Positive Clinical Data on Biomarkers in Patients Receiving Reqorsa® Gene Therapy Published at the 2026 ASCO Annual Meeting

On May 26, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that its research collaborators’ abstract was published at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract details positive clinical data from studies of predictive biomarkers in patients receiving its lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of lung cancer.

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"This clinical validation, derived from patients in our Acclaim clinical trials, substantiates earlier preclinical evidence revealing that Non-Small Cell Lung Cancer (NSCLC) patients receiving REQORSA who exhibit high Trop-2 levels and low PTEN levels experience prolonged Progression Free Survival (PFS), underscoring the critical role these biomarkers play in predicting treatment efficacy and advancing our understanding of this novel gene therapy," said Ryan Confer, President and Chief Executive Officer at Genprex. "These findings represent a substantial leap forward for personalized medicine in lung cancer, allowing for a targeted approach to potentially improve treatment outcomes and optimize resource allocation within the therapeutic landscape."

The featured Genprex-supported abstract at ASCO (Free ASCO Whitepaper) 2026:

Title: "Predictive biomarkers for PFS in patients receiving quaratusugene ozeplasmid"

Abstract Number: e15184

Quaratusugene ozeplasmid is a gene therapy that delivers a plasmid coding for the TUSC2 tumor suppressor gene to lung cancer cells, as >80% of lung cancers have been shown to have decreased or absent TUSC2 protein. TUSC2 protein levels have not correlated with PFS, presumably because of the complexities of TUSC2 protein regulation. Preclinical studies have identified higher levels of Trop-2 protein in organoids and lower levels of PTEN protein in lung cancer cell lines as correlating with response (AACR 2026). Tumor tissue from patients in clinical trials with quaratusugene ozeplasmid were evaluated for Trop-2 and PTEN protein expression.

Monoclonal antibodies against Trop-2 (BSB148 from BioSB) and PTEN (138G6 from Cell Signaling Technology) were used for immunohistochemistry in paraffin sections from archival tumor samples in patients enrolled in three clinical trials with quaratusugene ozeplasmid and results expressed as H-scores. H-scores were calculated by evaluating diaminobenzidine staining intensity using the formula [1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)].

Data on Trop-2 and PTEN protein expression and data on PFS were available from 18 patients enrolled in clinical trials with quaratusugene ozeplasmid.

Six patients with NSCLC were enrolled in the Acclaim-1 trial in combination with osimertinib.
One patient was enrolled in the Acclaim-2 trial in combination with pembrolizumab.
Eleven patients with small cell lung cancer (SCLC) were enrolled in the Acclaim-3 trial in combination with atezolizumab.
In patients with NSCLC, Trop-2 H-scores above 100 correlated with prolonged PFS (p=0.05), and PTEN H-scores below 100 correlated with prolonged PFS (p=0.03).
In patients with SCLC, Trop-2 H-scores were universally low, and thus non-evaluable. PTEN H-scores in patients with SCLC did not correlate with prolonged PFS (p=0.53).
Following up on preclinical cell line and organoid models indicating that Trop-2 and PTEN protein expression correlated with response, levels of Trop-2 and PTEN protein were evaluated in patients treated with quaratusugene ozeplasmid. In conclusion, both Trop-2 H-scores above 100 and PTEN H-scores below 100 correlated with longer PFS in patients with NSCLC, but not in patients with SCLC.

Beyond the ASCO (Free ASCO Whitepaper) 2026 Abstract:

Following the clinical studies outlined above, Genprex completed additional analysis to evaluate the relationship between NSCLCs with high intensity staining (3+) and PFS. NSCLCs with 3+ Trop-2 staining had a strong relationship with PFS that was just outside the bounds for significance (p=0.053) and those with 3+ PTEN staining exhibited a trend for a negative relationship with PFS that was not statistically significant (p=0.309). These results are consistent with the H-score analysis regarding a strong positive relationship between Trop-2 expression and PFS. High (3+) Trop-2 expression will be investigated further as a potential biomarker for REQORSA.

"We look forward to additional studies using intensity staining to understand the correlation between Trop-2 expression and PFS, offering more concrete data for optimized patient selection," said Mark S. Berger, Chief Medical Officer at Genprex.

