Whitehawk Therapeutics Expands ADC Pipeline with New Option Agreement for Use of CPT113 Linker-Payload

On May 21, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported it entered into a new option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. Whitehawk’s ADC platform leverages CPT113 as the core linker-payload technology, adding its own proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index.

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Per the terms of the option agreement, Whitehawk will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs. Whitehawk anticipates submitting Investigational New Drug (IND) applications for multiple new programs over the next 12-24 months.

"This option agreement reflects our conviction in CPT113 as the core linker-payload foundation of our ADC platform, supported both by increasing external validation and by what we are seeing in our own existing programs. By layering on our proprietary CBCR bioconjugation process, we believe we further enhance ADC stability to deliver potential best-in-class ADCs," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "With HWK-007 and HWK-016 enrolling, and an IND for HWK-206 anticipated mid-year, we are building execution momentum across our portfolio. We now have the opportunity to further scale our pipeline and advance novel ADC programs toward the clinic in the next 12-24 months."

External Programs Validate CPT113 Linker-Payload Technology

Hangzhou DAC’s DXC006 is a CD56-directed ADC that utilizes CPT113. DXC006 is being evaluated in first-in-human Phase 1 dose escalation/expansion study in China (NCT06224855) in solid tumor populations, including small-cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and neuroendocrine neoplasms. Data from DXC006 were accepted for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper). The abstract points to this highly potent linker-payload translating to clinical activity and a favorable safety profile characterized by an absence of key safety concerns typically associated with a Top1i class. These abstract data were as of December 26, 2025.

Separately, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Johnson & Johnson disclosed JNJ‑95437446, an amivantamab-based EGFR/MET ADC that uses CPT113. In the poster, JNJ‑95437446 reported preclinical findings that support its ongoing Phase 1 clinical development (NCT07107230).

Whitehawk’s ADC platform builds on the CPT113 linker-payload technology with its proprietary CBCR bioconjugation process. Based on key nonclinical measures, Whitehawk’s CBCR-based ADC platform has demonstrated higher Drug-to-Antibody Ratio (DAR) and improved therapeutic index compared to DXC006. Whitehawk recently reported comprehensive preclinical data for its existing pipeline programs at AACR (Free AACR Whitepaper).

Whitehawk’s Clinical Pipeline

Phase 1 trials for PTK7-directed HWK-007 and MUC16-directed HWK-016 are advancing through dose-escalation, with data expected in the first half of 2027. Based on non-clinical modeling, both programs’ starting dose is expected to be above the anticipated minimally effective dose.

HWK-007 completed the first dose cohort at 2 mg/kg and is enrolling the second cohort at 4 mg/kg. HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). The design of this Phase 1 study will be presented during a Trials-in-Progress poster at ASCO (Free ASCO Whitepaper).
Title: A phase 1 study of HWK-007, a next-generation, protein tyrosine kinase 7 (PTK7)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors
Date & Time: May 30, 2026, 1:30-4:30 PM CDT
Poster: 292b
HWK-016 is enrolling the first dose cohort at 2.5 mg/kg. HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).

(Press release, Whitehawk Therapeutics, MAY 21, 2026, View Source [SID1234665959])

Obsidian Therapeutics to Present Phase 2 Clinical Data for OBX-115 in Advanced Melanoma in Oral Presentation at 2026 ASCO Annual Meeting

On May 21, 2026 Obsidian Therapeutics, Inc., a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported positive Phase 2 results in patients with advanced melanoma from the Phase 1/2 Agni-01 multicenter study of OBX-115. These data will be presented in an oral presentation by Allison S. Betof, M.D., Ph.D., FASCO, associate professor of medicine (oncology), Stanford School of Medicine, on Monday, June 1, 2026, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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OBX-115 is a novel engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 and designed to deliver an improved, patient-centric treatment regimen. With its potentially reduced treatment burden driven by option for less-invasive core needle biopsy tumor tissue procurement, exclusively low-dose lymphodepletion (LD) compatible with outpatient administration and elimination of IL2 in the treatment regimen, OBX-115, if approved, has the potential to become a meaningful therapeutic option and expand the cell therapy eligible population of patients with advanced or metastatic melanoma.

