On June 15, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF), a clinical-stage precision oncology company, reported that data from its Phase 1/2 TUSCANY trial in newly diagnosed AML patients treated with tuspetinib (TUS) in combination with standard of care dosing venetoclax and azacitidine (TUS+VEN+AZA triplet) was presented yesterday in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026) in Stockholm, Sweden.

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!

The TUS+VEN+AZA triplet is being developed as a mutation agnostic frontline therapy to treat large, mutationally unrestricted and diverse populations of newly diagnosed AML patients who are ineligible to receive induction chemotherapy. Nikolai Podoltsev, MD, PhD, Associate Professor Medical Oncology & Hematology, Clinical Director, Malignant Hematology, Yale School of Medicine, and an investigator in the TUSCANY study, reported updated safety and efficacy data from the 80 mg and 120 mg dose cohorts, as well as new data from the 160 mg dose of TUS in the TUS+VEN+AZA triplet.

"While there have been recent successes with targeted therapy in AML treatment, our multi-targeted approach with tuspetinib in combination is showing significant efficacy across mutations that have been historically difficult to treat, including TP53 mutations, where we thus far have achieved CRs in all of the four subjects at the highest dose cohort," said Rafael Bejar, MD, PhD, Chief Medical Officer, Aptose. "As a safe and effective inhibitor of multiple growth factor signaling pathways, the TUS+VEN+AZA triplet is a first line combination therapy with the potential to improve outcomes in nearly all AML populations."

The oral presentation at EHA (Free EHA Whitepaper) included updated safety, complete remission, minimal residual disease (MRD) assessments, and longer duration of follow-up:

Presentation title: TUSCANY Study of Safety and Efficacy of Tuspetinib Plus Standard of Care Venetoclax and Azacitidine in Study Participants with Newly Diagnosed AML Ineligible for Induction Chemotherapy

Presenter: Nikolai Podoltsev, MD, PhD, Associate Professor (Medical Oncology & Hematology), Department of Internal Medicine; Clinical Director, Malignant Hematology, Associate Program Director, Hematology / Medical Oncology Fellowship Program, Yale School of Medicine

Key findings:

32 (29 response evaluable), newly diagnosed AML patients have received the TUS+VEN+AZA combination:
4 received the 40 mg dose of TUS, 12 received the 80 mg dose of TUS, 3 received the 120 mg dose of TUS, and 13 received the 160 mg dose

The overall CRc rate across dose levels in response evaluable (29) patients was 86.2%.
The MRD negative rate among all patients dosed was 62.5%; MRD negative rate in CR/CRh patients was 86.2%.

At the 160 mg TUS dose level (n=13):
The overall CRc rate was 76.9% (10 of 13 patients), including 8 of 11 (72.7%) with unmutated (or wildtype) FLT3
100 % composite complete remission in all 4 patients with TP53-mutation with complex karyotype (TP53-mut/CK)

Regardless of mutation status, TUS is active in newly diagnosed AML patients
MRD-negative responses achieved across diverse genetic populations, including adverse TP53 mutations and CK
Responses continue to evolve with 19 subjects remaining on treatment, including 6 that moved on to stem cell transplantation

TUS can be administered safely with standard-of-care dosing of VEN/AZA
TUS PK properties were not significantly altered by VEN, AZA, antifungals or food
No treatment-related deaths
No treatment-related adverse events of QTc prolongation, CPK elevations or differentiation syndrome
Abstracts are available on the EHA (Free EHA Whitepaper)2026 website here. The presentation is available on the Aptose website here.

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study

The tuspetinib-based TUS+VEN+AZA triplet therapy is being advanced in the TUSCANY Phase 1/2 clinical study with the goal of creating an improved frontline therapy for newly diagnosed AML patients that is active across diverse AML populations, durable, and well tolerated. Earlier APTIVATE trials of TUS as a single agent and in combination as TUS+VEN demonstrated favorable safety and broad activity in diverse relapsed or refractory (R/R) AML populations that went beyond the more prognostically favorable NPM1 and IDH mutant subgroups. Indeed, responses were also in R/R AML patients with highly adverse TP53 and RAS mutations, and those with mutated or unmutated (wildtype) FLT3 genes.

