Flatiron Health Announces Research at ISPOR Europe 2026 Advancing Global Oncology Evidence for Health Technology Assessment

On November 5, 2026 Flatiron Health reported seven research abstracts to be presented at ISPOR—The Professional Society for Health Economics and Outcomes Research Europe 2026 conference, taking place November 8–11 in Vienna, Austria. The research examines how real-world evidence can support health technology assessment (HTA), how oncology findings may translate across countries, and how transparent validation can support the use of AI-derived data in research.

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Flatiron will also host a speaking session on scaling AI-curated oncology data across countries, featuring clinical and scientific experts discussing how to maintain data accuracy, consistency, and clinical relevance as datasets expand across markets and disease areas.

"Answering whether a cancer treatment works is only part of the challenge. Researchers and health technology assessment bodies also need to understand how that evidence applies to patients in different healthcare systems," said Nathan Hubbard, Chief Executive Officer, Flatiron Health. "Our research at ISPOR Europe examines what it takes to make those judgments with confidence, from understanding differences in treatment patterns to validating the quality of AI-derived data. This work can help strengthen the evidence that informs access to cancer treatments."

Flatiron combines multinational oncology data from the US, UK, Germany, and Japan with clinical expertise and analytical methods to address questions facing researchers, payers, and regulators. This year’s studies examine both the opportunities and practical considerations involved in generating evidence across healthcare systems, including population comparability, subsequent treatment choices, and differences in routine monitoring.

Research highlights include:

Evaluating when evidence can inform decisions across countries. Three studies examine the transportability of oncology evidence, including a structured approach to reviewing cross-country studies, benchmarking methods for comparing survival estimates, and a comparison of US and Finnish metastatic non–small cell lung cancer (NSCLC) cohorts. Together, the studies explore how researchers can assess whether international evidence is appropriate for local HTA questions.
Understanding how subsequent care affects survival analyses. An advanced NSCLC analysis examines how second-line treatment patterns can influence estimates of first-line treatment effects on real-world overall survival. The methods offer a way to distinguish the effects of initial therapy from differences in the treatment patients receive next.
Assessing AI-derived data quality and cross-country safety measurement. A UK prostate cancer study extends Flatiron’s VALID framework to evaluate data extracted using large language models. A separate study examines how laboratory monitoring practices in the UK, Germany, and Japan may influence detection of liver toxicity among patients receiving CDK4/6 inhibitors for advanced breast cancer.
Examining variation in metastatic prostate cancer treatment. A US study describes differences in treatment selection and androgen receptor pathway inhibitor reuse across racial, ethnic, and area-level socioeconomic groups, highlighting questions for further research into access and clinical decision-making.
At booth #1018, attendees can explore Flatiron’s global Panoramic datasets through live demonstrations of Flatiron Telescope, its AI-powered oncology intelligence platform.

Schedule a meeting with Flatiron Health at ISPOR Europe 2026 and follow Flatiron Health on LinkedIn for conference updates.

Featured Speaking Session

Setting the global standard: What it takes to scale AI-curated oncology data across countries

Tuesday, November 10 | 15:15–15:45 | Exhibit Hall

Arun Sujenthiran, MD, Clinical Lead and Senior Medical Director, International, and Qianyi Zhang, MS, Director, Research Sciences, will discuss Flatiron’s approach to transparent data validation and its application across US and international oncology datasets.

Abstracts and Poster Presentations

Key Considerations for Synthesizing Cross-Country Oncology RWE Transportability Studies

This study identifies five recurring methodological dimensions across oncology transportability studies and proposes a practical checklist to help HTA bodies and regulators interpret international real-world evidence.

Poster Session 1 | SA8
Monday, November 9 | 10:30–13:30
Discussion period: 12:30–13:30

Benchmarking as a Tool for Assessing Cross-Country Comparability of Survival Evidence for HTA

Using exploratory case studies in metastatic NSCLC and multiple myeloma, this analysis examines how comparisons of predicted and reference survival estimates may help researchers assess the suitability of international evidence for HTA.

Poster Session 1 | HTA28
Monday, November 9 | 10:30–13:30
Discussion period: 12:30–13:30

Comparison of Patient Characteristics and First-Line Treatment Patterns in Metastatic NSCLC: US and Finland Cohorts to Inform Overall Survival Transportability Analyses

This study compares patient characteristics and first-line treatment patterns in US and Finnish cohorts to inform future analyses of whether survival findings can be applied across the two settings.