About Acclaim-1

The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with AstraZeneca’s Tagrisso (osimertinib) in patients with late-stage NSCLC with activating epidermal growth factor receptor (EGFR) mutations whose disease progressed after treatment with Tagrisso or or Tagrisso-containing regimens. Acclaim-1 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for use of REQORSA in combination with TKI Tagrisso for the treatment of NSCLC patients with EGFR mutations whose tumors progressed after treatment with Tagrisso.

About Acclaim-3

The Acclaim-3 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating REQORSA in combination with Genentech, Inc.’s Tecentriq (atezolizumab) as maintenance therapy in patients with extensive stage small cell lung cancer (ES-SCLC) who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Acclaim-3 received Fast Track Designation by the FDA for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. The FDA also granted Orphan Drug Designation to REQORSA for the treatment of SCLC.

(Press release, Genprex, MAY 26, 2026, View Source [SID1234666051])

Hoth Therapeutics Awarded U.S. Patent for Cancer-Fighting HT-KIT Oncology Platform

On May 26, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) ("Hoth" or the "Company"), a clinical-stage biopharmaceutical company, reported that the U.S. Patent and Trademark Office ("USPTO") has issued a Notice of Allowance for Hoth’s HT-KIT therapeutic.

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The allowed claims cover antisense oligomers of 25 to 50 linked nucleosides directed to splicing-relevant regions of the MS4A6A pre-mRNA, including intron 3, exon 4, and the intron 3/exon 4 junction, together with pharmaceutical compositions and methods for modulating MS4A6A mRNA splicing in cells or tissues. Hybridization of the disclosed oligomers is intended to reduce cell-surface expression of the high-affinity IgE receptor (FcεRI), a central driver of mast cell activation in allergic and inflammatory disease.

Strategic Importance

Foundational IP Position. Allowance establishes composition-of-matter coverage for the Company’s lead antisense oligomer (SEQ ID NO: 22), including modified, morpholino, and pharmaceutical composition embodiments, providing a defensible basis for the underlying chemistry of the platform.
Mechanistic Differentiation. By reducing surface expression of FcεRI via exon-skipping of MS4A6A pre-mRNA, the approach addresses a node upstream of histamine release and IgE-mediated degranulation, distinct from antihistamine, anti-IgE antibody, and small-molecule mast cell inhibitor approaches.
Broad Indication Coverage. Allowed method claims and related disclosures span asthma, atopic dermatitis, chronic rhinitis, allergic conjunctivitis, chronic sinusitis, anaphylaxis prevention, and mast cell–driven diseases including mastocytosis and mast cell tumors.
Reinforces HT-KIT. The allowed claims strengthen the intellectual property foundation underlying HT-KIT, the Company’s orphan drug–designated program for mast cell–driven disease.
Combination Optionality. The application as filed also describes combination approaches with antisense oligomers targeting FcεRIβ (MS4A2) pre-mRNA splicing, supporting future development of dual-target compositions.
Management Commentary

"This Notice of Allowance is a meaningful validation of the science underlying our mast cell platform and an important addition to the intellectual property foundation supporting HT-KIT," said Robb Knie, Chief Executive Officer of Hoth Therapeutics.

About HT-KIT

HT-KIT is Hoth Therapeutics’ orphan drug–designated program directed at mastocytosis and other mast cell–driven diseases. The program is built around antisense oligomer–mediated modulation of pre-mRNA splicing to reduce pathological mast cell signaling. Hoth expects to finalize its IND submission in 2026, followed by first-in-human studies.

Biotechnology Operations Continue Under Subsidiary Structure
The Company ‘s is exploring placing its biotechnology pipeline and therapeutic development programs under a separate, wholly owned subsidiary with dedicated management and operational resources. The restructuring is intended to preserve the value of the biotechnology portfolio for shareholders while enabling the parent company to pursue emerging opportunities in AI semiconductor infrastructure and advanced computing technologies.