The TUSCANY Phase 1/2 study, being conducted at 10 leading U.S. clinical sites by elite clinical investigators, is designed to test various doses and schedules of TUS in combination with standard dosing of AZA and VEN for patients with AML who are ineligible to receive induction chemotherapy. A convenient, once daily oral agent, TUS, is being administered in 28-day cycles.

More information on the TUSCANY Phase 1/2 study can be found on www.clinicaltrials.gov (here).

(Press release, Aptose Biosciences, JUN 15, 2026, View Source [SID1234668735])

On June 15, 2026 Enterome SA, a clinical-stage company pioneering OncoMimics, a new class of off-the-shelf, multi-targeted immune therapies to expand specific CD8 T-cells in vivo, reported new interim data from the ongoing Phase 1/2 SIDNEY study of OncoMimics EO2463 in patients with indolent non-Hodgkin lymphoma (iNHL). The data are being presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm (Abstract PF938, Poster Session 1).

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!

SIDNEY is a multi-cohort study evaluating EO2463 as monotherapy in patients who are previously untreated and having low-tumor-burden disease suitable for watchful waiting (Cohort 2; N=25), in combination with rituximab in patients previously untreated with low-tumor burden disease requiring treatment (Cohort 3; N=6), and in combination with lenalidomide plus rituximab (R2) in patients with relapsed/refractory (Cohorts 1+4; N=23). EO2463 continued to be well tolerated across all settings.

Positive immune responses were confirmed in 43 of 48 tested patients (90%). EO2463 rapidly induced expansion of EO2463-mimic and B cell target peptide-specific CD8 T cells, predominantly displaying an effector memory phenotype cross-reactive with cancerous B-cell lineage markers. Responses were durable, with specific CD8 T cells detectable up to 34 months after the last EO2463 administration.

EO2463 demonstrated clinical activity across treatment settings. As monotherapy in patients who are usually recommended watchful waiting, EO2463 produced a 41% objective response rate (ORR) (Lugano criteria). Patients receiving EO2463 plus R2 combination achieved a 74% ORR, and 61% complete response rate, with a median duration of objective response of 35.2 months.

Importantly, EO2463-induced CD8 T cell expansions were significantly associated with objective response on EO2463 monotherapy and complete responses on EO2463 in combination with R2, suggesting that the EO2463 treatment and mechanism of action is linked to the clinical outcome in both settings. The data show that, on EO2463 monotherapy, higher early expansion was statistically significantly associated with objective response. These data also support development of a predictive biomarker based on the EO2463-induced immune responses.

"The EHA (Free EHA Whitepaper) data demonstrate that EO2463 consistently induces rapid and durable expansions of CD8 T cells against the B-cell lineage markers targeted by EO2463 while having a favorable tolerability profile. The significant association between expansion of specific CD8 T cells and objective responses both for EO2463 monotherapy and EO2463 in combination with standard of care supports continued development of EO2463 as a novel immunotherapy for B cell lymphomas," said Jan Fagerberg, MD, Chief Medical Officer of Enterome.

"These data confirm EO2463’s unique profile as an off-the-shelf immunotherapy that generates rapid, durable and clinically meaningful immune responses across treatment settings. Patients in the watch-and-wait setting currently receive no active treatment despite the psychological burden of their diagnosis. We believe EO2463 could change that paradigm and are actively seeking partners and investors to advance its registrational development," said Pierre Belichard, Chief Executive Officer of Enterome.

Updated data from the ongoing SIDNEY trial will also be presented at the Pan Pacific Lymphoma Conference (PPLC) in Hawaii (July 20–24, 2026). Enterome will attend the BIO International Convention 2026 in San Diego (June 22–25).