Poster Session 2 | SA30
Monday, November 9 | 16:00–19:00
Discussion period: 18:00–19:00

Controlling for What Comes Next: Estimating Generalized Direct Effects of First-line Therapy on Real-world Overall Survival Using Counterfactual Second-line Distributions in Advanced Non-small Cell Lung Cancer

This analysis explores a method for estimating first-line treatment effects on survival under alternative second-line treatment scenarios, helping researchers account for differences in subsequent care.

Poster Session 4 | MSR200
Tuesday, November 10 | 16:00–19:00
Discussion period: 18:00–19:00

Extending the Validation of Accuracy for Large Language Model (LLM)–/Machine Learning (ML)–Extracted Information and Data (VALID) Framework Globally: Quality Assessment of LLM-Derived Prostate Cancer Real-World Data in the UK

Applying the VALID framework to a UK prostate cancer dataset, this study evaluates LLM-derived data through variable-level assessments, clinical plausibility checks, and replication analyses.

Poster Session 5 | MSR263
Wednesday, November 11 | 09:00–11:30
Discussion period: 09:00–10:00

Real-World First-Line Treatment (tx) Patterns in Androgen Receptor Pathway Inhibitor (ARPI)-Experienced Metastatic Castration-Resistant Prostate Cancer (mCRPC) by Race/Ethnicity and Area-Level Socioeconomic Status (SES) in the US

This study describes variation in first-line treatment selection and ARPI reuse across racial, ethnic, and area-level socioeconomic groups among US patients with ARPI-experienced metastatic castration-resistant prostate cancer.

Poster Session 1 | HSD15
Monday, November 9 | 10:30–13:30
Discussion period: 12:30–13:30

Cross-Country Differences in Real-World Laboratory Monitoring Intensity and Hepatotoxicity Adverse Event Detection Among Initiators of CDK4/6 Inhibitors for Advanced Breast Cancer

This study examines how differences in laboratory monitoring across the UK, Germany, and Japan may influence observed liver toxicity rates and the interpretation of cross-country safety evidence.

Poster Session 5 | RWD173
Wednesday, November 11 | 09:00–11:30
Discussion period: 09:00–10:00

(Press release, Flatiron Health, NOV 5, 2026, View Source [SID1234674364])

Zai Lab Presents Updated Clinical Data Demonstrating Zocilurtatug Pelitecan (Zoci) Induces Clinically Meaningful Responses and a Manageable Safety Profile in Previously Treated Extrapulmonary Neuroendocrine Carcinomas

On November 5, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovation-driven, global biopharma company, reported that updated data from a Phase 1b/2 trial of zocilurtatug pelitecan (zoci, formerly ZL-1310), a DLL3-targeting antibody-drug conjugate (ADC), will be shared tomorrow at the North American Neuroendocrine Tumor Society (NANETS) 2026 Multidisciplinary NET Medical Symposium in Las Vegas. The data indicate that zoci demonstrated clinically meaningful, durable anti-tumor responses in patients with previously treated advanced extrapulmonary neuroendocrine carcinomas (epNECs), aggressive cancers that arise outside the lung and share biological characteristics with small cell lung cancer.

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There is currently no established standard of care for patients with epNECs who progress on or after first-line platinum-based chemotherapy. Chemotherapy regimens commonly used in clinical practice have limited efficacy, particularly in gastroenteropancreatic NEC (GEP-NEC), and outcomes remain poor.1

"Given the aggressiveness of epNECs and the relatively limited treatment options following platinum-based chemotherapy, patients who have advanced or metastatic disease need additional options," said Amr Mohamed, M.D., study investigator and Director of the Neuroendocrine Tumor Program at UH Seidman Cancer Center, University Hospitals and Case Western Reserve University. "The efficacy and safety data from this trial are encouraging and underscore the possibility that zoci could play a key role in a new standard of care for patients with epNEC."

Updated data from the Phase 1b/2 clinical trial of zoci (NCT06885281) showed clinically meaningful responses in patients with advanced or metastatic epNECs that had progressed on or after platinum-based chemotherapy. The study evaluated zoci administered intravenously as monotherapy at 1.6 mg/kg every three weeks. Tumor response was evaluated by investigator-assessed RECIST v1.1 with additional assessments for some NECs.

