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Trials — EHA 2026

The primary artifact of this vault: one Markdown file per trial / readout. EHA 2026 is a clinical-readout meeting, so the unit of analysis is the trial — not the speaker, not the tool, not the company. Same per-trial schema as ASH 2026 and ASCO 2026; EHA adds an explicit European cooperative-group sub-axis (HOVON, GIMEMA, GELTAMO, GMLL, IFM, LYSA, NCRI) and an EBMT registry sub-axis on transplant / cellular therapy.

Status: Template + master index. Per-trial pages will be populated in two waves: (1) regular abstracts upon HemaSphere-supplement release on May 12, 2026, 15:30 CEST (tomorrow); (2) Late-Breaking Abstracts on June 2, 2026, 15:30 CEST. Pre-meeting stubs flagged *expected, subject to embargo* are sourced from company toplines, ASCO 2026 heme subset (May 29 – Jun 2), and analyst preview pieces; numbers can shift on the actual abstract reveal.

Per-trial template

Each trial file (e.g., epcore-nhl-2-update.md) follows this schema. Copy and fill:

# <Trial acronym / name> — <Drug regimen, indication, line>

> **Abstract:** <abstract #, e.g., LB1234 / Presidential Symposium S100 / Oral S567> · **Session:** <session name, date, time CEST, hall> · **Embargo:** <date>

## At a glance

- **Sponsor:** <pharma / cooperative group (HOVON, GIMEMA, GELTAMO, GMLL, IFM, LYSA, NCRI, etc.)>
- **PI / presenter:** <name, institution>
- **NCT ID:** <NCTxxxxxxxx>
- **Phase:** <1 / 1b / 2 / 2-3 / 3 / pivotal / registry>
- **Design:** <arms, randomization, blinding>
- **N:** <enrolled / analyzed>
- **Primary endpoint(s):** <PFS / OS / EFS / CR rate / MRD-neg / VOC-free / FVIII expression>
- **Comparator:** <SOC / placebo / active comparator / historical>
- **Indication:** <heme disease, subtype, biomarker / cytogenetic selection>
- **Line:** <frontline / 1L / 2L / 3L+ / maintenance / post-transplant / post-CAR-T>

## Headline result

<One paragraph. Numbers + HR + p-value if known. If pre-embargo, mark
`*expected per <company> topline <date>*` or `*pre-embargo per <analyst source>*`
or `*ASCO 2026 readout, EHA 2026 update expected*`.>

## Mechanism / class

<Drug class, target, prior approvals (FDA + EMA). For CAR-T: construct details
(costim domain, CD-target, manufacturing). For bispecifics: format (IgG-like, BiTE,
DART). For gene therapy: vector + payload. Cross-link to related AACR mechanism
sessions.>

## Discussant takeaway

<Named discussant + key framing once known. EHA discussant identity is itself
a signal — senior figures in the relevant European disease group set the
post-meeting narrative.>

## Practice-changing?

<Yes / no / pending, with rationale: ESMO / EHA guideline implications, EMA / CHMP
filing path, unmet need, prior SOC. For non-malignant heme: ESH / EHA guideline
path. Flag any EU-only or EU-first approval angles.>

## Cross-links

- **AACR 2026:** <related mechanism / poster / session, if applicable>
- **AACR 2025:** <prior-year mechanism work>
- **ASCO 2026:** <heme readout earlier in the year, if applicable>
- **ASH 2026:** <December update expected, if applicable — flag "EHA-first, ASH-update">
- **ESMO 2026:** <if heme readout was presented there>
- **Other EHA 2026 trials:** <same class, same disease>
- **JPM 2026 / 2027:** <sponsor presentation / deal>

## Sources

- EHA abstract (HemaSphere supplement): <URL or "pending May 12 release">
- Company press release: <URL>
- Trade-press recap: <OncLive / Healio / ASCO Post URL>
- ClinicalTrials.gov: <NCT URL>
- EU CTR (EudraCT) / CTIS: <URL, if applicable>

Master trial index (pre-meeting watch list)

Pre-meeting shortlist for stub creation. All entries below are pre-abstract-release, sourced from company pipelines + AACR 2026 mechanism sessions + ASCO 2026 heme subset + EHA 2025 / ASH 2025 prior-year readouts + analyst preview pieces — to be reconciled with the May 12, 2026 abstract drop and the June 2 LBA release. Result column entries marked italic are speculative / not yet disclosed.

