On May 14, 2025 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported its abstract has been selected for a poster presentation at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting (EHA) (Free EHA Whitepaper) being held June 12-15 in Milan, Italy (Press release, Karyopharm, MAY 14, 2025, View Source [SID1234653063]). The abstract contains data on selinexor monotherapy in a hard-to-treat, heavily pretreated myelofibrosis patient population from the Phase 2 XPORT-MF-035 trial.

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"We are encouraged by our new data in hard-to-treat myelofibrosis patients where we observed spleen volume reduction, symptom improvement, hemoglobin stabilization and evidence of disease modification with selinexor monotherapy, addressing all four hallmarks of the disease," said Reshma Rangwala, MD, PhD, Chief Medical Officer of Karyopharm. "This new data adds to our growing body of evidence highlighting selinexor’s potential in patients with myelofibrosis."

The accepted abstract and data highlights are below.

Abstract number: PS1821
Title: A study to evaluate single-agent selinexor versus physician’s choice in participants with previously treated myelofibrosis
Date/Time: Saturday, June 14, 18:30-19:30 CEST
Presenter: Alessandro Lucchesi, MD
Highlights

Data from the XPORT-MF-035 (NCT04562870) Phase 2, randomized, open-label trial of selinexor versus physician’s-choice (PC) in hard-to-treat patients with heavily pretreated myelofibrosis indicated signs of single-agent clinical activity with selinexor, including spleen volume reduction, hemoglobin stabilization, symptom improvement and evidence of disease modification.
Patients were randomized 1:1 to either selinexor monotherapy or PC. Selinexor was administered at 80 mg weekly for the first two cycles and then decreased to 60 mg weekly from cycle 3 onwards. An optional crossover was available for PC treated patients if they met predefined spleen progression criteria.
In total, 12 patients were randomized to the selinexor arm and 12 patients to the PC arm; 6 patients crossed over from PC to selinexor. Inclusive of crossover, spleen volume reduction of 25% or more (SVR25) at anytime was achieved in 8/12 (67%) efficacy evaluable selinexor treated patients versus 3/8 (38%) efficacy evaluable patients treated with PC. Spleen volume reduction of 35% or more (SVR35) at anytime was observed in 4/12 (33%) efficacy evaluable patients treated with selinexor versus 1/8 (13%) efficacy evaluable patients treated with PC.
Patients treated with selinexor had higher mean hemoglobin levels throughout the study duration and lower rates of red blood cell transfusions than those treated with PC.
Data on key cytokines that are relevant to myelofibrosis pathogenesis, symptom development, and anemia including IL-6, IL-8, TNFa, and hepcidin, demonstrated greater reductions at week 4 compared to baseline in patients treated with selinexor than patients treated with PC.
Most common (≥25% overall) treatment emergent adverse events (TEAEs) in the randomized arms were decreased weight (selinexor: 50%; PC: 50%), anemia (25%; 58%), asthenia (42%; 25%), nausea (33%; 25%), thrombocytopenia (33%; 25%) and upper respiratory tract infection (25%; 33%). Most common (≥15% in any arm) Grade 3+ TEAEs were anemia (17%; 58%), cardiac failure (0%; 17%), decreased appetite (17%; 0%) and nausea (17%; 0%). No treatment discontinuations due to TEAEs were observed in the selinexor arm.
About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor and the first of Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds for the treatment of cancer. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1. XPOVIO is approved in the U.S. and marketed by Karyopharm in multiple oncology indications, including: (i) in combination with VELCADE (bortezomib) and dexamethasone (XVd) in adult patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in adult patients with heavily pre-treated multiple myeloma; and (iii) under accelerated approval in adult patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. XPOVIO (also known as NEXPOVIO in certain countries) has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including but not limited to the European Union, the United Kingdom, Mainland China, Taiwan, Hong Kong, Australia, South Korea, Singapore, Israel, and Canada. XPOVIO/NEXPOVIO is marketed in these respective ex-U.S. territories by Karyopharm’s partners: Antengene, Menarini, Neopharm, and FORUS. Selinexor is also being investigated in several other mid- and late-stage clinical trials across multiple high unmet need cancer indications, including in endometrial cancer and myelofibrosis.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at: Tel: +1 (888) 209-9326; Email: [email protected]