In the study’s primary efficacy population of 60 patients by the data cutoff, investigator-assessed confirmed ORR was 40.0% (24/60; 95% CI: 27.6%-53.5%), and disease control rate was 55.0% (33/60, 95% CI: 41.6%-67.9%).
Treatment with zoci decreased tumor sizes in multiple epNEC subtypes: Confirmed ORR was 35.9% (14/39, 95% CI: 21.2%-52.8%) in GEP-NEC and 47.6% (10/21, 95% CI: 25.7%-70.2%) in other epNECs.
Overall median duration of response (mDOR) was 5.6 months (95% CI: 3.0-9.3).
Among 18 responders with at least 6 months of opportunity for follow-up from initial response, 6 (33.3%) remain in response or had a response lasting 6 months or longer.
Zoci demonstrated a manageable safety profile: Among all 133 patients in the study, 12.8% (17/133) experienced Grade ≥3 treatment-related adverse events (TRAEs) and 29.3% (39/133) experienced Grade ≥3 treatment-emergent adverse events (TEAEs), with anemia (7/133, 5.3%) and neutropenia (5/133, 3.8%) as the highest Grade ≥3 TEAEs. Grade 2 interstitial lung disease (ILD)/pneumonitis was reported in 2 patients (1.5%), with no Grade ≥3 ILD events observed. Treatment related discontinuation occurred in 1/133 (0.8%) patients; only one Phase 2 participant experienced a fatal TEAE, determined by the investigator to be unrelated to the study drug.
Efficacy results from this larger dataset are consistent with those previously reported at AACR (Free AACR Whitepaper) 2026. Data from patients recently enrolled in Phase 2 is not yet sufficiently mature for analysis, and follow-up is ongoing. Additional data is expected in 2027.

DLL3 expression was assessed by immunohistochemistry. Antitumor activity was observed across the spectrum of DLL3 expression levels, including in patients with low or absent DLL3 expression.

"We are increasingly excited about the potential of zoci to provide an important new targeted therapeutic option for patients with multiple cancer types that commonly express DLL3, including epNECs," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "We are pleased that results from this larger dataset, with longer follow-up, are consistent with the earlier data we shared at AACR (Free AACR Whitepaper). A confirmed objective response rate of 40 percent, including response in multiple epNEC subtypes, with anti-tumor activity observed over time and a treatment related discontinuation rate of less than one percent, are encouraging signals for patients who have few treatment options following platinum-based chemotherapy. We are pursuing an accelerated approval pathway for zoci in previously treated epNECs and will continue to advance our clinical programs for this disease with urgency."

Zai Lab has completed enrollment in the Phase 2 second-line expansion cohort of the Phase 1b/2 zoci monotherapy trial. Based on feedback from the U.S. Food and Drug Administration (FDA), the company will pursue a potential accelerated approval pathway based on this single-arm expansion study with topline data expected in 2027. Zai Lab also intends to initiate a global Phase 3 first-line maintenance trial of zoci monotherapy in epNECs next year.

In August, the U.S. FDA granted Orphan Drug Designation (ODD) to zoci for the treatment of NECs, following receipt of ODD for zoci in pulmonary NECs from the European Medicines Agency. The U.S. FDA previously granted Fast Track designation (FTD) to zoci for EP-NECs, as well as FTD and ODD to zoci for SCLC.

NANETS 2026 zoci presentation details:

Abstract title: Phase 1b/2 Study of Zocilurtatug Pelitecan in Patients with Advanced Extrapulmonary Neuroendocrine Carcinomas (epNEC)

Abstract ID: 36547

Presenter: Amr Mohamed, M.D.

Date/time: Friday, November 6, 2026, 9:34–9:46 AM PT

Session/location: Featured Abstracts 2: Emerging Strategies in High-Grade and Advanced NENs

Notes:

1 Sorbye H, Hjortland GO, Vestermark LW, et al. Characteristics and treatment outcome in a prospective cohort of 639 advanced high-grade digestive neuroendocrine neoplasms (NET G3 and NEC). The NORDIC NEC 2 study. British Journal of Cancer. 2025;133:316-324. doi:10.1038/s41416-025-03054-w

About Zocilurtatug Pelitecan (zoci, formerly ZL-1310)

Zoci is a novel, potential first-in-class antibody-drug conjugate (ADC), that targets Delta-like ligand 3 (DLL3), a validated therapeutic target that is overexpressed in small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs), including extrapulmonary NECs, making it a promising target for the treatment of these aggressive, lethal and difficult-to-treat malignancies. The DLL3 antigen is generally associated with poor clinical outcomes.