(Press release, Hoth Therapeutics, MAY 26, 2026, View Source [SID1234666067])

BriaCell Receives Positive Recommendation from Data Safety Monitoring Board (DSMB) for Phase 3 Study in Metastatic Breast Cancer

On May 26, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has issued its sixth consecutive positive recommendation following review of safety data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

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Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.

"We are highly encouraged by the sixth consecutive positive recommendation of the DSMB for continuation of BriaCell’s pivotal Phase 3 Bria-ABC study," said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. "This important milestone represents another step forward in advancing BriaCell’s novel immunotherapy approaches for patients with urgent unmet medical needs."

(Press release, BriaCell Therapeutics, MAY 26, 2026, View Source [SID1234666084])

GSK to showcase long-term outcomes and pipeline expansion with latest oncology research at ASCO and EHA

On May 26, 2026 GSK plc (LSE/NYSE: GSK) reported it will present new data from its expanding oncology portfolio and pipeline at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (29 May – 2 June) in Chicago, IL and the 31st European Hematology Association (EHA) (Free EHA Whitepaper) Congress (11 – 14 June) in Stockholm, Sweden. These findings demonstrate long-term outcomes for current therapies and pipeline expansion into additional tumour types and earlier treatment lines to advance practice-changing medicines for people with cancer.

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First results for velzatinib in first-line (1L) advanced gastrointestinal stromal tumours (GIST) will show promising activity and tolerability across KIT mutations. These data have accelerated initiation of the StrateGIST Frontline phase III clinical trial given the need for therapies in 1L that broadly inhibit clinically relevant KIT variants, a key driver of relapse today.

Data for velzatinib across clinically relevant KIT mutations in all lines, including 1L and second-line (2L) advanced GIST, will show encouraging anti-tumour activity and tolerability supporting the potential for a differentiated clinical profile (ASCO oral presentation abstract #11501).
Analyses of velzatinib will show broad activity and substantial circulating tumour DNA (ctDNA) clearance of clinically meaningful KIT mutations and inhibition of GIST tumour cells (ASCO rapid oral presentation abstract #11520).
New DREAMM clinical trial programme data will show durable benefit with belantamab mafodotin combinations in relapsed or refractory multiple myeloma (RRMM) and potential in newly diagnosed multiple myeloma

Four-year results from DREAMM-7 will show long-term efficacy, including overall survival, depth of response and health-related quality of life, reinforcing belantamab mafodotin with bortezomib and dexamethasone as a potential new standard of care in RRMM (EHA abstract #PS1862).
DREAMM-8 long-term responder and sustained minimal residual disease negativity analyses will show depth and durability of response for patients treated with belantamab mafodotin in combination with pomalidomide and dexamethasone in RRMM (ASCO abstract #7565 and rapid oral presentation abstract #7515).
In transplant-ineligible newly diagnosed multiple myeloma patients, final DREAMM-9 analysis will provide clinical evidence of meaningful activity with an optimised induction/maintenance dosing strategy of belantamab mafodotin (ASCO oral presentation abstract #7503).
Latest modelling data will predict the cure rate with dostarlimab plus chemotherapy in dMMR/MSI-H primary advanced or recurrent endometrial cancer, supporting patient care

New long-term analyses from the phase III RUBY trial will reinforce the sustained benefit of dostarlimab plus chemotherapy in patients with mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) primary advanced or recurrent endometrial cancer. Building from these results, new modelling analyses predict the proportion of patients who may be considered "cured"—defined as those who survive their disease and no longer experience disease-related mortality. These data complement traditional clinical trial measures, such as progression-free and overall survival, to support clinicians in advising their patients on treatment options and potential outcomes (ASCO oral presentation abstract #5501).
New analyses will show momelotinib can deliver symptom control across myelofibrosis patient subgroups and when switching from ruxolitinib