EHA 2026 Presentation Details

Title: EO2463 an off-the-shelf multi-target peptide immunotherapy: in vivo CD8 T cell expansion kinetics correlates with efficacy in patients with follicular (FL) and marginal zone (MZL) lymphoma. Study EONHL1-20/SIDNEY (NCT04669171)
Abstract: PF938 | Poster Session 1, Friday June 12, 2026
European Hematology Association Congress 2026, Stockholm, Sweden
Poster viewing: 08:00–18:45 CEST | Presenter-attended session: 18:45–19:45 CEST

SIDNEY (NCT04669171) is an ongoing open-label Phase 1/2 study evaluating the safety, tolerability, immunogenicity and preliminary efficacy of EO2463 as monotherapy and in combination regimens patients with follicular lymphoma and marginal zone lymphoma. The trial includes a dedicated watch-and-wait monotherapy cohort, a first-line low-tumor-burden combination cohort with rituximab, and relapsed/refractory cohorts treated with EO2463+R2. Interim data continue to support further evaluation of EO2463 both as a standalone treatment and in combination with established anti-lymphoma therapies.

EO2463 is an off-the-shelf OncoMimics active immunotherapy composed of four synthetic microbial-derived peptides designed to mimic the B-cell lineage markers CD20, CD22, CD37 and CD268 (BAFF receptor), plus the helper peptide UCP2. This multi-target approach is intended to expand in vivo pre-existing memory CD8 T cells, selectively targeting malignant B cells, broaden target coverage and obviate antigen escape. In May 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to EO2463 for treatment of patients with follicular lymphoma.

OncoMimics consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs) of solid tumors, or lineage markers (e.g. as observed in B cell lymphomas). These peptides induce a fast and potent in vivo expansion of effector-memory CD8 T-cells, naturally primed by gut bacteria, and cross-reactive with TAAs/B cell markers, thereby eliciting cytotoxic responses against tumor cells. Because they are recognized as foreign entities by the immune system, OncoMimics help overcome the self-tolerance that limits the ability of many cancer immunotherapies to trigger rapid, potent, and durable endogenous immune responses. The synthetically produced OncoMimics peptides are selected and designed in silico by mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple highly immunogenic peptides specifically designed to broaden target coverage, mitigate tumor heterogeneity and obviate the cancer’s ability to escape the therapeutic intervention.

(Press release, Enterome, JUN 15, 2026, View Source [SID1234668734])

On June 15, 2026 Daiichi Sankyo reported Vanflyta (quizartinib) has been approved in China for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an adequate validated test. Vanflyta is a FLT3 inhibitor being developed and commercialized by Daiichi Sankyo (TSE: 4568).

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!

Approximately 82,000 new cases of leukemia were diagnosed in China in 2022.1 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia cases in China.2 Up to 37% of newly diagnosed patients with AML have a FLT3 gene mutation and approximately 80% of these are FLT3-ITD mutations, which drive cancer growth and contribute to increased risk of relapse and shorter overall survival.3,4 The five-year survival rate for patients with FLT3-ITD positive AML has been reported at approximately 20%.

The approval of Vanflyta by China’s National Medical Products Administration (NMPA) is based on results from the QuANTUM-First phase 3 trial published in The Lancet. In QuANTUM-First, Vanflyta combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, demonstrated a 22% reduction in the risk of death compared to standard chemotherapy alone (HR = 0.78 [95% CI: 0.62-0.98; p=0.032]) in patients with newly diagnosed FLT3-ITD positive AML. Median overall survival (OS) was 31.9 months for patients receiving Vanflyta (n=268; 95% CI: 21.0-NE) compared to 15.1 months for patients in the control arm (n=271; 95% CI: 13.2-26.2) at a median follow-up of 39.2 months.