Zoci remains on track to become Zai Lab’s first global oncology launch. In addition to the Phase 3 combination trial in first-line extensive stage SCLC that Zai Lab is advancing toward initiation, the Company is also conducting the Phase 3 DLLEVATE study evaluating zoci in previously treated extensive stage SCLC (ES-SCLC) vs. physician’s choice of chemotherapy, and a Phase 1/2 trial in neuroendocrine carcinomas and other DLL3-positive solid tumors. Data presented at ESMO (Free ESMO Whitepaper) 2026 from an ongoing global Phase 1b trial in first-line ES-SCLC showed that zoci 1.6 mg/kg plus atezolizumab achieved a confirmed ORR of 81.8% (27/33), 6 months PFS 81.9% and was well tolerated, with Grade ≥ 3 adverse events related to zoci in 9.1% (3/33) of patients. Earlier data presented at AACR (Free AACR Whitepaper) 2026 from the monotherapy part of the same Phase 1 trial in previously-treated ES-SCLC demonstrated that zoci achieved meaningful intracranial efficacy, including in patients who have not received radiotherapy to the brain.

Earlier this year, Zai Lab entered into a global clinical trial collaboration with Amgen to evaluate zoci in combination with Amgen’s IMDELLTRA (tarlatamab-dlle), a DLL3/CD3 bispecific T-cell engager (TCE), for ES-SCLC, and a clinical collaboration with Boehringer Ingelheim to evaluate zoci in combination with obrixtamig, a DLL3/CD3 bispecific TCE, for ES-SCLC and other NECs.

(Press release, Zai Laboratory, NOV 5, 2026, View Source [SID1234674363])

Pilatus Biosciences Presents New Preclinical Data at SITC 2026 Demonstrating Potential of PLT012 to Overcome Immunotherapy Resistance in Liver Cancer

On November 5, 2026 Pilatus Biosciences, a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported the presentation of new preclinical data supporting the therapeutic potential of PLT012, its investigational anti-CD36 monoclonal antibody, in overcoming acquired resistance to PD-1 immunotherapy in hepatocellular carcinoma (HCC) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting, held November 4-8, 2026, in Phoenix, Arizona.

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The research, conducted in collaboration with investigators at Zhongshan Hospital, Fudan University, identifies a previously underexplored mechanism of immunotherapy resistance in which sustained PD-1 treatment and selection lead to immunoediting-driven metabolic reprogramming in tumor cells, creating a lipid-rich, immunosuppressive tumor microenvironment. Increased expression of CD36, a key regulator of lipid uptake, was associated with impaired antitumor immune responses and acquired treatment resistance.

In preclinical models of PD-1-resistant liver cancer, PLT012 treatment counteracted CD36-associated immunosuppressive effects within the tumor microenvironment and significantly inhibited tumor growth, supporting CD36 inhibition as a potential therapeutic strategy for patients who develop resistance to existing checkpoint inhibitors.

"Acquired resistance to PD-1 immunotherapy remains a significant challenge in treating advanced liver cancer, with limited therapeutic options available once patients stop responding," said Yi-Ru Yu, Ph.D., Head of Biology, R&D, Pilatus Biosciences. "Our findings highlight the critical role of lipid metabolic reprogramming in acquired PD-1 resistance and demonstrate the potential of PLT012 to tackle lipid-mediated immunosuppression, with tumor growth inhibition observed in preclinical models. These results provide further mechanistic validation of our approach and reinforce the potential of PLT012 to address an important unmet need in liver cancer."

The study utilized a preclinical model of acquired PD-1 resistance, developed through three generations of consecutive anti-PD-1 treatment and selection, combined with multi-omic analyses to characterize changes in tumor metabolism and immune activity.

Key findings include:

Metabolic reprogramming drives treatment resistance: Acquired PD-1 resistance was associated with epigenetic and transcriptional changes that increased lipid metabolism in tumor cells, contributing to an immunosuppressive tumor microenvironment.
CD36 contributes to immune dysfunction: Increased CD36 expression on tumor-infiltrating immune cells was associated with reduced effector T-cell and natural killer cell activity, alongside increased immunosuppressive macrophage and neutrophil populations.
PLT012 demonstrates antitumor activity: Targeting CD36 with PLT012 mitigated lipid-associated immunosuppression and significantly inhibited tumor growth in preclinical models resistant to PD-1 treatment.
"These findings strengthen the scientific rationale for advancing PLT012 in HCC following prior immunotherapy," said George E. Peoples, M.D., Chief Medical Officer, Pilatus Biosciences. "Our planned Phase 1/2 development will prioritize monotherapy dose optimization and rational combination studies, supported by biomarker analyses. By linking CD36 target engagement and changes in the tumor immune microenvironment with clinical outcomes, we aim to establish preclinical-to-clinical concordance and determine whether the immune effects observed in our models translate into durable antitumor activity in patients."