XPOVIO (selinexor) is a prescription medicine approved:

In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy (XVd).
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody (Xd).
For the treatment of adult patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
SELECT IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Thrombocytopenia: Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care.
Neutropenia: Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony‐stimulating factors.
Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care.
Hyponatremia: Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care.
Serious Infection: Monitor for infection and treat promptly.
Neurological Toxicity: Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes.
Embryo‐Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception.
Cataract: Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract.
Adverse Reactions

The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract and vomiting. Grade 3‐4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia and neutropenia. In the BOSTON trial, fatal adverse reactions occurred in 6% of patients within 30 days of last treatment. Serious adverse reactions occurred in 52% of patients. Treatment discontinuation rate due to adverse reactions was 19%.
The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea and upper respiratory tract infection. In the STORM trial, fatal adverse reactions occurred in 9% of patients. Serious adverse reactions occurred in 58% of patients. Treatment discontinuation rate due to adverse reactions was 27%.
The most common adverse reactions (incidence ≥20%) in patients with DLBCL, excluding laboratory abnormalities, are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3‐4 laboratory abnormalities (≥15%) are thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. In the SADAL trial, fatal adverse reactions occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal adverse reactions was infection (4.5% of patients). Serious adverse reactions occurred in 46% of patients; the most frequent serious adverse reaction was infection (21% of patients). Discontinuation due to adverse reactions occurred in 17% of patients.
Use In Specific Populations

Lactation: Advise not to breastfeed.

For additional product information, including full prescribing information, please visit www.XPOVIO.com.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1‐888‐209‐9326 or FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch.

On May 14, 2025 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, reported financial results and business highlights for the first quarter of 2025 (Press release, IO Biotech, MAY 14, 2025, View Source [SID1234653062]). The company continues to advance its pipeline, presenting new data further defining the mechanism of action for its T-Win therapeutic cancer vaccines, and reaffirming its expectation that the Phase 3 pivotal trial will readout in the third quarter of 2025.

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"IO Biotech continues to make meaningful progress developing novel cancer therapies that are designed to address significant unmet needs in melanoma and other hard-to-treat cancers, and we are thrilled to be recognized for our work by Fast Company as one of the most innovative companies in the world," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "This year, we remain focused on delivering our Phase 3 data, preparing a Biologics License Application (BLA) and planning for commercialization of Cylembio (imsapepimut and etimupepimut, adjuvanted), our potentially first-in-class, immune-modulatory, off-the-shelf therapeutic cancer vaccine."

Dr. Zocca continued, "Additionally, we continue to explore potential collaborations to expand the global impact of our product candidates and our platform across multiple cancer types."

Recent Business Highlights

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The company’s pivotal Phase 3 trial (IOB-013/KN-D18) is progressing as planned with the readout of the primary endpoint of progression free survival (PFS) still expected in the third quarter of 2025. The trial is evaluating the company’s lead investigational vaccine, Cylembio (imsapepimut and etimupepimut, adjuvanted), in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of advanced melanoma. The company continues to plan to submit a BLA to the U.S. Food & Drug Administration (FDA) in 2025 for Cylembio and, subject to FDA approval, launch a potentially first-in-class therapeutic cancer vaccine for patients with advanced melanoma in the US in 2026.

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The company completed enrollment in its perioperative Phase 2 solid tumor basket trial (IOB-032/PN-E40), studying treatment with Cylembio in combination with pembrolizumab in patients with resectable squamous cell carcinoma of the head and neck (SCCHN) and melanoma in January. The company expects initial data from the perioperative trial as well as longer-term data from the company’s other ongoing Phase 2 basket trial, IOB-022/KN-D38, in patients with advanced SCCHN or non-small cell lung cancer (NSCLC) in the second half of 2025.

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On May 6, 2025, the company announced that it drew tranche A (€10.0 million) from the loan facility it entered into with the European Investment Bank (EIB) in December 2024. The company also believes that it has satisfied the conditions for the second tranche (€12.5 million) of the EIB loan facility.