Oral Presentation Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients with advanced melanoma that has progressed on/after immune checkpoint inhibitors (ICI): Phase 2 results
Session Title: Oral Abstract Session – Melanoma/Skin Cancers
Abstract: #9507
Location: Grand Ballroom S100bc
Session Date and Time: June 1, 8:00AM-11:00AM CT
Presentation Time: 10:12 AM-10:24 AM CT

Data to be presented are from the single-arm open-label Phase 1/2 Agni-01 multicenter study (NCT06060613) assessing the safety and efficacy of OBX-115 in adult patients with advanced melanoma that has progressed following treatment with ICI. Results from the January 22, 2026 data cutoff include 15 patients treated at the recommended phase 2 dose (RP2D), with n=6 from Phase 1 and n=9 from Phase 2.

OBX-115 demonstrated strong efficacy with a 67% objective response rate (ORR) in a difficult-to-treat advanced melanoma patient population

Study conducted in high unmet need melanoma patients, including a majority (93%) who were previously treated with doublet ICI
73% of patients had progression after anti–PD-1 + anti–CTLA-4 doublet therapy, a group with particularly low response rates to subsequent therapy
67% ORR (per RECIST v1.1), including 2 confirmed complete responses (CR) and 8 confirmed partial responses (PR) (compared to 1 CR and 9 PRs in abstract text)
Durable clinical benefit, including 8 of 10 responses ongoing as of the median 4.3 month study follow-up
OBX-115 continues to deliver consistent, favorable safety profile; treatment regimen with low-dose lymphodepletion and no IL2

All patients received low-dose LD, including 4 in the outpatient setting
No dose-limiting toxicities (DLT), treatment-related mortality (TRM), immune effector cell-associated neurotoxicity syndrome (ICANS) or ICU transfers
Majority of treatment-emergent adverse effects (TEAEs) occurring in ≥20% of patients were Grade 2 or less
Dr. Betof commented, "These data highlight OBX-115’s promising safety and efficacy profile, demonstrating the potential for durable benefit with low rates of major safety signals, including no DLTs, ICU transfer or TRM. The notable reduction in patient treatment burden relative to other therapies, driven by attributes such as core needle biopsy tumor tissue procurement and treatment regimen with outpatient-compatible low-dose lymphodepletion and without IL2, could be very beneficial and broaden the number of cell therapy eligible patients."

"Results from the Agni-01 study, including the 67% ORR, with 80% of responses ongoing as of the median 4.3 month study follow up, further emphasize OBX-115’s potential in advanced melanoma. We are highly encouraged by the anticipated benefit demonstrated in patients with difficult-to-treat advanced melanoma, including patients with disease progression following anti–PD-1 combination exposure," said Parameswaran Hari, M.D., M.S., Chief Medical Officer of Obsidian. "We have been in discussions with the FDA, and after reaching alignment on key design elements including eligibility criteria, clinical trial endpoints and drug product potency assay, plan to pursue a single-arm accelerated approval pathway. We look forward to continuing to advance OBX-115 through the clinic and plan to begin treating patients in the registration-enabling cohort of our multicenter study in mid-2026."

Obsidian is also investigating OBX-115 in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC Phase 1 data are expected in the first half of 2027.

About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential, if approved, to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process designed to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

(Press release, Obsidian Therapeutics, MAY 21, 2026, View Source [SID1234665975])

Rgenta Therapeutics Presents Positive Preliminary Data from Ongoing Phase 1a/b Clinical Trial of RGT-61159 in Patients with Adenoid Cystic Carcinoma and Colorectal Cancer at the 2026 ASCO Meeting

On May 21, 2026 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported positive preliminary data from its ongoing Phase 1a/b clinical trial of RGT-61159, an oral small molecule targeting MYB, in patients with advanced, relapsed or refractory adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting being held this week in Chicago. The early data supports promising and durable anti-tumor activity in advanced ACC, demonstrated MYB target engagement and an attractive, well-tolerated safety profile at RP2Ds for once-daily oral administration of RGT-61159.