Post-hoc analyses from SIMPLIFY-1 and MOMENTUM will further build evidence for momelotinib across patient risk profiles in myelofibrosis, demonstrating consistent spleen, symptom and anaemia responses. Data will show earlier initiation of treatment before progression may be associated with better outcomes, underscoring the importance of initiating treatment before progression (EHA abstract #PS1995).
New analyses from SIMPLIFY-1 and SIMPLIFY-2 will show that most patients in the trials could transition directly from ruxolitinib to momelotinib without acute symptom worsening. Symptoms remained stable or improved in the majority of patients. These data address a key challenge in treatment sequencing (EHA abstract #PS2001).
Full list of GSK’s presentations at ASCO (Free ASCO Whitepaper):
Belantamab mafodotin
Abstract Name Presenter Presentation details
Durable clinical benefit with B-cell maturation antigen (BCMA) – directed therapy, belantamab mafodotin plus pomalidomide and dexamethasone (BPd) in relapsed/refractory multiple myeloma (RRMM): DREAMM-8 long-term responder (LTR) analysis M. Dimopoulos
Abstract #7565

Poster Session

Long-term outcomes with sustained minimal residual disease (MRD) negativity in belantamab mafodotin-treated patients (pts) with relapsed/refractory multiple myeloma (RRMM): An update from DREAMM-8 M. Dimopoulos
Abstract #7515

Rapid Oral Abstract Session

PFS2 outcomes by prior therapy from DREAMM-8: A phase 3 study assessing belantamab mafodotin (belamaf), pomalidomide, and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) G. Cengiz-Seval Abstract #7566
Poster Session

Matching-adjusted indirect comparison (MAIC) for belantamab mafodotin (belamaf) with pomalidomide and dexamethasone (BPd) vs daratumumab with pomalidomide and dexamethasone (DPd) in relapsed/refractory multiple myeloma (RRMM) J. Richter
Abstract #e19574

Online Publication

Comparative efficacy of belantamab mafodotin plus bortezomib and dexamethasone (BVd) vs standard of care in patients with relapsed/refractory multiple myeloma (RRMM) J. Richter
Abstract #7568

Poster Session

DREAMM-9 final analysis: Belantamab mafodotin (belamaf), bortezomib, lenalidomide, and dexamethasone (BVRd) for transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM) S. Usmani
Abstract #7503

Oral Abstract Session

Gaps in access to chimeric antigen receptor T-cell (CAR-T) therapy post leukapheresis: Waiting time and post-leukapheresis treatment patterns in relapsed/refractory multiple myeloma (RRMM)– Real-world evidence from U.S. claims S. Ailawadhi
Abstract #7530

Poster Session

Dostarlimab
Abstract Name Presenter Presentation details
Long-term survival rates and cure modeling with dostarlimab plus chemotherapy in mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial M. Powell
Abstract #5501

Oral Abstract Session

Safety and efficacy of dostarlimab monotherapy as first-line treatment in programmed cell death-ligand 1-positive recurrent/metastatic head and neck squamous cell carcinoma: Results from a Phase 2 trial R. Haddad
Abstract #6037

Poster Session

Niraparib
Abstract Name Presenter Presentation details
Efficacy prediction for progression-free survival (PFS) and overall survival (OS) by genomic instability score (GIS) cutoffs patients (pts) with advanced ovarian cancer (aOC): Post hoc results from phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial B. Monk
Abstract #5565

Poster Session

Genomic instability score (GIS) and real-world outcomes in patients (pts) with advanced ovarian cancer (AOC) using a U.S. health database E. Swisher
Abstract #e17565

Online Publication

Predictors of real-world progression-free survival in patients with epithelial ovarian cancer who received 1LM niraparib: Post-hoc analysis of the 1NSPIRE chart review study L. Landrum
Abstract #e17556

Online Publication

Velzatinib
Abstract Name Presenter Presentation details
Velzatinib (IDRX-42) as 1L or 2L therapy for advanced gastrointestinal stromal tumors (GISTs) by KIT mutation status: A subset analysis of the phase 1/1b StrateGIST 1 study R. Jones
Abstract #11501

Oral Abstract Session

Efficacy of velzatinib (IDRX-42) in patients with advanced/metastatic GIST by line of therapy and circulating tumor DNA response in the phase 1/1b StrateGIST 1 trial M. Heinrich
Abstract #11520

Rapid Oral Abstract Session

StrateGIST 3: A randomized, phase 3 study of velzatinib (IDRX-42) versus sunitinib in patients with advanced gastrointestinal stromal tumors after imatinib therapy S. George
Abstract #TPS11588