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IO Biotech was named to Fast Company’s World’s Most Innovative Companies of 2025 list for its potentially game-changing approach to immune-modulatory cancer vaccines, earning its place on the coveted list as the 9th most innovative company in the world in the biotechnology category.

Upcoming Investor Conferences

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TD Cowen’s 6th Annual Oncology Innovation Summit: Insights for ASCO (Free ASCO Whitepaper) & EHA (Free EHA Whitepaper): Mai-Britt Zocca, PhD, President and CEO, Amy Sullivan, CFO, and Qasim Ahmad, MD, CMO, will participate in a fireside chat beginning at 10:30 AM ET on May 27, 2025.

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Jefferies Global Healthcare Conference: Mai-Britt Zocca, PhD, President and CEO, will give a presentation beginning at 7:35 AM ET on June 4, 2025.

The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at View Source

First Quarter 2025 Financial Results

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Net loss for the three months ended March 31, 2025, was $22.4 million, compared to $19.5 million for the three months ended March 31, 2024.

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Research and development expenses were $16.4 million for the three months ended March 31, 2025, compared to $14.3 million for the three months ended March 31, 2024. The company recognized $0.6 million in research and development equity-based compensation for the three months ended March 31, 2025 and 2024, respectively.

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General and administrative expenses were $6.2 million for the three months ended March 31, 2025, compared to $5.9 million for the three months ended March 31, 2024. The company recognized $1.0 million in general and administrative equity-based compensation for the three months ended March 31, 2025 and 2024, respectively.

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Cash and cash equivalents as of March 31, 2025 were $37.1 million, compared to $60.0 million at December 31, 2024. During the three months ended March 31, 2025, the company used cash, cash equivalents and restricted cash of $22.9 million. On May 6, 2025, the company drew tranche A of the EIB loan facility of €10.0 million before payment of certain fees and transaction related expenses. The company continues to expect that it will have sufficient cash to run the company into the second quarter of 2026, assuming draw down of the first three committed tranches of the EIB loan facility.

About Cylembio

Cylembio (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the three ongoing company-sponsored clinical trials is now complete.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.

Cylembio is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression free survival. Top-line data readout is expected in the third quarter of 2025. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

About IOB-032/PN-E40 Phase 2 Solid Tumor Basket Trial

IOB-032/PN-E40 (NCT05280314) is a multicenter Phase 2 basket trial investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) as neo-adjuvant/adjuvant treatment of patients with solid tumors at sites in Australia, the United States, France, Germany, Spain, and Denmark. The study completed enrollment in all cohorts: 18 patients with melanoma in cohort A and 16 patients with SCCHN in cohort B, both as single arm cohorts receiving combination of Cylembio with pembrolizumab. In cohort C, 61 melanoma patients were randomized 1:1 to either the combination of Cylembio with pembrolizumab or pembrolizumab alone. In the neo-adjuvant period, for all cohorts, treatment is every 3 weeks (Q3W) for 3 cycles (melanoma) or 2-3 cycles (SCCHN). Patients entering the study will be scheduled for surgery and begin neoadjuvant treatment 4-9 weeks prior. Surgery will be followed by adjuvant treatment with the same regimen for 15 cycles. Cohort C patients with poor pathological response to pembrolizumab alone in the neo-adjuvant phase (>10% residual viable tumor) may cross over to combination treatment post-surgery. The primary endpoint is major pathological response at surgery (≤10% residual viable tumor; central assessment). IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

On May 14, 2025 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company innovating small molecule kinase inhibitor therapeutics to treat pulmonary arterial hypertension ("PAH"), reported financial results for the quarter ended March 31, 2025 and highlighted recent developments (Press release, Inhibikase Therapeutics, MAY 14, 2025, View Source [SID1234653061]).

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"During our first quarter of 2025, we continued to build out our senior leadership team and key infrastructure areas to position the Company to advance IKT-001 toward a late-stage clinical trial in PAH," said Mark Iwicki, Chief Executive Officer of Inhibikase. "With our core team now in place, and with ongoing refining of our study protocol with key opinion leaders, IKT is well placed to initiate our Phase 2b clinical study of IKT-001 in PAH in the second half of 2025." The IMPRES Phase 3 study of imatinib mesylate previously demonstrated improved exercise capacity and hemodynamics in patients with advanced PAH. We continue to believe that systemic exposure of imatinib with IKT-001 can be well tolerated and provide strong efficacy to patients suffering from PAH.

