Hematology Today—June 15, 2026

LucidQuest

4 days ago

This week’s Hematology update highlights regulatory actions, clinical progress, data releases, and pipeline expansion across blood disorders and malignancies.

In Today’s Newsletter

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💉 Cellectis wins FDA RMAT for lasme-cel in r/r B-ALL [1] [US • 09 Jun 2026]

https://www.cellectis.com/en/press/cellectis-receives-fda-rmat-designation-for-lasme-cel-the-first-allogeneic-car-t-therapy-in-a-pivotal-trial-for-patients-with-r-r-b-all/
Context: Designation was supported by Phase 1 BALLI-01 data; pivotal Phase 2 BALLI-01 is open for enrollment.
Key point: FDA granted RMAT designation to lasme-cel, Cellectis’s CD22 allogeneic CAR-T candidate for r/r B-ALL.
Implication: May influence prescriber choice and payer reviews pending full data.

🩸 Pfizer gains FDA expanded HYMPAVZI label in hemophilia [2] [US • 08 Jun 2026]

https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-hympavzi-treatment-two-additional
Context: BASIS and BASIS KIDS supported the update; HYMPAVZI is once-weekly, subcutaneous, non-factor prophylaxis.
Key point: FDA expanded HYMPAVZI (marstacimab-hncq) for hemophilia A or B patients aged 12+ with inhibitors and children aged 6–11 with or without inhibitors.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 Immuneering doses first patient in Phase 3 pancreatic cancer trial [3] [Global • 11 Jun 2026]

https://ir.immuneering.com/news-releases/news-release-details/immuneering-announces-first-patient-dosed-pivotal-phase-3
Context: The global randomized Phase 3 trial uses overall survival as the primary endpoint; topline data are expected in mid-2028.
Key point: Immuneering dosed the first patient in MAPKeeper 301, testing atebimetinib plus modified gemcitabine/nab-paclitaxel in 1L metastatic PDAC.
Implication: May influence prescriber choice and payer reviews pending full data.

🎯 Kura and Kyowa Kirin report ziftomenib plus 7+3 AML data [4] [US • Japan • 11 Jun 2026]

https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-report-encouraging-long-term
Context: Median OS was not reached in either cohort; the combination remains investigational in frontline AML.
Key point: Ziftomenib plus 7+3 showed 96% CRc in newly diagnosed NPM1-m AML and 90% CRc in KMT2A-r AML in single-arm KOMET-007.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Oryzon reports iadademstat AML updates at EHA 2026 [5] [Spain • US • 11 Jun 2026]

https://www.oryzon.com/en/news-events/news/oryzon-presents-updated-positive-clinical-data-iadademstat-acute-myeloid-leukemia
Context: FRIDA data in FLT3-mutated r/r AML showed 67% CRc with iadademstat plus gilteritinib.
Key point: Iadademstat plus azacitidine and venetoclax showed 100% ORR and 89% CRc in ALICE-2 first-line AML data.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 C4 Therapeutics presents cemsidomide myeloma Phase 1 data [6] [US • 11 Jun 2026]

https://ir.c4therapeutics.com/news-releases/news-release-details/c4-therapeutics-presents-phase-1-data-european-hematology
Context: Phase 1 data included 73 patients; median prior lines were seven, and 75% had prior BCMA therapy.
Key point: Cemsidomide plus dexamethasone achieved 53% ORR at the 100 µg recommended Phase 2 dose in heavily pretreated RRMM.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Genmab reports EPCORE FL-1 subgroup data in R/R FL [7] [EU • 11 Jun 2026]

https://ir.genmab.com/news-releases/news-release-details/genmab-presents-epcorer-fl-1-subgroup-data-demonstrating
Context: The Phase 3 post-hoc analysis found PFS benefits favoring epcoritamab plus R2 across FLIPI, POD24, and NHL-5 groups.
Key point: Epcoritamab plus rituximab and lenalidomide showed sustained efficacy across EPCORE FL-1 follicular lymphoma subgroups.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 T-CURX gets Swissmedic approval for TCX-001 Phase 1 CAR-T trial [8] [Switzerland • 11 Jun 2026]

https://www.t-curx.com/news/2026/june-11-t-curx-non-viral-siglec-6-lead-car-t-program-tcx-001-was-approved-for-first-in-human-phase-1-clinical-trial-in-patients-with-relapsed-refractory-aml-and-cll
Context: The study will enroll up to 23 adults and assess safety, tolerability, dose-limiting toxicities, and recommended Phase 2 dose.
Key point: Swissmedic approved T-CURX’s first-in-human Phase 1 trial of TCX-001, a Siglec-6 CAR-T for r/r AML and CLL.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Multiple AML updates clustered around EHA 2026, spanning menin inhibition, LSD1 inhibition, and Siglec-6 CAR-T.
FDA action supported two access-oriented stories, Cellectis’s RMAT designation and Pfizer’s expanded HYMPAVZI label.
Bispecific and degrader data continued to move earlier and broader in hematologic malignancies.
Several programs remain investigational, so interpretation depends on trial design, maturity, and confirmatory data.

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FAQ

What is lasme-cel from Cellectis?

Lasme-cel is a CD22-targeting allogeneic CAR-T candidate for r/r B-ALL. FDA granted RMAT designation based on Phase 1 BALLI-01 data. [1]

What changed for Pfizer’s HYMPAVZI label?

FDA expanded HYMPAVZI to include hemophilia A or B patients aged 12+ with inhibitors and children aged 6–11 with or without inhibitors. [2]

What is Immuneering testing in MAPKeeper 301?

MAPKeeper 301 is testing atebimetinib plus modified gemcitabine/nab-paclitaxel versus GnP alone in 1L metastatic PDAC. The primary endpoint is OS. [3]

Is ziftomenib plus 7+3 approved in newly diagnosed AML?

No. Kura and Kyowa Kirin stated that ziftomenib plus 7+3 is investigational in newly diagnosed AML. [4]

What did Genmab report for epcoritamab plus R2?

Genmab reported EPCORE FL-1 subgroup data showing PFS and response benefits across R/R follicular lymphoma risk groups. [7]

What is TCX-001 from T-CURX?

TCX-001 is a non-viral, autologous Siglec-6 CAR-T candidate approved by Swissmedic for a first-in-human Phase 1 trial in r/r AML and CLL. [8]

Entities / Keywords

Cellectis, lasme-cel, lasmecabtagene timgedleucel, CD22 CAR-T, allogeneic CAR-T, r/r B-ALL, BALLI-01, RMAT
Pfizer, HYMPAVZI, marstacimab-hncq, hemophilia A, hemophilia B, inhibitors, BASIS, BASIS KIDS
Immuneering, atebimetinib, MAPKeeper 301, mGnP, GnP, MEK inhibitor, PDAC, pancreatic cancer
Kura Oncology, Kyowa Kirin, ziftomenib, KOMZIFTI, KOMET-007, KOMET-017, NPM1-m AML, KMT2A-r AML, 7+3
Oryzon, iadademstat, LSD1 inhibitor, ALICE-2, FRIDA, azacitidine, venetoclax, gilteritinib, FLT3-mutated AML
C4 Therapeutics, cemsidomide, IKZF1/3 degrader, dexamethasone, RRMM, MOMENTUM
Genmab, AbbVie, epcoritamab, EPKINLY, TEPKINLY, EPCORE FL-1, R2, follicular lymphoma
T-CURX, TCX-001, Siglec-6, Swissmedic, Sleeping Beauty, AML, CLL, non-viral CAR-T