"Newly diagnosed FLT3-ITD positive AML has long been associated with poor outcomes, even with intensive chemotherapy," said Professor Wang Jianxiang, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and leading primary investigator in China of the QuANTUM-First trial. "In the QuANTUM-First study, Vanflyta in combination with standard chemotherapy, followed by monotherapy maintenance treatment, significantly extended survival of patients. The approval of Vanflyta in China now brings a new treatment option for eligible patients with this aggressive and difficult-to-treat form of leukemia."

"The approval of Vanflyta as the first FLT3 inhibitor available for use in the newly diagnosed setting in China marks an important milestone for patients. FLT3-ITD positive AML is a subtype of AML associated with rapid disease progression and historically limited treatment options," said Michio Hayashi, China President, Daiichi Sankyo. "As the third oncology medicine from our pipeline approved in China, Vanflyta reflects our commitment to delivering innovation for patients."

The safety profile of Vanflyta was evaluated in 268 patients with newly diagnosed FLT3-ITD positive AML. The most common grade 3 or 4 adverse reactions (occurring in ≥10% of patients) were decreased platelet count (40%), decreased hemoglobin (35.5%), decreased neutrophil count (21.5%) and increased alanine aminotransferase (12.1%). QTcF > 500 ms occurred in 2.3% of patients receiving Vanflyta and 0.8% of patients discontinued Vanflyta due to QT prolongation. Ventricular arrhythmia events with Vanflyta were uncommon. Two (0.8%) patients receiving Vanflyta experienced cardiac arrest with recorded ventricular fibrillation on ECG (one with fatal outcome), both in the setting of severe hypokalemia.

About QuANTUM-First

QuANTUM-First is a randomized, double-blind, placebo-controlled, global phase 3 study evaluating Vanflyta in combination with standard induction and consolidation therapy, including hematopoietic stem cell transplant, and as maintenance monotherapy, in adult patients aged 18-75 with newly diagnosed FLT3-ITD positive AML. Patients were randomized 1:1 to receive Vanflyta or placebo combined with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy followed by up to three years of treatment with single-agent maintenance. There was no re-randomization at the start of post-consolidation therapy

The primary study endpoint was OS. Secondary endpoints included event-free survival, post-induction rates of complete remission (CR) and composite complete remission (CRc) and the percentage of patients who achieve CR or CRc with FLT3-ITD measurable residual disease negativity. Safety and pharmacokinetics, along with exploratory efficacy and biomarker endpoints including duration of CR, also were evaluated.

QuANTUM-First enrolled 539 patients in Asia, Europe, North America, Oceania and South America. For more
information, visit ClinicalTrials.gov

About FLT3-ITD Positive Acute Myeloid Leukemia

More than 487,000 new cases of leukemia were reported globally in 2022, with more than 305,000 deaths.6 AML
accounts for 23.1% of total leukemia cases worldwide and is most common in adults.7,8 In China, nearly 82,000
people were diagnosed with leukemia in 2022 and more than 50,000 people died from the disease, making it the
tenth deadliest cancer.1 AML is a common and aggressive subtype, accounting for approximately 50% of leukemia
cases in China

A number of gene mutations have been identified in AML and FLT3 (FMS-like tyrosine kinase 3) mutations are the
most common.4 Approximately 80% of FLT3 mutations are FLT3-ITD mutations, which drive cancer growth and
contribute to particularly unfavorable prognosis, including increased risk of relapse and shorter overall survival.3,4
FLT3-ITD mutations occur in about 25% of all AML cases, with frequency reported as high as 30%.

About Vanflyta

Vanflyta (quizartinib) is an oral, highly potent type II FLT3 inhibitor that targets FLT3-ITD mutations.

Vanflyta is approved in more than 35 countries/regions in combination with standard cytarabine and anthracycline
induction and cytarabine consolidation, and as maintenance monotherapy following consolidation therapy, for the
treatment of adult patients with newly diagnosed FLT3-ITD positive AML based on the results from the QuANTUMFirst trial.