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"While still early, these data are encouraging and supportive of the potential of RGT-61159 as a promising anti-tumor agent with a favorable safety profile in a particularly aggressive form of cancer, ACC," said Dr. Ho, M.D., Chief of Head and Neck Medical Oncology at Memorial Sloan Kettering Cancer Center. "Further, these data demonstrate that RGT-61159 knockdown of MYB protein, an oncogene that drives cancer progression, is a promising approach for treating cancers that over-express MYB. I look forward to the final results from this study and seeing the continued maturity of efficacy, safety and durability data."

Simon Xi, Ph.D., co-founder and chief executive officer of Rgenta added, "These are the first clinical data generated for RGT-61159 and we are pleased with the early results showing an impressive disease control rate and anti-tumor activity in ACC that deepens over time. In addition, RGT-61159 has demonstrated a favorable, well-tolerated safety profile. We look forward to initially advancing RGT-61159 into further development in ACC, an indication with a high unmet need, and plan to expand into other MYB-driven cancers in the future."

Rgenta’s Phase 1a/b clinical trial of RGT-61159 is a multi-center, open-label dose escalation and expansion study in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is evaluating safety, tolerability, pharmacokinetics, target engagement and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

Preliminary data from the initial patients in the trial showed clinically meaningful disease control of 84.6% in 39 evaluable patients, with 3 patients achieving partial response according to RECIST criteria (2 confirmed). Responses continued to deepen with longer treatment duration. Patients with partial responses have remained on study for a mean of 8.2 months, while all ongoing patients across the trial have a mean on-study duration of 7.3 months. RGT-61159 was well tolerated with the most common adverse events being fatigue, anemia, diarrhea and nausea.

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of oncogenic MYB protein production, which has the potential to inhibit proliferation or induce cell death of cancer cells that overexpress MYB protein. MYB acts as a master regulator of cell proliferation differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemias (AML), T-cell acute lymphoblastic leukemias (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer.

About Adenoid Cystic Carcinoma (ACC)
It is estimated that approximately 200,000 people are living with ACC throughout the world including 11,000 in the US. While it is a rare cancer, ACC is the second most common cancer type arising in the salivary gland and is an aggressive malignancy with a tendency to infiltrate surrounding nerves and metastasize to distant sites. Overactivation of the MYB oncogene has been described as a hallmark of ACC and is noted in over 90% of ACC. Treatment for ACC is extremely challenging and may include surgery and/or radiation, which often fails to control local tumor recurrence and distant metastases. There are no effective targeted therapies available for patients with recurrent and/or metastatic disease. There is thus an unmet medical need for new therapeutic targets and treatment strategies for patients with this fatal cancer.

About Colorectal Cancer (CRC)
CRC is the third most prevalent cancer and the second leading cause of cancer-related mortality worldwide. According to the World Health Organization, in 2022, more than 1.9 million cases of CRC were diagnosed. Despite the improved early detection of CRC and the recent success of targeted therapeutics, approximately 15%-30% of patients present with metastases and 20%-50% of patients with initially localized disease will develop metastases. Patients with relapsed or refractory CRC who have exhausted all the available standard of care therapy options, have a very poor prognosis. MYB is significantly overexpressed in 80-85% of CRC and has been frequently found to be a predictive biomarker of tumor aggressiveness and poor prognosis. Developing novel therapies to treat patients with metastatic CRC remains a major unmet medical need.

(Press release, Rgenta Therapeutics, MAY 21, 2026, View Source [SID1234665991])

Ascentage Pharma Releases Latest Clinical Data from Multiple Trials at ASCO 2026

On May 21, 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, differentiated therapies to address unmet medical needs in cancer, reported that six abstracts from its clinical studies, selected for presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, are now available on ASCO (Free ASCO Whitepaper)’s official website. Three of the six studies have been selected for rapid oral presentations, and three as poster presentations. These abstracts report data from ongoing studies evaluating the company’s three lead drug candidates, including BCR-ABL inhibitor olverembatinib(HQP1351); Bcl-2 inhibitor lisaftoclax (APG-2575); and MDM2-p53 inhibitor alrizomadlin (APG-115).