Poster Session

Full list of Alliance, investigator-initiated studies and supported collaborative studies at ASCO (Free ASCO Whitepaper):
Abstract Name Presenter Presentation details
Belantamab mafodotin with daratumumab, lenalidomide and dexamethasone in transplantineligible, newly diagnosed multiple myeloma patients: Phase 1/2 BelaDRd study E. Terpos
Abstract #7512

Oral Abstract Session

ISABELA: A phase 2 study of isatuximab, belantamab mafodotin, pomalidomide, and dexamethasone in relapsed/refractory multiple myeloma A. Yee
Abstract #7562

Poster Session

Organ preservation strategy using dostarlimab for dMMR/MSI-H resectable solid tumors with wholegenome based MRD monitoring (D-CURE: EPOC2401) Y. Matsubara
Abstract #TPS2697

Poster Session

Niraparib and dostarlimab in locally advanced head and neck squamous cell carcinoma (LAHNSCC) treated with (chemo)radiotherapy (CRT): Results from the phase IB-II TTCC-2022-01 RADIAN trial M. Oliva
Abstract #6096

Poster Session

Age-related differences in patient burden in endometrial cancer: Findings from the International EXPRESSION XI/IMPROVE Survey P. Combe
Abstract #e17622

Online Publication

Gliofocus: A global, open-label, randomized phase 3 study comparing niraparib with temozolomide in newly diagnosed MGMTunmethylated glioblastoma Y. Umemura
Abstract #TPS2102

Poster Session

Phase Ib study of momelotinib during and following hematopoietic stem cell transplantation for patients with primary or secondary myelofibrosis G. Hobbs
Abstract #TPS6607

Poster Session

A phase 2 study to assess the safety and efficacy of bomedemstat (IMG-7289) in combination with momelotinib in patients with myelofibrosis C. Rinaldi
Abstract #TPS6605

Poster Session

Neoadjuvant DAN-222 plus niraparib in high-risk HER2-negative breast cancer: Results from the ISPY 2 adaptive platform trial K. Yeung
Abstract #625

Poster Session

TBCRC 050: A phase 1b/2 trial of niraparib and trastuzumab in HER2-positive metastatic breast cancer (MBC): Efficacy and correlative analyses E. Stringer-Reasor
Abstract #1056

Poster Session

An observational study to investigate the effectiveness and safety of niraparib maintenance therapy after frontline chemotherapy for Taiwanese patients with advanced ovarian cancer: Interim results H. Chou
Abstract #e17546

Online Publication

Circulating tumor DNA (ctDNA) from a phase II study of adjuvant dostarlimab with pelvic radiation in locally advanced, mismatch repair-deficient (MMR-D) endometrial cancer (D-RT Study) G. Sotolongo
Abstract #5613

Poster Session

Full list of GSK’s presentations at EHA (Free EHA Whitepaper):
Belantamab mafodotin
Abstract Name Presenter Presentation details
Overall survival of anti-BCMA therapies: Indirect comparison of belantamab mafodotin/bortezomib/dexamethasone (BVd) vs teclistamab/daratumumab (tec-dara) in relapsed/refractory multiple myeloma (RRMM) J. Richter
Abstract #PS1933

Poster Session

The emerging ‘transplant deferred’ population in newly diagnosed multiple myeloma (NDMM) represents a substantial evidence gap in the novel-agent era S. Kumar
Abstract #PB3365

Online Publication

Patient characteristics and initial real-world dosing experience with belantamab mafodotin-based combinations for relapsed/refractory multiple myeloma E. Zamagni
Abstract #PB3253

Online Publication

Design of the phase 2 ALANIS study: Belantamab mafodotin in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) in patients with newly diagnosed amyloid light chain amyloidosis E. Kastritis
Abstract #PB3262

Online Publication

Belantamab mafodotin, bortezomib, and dexamethasone vs daratumumab, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: Updated 4-year results of the phase 3 DREAMM-7 trial V. Hungria
Abstract #PS1862

Poster Session

Belantamab mafodotin, pomalidomide, and dexamethasone (BPd) demonstrated improved outcomes as second-line therapy vs pomalidomide, bortezomib, and dexamethasone (PVd) in patients with multiple myeloma M. Beksac
Abstract #PS1877