Vanflyta also is approved in Japan as a monotherapy for the treatment of patients with relapsed/refractory AML
that is FLT3-ITD mutation positive, as detected by an approved test, based on results from the QuANTUM-R trial.

About the Vanflyta Clinical Development Program

The Vanflyta clinical development program includes the QuANTUM-Wild phase 3 trial in adult patients with newly
diagnosed FLT3-ITD negative AML, a phase 1/2 trial in pediatric and young adult patients with relapsed/refractory
FLT3-ITD positive AML in Asia, Europe and North America and several phase 1/2 combination studies as part of a
strategic collaboration with The University of Texas MD Anderson Cancer Center.

(Press release, Daiichi Sankyo, JUN 15, 2026, View Source [SID1234668731])

On June 14, 2026 Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, reported that seventeen clinical updates from its core assets were presented at the 31st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) (EHA2026), including eight poster presentations. The presentations featured data from ongoing clinical studies of olverembatinib (HQP1351), the first third-generation BCR-ABL1 inhibitor approved in China, and lisaftoclax (APG-2575), the first approved China-developed Bcl-2 selective inhibitor. The EHA (Free EHA Whitepaper)2026 Congress convened in Stockholm, Sweden, from June 11 to 14, 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!

At the EHA (Free EHA Whitepaper)2026 Congress, presentations on olverembatinib comprised key concurrent updates across two therapeutic areas: chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In CML, olverembatinib demonstrated deep and durable responses in patients with chronic-phase CML (CML-CP) without the T315I mutation, in whom the disease was resistant and/or intolerant to first-line TKI therapy, supporting its potential as a second-line treatment option. For CML-CP patients who have failed treatment with at least two prior TKIs, olverembatinib can be used as a standard treatment option. In addition, olverembatinib showed positive clinical data in CML patients with multiline TKI resistance and co-occurring high-risk genetic mutations. In Ph+ ALL, olverembatinib continued to demonstrate robust clinical response, with updated data from the first-line global registrational Phase III study (POLARIS-1) further validating its deep response rate and manageable safety profile. The chemotherapy-free combination regimen with lisaftoclax yielded encouraging clinical data in subpopulations such as pediatric patients with relapsed/refractory Ph+ ALL.

Updated data from the registrational Phase II study of lisaftoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) were also presented. Stratified analyses correlating baseline characteristics with prognosis provided important insights that will inform refinement of treatment strategies and optimization of individualized dosing regimens across different patient populations. The real-world data on lisaftoclax in myeloid neoplasms also provides robust evidence for its clinical utility.

Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: "The clinical updates on olverembatinib and lisaftoclax presented at EHA (Free EHA Whitepaper)2026 further validate the therapeutic value of these two key assets in the global hematologic malignancy field. Olverembatinib has the potential to become an important treatment option for CML, while offering new treatment possibilities for Ph+ ALL patients. The updated data from the registrational Phase II study of lisaftoclax in CLL/SLL will help guide individualized dosing strategies across different patient populations. Its real-world data in myeloid malignancies further strengthens our confidence in its clinical application among such patients. We are particularly encouraged by the promising combination data. Looking ahead, we will continue to accelerate the global clinical development of our key assets, while actively exploring more innovative combination treatment strategies to provide meaningful treatment options for patients around the world."

Key highlights of the selected poster presentations at EHA (Free EHA Whitepaper)2026 are as follows (for more information of the Company’s candidates, please visit the official EHA (Free EHA Whitepaper) website):

EFFICACY OF OLVEREMBATINIB IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) WITH PRIOR RESISTANCE TO PONATINIB OR ASCIMINIB AND ASXL1 MUTATIONS

● Abstract Number: EHA (Free EHA Whitepaper)-3991 (PS1727)