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This year’s ASCO (Free ASCO Whitepaper) Annual Meeting will take place in person at McCormick Place in Chicago, IL, and online, May 29 – June 2, 2026. The ASCO (Free ASCO Whitepaper) Annual Meeting showcases cutting-edge research in clinical oncology and advanced cancer therapies and is the world’s largest gathering in the clinical oncology community.

The key clinical results from Ascentage Pharma’s abstracts selected for the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting are as follows:

Rapid Oral Presentations

Olverembatinib (HQP1351) combined with blinatumomab in patients with lymphoid blast phase chronic myeloid leukemia (CML-LBP) or Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia (Ph+ BCP-ALL)

Abstract #: 6513

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: May 30, 2026, 1:51 – 1:57 p.m., Central Time (May 31, 2026, 2:51 – 2:57 a.m., Beijing Time)

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

Highlights:

● This multicenter, open-label phase Ib study evaluated the combination of olverembatinib and blinatumomab in patients with relapsed/refractory (R/R) Ph+ BCP-ALL or CML-LBP.

● Among five patients with measurable residual disease (MRD) positivity and no complete response (CR) at study entry, four achieved CR, and two achieved MRD negativity, with an overall manageable safety profile.

● This study provides initial clinical evidence supporting the feasibility of combining olverembatinib with immunotherapy in patients with CML-LBP and R/R Ph+ BCP-ALL in an international patient population.

Updated efficacy and safety of olverembatinib (HQP1351) as second-line therapy in patients with chronic-phase chronic myeloid leukemia (CP-CML)

Abstract #: 6510

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: May 30, 2026, 1:21 – 1:27 p.m., Central Time (May 31, 2026, 2:21 – 2:27 a.m., Beijing Time)

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

Highlights:

● This is a single-arm, multicenter, open-label study conducted in China, evaluating the efficacy and safety of olverembatinib as a second-line therapy in patients with CP-CML.

● Among 42 evaluable patients, at cycle 24, the complete cytogenetic response (CCyR) rate reached 91.3%, and the major molecular response (MMR) rate reached 60.9%. Among 32 patients who failed first-line second-generation TKIs, 81.3% achieved CCyR and 50% achieved MMR, with a favorable safety profile.

● Olverembatinib shows good tolerability and leads to high MMR and CCyR in patients with CP- CML without T315I mutation that is resistant/intolerant to first-line TKls.

Alrizomadlin (APG-115) alone or in combination with lisaftoclax (APG-2575) for the treatment of pediatric patients with relapsed/metastatic rhabdomyosarcoma (RMS) or other soft-tissue sarcomas (STSs)

Abstract #: 10012

Session Title: Pediatric Oncology II

Date and Time: May 30, 2026, 8:00 – 8:06a.m., Central Time (May 30, 2026, 9:00 -9:06 p.m., Beijing Time)

First Author: Yizhuo Zhang, MD, Department of Pediatric Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China

Highlights:

● This is a multicenter clinical trial conducted in China, evaluating the safety and preliminary efficacy of alrizomadlin (APG-115) as monotherapy or in combination with lisaftoclax (APG-2575) in heavily pretreated pediatric patients with neuroblastoma (NB), as well as relapsed/metastatic rhabdomyosarcoma (RMS), Ewing sarcoma (EWS), and other soft-tissue sarcomas (STSs).

● Results showed that no dose-limiting toxicities (DLT) were observed in either monotherapy or combination groups. Adverse events were mainly gastrointestinal and hematologic, with few serious adverse events, and no treatment-related deaths or discontinuations. In terms of clinical benefit, one patient with refractory RMS in the monotherapy group achieved CR; in the combination group, the objective response rate (ORR) was 30% and the disease control rate (DCR) was 80%.

● This regimen demonstrated a manageable safety profile and preliminary antitumor activity in pediatric solid tumors, warranting further investigation.