Poster Session

Development and preliminary content validation of the PROSIM-Q: A patient-reported ocular symptom and impact questionnaire for oncology trials F. Pompilus
Abstract #PS1938

Poster Session

DREAMM-15: A study assessing the efficacy and safety of extended dosing of belantamab mafodotin in combination with standard of care therapies in patients with relapses-refractory multiple myeloma D. Sborov
Abstract #PB3225

Online Publication

Real-world treatment patterns and outcomes of relapsed/refractory multiple myeloma in China: Insights from the NICHE-MM registry (2018–2025) G. An
Abstract #PB3302

Online Publication

Resource utilization and costs related to the adverse events management of relapsed/refractory multiple myeloma in Brazil: Microcosting from the private healthcare system perspective S. Tanaka
Abstract #PB4473

Online Publication

Durable clinical benefit with B-cell maturation antigen therapy, belantamab mafodotin, pomalidomide, and dexamethasone, in relapsed/ refractory multiple myeloma: DREAMM-8 long-term responder analysis M. Dimopoulos
Abstract #PF764

Poster Session

Long-term outcomes with sustained minimal residual disease (MRD) negativity in belantamab mafodotin-treated patients (pts) with relapsed/refractory multiple myeloma (RRMM): An update from DREAMM-8 M. Dimopoulos
Abstract #PF792

Poster Session

PFS2 outcomes by prior therapy from DREAMM8: Belantamab mafodotin, pomalidomide, and dexamethasone vs pomalidomide, bortezomib, and dexamethasone in patients with relapsed/refractory multiple myeloma G. Cengiz-Seval
Abstract #PF776

Poster Session

DREAMM-9 final analysis: Belantamab mafodotin (belamaf), bortezomib, lenalidomide, and dexamethasone (BVRd) for transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM) E. Ocio
Abstract #PF762

Poster Session

Matching-adjusted indirect comparison for belantamab mafodotin with pomalidomide and dexamethasone vs daratumumab with pomalidomide and dexamethasone in relapsed/refractory multiple myeloma M. Beksac
Abstract #PF832

Poster Session

Gaps in access to chimeric antigen receptor T-cell therapy post leukapheresis: Waiting time and treatment patterns in relapsed/refractory multiple myeloma: real-world evidence from US claims M. Purser
Abstract #PS1937

Poster Session

Extrapolated progression-free survival with belantamab mafodotin/lenalidomide/dexamethasone exceeds 7 Years in intermediatefit and frail, transplant-ineligible, newly diagnosed multiple myeloma E. Terpos
Abstract #PF789

Poster Session

Momelotinib
Abstract Name Presenter Presentation details
Characterization of symptoms after immediate transition from ruxolitinib to momelotinib in patients with myelofibrosis: Post hoc analyses of the phase 3 SIMPLIFY-1 and SIMPLIFY-2 trials P. Vachhani
Abstract #PS2001

Poster Session

Outcomes with momelotinib in patients with intermediate-1– vs intermediate-2–/high-risk myelofibrosis: Post hoc analyses of the phase 3 SIMPLIFY-1 and MOMENTUM trials P. Bose
Abstract #PS1995

Poster Session

Real-world hematologic outcomes with momelotinib in patients with myelofibrosis and anemia: A German retrospective chart review H. Al-Ali
Abstract #PB3455

Online Publication

ATLAS: A randomized, double-blind, placebocontrolled, adaptive seamless phase 2/3 study to assess the safety and efficacy of momelotinib in patients with VEXAS syndrome D. Beck
Abstract #PB3163

Online Publication

Anemia recovery identifies prognostic heterogeneity in cytopenic myelofibrosis: A population based real-world analysis R. Garcia Delgardo
Abstract #PB3448

Online Publication

Real-world characteristics, treatment patterns, and survival in patients with myelofibrosis and those using ruxolitinib: A nationwide study stratified by baseline and early transfusion status Y. Chen
Abstract #PB3503