● First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center

● Key Highlights: This Phase Ib study performed mutational analyses on 22 patients with ponatinib- and/or asciminib-resistant CP-CML and evaluated the antileukemic activity of olverembatinib across different mutational backgrounds. ASXL1 mutations were present in 40.9% (9/22) of patients. After olverembatinib treatment, 44.4% (4/9) of patients with ASXL1 mutations achieved clinical responses, including 22.2% (2/9) who achieved MMR, one of whom achieved MR4.5. This study provided the first evidence that olverembatinib is active in patients with ponatinib- and/or asciminib-resistant CP-CML, including those harboring challenging genotypes such as ASXL1 mutations, highlighting its potential as a treatment option for patients with multi-line TKI-resistant disease.

UPDATED EFFICACY AND SAFETY OF OLVEREMBATINIB (HQP1351) AS SECOND-LINE THERAPY IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML)

● Abstract Number: EHA (Free EHA Whitepaper)-3388 (PS1733)

● First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

● Key Highlights: This single-arm, multicenter, open-label Phase II study evaluated olverembatinib as a second-line treatment in patients with CP-CML without the T315I mutation. Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate was 76.2% and the major molecular response (MMR) rate was 47.6%. Responses deepened over time with longer treatment duration, and olverembatinib exhibited manageable tolerability with no treatment-related deaths. These findings support the potential of olverembatinib to induce durable and deep responses in patients with CP-CML without the T315I mutation whose disease was resistant and/or intolerant to first-line TKI therapy, further supporting its role as a second-line treatment option.

THE EFFICACY AND SAFETY OF SWITCHING TO OLVEREMBATINIB OR CONTINUING ORIGINAL TKI THERAPY IN CML-CP PATIENTS TREATED WITH AT LEAST TWO PRIOR TKIS: A PROSPECTIVE, MULTICENTER, CONTROLLED TRIAL

● Abstract Number: EHA (Free EHA Whitepaper)-4595 (PS1728)

● First Author: Bingbing Wen, the Second People’s Hospital of Shenzhen

● Key Highlights: This prospective, multicenter, controlled trial enrolled 105 patients with CML-CP who had received at least two prior TKIs for ≥18 months and failed to achieve MMR. Patients were assigned in a 1:2 ratio to either switch to olverembatinib (40 mg orally every other day) or continue their most recent TKI therapy. Results showed that the 6-month MMR rate was significantly higher in the olverembatinib group than in the control group (54.3% vs 10.0%; P<0.001). At 12 months, the cumulative incidence of MMR was 57.14% in the olverembatinib group compared with 21.43% in the control group (P<0.0001). Common grade 3/4 hematologic treatment-emergent adverse events (TEAEs) included thrombocytopenia (42.86%) and anemia (17.14%). Grade 3/4 non-hematologic adverse events were rare. Notably, 78.57% of adverse events related to prior TKI therapy improved after patients switched to olverembatinib. These findings support olverembatinib as a potential standard of care for patients with CML-CP previously treated with at least two TKIs.

UPDATED RESULTS OF POLARIS-1 (PART 1), A GLOBAL REGISTRATIONAL PHASE 3 STUDY: OLVEREMBATINIB COMBINED WITH LOW-INTENSITY CHEMOTHERAPY IN NEWLY DIAGNOSED PH+ ALL

● Abstract Number: EHA (Free EHA Whitepaper)-3437 (PS1479)

● First Author: Suning Chen, The First Affiliated Hospital of Soochow University

● Key Highlights: This global, multicenter, registrational Phase III study (POLARIS-1 Part 1) is evaluating the efficacy and safety of olverembatinib in combination with reduced-intensity chemotherapy in patients with newly diagnosed Ph+ ALL. A total of 55 patients were enrolled. By the end of induction, the CR/CRi rate reached 94.4% and the MRD-negative CR rate reached 63.0%. MRD-negativity rates increased over time, reaching 93.1% by the end of cycle 9. The regimen demonstrated a manageable safety profile, with no meaningful differences in efficacy or safety observed between the 30 and 40mg dose groups. Encouraging activity was also observed in patients with adverse prognostic genotypes, including IKZF1plus. These findings suggest that olverembatinib combined with low-intensity chemotherapy may induce rapid, deep, and sustained MRD-negative responses in patients with newly diagnosed Ph+ ALL, while maintaining a favorable safety profile, and provide important evidence supporting its use in the frontline setting.