Poster Presentations

Updated clinical and translational results of olverembatinib (HQP1351) in patients with succinate dehydrogenase (SDH)-deficient tumors

Abstract #: 11539

Session Title: Sarcoma

Date and Time: June 1, 2026, 1:30 – 4:30 p.m., Central Time (June 2, 2026, 2:30 – 5:30 a.m., Beijing Time)

First Author: Haibo Qiu, MD, PhD, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China

Highlights:

● This study in SDH-deficient tumors evaluated the efficacy of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumors (GIST) and paraganglioma.

● Among 26 patients with SDH-deficient GIST, 6(23.1%)pts experienced PR as best response, with a median progression-free survival (PFS) of 25.7 months; among 6 patients with SDH-deficient paraganglioma, best responses were observed in 4 patients, with SD lasting≥4 cycles(CBR, 66.7%) and a median PFS of 8.25 months.

● This study, for the first time, revealed that olverembatinib inhibits fatty acid-promoted tumor cell migration by targeting the p38-CD36 pathway, providing a further insight on the mechanism of action of olverembatinib in SDH-deficient tumors.

A phase 3 study of olverembatinib (HQP1351) in patients with chronic-phase chronic myeloid leukemia: POLARIS-2 trial in progress

Abstract #: TPS6608

Session Title: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date and Time: June 1, 2026, 9:00 a.m. – 12:00 p.m., Central Time (June 1, 2026, 10:00 p.m. -Tuesday June 2, 2026, 1:00 a.m., Beijing Time)

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

Highlights:

● This FDA and EMA-cleared, global Phase III registrational clinical trial (POLARIS-2) is evaluating olverembatinib in patients with chronic-phase CML

● The study includes two independent cohorts. In Part A, patients with chronic-phase CML who have received at least two prior TKIs are randomized in a 2:1 ratio to receive olverembatinib or bosutinib; Part B is a single-arm study evaluating olverembatinib in patients harboring the T315I mutation. The primary endpoint for both parts is the MMR rate at or by 24 weeks.

A global multicenter, open-label, randomized, phase 3 registrational study of lisaftoclax (APG-2575) in previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): GLORA trial in progress

Abstract #: TPS7101

Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Date and Time: June 1, 2026, 9:00 a.m. – 12:00 p.m., Central Time (June 1, 2026, 10:00 p.m. -Tuesday June 2, 2026, 1:00 a.m., Beijing Time)

First Author: Matthew Steven Davids, MD, Dana-Farber Cancer Institute

Highlights:

● GLORA is a global, multicenter, open-label phase 3 registrational study.

● The aim of the study is to evaluate the efficacy and safety of lisaftoclax in combination with a BTK inhibitor in patients with CLL/SLL. Eligible patients have CLL/SLL and, after 12 months of BTKi monotherapy, have achieved neither complete response (CR) nor progressive disease (PD). The study plans to enroll approximately 440 patients across 126 centers in 18 countries and is currently enrolling.

(Press release, Ascentage Pharma, MAY 21, 2026, View Source [SID1234666007])

Genmab to Highlight Advances Across Its Oncology Portfolio at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2026 Congress

On May 21, 2026 Genmab A/S (Nasdaq: GMAB) reported that 23 abstracts, including 20 abstracts evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, will be presented or published at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL, from May 29-June 2, and at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden, from June 11-14.

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Key presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will highlight data evaluating the potential utility of epcoritamab across multiple settings, including as a monotherapy, in combination regimens, in fixed-duration use and in earlier lines of therapy. Oral sessions will feature the first presentation of the full results from the Phase 3 EPCORE DLBCL-1 trial comparing epcoritamab monotherapy to investigator’s choice chemotherapy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), as well as additional data from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone in patients with R/R follicular lymphoma (FL). Additional presentations will include real-world evidence and health economic and outcomes research data, as well as overviews of trials-in-progress evaluating late-stage medicines.

"This year at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), Genmab will once again present data highlighting the depth and breadth of the epcoritamab development program, including encouraging results across multiple treatment settings for patients with B-cell malignancies. These findings underscore the versatility of epcoritamab as a monotherapy, in combination regimens and as a potential core therapy across the spectrum of B-cell malignancies," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Additional presentations and publications at ASCO (Free ASCO Whitepaper) will further reflect our commitment to advancing other antibody-based therapeutics."