Online Publication

Full list of Alliance, investigator-initiated studies and supported collaborative studies at EHA (Free EHA Whitepaper):
Abstract Name Presenter Presentation details
MRD-guided maintenance therapy with belantamab mafodotin and lenalidomide after auto-HCT in newly diagnosed multiple myeloma: Interim analysis Y. Aljawai
Abstract #PS1878

Poster Session

De-escalated dosing of belantamab mafodotin plus Vd reduces the incidence of ocular events while maintaining efficacy in relapsed/refractory multiple myeloma: A Czech multicenter phase 2 study T. Popkova
Abstract #PS1870

Poster Session

High MRD negativity rates and prolonged PFS with belantamab mafodotin plus daratumumab, lenalidomide, and dexamethasone in transplant ineligible newly-diagnosed myeloma: Results of the BelaDRd study E. Terpos
Abstract #S204

Oral Abstract Session

A phase I/II study of gilteritinib and momelotinib in adults with relapsed or refractory FLT3-mutated acute myeloid leukemia L. Campoverde
Abstract #PF550

Poster Session

Dynamic cytopenia patterns in myelofibrosis: A real-world analysis from the ERNEST-3 registry T. Barbui
Abstract #PS2002

Poster Session

Phase 2 study to assess the safety and efficacy of bomedemstat (IMG-7289) in combination with momelotinib in patients with myelofibrosis C. Rinaldi
Abstract #PB3508

Online Publication

About GIST
Gastrointestinal stromal tumours (GIST) are the most common subtype of soft tissue sarcoma, with about 80,000 to 120,000 patients diagnosed with GIST per year worldwide.1 GIST typically presents in the gastrointestinal tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation and survival of tumour cells (primary or activating mutations in exons 9 and 11).2 Additionally, about 90% of patients treated in the first-line develop new KIT mutations (secondary or resistance mutations in exons 13 and 17) that typically lead to relapse with limited therapeutic options.3 There are no approved tyrosine kinase inhibitors (TKIs) that inhibit the full spectrum of clinically relevant primary and secondary mutations in KIT.

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.4,5 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.6 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.7 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.8,9

About endometrial cancer
Endometrial cancer is found in the inner lining of the uterus, known as the endometrium. Endometrial cancer is the most common gynaecologic cancer in developed countries,10 with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.4 Incidence rates are expected to rise by approximately 40% between 2020 and 2040.11 In Europe, approximately 121,000 people are estimated to be diagnosed with primary advanced or recurrent endometrial cancer each year.12 Approximately 15-20% of patients with endometrial cancer will be diagnosed with advanced disease at the time of diagnosis.13 Among patients with primary advanced or recurrent endometrial cancer, approximately 75% have mismatch repair proficient/microsatellite stable tumours (MMRp/MSS).14

About myelofibrosis
Myelofibrosis is a rare blood cancer that disrupts the body’s normal production of blood cells because of dysregulated Janus kinase (JAK)-signal transducer and activator of transcription protein signalling. The clinical hallmarks of myelofibrosis are splenomegaly (enlarged spleen), severely low blood counts, including anaemia and thrombocytopenia, and debilitating constitutional symptoms, such as fatigue, night sweats and bone pain, attributable to ineffective haematopoiesis and excessive production of proinflammatory cytokines.15,16

About ovarian cancer
Ovarian cancer is the eighth most common cancer in women worldwide.17 Despite high response rates to platinumbased chemotherapy in the first-line setting, approximately 85% of patients will experience disease recurrence. Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.18

About velzatinib (IDRX-42)
Velzatinib is a highly selective, investigational small molecule tyrosine kinase inhibitor (TKI) designed to target all key KIT mutations in GIST. The US Food and Drug Administration (FDA) has granted velzatinib Fast Track designation for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and Orphan Drug designations for the treatment of GIST.

About belantamab mafodotin
Belantamab mafodotin is an antibody-drug conjugate comprising a humanised b-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

For product and important safety information, please consult the country’s relevant summary of product characteristics:

The EU product information is available at: BLENREP-EPAR-MEDICINE-OVERVIEW_EN.PDF-0
The US product information is available at: BLENREP-PI-MG.PDF
About dostarlimab
Dostarlimab, a programmed death receptor-1 (PD-1)-blocking antibody, is the backbone of GSK’s ongoing immunooncology-based research and development programme. A robust clinical trial programme includes studies of dostarlimab alone and in combination with other therapies in gynaecologic, colorectal and lung cancers, as well as where there are opportunities for transformational outcomes.