Poster Presentation Details

Title: Immunoediting-Induced Lipid Metabolism Fosters Acquired PD-1 Resistance in Hepatocellular Carcinoma via CD36-Mediated Immune Suppression

Poster Number: 380

Conference: Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting

Date: November 7, 2026

Location: Phoenix Convention Center, Phoenix, Arizona

(Press release, Pilatus Biosciences, NOV 5, 2026, View Source [SID1234674362])

Signatera™ Monitoring During First-Line Immunotherapy Showed ctDNA Clearance is Associated with Long-Term Survival Across Four Metastatic Cancers

On November 5, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported it will present important new Signatera data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, taking place November 4–8 in Phoenix, Arizona.

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Immune checkpoint inhibitors (ICIs) have transformed treatment for many metastatic cancers, and some patients achieve durable disease control.1 However, it remains challenging for clinicians to determine how long to continue therapy, since imaging alone is prone to error and cannot show whether disease has cleared at the molecular level.2,3 As a result, treatment duration remains an open question, particularly for patients who achieve a durable clinical response.

A real-world analysis at SITC (Free SITC Whitepaper) studied outcomes of 424 patients treated with first-line immunotherapy across stage IV melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) colorectal cancer (CRC), and non-small cell lung cancer (NSCLC). The Signatera test was used to identify complete molecular responders (CMRs), defined as patients with two consecutive negative results. Findings showed:

Improved survival in Signatera MRD-negative patients: CMRs had a 36-month overall survival (OS) of 93.2% vs. 77.9% in all other patients (HR 0.24; P=0.0003).
Favorable survival across tumor types: At 36 months, OS in CMRs ranged from 83.1% (NSCLC) to 100% (MSI-H CRC).
No significant survival difference with early ICI discontinuation: OS for CMRs who remained on IO was 93.5% vs. those who stopped (89.4%) (P=0.42).
"For patients with metastatic cancer who achieve a durable response, deciding how long to continue immunotherapy is one of the most difficult clinical decisions," said Meghan J. Mooradian, MD, Cutaneous Medical Oncology, Mass General Brigham Cancer Institute, and lead author of the study. "Because imaging alone may not fully capture whether disease has been completely cleared, our findings support further investigation of molecular response as a biomarker to help personalize treatment duration and identify patients who may discontinue therapy early."

"Melanoma, kidney, lung, and colorectal cancers differ biologically, yet sustained Signatera negativity was associated with favorable survival in each," said Alexey Aleshin, MD, Corporate Chief Medical Officer and General Manager, Oncology, Natera. "These data support the role of Signatera in identifying exceptional ICI responders who may be able to de-escalate treatment."

References

Wolchok JD, et al. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma. N Engl J Med 2025;392:11-22.
Steimle AK, et al. Circulating Tumor DNA (ctDNA) Clearance After Immune Checkpoint Inhibition (ICI) with Radiotherapy (RT) as a Prognostic Biomarker for Advanced Melanoma. Cancers 2026;18(18):3032.
Anagnostou V, et al. Immuno-oncology trial endpoints: Capturing clinically meaningful activity. Clin Cancer Res 2017;23(17):4959-69.

(Press release, Natera, NOV 5, 2026, View Source [SID1234674361])

Iksuda to Present First Clinical Data for IKS03 in Advanced B-Cell Non-Hodgkin Lymphomas at ASH

On November 5, 2026 Iksuda Therapeutics (Iksuda), the developer of class leading, antibody drug conjugates (ADCs), reported the presentation of preliminary data from the dose escalation portion of its Phase 1 study of IKS03, a CD19-directed ADC, in patients with advanced B-cell non-Hodgkin lymphoma (B-NHL), at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 12–15, 2026, New Orleans, Louisiana.

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As of 8 July 2026, 21 patients (median age 67 years) with a median of four prior lines of therapy (range 2-8) have been treated with IKS03 across five dose levels up to 3.1 mg/m2 (approximately 84µg/kg). A maximum tolerated dose (MTD) has not been reached.

