1stOncology™: Cancer Intelligence Service – Page 118 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

MaaT Pharma Provides Business Update and Reports Financial Results for the First Quarter 2026

On May 26, 2026 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported a business update and announced its cash position as of March 31, 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"During the first quarter of 2026, we continued to execute with financial discipline while supporting the advancement of our clinical and regulatory priorities. The drawdown of EIB Tranche B, combined with ongoing operational optimization, has extended our cash runway into November 2026 supporting the upcoming regulatory steps, including the planned re-examination of the Marketing Authorization Application for MaaT013 (Xervyteg)," stated Eric Soyer, CFO of MaaT Pharma.

Pipeline highlights

In Hemato-Oncology

Acute Graft-versus-Host Disease (aGvHD) – MaaT013 (Xervyteg)

In January 2026, MaaT Pharma transitioned the Early Access Program in Europe to Clinigen, allowing MaaT Pharma to leverage the infrastructure of Clinigen and start expanding patient access. The Company has treated approximately 230+ patients under the Early Access Program in 13 different countries to date, and data from the EAP has been presented at major medical congresses.
In March 2026, during the EBMT 2026 annual congress:
The final results of the ARES pivotal trial evaluating MaaT013 (Xervyteg) in aGvHD were presented during an oral presentation during the presidential symposium at EBMT 2026 Annual Congress on March 23, 2026.
MaaT Pharma‘s strategic partner Clinigen hosted a dedicated Industry Symposium on advancing care for steroid-refractory gastrointestinal aGvHD, in the context of the transition in January 2026 of the EAP program to Clinigen, and the ongoing commercial readiness activities, subject to the marketing approval of MaaT013 (Xervyteg).
The Company also presented results from the CHRONOS study, one of the largest real-world studies including refractory GI-aGvHD patients (n=59) treated with third-line best available treatments other than microbiome-based therapy, and announced publication in April 2026 of those retrospective data in Bone Marrow Transplantation Journal. Results from CHRONOS included 29% 12-month overall survival and 37% Day-28 GI-overall response rate, thus supporting the urgent need for new therapeutic options in this indication.
MaaT013 (Xervyteg) Regulatory Plan:
As a post period event, MaaT Pharma announced in May 2026 that during the Oral Explanation with EMA’s CHMP, the Company was informed of a "negative trend" in relation with the upcoming June 2026 CHMP vote. Subject to the formal vote at the June 2026 CHMP meeting, the Company intends to request a re-examination of the application.
As previously announced, the U.S. development plan remains underway, with no material cash impact, to ensure a potential launch in a timely manner of the future clinical study in the U.S, subject to appropriate funding and regulatory, clinical, and operational readiness.
Additionally, the Company continues to expand its U.S. footprint through its EAP, with recurring patient requests from leading hospitals such as City of Hope (Duarte- Los Angeles, CA), Massachusetts General Hospital (Boston, MA), the University of Alabama Hospital (Birmingham, AL), Miami Cancer Institute (Miami, FL), Chicago Medical Center (Chicago, IL) and Advocate Lutheran Hospital (Park Ridge, IL).

Allogenic Hematopoietic Stem Cell Transplant (allo-HSCT) – MaaT033

In January 2026, as a post period event, a third routine evaluation was conducted and reconfirmed the favorable safety profile of MaaT033 in this trial. The Phase 2 PHOEBUS trial is ongoing and is potentially pivotal in Europe. Topline results (1-year overall survival) are expected in Q4 2028.
In March 2026, the Company presented a poster of the PHOEBUS Phase 2 trial during the EBMT 2026 annual congress, detailing the design and the favorable safety profile confirmed by the 5 DSMBs assessments since 2025.

In Immuno-Oncology

MaaT034 – Next-generation drug candidates with co-cultured technology

In 2026, the Company is focusing on GMP batch production and regulatory readiness and targets to initiate a First-in- Human trial in 2027, subject to appropriate funding, with a development strategy that will place a particular focus on the U.S. market.
In January 2026, MaaT Pharma announced that the first patient was randomized in the IMMUNOLIFE trial evaluating the potential of MaaT033 in combination with Regeneron’s Cemiplimab in enhancing disease control rate versus best investigator’s choice in patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance to PD-1/PD-L1 blockade following antibiotic (ATB) exposure and who present ATB-induced gut dysbiosis. The Company was also informed by PICASSO’s academic sponsor that topline results could be expected in H1 2026. However, the timing remains subject to the sponsor’s discretion and the Company has no control over the study results communication timelines. The PICASSO expected data are intended to provide complementary insights only and do not directly impact MaaT034’s development strategy.

Cash position[1]

As of March 31, 2026, total cash and cash equivalents were EUR 18.1 million (as compared to EUR 24.9 million as of December 31, 2025), not including the drawdown in April 2026 of Tranche B (EUR 6 million) of the European Investment Bank (EIB) loan financing.
The Company has taken cash management measures to extend its financial visibility into November 2026 (vs August 2026), covering the upcoming regulatory milestones including the re-examination process, while continuing to advance its pipeline.