Dostarlimab was discovered by AnaptysBio, Inc. and licensed to TESARO, Inc., under a collaboration and exclusive license agreement signed in March 2014. Under this agreement, GSK is responsible for the ongoing research, development, commercialisation and manufacturing of dostarlimab. 

For product and important safety information, please consult the country’s relevant summary of product characteristics:

The EU product information is available at: JEMPERLI-EPAR-PRODUCT-INFORMATION_EN.PDF
The US product information is available at: JEMPERLI-PI-MG.PDF
About momelotinib
Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: JAK1, JAK2, and activin A receptor, type I (ACVR1).19,20,21,22 Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.19,20,22 Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin levels, potentially contributing to anaemia-related benefit.19,20,21,22

For product and important safety information, please consult the country’s relevant summary of product characteristics:

The EU product information is available at: OMJJARA-EPAR-PRODUCT-INFORMATION_EN.PDF
The US product information is available at: OJJAARA-PI-PIL.PDF
About niraparib
Niraparib is an oral, once-daily Poly (ADP-ribose) polymerase (PARP) inhibitor indicated in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy; and for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and who have been selected based on a US FDA-approved companion diagnostic for niraparib.

(Press release, GlaxoSmithKline, MAY 26, 2026, View Source [SID1234666052])

Citius Oncology Announces Presentation of LYMPHIR® Phase 1 Combination Study Data at the 2026 American Society of Clinical Oncology Annual Meeting

On May 26, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported that University of Pittsburgh Medical Center’s investigator-initiated trial evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA) has been selected for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), taking place May 29 – June 2, 2026, in Chicago, Illinois.

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The abstract, submitted by investigators at the University of Pittsburgh Medical Center, was selected for presentation from more than 8,500 submissions reviewed by the ASCO (Free ASCO Whitepaper) Scientific Program Committee. The full abstract was made available on May 21, 2026, via the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) website.

"We are pleased to see this investigator-sponsored study selected for presentation at ASCO (Free ASCO Whitepaper), reflecting continued clinical interest in denileukin diftitox-cxdl across multiple tumor types," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "We look forward to engaging with the clinical oncology community to discuss the encouraging topline Phase 1 data evaluating Treg cell suppression in combination with checkpoint inhibitors."

Abstract Details:

Abstract Number: 2564
Title: Depletion of T-regulatory cells by denileukin diftitox-cxdl (E7777) in combination with pembrolizumab in relapsed/refractory (r/r) gynecologic malignancies: Phase 1 study results
Session Type: Poster Session – Developmental Therapeutics—Immunotherapy
Poster Board: 354
Date and Time: May 30, 2026, 1:30 PM-4:30 PM CDT
The Phase 1 study evaluated the safety, tolerability, and preliminary activity of denileukin diftitox-cxdl in combination with pembrolizumab in patients with relapsed or refractory gynecologic malignancies.

The ASCO (Free ASCO Whitepaper) Annual Meeting is one of the world’s largest and most influential oncology conferences, bringing together an estimated 35,000 oncology professionals from around the globe. The meeting serves as a premier forum for the presentation of cutting-edge cancer research, with abstracts selected through a highly competitive peer-review process.

About the Study

This open‑label, dose‑escalation, investigator‑initiated Phase 1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee‑Women’s Hospital, enrolled patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days 1–3 of each 21‑day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200 mg IV) on Day 1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression.

The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.

About Gynecologic Cancers

Recurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new endometrial cancer cases expected in the United States in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6%) and approximately 20,000 new diagnoses each year in the United States2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum‑based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD‑1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR’s transient depletion of regulatory T‑cells may enhance anti‑tumor immune responses and help overcome immunotherapy resistance in these difficult‑to‑treat tumors.

About LYMPHIR (denileukin diftitox‑cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Oncology, MAY 26, 2026, View Source [SID1234666068])