Lymphoma — DLBCL + bispecifics

Trial Sponsor Indication Phase Endpoint Status (pre-abstract-release)
EPCORE NHL-2 / -3 / -5 interim Genmab / AbbVie r/r DLBCL + 1L combinations 1b/2 / 3 PFS / CR / durability 2-yr interim of epco mono; 1L combination signal
GO29781 / glofit + Pola-R-CHP (SKYGLO) Roche 1L DLBCL high-IPI 3 PFS / EFS Interim topline tracking; ASH 2026 update expected
SUNMO / STARGLO follow-up Roche r/r DLBCL glofit + GemOx 3 OS EHA tends to host SUNMO/STARGLO long-term
frontMIND interim Incyte / MorphoSys 1L DLBCL high-IPI (tafa+lena+R-CHOP) 3 PFS interim ASCO 2026 LBA7000 PFS+; EHA reconcile + ASH update
POLARIX 5-yr follow-up Roche 1L DLBCL (pola-R-CHP) 3 OS update Long-term durability

Lymphoma — CLL + indolent

Trial Sponsor Indication Phase Endpoint Status
BRUIN CLL-321 European subset / pirtobrutinib Lilly covalent-BTKi-resistant CLL 3 PFS Pivotal interim — Presidential Symposium candidate
GAIA / CLL13 follow-up German CLL Study Group frontline fit CLL 3 MRD-neg / PFS Fixed-duration ven combos long-term
FLAIR long-term follow-up UK NCRI frontline CLL 3 PFS / MRD Ibrutinib+ven vs FCR; ibr+ven vs ibr
MAJIC AbbVie / academic frontline CLL 3 MRD-neg / PFS Acalabrutinib + ven fixed-duration
TRANSCEND CLL 004 follow-up BMS r/r CLL liso-cel 1/2 DOR / OS 2-3 yr durability European cohort
Mosunetuzumab FL long-term Roche r/r FL 2 DOR 5-yr durability

Myeloma — CAR-T + bispecifics

Trial Sponsor Indication Phase Endpoint Status
CARTITUDE-4 long-term + CARTITUDE-5 interim J&J / Legend r/r MM / NDMM 3 PFS / OS European-cohort durability + frontline pivot interim
KarMMa-3 long-term + KarMMa-9 interim BMS / 2seventy r/r MM / NDMM 3 PFS Frontline ide-cel pivot interim
MajesTEC-3 / -5 interim teclistamab J&J r/r MM + 1L combos 3 PFS ASCO 2026 readout, EHA interim, ASH long-term
MonumenTAL-3 interim talquetamab J&J r/r MM 1–3L 3 PFS Pivotal interim
RedirecTT-1 / -2 update J&J EMD MM dual bispecific 1b/2 ORR Dual bispecific (BCMA + GPRC5D)
IFM 2020-02 / HOVON-MM frontline IFM / HOVON NDMM 3 PFS / MRD European cooperative-group frontline
Allogeneic BCMA CAR-T Allogene / Caribou / others r/r MM 1 safety + ORR Class watch

Acute leukemias — AML + ALL

Trial Sponsor Indication Phase Endpoint Status
Revumenib AUGMENT-101 + combos (European) Syndax r/r KMT2A-r / NPM1-mut AML 1/2 + combos CR / MRD Post-approval European real-world + combos with ven/aza
Ziftomenib KOMET-001 / -007 / -008 European Kura r/r NPM1-mut AML + frontline combos 2 / 3 CR / OS Post-approval European cohort + frontline pivot interim
HOVON-AML / GMLL frontline maintenance HOVON / GMLL post-induction AML 3 RFS / OS European cooperative-group venetoclax maintenance
FLT3 inhibitors evolution various FLT3-mut AML 3 OS Gilteritinib, quizartinib follow-up; new TKIs European cohorts
Frontline IDH inhibitors (European) Servier / others IDH1/2-mut AML 3 EFS / OS Ivosidenib, enasidenib, olutasidenib frontline — EMA-relevant
GRAALL / ALL CAR-T European GRAALL / academic r/r B-ALL 3 + registry EFS / OS Adult ALL European pivot + brexu-cel real-world

MDS / MPN

Trial Sponsor Indication Phase Endpoint Status
Imetelstat post-approval European Geron lower-risk MDS, transfusion-dependent reg / 4 TI rate Post-IMerge European real-world; Nordic MDS Group cohort
COMMANDS European follow-up BMS / Acceleron lower-risk MDS ESA-naive luspatercept 3 TI rate Long-term durability European subset
IDH inhibitors in MDS Servier IDH-mut MDS 2/3 response Frontline + post-HMA European cohorts
Momelotinib / pacritinib MF European GSK / Sobi myelofibrosis 3 / 4 symptom + anemia Post-approval European real-world
IPSS-M-guided transplant (EBMT) EBMT MDS frontline transplant decision registry OS EBMT registry IPSS-M cohort