Revenues in Q1 20261

MaaT Pharma reported revenues of EUR 0.8 million for the first quarter of 2026 (reported EAP revenues were EUR 1.1 million for the same period of 2025).
Since January 2026 and the transition to the EAP program to Clinigen, MaaT Pharma is now selling the product to Clinigen, which then supplies hospitals in Europe. As a result, revenues generated by the Company are now based on the financial terms of the licensing agreement. Consequently, the net income reported by MaaT Pharma in Q1 2026, based on transfer price and royalties, was EUR 0.8 million, and would have been EUR 1.3 million pre-transition.
The slight decrease in reported revenues was therefore mostly attributable to the change in revenue accounting. On a same like-for-like basis, revenues generated by MaaT013 (Xervyteg) in Q1 2026 reflected a 19% increase year-over-year, underlining the sustained demand for the product.

Financial calendar*

June 16, 2026: Annual General Meeting
September 29, 2026: Publication of H1 2026 results
November 16, 2026: Publication of revenues & cash for Q3 2026
*Indicative calendar that may be subject to change.

Availability of the Documents Preparatory to the Annual General Meeting

The Company’s shareholders are invited to attend the Combined General Meeting to be held on Tuesday, June 16, 2026, at 9:30 a.m. at the Company’s offices, 70 avenue Tony Garnier – 69007 Lyon, France.
The preliminary notice of meeting, including the agenda and draft resolutions, was published in the Bulletin des Annonces Légales et Obligatoires (BALO) No. 56 dated May 11, 2026, and the notice of meeting will be published in the legal gazette "Le Tout Lyon" on May 27, 2026.
As of today, all information and documents referred to in Articles R. 22-10-23, R. 225-81 and R. 225-83 of the French Commercial Code are available on the Company’s website: maatpharma.com
In accordance with Articles L. 225-115 and R. 225-83 of the French Commercial Code, the full text of the documents to be presented at the General Meeting will also be made available at the Company’s registered office.
The General Meeting will be broadcast live in full by video, and the connection details will be available on the Company’s website. A replay will be made available no later than seven business days after the General Meeting has been held.

Upcoming conferences participation*

June 24-25, 2026 – Portzamparc Conference Mid & Small Caps 2026, Paris

(Press release, MaaT Pharma, MAY 26, 2026, View Source [SID1234666055])

Kura Oncology Reports Strong Clinical Activity and Safety with Darlifarnib + Adagrasib in KRAS G12C-Mutated Solid Tumors

On May 26, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported compelling first-in-human data from the FIT-001 clinical trial of its next-generation farnesyl transferase inhibitor (FTI) darlifarnib in combination with adagrasib in heavily pretreated patients with KRAS G12C-mutated advanced solid tumors. The results will be presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 30, 2026.

The combination of darlifarnib plus adagrasib demonstrated meaningful antitumor activity in heavily pretreated pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC) patients with prior KRAS inhibitor (KRASi) exposure, as well as KRASi-naïve colorectal cancer (CRC) patients. These data provide clinical proof-of-mechanism for Kura’s FTI platform as a precision combination that blocks RHEB-dependent mTORC1 signaling, a key resistance pathway shared across multiple targeted therapy classes.

"These results are very encouraging for patients and represent a major milestone for the FTI field," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Darlifarnib delivered robust tumor shrinkage and high objective response rates across KRAS G12C-mutated PDAC, NSCLC and CRC. These data compare favorably to adagrasib monotherapy benchmarks and demonstrate consistent, meaningful clinical activity in three difficult-to-treat tumor types. This marks "three-for-three" for targeting the mTORC1-RHEB pathway using an FTI approach to overcome resistance to targeted therapies, building on prior positive combinations with VEGFR tyrosine kinase inhibitors and PI3Kα inhibitors, and now KRAS inhibitors. With compelling clinical activity across multiple tumor types and a manageable safety profile, darlifarnib is well-positioned as a preferred combination partner for KRAS inhibitors and other precision therapies."

"RAS inhibitors have raised the bar in the treatment of KRAS-mutated cancers, but resistance remains a major limitation of current therapies," said David S. Hong, M.D., Deputy Chair of the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center. "This approach targeting a key downstream resistance node is exciting, and the early activity and tolerability of darlifarnib plus adagrasib support further development of this combination to deepen and extend responses."