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

Abstracts accepted for presentation at ASCO (Free ASCO Whitepaper):

Epcoritamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
7002*

Phase 2 trial of epcoritamab in combination with rituximab-mini CVP for older unfit/frail or anthracycline-ineligible adult patients with newly diagnosed diffuse large B-cell lymphoma: Interim futility analysis Oral presentation

Saturday, May 30, 3:00 PM-6:00 PM CDT
7061 Epcoritamab (epcor) + chemoimmunotherapy (CIT) in patients (pts) with relapsed/refractory large B cell lymphoma (R/R LBCL) eligible for autologous stem cell transplant (ASCT): Pooled results from Arms 4 and 10 of EPCORE NHL-2 Poster

Monday, June 1, 9:00 AM-12:00 PM CDT
e19003

NHL-6: Phase 2 study of subcutaneous (SC) epcoritamab as outpatient treatment for 2L+ relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) Publication Only

NA

*Investigator-led trial

Rinatabart sesutecan (Rina-S):

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
TPS5646 RAINFOL-03 (ENGOT-EN-31/GOG-3128): A phase 3, open-label, randomized study of Rinatabart sesutecan vs investigator’s choice of chemotherapy in patients with endometrial cancer after platinum-based chemotherapy and programmed death ligand 1 inhibition Poster

Monday, June 1, 9:00 AM-12:00 PM CDT
TPS5641 RAINFOL-04 (ENGOT-OV96/GOG-3134): A phase 3, open-label, randomized study of Rinatabart sesutecan plus standard of care (SOC) vs SOC as maintenance treatment after second-line platinum-based chemotherapy in patients with recurrent platinum-sensitive ovarian cancer Poster Monday, June 1, 9:00 AM-12:00 PM CDT

Petosemtamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
TPS8662 Petosemtamab plus pembrolizumab as first-line (1L) treatment of PD-L1 high metastatic non-small cell lung cancer (NSCLC): Global phase 2 trial Poster

Sunday, May 31, 9:00 AM-12:00 PM CDT
Abstracts accepted for presentation at EHA (Free EHA Whitepaper):

Epcoritamab:

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S229

Clinically Relevant Subgroup Analysis from the Randomized Phase 3 EPCORE FL-1 Trial: Treatment (Tx) Effect of Epcoritamab with Lenalidomide and Rituximab (R2) in R/R Follicular Lymphoma (FL) Oral Presentation

Thursday, June 11, 16:45-18:00 CEST
S235 Results From EPCORE DLBCL-1: Randomized Phase 3 Study of Epcoritamab (Epcor) Vs Investigator’s Choice Chemoimmunotherapy (CIT) in Patients with Relapsed/Refractory Large B-cell Lymphoma (R/R LBCL) Oral Presentation

Friday, June 12,
17:15-18:30 CEST

S153*

Fixed Duration Venetoclax Plus Epcoritamab Shows Favorable Tolerability and High Response Rates with Early Molecular Responses in R/R CLL/SLL: Interim Analysis of the Randomized HOVON 165/AETHER Trial Oral Presentation

Sunday June 14,
11:00-12:15 CEST
*Investigator-led trial

PF977

Sustained Remissions Beyond 4 Years with Epcoritamab Monotherapy: Long-term Follow-up Results from the Pivotal EPCORE NHL-1 Trial in Patients with Relapsed or Refractory Large B-cell Lymphoma Poster

Friday, June 12, 18:45-19:45 CEST

PF1007

Epcoritamab + R-mini-chop Results in 2-year Remissions and High MRD-negativity Rates in Elderly Patients with Newly Diagnosed DLBCL: Results from the EPCORE NHL-2 Trial Poster

Friday, June 12, 18;45-19:45 CEST

PF1069

Reduced CD20 Expression and Intratumoral CD3+ T Cells Following Epcoritamab Treatment Are Associated with Progressive Disease in a Subset of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Poster