IKS03 showed a highly differentiated and manageable safety profile, with treatment-related adverse events (TRAEs) affecting only seven of 21 patients. Compared with other treatments across modalities, there was a markedly lower frequency of high-grade neutropenia and thrombocytopenia and an absence of peripheral neuropathy. A single Grade 4 neutropenia (4.8%), a dose-limiting toxicity, was observed in the fourth dose cohort in a patient with follicular lymphoma and bone marrow involvement, and who had previously received six prior regimens including CAR-T. On resolution, the patient remained on therapy and in response. There were only two Grade 3 neutropenia events, and all remaining TRAEs were mild or moderate (Grade 1–2). No patient experienced a Grade 5 event or a treatment-related serious adverse event, and none stopped treatment because of an adverse event. Non-haematological toxicity was both limited and low-grade.

Responses to treatment were observed from the lowest dose level (around 20 µg/kg) and across all dose cohorts. Of 17 patients evaluable for efficacy (those who had completed two treatment cycles across the first four dose levels), nine responded, giving an overall objective response rate (ORR) of 53%, with two patients achieving stable disease. Five patients (29%) achieved a complete metabolic response: two with follicular lymphoma and one each with diffuse large B-cell lymphoma, marginal zone lymphoma and T cell/histiocyte-rich large B-cell lymphoma. Four patients (24%) achieved a partial metabolic response, two each with follicular lymphoma and marginal zone lymphoma.

Responses were seen in patients who were CAR-T naïve, as well as in those who had received prior CAR-T (3 of 4 patients), including a durable complete response in a patient who had received 8 prior regimens which included failed responses to CAR-T and allogeneic transplantation. Of the eight patients who did not respond, five were being treated for Richter-transformed diffuse large B-cell lymphoma, well known to be highly aggressive and difficult to treat.

Responses have lasted up to 14 months. Currently, six of the nine responders eligible for efficacy assessment at the time of writing remain on treatment. Dose escalation is ongoing and updated results will be presented at the convention.

Dr. Dave Simpson, Chief Executive Officer, Iksuda Therapeutics, commented: "These first clinical data for IKS03 are incredibly exciting. To see responses in patients treated from the lowest dose level and across all cohorts, in heavily pretreated patients including those who had previously received CD19-directed CAR-T therapy, is immensely rewarding, whilst the safety profile is distinct from all other therapies in use for these cancers. These results support the design strategy of tumour-selective payload release, and we look forward to onward progression of this exciting program."

Prof. Enrico Derenzini, European Institute of Oncology IRCCS, Milan, added: "Patients with relapsed or refractory B-cell lymphoma who have already received several lines of treatment have limited options. To see responses at this early stage, alongside a manageable safety profile, is encouraging and supports further evaluation of IKS03."

The Phase 1 study (NCT05365659) is a first-in-human, multicentre trial of IKS03 in patients with relapsed or refractory B-NHL who have received at least two prior systemic therapies. Part I (dose escalation) uses a 3+3 design to determine the MTD and recommended Phase 2 dose in patients with CD19-positive follicular, marginal zone, mantle cell, large B-cell (including Richter-transformed) or high-grade B-cell lymphoma. Part II will assess efficacy in disease-specific expansion cohorts. Around 140 patients are expected to be enrolled across the study.

Presentation details
Abstract number: 5456
Title: First-in-human phase 1 trial to determine safety and preliminary antineoplastic activity of IKS03, a CD19-targeting PBD prodrug antibody drug conjugate, in advanced B-cell non-Hodgkin lymphomas
Presenter: Prof. Enrico Derenzini
Session Name: 629. Aggressive Lymphomas, Non-Cellular Immunotherapy including Bispecific Antibodies: Poster III
Session Date: December 14, 2026
Session Time: 12/14/2026 6:00:00 PM – 12/14/2026 8:00:00 PM
Presentation Time: 12/14/2026 6:00:00 PM – 12/14/2026 8:00:00 PM
Room: MCCNO – Hall F

About IKS03

IKS03 is a best-in-class CD19-targeting ADC delivering a tumour-activated prodrug pyrrolobenzodiazepine (PBD) which was licensed from LigaChem Biosciences (formerly LegoChem Biosciences). Preclinical testing demonstrated best-in-class efficacy (vs in-clinic and marketed CD19-targeted therapies) in in vivo xenograft models and significantly raised maximum tolerated dose (MTD) in non-human primate disease models, demonstrating its potential to be the leading anti-CD19 therapy in B-cell cancers.

(Press release, Iksuda Therapeutics, NOV 5, 2026, View Source [SID1234674360])