Recent Developments:

Announced the appointments of Mark Iwicki as Chief Executive Officer, Chris Cabell, M.D., M.H.S, FACC, as President and Head of Research & Development, and John Adams, Ph.D., as Chief Scientific Officer, and David McIntyre as Chief Financial Officer.
Advancement of IKT-001 as a therapy in PAH:
The Company has continued to meet with key opinion leaders and other experts in PAH with a view to refining the Company’s proposed study design for the forthcoming Phase 2b clinical study of IKT-001 in PAH. The Company expects to finalize the study design in the ensuing weeks.
The Company previously received its "Study May Proceed" letter for the Phase 2b trial in September 2024, noting that the active ingredient in IKT-001, imatinib, has previously been shown to have a meaningful impact on key efficacy parameters such as 6 minute walk distance in advanced PAH.
First Quarter 2025 Financial Results

Net Loss: Net loss for the quarter ended March 31, 2025, was $13.7 million, or $0.15 per share, compared to a net loss of $4.6 million, or $0.73 per share in the quarter ended March 31, 2024.

R&D Expenses: Research and development expenses were $10.5 million for the quarter ended March 31, 2025, compared to $2.8 million for the quarter ended March 31, 2024. This includes a non-cash charge for in-process research and development expense of $7.4 million associated with the Company’s acquisition of CorHepta, which was effective on February 21, 2025.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended March 31, 2025 were $5.2 million compared to $2.0 million for the quarter ended March 31, 2024.

Cash Position: Cash, cash equivalents and marketable securities were $93.2 million as of March 31, 2025.

On May 14, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell therapies for cancer and autoimmune diseases, reported new preclinical data from its INB-619 program at the 2025 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting (Press release, In8bio, MAY 14, 2025, View Source [SID1234653060]). The data shows that INB-619, a CD-19 targeted γδ TCE, successfully eliminated disease-causing B cells in blood samples from patients with active Systemic Lupus Erythematosus (SLE, or Lupus).

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These findings highlight the potential of INB-619 as a novel treatment option for autoimmune diseases, where harmful B cells secrete antibodies that drive inflammation and tissue damage. Unlike traditional TCEs that target CD3 and can often trigger severe side effects, INB-619 harnesses the unique properties of γδ T cells to selectively clear B cells while minimizing inflammatory responses.

William Ho, Chief Executive Officer of IN8bio, commented, "Our findings show that INB-619 not only eliminates pathogenic B cells, but also expands γδ T cell levels, which are often reduced in patients with chronic disease. This represents a fundamentally different approach to immune modulation – one that could potentially lead to safer, more effective treatments for autoimmune diseases and beyond."

Highlights from the Preclinical Data:

INB-619 demonstrated complete, targeted depletion of B cells in lupus patient-derived samples.
IN8bio’s γδ TCE successfully expands both Vδ1+ and Vδ2+ subtypes of γδ T cells, which are critical for targeting both circulating and tissue-resident B cells to potentially achieve deeper B cell depletion.
Unlike conventional CD3-based TCEs, INB-619 did not trigger significant release of inflammatory cytokines such as IL-6, which are commonly associated with serious toxicities, including CRS.
The study reinforces the potential of γδ T cell engagers as a safer, more precise immunotherapy platform for autoimmune diseases.
With these encouraging results, IN8bio continues to explore potential partnerships and additional autoimmune and cancer indications where γδ T cell biology and B cell targeting intersect.

On May 14, 2025 Genmab A/S (Nasdaq: GMAB) reported that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025 (Press release, Genmab, MAY 14, 2025, View Source [SID1234653059]).

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Two oral presentations will feature data from the Phase 1/2 EPCORE NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritamab plus polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2 EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster.

All abstracts accepted for presentation have been published and may be accessed online via the EHA (Free EHA Whitepaper) Open Access Library.