Cell and gene therapy — durability + access

Trial Sponsor Indication Phase Endpoint Status
Exa-cel / Casgevy European real-world Vertex / CRISPR sickle cell + beta-thalassemia reg / 4 VOC-free / TI Post-approval European treatment-center early experience; Karolinska data prominent
Lovo-cel / Lyfgenia European bluebird bio sickle cell reg / 4 VOC-free EU access pathway; second-malignancy reporting
In-vivo base / prime editing for SCD Beam / Editas / Verve / Prime sickle cell (early phase) 1 safety + edit efficiency Class watch — next gen
Roctavian (val-rox) European long-term BioMarin hemophilia A reg / 4 FVIII expression curve 2–4 yr durability European cohort
Hemgenix (etranadez) European long-term CSL hemophilia B reg / 4 FIX expression curve 2–4 yr durability European cohort
CAR-T 4–5-yr durability (axi-cel, liso-cel, cilta-cel, ide-cel) Kite / BMS / J&J r/r LBCL + MM reg / 4 DOR / PFS / SPM EBMT registry European cohort durability + SPM
Beta-thalassemia gene therapy long-term Vertex / bluebird TDT reg / 4 TI rate Casgevy + ex-betibeglogene post-approval European

Non-malignant heme

Trial Sponsor Indication Phase Endpoint Status
Mim8 / next-gen FVIIIa-mimetic Novo Nordisk hemophilia A (with / without inhibitors) 3 bleed rate Post-FRONTIER pivot data; European cohort
Concizumab / fitusiran European follow-up Novo / Sanofi hemophilia A/B with inhibitors 3 bleed rate Real-world + long-term European
Mitapivat in SCD / thalassemia Agios sickle cell / thalassemia 2/3 Hb / VOC RISE UP and ENERGIZE follow-up
Etavopivat follow-up Novo Nordisk (ex-Forma) sickle cell 3 Hb / VOC HIBISCUS pivot update
PNH C5 vs C3 inhibitor head-to-heads Alexion / Novartis / Apellis PNH 3 hemoglobin / TI Pegcetacoplan, iptacopan, danicopan combos
Caplacizumab / rituximab iTTP follow-up Sanofi / academic iTTP 3 / registry exacerbation rate Long-term European cohort
Factor XI inhibitors heme implications various thrombosis 3 bleed / VTE Abelacimab, milvexian, asundexian — cardiology spillover

Cross-cutting themes (for themes.md)

To synthesize across trials/ once populated:

  1. EHA-first → ASH-update lineage. Many trials get a phase-2 mature / phase-3 interim at EHA and a longer-follow-up update at ASH six months later. Map this lineage in themes.md to identify which EHA 2026 readouts will set the ASH 2026 framing.
  2. European cooperative-group dominance. HOVON, GIMEMA, GELTAMO, GMLL, IFM, LYSA, NCRI studies that don't always travel to ASH. The European-only investigator network and the EMA / CHMP regulatory read-through.
  3. The "CAR-T tail" in European registries. EBMT registry data on axi-cel, liso-cel, cilta-cel, ide-cel European durability and SPM signal. Real-world vs pivotal-trial gap is the load-bearing curve.
  4. Bispecifics + CAR-T compete and combine — European edition. Sequencing data from European real-world (DLBCL: bispecific-after-CAR-T; MM: same). Class read-through to solid-tumor T-cell engagers (DLL3, B7-H3 — cross-link to lung / SCLC at ESMO).
  5. Menin / IDH / FLT3 mature in AML — European cohorts. Revumenib and ziftomenib post-approval European real-world; combinations with ven/aza, FLT3, IDH; frontline pivots. Cross-link to AACR 2026 menin / leukemia mechanism sessions.
  6. Gene therapy for SCD — European access + durability. Casgevy / Lyfgenia 2–3 yr European post-approval data; EMA approval status; Stockholm / Karolinska treatment-center experience. Payer access bottlenecks distinct from US.
  7. Red cell biology / non-malignant heme — EHA strength. Mitapivat, etavopivat, hemoglobinopathy gene therapy, PNH inhibitors — proportionally larger at EHA than at ASH.
  8. AACR ↔ EHA ↔ ASH mechanism-to-clinic continuity. Each EHA practice-changing trial traces to a 1–3 year prior AACR mechanism session and forward-projects to an ASH long-term update. Map the lineage in themes.md.