SAFETY AND PRELIMINARY EFFICACY OF OLVEREMBATINIB (HQP1351) COMBINED WITH LISAFTOCLAX (APG-2575) IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY (R/R PH+ ALL): RESULTS OF A PHASE 1B STUDY

● Abstract Number: EHA (Free EHA Whitepaper)-4691 (PS1473)

● First Author: Jingliao Zhang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

● Key Highlights: This open-label, dose-escalation Phase Ib study evaluated olverembatinib in combination with lisaftoclax in pediatric patients with relapsed/refractory (R/R) Ph+ ALL who are resistant or intolerant to at least one prior TKI. A total of 17 patients were enrolled, with a median age of 13 years, and 40% harbored ABL1 mutations, including T315I. Among nine efficacy-evaluable patients, the combination achieved an overall response rate (ORR) of 88.9%, an MRD-negativity rate of 66.7% (8/12 at cycle 2 day 28), and 93.3% of patients (14/15 at cycle 2 day 28) achieved MMR or better. Both agents were detectable in cerebrospinal fluid (CSF), providing evidence of CNS penetration, and demonstrated activity across ABL1 mutation subgroups. The regimen showed a manageable safety profile with no treatment-related deaths. These findings support the potential of this chemotherapy-free oral dual-targeted regimen to induce rapid and deep remissions, and may provide a novel treatment option for pediatric patients with R/R Ph+ ALL.

REAL-WORLD EFFICACY AND SAFETY OF LISAFTOCLAX IN MYELOID NEOPLASMS: A MULTICENTER STUDY

● Abstract Number: EHA (Free EHA Whitepaper)-5454 (PF562)

● First Author: Chen Cao, Qilu Hospital of Shandong University

● Key Highlights: This multicenter real-world (retrospective) study evaluated the efficacy and safety of the novel BCL-2 inhibitor lisaftoclax in patients with myeloid neoplasms. A total of 30 patients (median age 63) were enrolled, including 25 patients with acute myeloid leukemia (AML, 83%), 3 with myelodysplastic syndromes (MDS, 10%), and 2 with chronic myelomonocytic leukemia (CMML, 7%). In patients with AML, the CR/CRi rate reached 72%, with the highest response observed in the ELN low-risk subgroup (87%). Among patients achieving CR/CRi, the MRD-negativity rate was 61%. The CR/CRi rate was 100% in patients with NPM1 mutations and 83% in patients with IDH2 mutations. Among the three patients with MDS, two achieved CRi. Regarding safety, grade≥3 treatment-emergent adverse events (TEAEs) were primarily hematologic adverse events, including thrombocytopenia (27%), anemia (23%), and neutropenia (20%). Overall safety was manageable. These findings demonstrate promising efficacy and manageable safety of lisaftoclax in the real-world treatment of myeloid neoplasms, particularly AML.

CORRELATION OF BASELINE CHARACTERISTICS WITH PROGNOSIS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) TREATED WITH LISAFTOCLAX (APG-2575) IN A PIVOTAL PHASE 2 STUDY

● Abstract Number: EHA (Free EHA Whitepaper)-3984 (PS1713)