"Together with AbbVie, we have made tremendous progress advancing our broad epcoritamab development program and we are pleased to share important results at EHA (Free EHA Whitepaper) 2025 evaluating epcoritamab in a variety of treatment settings and patient populations," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "The data presented at EHA (Free EHA Whitepaper) further reinforce our commitment to epcoritamab and its potential to become a core therapy across B-cell malignancies."

Several abstracts evaluating epcoritamab will also be presented at the 18th International Conference on Malignant Lymphoma (ICML), taking place June 17-21, 2025, in Lugano, Switzerland.

Abstracts accepted for presentation at EHA (Free EHA Whitepaper) include:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S245 First Disclosure of Epcoritamab + R-ICE in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) Eligible for Autologous Stem Cell Transplantation (ASCT): EPCORE NHL-2 Oral Sunday, June 15
11:00-12:15 CEST
S247 Durable Efficacy with Fixed-Duration Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for 1L Diffuse Large B-cell Lymphoma (EPCORE NHL-5) Oral Sunday, June 15
11:00-12:15 CEST
PF881 Epcoritamab Monotherapy Demonstrates Deep and Durable Responses at Three-Year follow-up in Patients with Relapsed/Refractory Follicular Lymphoma Poster Friday, June 13 18:30-19:30 CEST

PF885 Epcoritamab Plus Lenalidomide and Rituximab Achieves High Response Rates and Survival Benefits Compared with Usual Care in Relapsed/Refractory Follicular Lymphoma: A Comparative Analysis Poster Friday, June 13 18:30-19:30 CEST
PF920 Sustained Remission in R/R DLBCL with Epcoritamab Monotherapy: EPCORE NHL-1 3y Results and Novel Subgroup Analyses in Patients with Complete Response at 2y Poster Friday, June 13 18:30-19:30 CEST

PS1886 Matching-Adjusted Indirect Comparison of Epcoritamab with Rituximab + Lenalidomide vs Tafasitamab with Rituximab + Lenalidomide in Second-Line+ Follicular Lymphoma Poster Saturday, June 14 18:30-19:30 CEST

PS1898 Patient-Reported Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Treated with Epcoritamab within the Entire Study Cohort and in Patients with Symptoms at Baseline Poster Saturday, June 14 18:30-19:30 CEST

PS1968 Match-Adjusted Comparative Analysis of Epcoritamab + R-DHAX/C or R-ICE vs R-DHAX/C or R-ICE In 2L+ Transplant-Eligible Patients with Diffuse Large B-Cell Lymphoma Poster Saturday, June 14 18:30-19:30 CEST

PS1942 Match-Adjusted Comparative Analysis of the Efficacy Of Epcoritamab + R-Mini-CHOP vs R-Mini-CHOP in Previously Untreated Diffuse Large B-Cell Lymphoma Poster Saturday, June 14 18:30-19:30 CEST

PS1932 Treatment Outcomes in Newly Diagnosed Diffuse Large B-Cell Lymphoma Patients with High Cardiovascular Risk, and Treated with Non-Anthracycline Containing Regimens Poster Saturday, June 14 18:30-19:30 CEST

PS1944 Patient Preferences for Attributes of Bispecific Antibodies Indicated for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United States Poster Saturday, June 14 18:30-19:30 CEST

PS1912 Circulating Tumour DNA-Directed Intervention with Epcoritamab Alone or in Combination with Lenalidomide and Rituximab is Feasible in the Early Post-CAR-T Population at High Risk of Relapse: Preliminary Data from EpLCART Poster Saturday, June 14 18:30-19:30 CEST

PS1979 Epcoritamab with Gemcitabine, Dexamethasone, and Cisplatin (Epco-GDP) in Relapsed, Refractory Large B-cell Lymphoma – An Interim Analysis of Phase II Multicenter Investigator-initiated Trial Poster Saturday, June 14
15:30-16:00 CEST
PS1892 Phase II Investigator-initiated Trial of Epcoritamab-Lenalidomide in Treatment Naïve Follicular Lymphoma Poster Saturday, June 14
18:30-19:30 CEST
The safety and efficacy of these investigational uses have not been established.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemoimmunotherapy in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.