Friday, June 12, 18:45-19:45 CEST

PF1081

Pharmacodynamic Biomarkers Support the Clinical Benefit of Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL): Analyses from EPCORE FL-1 Poster

Friday, June 12, 18:45-19:45 CEST

PS2035

Anchored Matching-adjusted Indirect Comparison of Epcoritamab, Lenalidomide, and Rituximab Vs Tafasitamab, Lenalidomide, and Rituximab in Relapsed/Refractory Follicular Lymphoma: EPCORE FL-1 Vs Inmind Poster

Saturday, June 13, 18:45-19:45 CEST
PS2042

Comparative Effectiveness of Epcoritamab, Lenalidomide, and Rituximab in EPCORE FL-1 Vs Real-world Chemoimmunotherapy in Relapsed/Refractory Lymphoma Poster

Saturday, June 13, 18:45-19:45 CEST

PS2052

Comparative Analyses of Epcoritamab in Combination with Lenalidomide and Rituximab Vs Obinutuzumab and Bendamustine in Relapsed/Refractory Follicular Lymphoma Poster

Saturday, June 13, 18:45-19:45 CEST
PS2070

Epcoritamab + Chemoimmunotherapy in Patients with Relapsed/Refractory Large B-cell Lymphoma Eligible for Autologous Stem Cell Transplant: Pooled Results from Arms 4 And 10 of EPCORE NHL-2 Poster

Saturday, June 13, 18:45-19:45 CEST

PS2082

Fixed-duration Epcoritamab Monotherapy Induces High Response and MRD-negativity Rates in Elderly Patients with Newly Diagnosed Large B-cell Lymphoma and Comorbidities: Results from EPCORE DLBCL-3 Poster

Saturday, June 13, 18:45-19:45 CEST

PS2086

Epcoritamab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL): Insights from the Real-world Epcoritamab Patient Characteristics and Outcomes Research (Real-epcor) Study Poster

Saturday, June 13, 18:45-19:45 CEST

PS2497

Epcoritamab Plus Lenalidomide and Rituximab Improves or Preserves Health-related Quality of Life in Patients with Relapsed/Refractory Follicular Lymphoma Who Had High Symptom Burden or Adverse Events Poster

Saturday, June 13, 18:45-19:45 CEST

NA

Epcoreal: A Prospective Observational Trial-in-progress of Epcoritamab in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Follicular Lymphoma Publication Only

NA

NA

Epcoritamab With Lenalidomide and Rituximab in Chinese Patients with Relapsed or Refractory Follicular Lymphoma: A Subgroup Analysis from the Phase 3 Epcore FL-1 Trial Publication Only

NA

NA

Cost Per Complete Responder for Epcoritamab + Lenalidomide and Rituximab (R2) Vs Tafasitamab + R2 in Relapsed or Refractory Follicular Lymphoma: A US Medicare Perspective Publication Only

NA

The safety and efficacy of epcoritamab, Rina-S and petosemtamab have not been established for these investigational uses.

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

Please see local country prescribing information for all labeled indication and safety information.

About Rinatabart Sesutecan (Rina-S; GEN1184)
Rina-S; GEN1184 is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRα, a hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical development program for Rina-S continues to expand, with multiple ongoing Phase 3 studies in patients with ovarian and endometrial cancer, alongside evaluation in other tumor types with unmet needs. The safety and efficacy of rinatabart sesutecan have not been established. Please visit View Source for more information.

About Petosemtamab (GEN1158)
Petosemtamab is an investigational bispecific antibody targeting the epidermal growth factor receptor (EGFR) and the leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5). By engaging both receptors, petosemtamab is designed to inhibit EGFR signaling and trigger EGFR degradation selectively in LGR5+ cancer stem-like cells to support multiple anti-tumor mechanisms, including enhanced immune-mediated activity. It is currently being investigated in head and neck squamous cell carcinoma (HNSCC) and other solid tumors, including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The safety and efficacy of petosemtamab have not been established. Please visit View Source for more information.

(Press release, Genmab, MAY 21, 2026, View Source [SID1234665928])