Key Highlights (Phase 1a, N=30; 26 response evaluable):

77% (20/26) of response-evaluable patients achieved tumor shrinkage, including 94% (15/16) of response-evaluable, KRASi-naïve patients
Objective response rate (ORR): 67% in PDAC, 50% in NSCLC, and 29% in KRASi-naïve CRC
Responses were observed across dose levels and tumor types
Clinical activity observed in heavily pre-treated patients, including those with prior KRASi exposure
In NSCLC, confirmed partial response and 84% target lesion reduction observed in a patient previously treated with a KRAS inhibitor
Median follow-up time (range): PDAC 6.7 (4.0-10.4) months; NSCLC 6.9 (3.2-11.8) months; CRC 8.9 (1.2-13.2) months
37% of patients remained on study treatment at time of data cutoff (March 25, 2026)
Combination was well tolerated with a manageable safety profile
Best Percent Change in Target Lesion Size: PDAC, NSCLC and CRC

Best Percent Change in Target Lesion Size: PDAC, NSCLC and CRC

The waterfall plot shows best percent change from baseline in target lesion size among response-evaluable patients. Objective responses were observed across all three tumor types and dose levels. Bars that extend below the -30% horizontal line indicate target lesion reductions meeting the RECIST threshold for response, and all PRs represent confirmed partial responses.

Darlifarnib is designed to address resistance across multiple targeted therapies by inhibiting RHEB farnesylation, resulting in a sustained blockade of mTORC1 signaling and enhancing anti-tumor activity of RAS inhibitors. In pre-clinical models, darlifarnib enhances anti-tumor activity of RAS inhibitors in NSCLC and CRC.

Patients were administered darlifarnib 3 mg, 5 mg, or 8 mg once daily on days 1-7 and 15-21 of each 28-day cycle in combination with adagrasib 400 mg twice daily. The darlifarnib 8 mg dose will not be advanced for further evaluation in the darlifarnib and adagrasib combination.

The full ASCO (Free ASCO Whitepaper) presentation will be available starting May 30, 2026, at 5:00 a.m. PT / 8:00 a.m. ET on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section.

Virtual Investor Event
Kura will host a webcast and conference call on June 3, 2026, at 12:15 p.m. PT / 3:15 p.m. ET featuring management and David S. Hong, M.D., Deputy Chair of the Department of Investigational Cancer Therapeutics, The University of Texas M.D. Anderson Cancer Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.

About the FIT-001 Trial
FIT-001 (NCT06026410) is a Phase 1 clinical trial evaluating darlifarnib (KO-2806) as a monotherapy and in combination with targeted therapies in patients with advanced solid tumors. The trial includes an escalation cohort of patients with RAS-altered advanced solid tumors, as well as dose escalation and dose optimization cohorts evaluating darlifarnib with cabozantinib in advanced renal cell carcinoma, and with adagrasib in KRAS G12C-mutant advanced PDAC, NSCLC, and CRC.

(Press release, Kura Oncology, MAY 26, 2026, View Source [SID1234666054])

Kazia Therapeutics Expands Ongoing Phase 1b Trial of Paxalisib in Advanced Breast Cancer

On May 26, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), a clinical-stage oncology company advancing therapies designed to reprogram cancer biology and overcome treatment resistance, reported plans to expand its ongoing Phase 1b clinical trial evaluating lead asset paxalisib in combination with standard-of-care therapies in patients with advanced triple negative breast cancer ("TNBC"). Based on continued encouraging safety, tolerability and clinical activity data observed to date, planned enrollment has increased from 12 to 36 patients.

The expansion is intended to further evaluate the safety, tolerability, dose optimization and preliminary efficacy of the paxalisib-based combination regimen with pembrolizumab and chemotherapy. The expanded dataset is expected to provide a more meaningful assessment of objective response rate ("ORR"), progression-free survival ("PFS") and translational biomarkers. Additional clinical trial updates are anticipated throughout 2026 and into 2027.

"We remain encouraged by the safety and tolerability data observed to date, and expanding enrollment allows us to generate a broader clinical and translational dataset as we advance paxalisib in difficult-to-treat advanced breast cancer, such as TNBC," said Dr. John Friend, CEO, Kazia Therapeutics. "Paxalisib’s mechanism, modulating key resistance and immune-related pathways, addresses the very reasons that current therapies fail, and we believe it holds meaningful potential for an underserved patient population. While we planned to present scientific progress at ASCO (Free ASCO Whitepaper) 2026, we made the decision to withdraw our abstracts solely to protect our intellectual property position ahead of anticipated filings. The withdrawal was not related to any safety or clinical concerns. We expect to share additional clinical and translational updates in the coming months."

The Phase 1b study is evaluating paxalisib in combination with established breast cancer regimens across multiple dose cohorts. The trial expansion is supported by a recently published preclinical study in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR"), demonstrating that dual PI3K/mTOR inhibition with paxalisib altered tumor cell state and immune signaling in preclinical TNBC models. TNBC accounts for approximately 15 to 20 percent of all breast cancer diagnoses and is associated with poorer outcomes relative to other breast cancer subtypes.

(Press release, Kazia Therapeutics, MAY 26, 2026, View Source [SID1234666053])

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.

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

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

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])

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.

"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])