 2026]

https://ir.fulcrumtx.com/news-releases/news-release-details/fulcrum-therapeutics-announces-discontinuation-pociredir-program
Context: Fulcrum discontinued pociredir, an oral EED inhibitor being developed for sickle cell disease.
Key point: The company cited FDA feedback on PRC2-related malignancy risk and said there was no viable regulatory path forward.
Implication: Introduces regulatory uncertainty that may reshape development strategy and capital allocation.

✂️ CorrectSequence reports CS-206 base editing SCD follow-up [10] [China • 02 Jun 2026]

http://correctsequence.com/news/shownews.php?id=504
Context: CorrectSequence Therapeutics reported follow-up for China’s first SCD patient treated clinically with CS-206 base editing.
Key point: The patient had more than 15 months without VOCs after CS-206 reinfusion, with no product-related adverse events reported.
Implication: Access and interpretation depend on broader clinical validation and longer follow-up.

Why it matters

Hematology readouts clustered around ASCO and EHA, with CML, AML, WM, MF and SCD all represented.
AML remains a major innovation focus, spanning single-cell MRD, menin inhibition and all-oral HMA plus venetoclax approaches.
Regulatory risk also moved the field, with Fulcrum’s pociredir discontinuation highlighting safety scrutiny around epigenetic mechanisms.
SCD development showed diverging signals, with one PRC2 program halted while a base-editing program reported early patient-level follow-up.
Convenience is becoming a theme, especially in all-oral AML regimens and potentially scalable gene-editing workflows.

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FAQ

What did Novartis report for Scemblix in newly diagnosed CML?

Novartis reported week-144 ASC4FIRST data showing higher MMR rates for Scemblix (asciminib) versus investigator-selected TKIs in newly diagnosed Ph+ CML-CP. [1]

What is the Mission Bio Tapestri finding in AML?

Mission Bio and academic partners said single-cell MRD profiling identified high CXCR4 expression on residual leukemic cells as a candidate predictive biomarker for motixafortide benefit. The analysis was retrospective. [2]

What did the EU approve for Bristol Myers Squibb’s Opdivo?

The European Commission approved Opdivo (nivolumab) plus AVD for previously untreated Stage III or IV classical Hodgkin lymphoma in adults and adolescents age 12+. [3]

What did Cellectar report for iopofosine I 131 in Waldenström macroglobulinemia?

Cellectar reported a post-BTKi CLOVER WaM subset analysis in r/r Waldenström macroglobulinemia, with a 79.2% major response rate and median duration of response of 16 months in n=24. [4]

What is ziftomenib’s status in the Kura and Kyowa Kirin AML update?

KOMZIFTI (ziftomenib) is FDA-approved as monotherapy for certain adult R/R NPM1-mutated AML patients, while the venetoclax/azacitidine combination remains investigational. [7]

Why did Fulcrum stop pociredir in sickle cell disease?

Fulcrum said FDA feedback raised concerns about PRC2-related malignancy risk after Tazverik’s withdrawal, leaving no viable regulatory path for pociredir in SCD. [9]

Entities / Keywords

Novartis, Scemblix, asciminib, ASC4FIRST, Ph+ CML-CP, TKIs, imatinib, nilotinib, dasatinib, bosutinib
Mission Bio, Tapestri, AML, MRD, CXCR4, motixafortide, BLAST
Bristol Myers Squibb, Opdivo, nivolumab, AVD, classical Hodgkin lymphoma, SWOG 1826
Cellectar Biosciences, iopofosine I 131, CLOVER WaM, Waldenström macroglobulinemia, BTKi
Oryzon Genomics, iadademstat, IDEAL, essential thrombocythemia, LSD1
Disc Medicine, DISC-0974, RALLY-MF, myelofibrosis, anemia, hepcidin, JAK inhibitor
Kura Oncology, Kyowa Kirin, ziftomenib, KOMZIFTI, KOMET-007, NPM1-mutated AML, venetoclax, azacitidine
Taiho Oncology, ASCERTAIN-V, decitabine-cedazuridine, venetoclax, newly diagnosed AML
Fulcrum Therapeutics, pociredir, EED, PRC2, sickle cell disease, Tazverik, tazemetostat
CorrectSequence Therapeutics, Zhengxu Biotech, CS-206, base editing, tBE, sickle cell disease, VOC