● First Author: Keshu Zhou, Henan Cancer Hospital

● Key Highlights: This correlative analysis from the pivotal Phase II study (NCT05147467) evaluated associations between baseline characteristics and prognosis in patients with R/R CLL/SLL treated with lisaftoclax. The study enrolled 77 patients with R/R CLL/SLL refractory to BTKis who received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median progression-free survival (PFS) was 23.9 months and the Independent Review Committee (IRC)-assessed ORR was 62.5%. Further analyses showed that TP53 mutation/del(17p), complex karyotype (CK), and mutations in SF3B1, KIT, BLM, and SETD2 were associated with significantly shorter PFS. Complex karyotype and tumor size were identified as independent risk factors for shorter PFS. These findings demonstrate that lisaftoclax has clinical activity in patients with R/R CLL/SLL refractory to BTKi therapy. Additionally, these data may help to identify patients with poorer prognosis based on baseline risk characteristics, supporting future risk stratification and risk-adapted combination treatment strategies.

(Press release, Ascentage Pharma, JUN 14, 2026, View Source [SID1234668732])

On June 14, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, reported first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress (Abstract #LB5006).

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!

In the ongoing Phase 1 study, a single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. At the higher dose level (DL2), LB2501 achieved a 100% objective response rate (ORR) (6/6) and an 83.3% complete response rate (CR) (5/6), with all responses ongoing at the time of data cutoff. LB2501 also showed a favorable safety profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or deaths reported.

"In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy. Backed by the commercial and scientific foundation we have built with CARVYKTI, we are well-positioned to advance this next generation of CAR-T delivery. These early data, with deep responses from a single infusion across patients, give us confidence in the path ahead."

LB2501 Demonstrates In Vivo CAR-T Generation and Early Clinical Activity

In an ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels, DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and 58.3% were refractory to their most recent treatment. The open-label, multi-center, dose-escalation study is evaluating safety, recommended Phase 2 dose, pharmacokinetics, and preliminary efficacy in adults with R/R B-NHL. The study was conducted without lymphodepletion.

At DL2, LB2501 achieved a 100% ORR (6/6) and an 83.3% CR rate (5/6), with responses observed across patients with diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Across both dose levels, the ORR was 50.0% (6/12), and the CR rate was 41.7% (5/12). At the time of data cutoff, all responses at DL2 were ongoing.

LB2501 showed a favorable safety profile. No DLTs, SAEs, ICANS, or deaths were reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. Infusion-related reactions occurred in 75.0% (9/12) of patients overall, with a median onset of 1.4 hours after infusion and a median recovery time of 18.6 hours. CRS occurred in 66.7% (8/12) of patients overall, with a median onset at Day 11 and a median duration of 4.5 days. IRR and CRS were all Grade 1–2, no patients required glucocorticoids for CRS management. Four patients received tocilizumab.

Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in 100% (6/6) of patients at DL2 and 83% (5/6) of patients at DL1. CAR-T cells remained detectable in peripheral blood for up to 116 days. Viral copy number in peripheral blood peaked immediately after infusion and decreased to undetectable concentrations within 24 hours.

Additional translational analyses further characterized the in vivo profile of LB2501. No evidence of non-specific transduction was detected in NK cells or other non-T/B/NK lymphocyte populations. Vector integrations were highly polyclonal and diverse. These findings support proof-of-concept for in vivo T-cell engineering, with polyclonal vector integration and rapid vector clearance.

"These early clinical findings are encouraging in a heavily pretreated relapsed or refractory B-cell non-Hodgkin lymphoma population," said Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China. "The responses observed at the higher dose level achieved a 100% objective response rate, together with a favorable safety profile and the absence of lymphodepletion, support further investigation of LB2501 as a novel in vivo CAR-T approach. The additional pharmacokinetic and translational findings presented at EHA (Free EHA Whitepaper) further support the feasibility of generating CAR-T cells directly within the patient." ‡

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study (NCT07002112) in patients with relapsed/refractory B-cell malignanciesi to assess safety, tolerability, and preliminary efficacy.[i]

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.iii

While treatment advances have improved outcomes for some patients, those with relapsed or refractory B-cell NHL, particularly after multiple lines of therapy, often face limited options.

(Press release, Legend Biotech, JUN 14, 2026, View Source [SID1234668730])