On October 20, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that the company and its research collaborators will present 25 abstracts—including five rapid oral presentations—demonstrating advances in methylation-based circulating tumor DNA (ctDNA) monitoring and liquid biopsy technology across lung, colorectal, and gastric cancers at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23-27 in Madrid, Spain.

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The studies span Guardant’s cancer portfolio, including tissue-free minimal residual disease (MRD) surveillance, treatment response, and resistance research. Significant studies were conducted independently by industry collaborators, academic institutions, and Guardant’s public-private partners using the company’s technologies and/or real-world data, underscoring the wide adoption of its platform across the research community.

"At ESMO (Free ESMO Whitepaper), we will showcase how InfinityAI is advancing our portfolio, strengthening the clinical relevance of our data, and delivering value to patients, healthcare professionals, and biopharma partners," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "We look forward to presenting new findings and connecting with the oncology community to discuss how Guardant’s solutions can advance cancer care globally."

Key data that will be presented include:

Rapid Oral 283RO: Assessing bemarituzumab in patients with advanced gastric and gastroesophageal junction cancer by fibroblast growth factor receptor 2 (FGFR2) amplification status in the FORTITUDE study, which suggests that FGFR2 amplification may identify a more treatment-sensitive subgroup.
Friday, Oct. 23, 2026, Session: 4:15-5:45 p.m., Presentation: 5:19-5:24 p.m., Location: Almeria Auditorium – Hall 9
Rapid Oral LBA73: Evaluating ctDNA-guided treatment intensification in untreated advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC) to identify patients who may benefit from intensified first-line therapy in the PACE-LUNG study—a multicenter, Phase II trial of additional chemotherapy for patients with persistent EGFR-mutant ctDNA in plasma at Week 3 after starting first-line osimertinib.
Saturday, October 24, 2026, Session: 8:30-10 a.m., Presentation: 8:30-8:35 a.m., Location: Almeria Auditorium – Hall 9
Rapid Oral 2636RO: Characterizing resistance mechanisms and predictors of early progression and long-term response to lorlatinib from the CROWN study. Findings suggest that baseline genomic complexity and on-treatment changes in methylation-based tissue-free assays may help identify patients at risk of early progression.
Saturday, Oct. 24, 2026, Session: 8:30-10 a.m., Presentation: 9:05-9:10 a.m., Location: Almeria Auditorium – Hall 9
Poster 4403P: Using serial Guardant360 Liquid testing in a Phase 2 study with MD Anderson to examine clonal and subclonal resistance during anti-EGFR rechallenge in metastatic colorectal cancer to distinguish genuine resistance evolution from changes caused by fluctuating ctDNA levels, potentially improving patient selection for anti-EGFR rechallenge.
Friday, October 23, 2026, Session: 3:15-4 p.m.
Poster 2566P: Exploring post-surgical MRD and pathological complete response (pCR) after perioperative nivolumab in resectable Stage III NSCLC. In this exploratory analysis from NADIM II, pCR was associated with MRD negativity and excellent 5-year survival. In non-pCR patients, MRD negativity identified patients with favorable long-term outcomes, whereas detectable MRD defined a high-risk subgroup with early recurrence.
Monday, October 26, 2026, Session: 12-12:45 p.m.
Additional Guardant Health presentations at ESMO (Free ESMO Whitepaper) 2026

Abstract

Full abstract title

Session details

Poster
424P

Impact of blood draw weekday on turnaround time of Guardant360 CDx liquid biopsy: A real-world analysis

Basic science
Friday, October 23, 2026
Session: 3:15-4 p.m.

Poster
1026P

Longitudinal ctDNA monitoring and radiological response to targeted therapies in early-phase clinical trials

Developmental therapeutics
Friday, October 23, 2026
Session: 3:15-4 p.m.

Poster
3275P

Clinical utility and interpretation challenges of circulating comprehensive genomic profiling in routine oncology practice

Pathology and molecular pathology
Friday, October 23, 2026
Session: 3:15-4 p.m.

Poster
4279P

Trastuzumab deruxtecan vs physician’s choice of chemotherapy in HR+, HER2-low metastatic breast cancer: A DESTINY-Breast06 ctDNA molecular response analysis

Translational research and biomarkers
Friday, October 23, 2026
Session: 3:15-4 p.m.

Poster
4311P

Genomic landscape of cancer of unknown primary: Prognostic stratification through molecular profiling

Translational research and biomarkers
Friday, October 23, 2026
Session: 3:15-4 p.m.

Poster
4386P

Beyond HER2 IHC: ERBB2 RNA-ISH stratifies benefit from T-DXd combinations

Translational research and biomarkers
Friday, October 23, 2026
Session: 3:15-4 p.m.

Poster
8P

Clinical efficacy and predictive biomarkers of mTOR inhibition combined with endocrine therapy following progression on PI3K inhibitors in hormone receptor–positive metastatic breast cancer

Advanced breast cancer, other
Saturday, Oct. 24, 2026
Session: 12-12:45 p.m.

Poster
45P

Real-world elacestrant outcomes in ESR1-mutant HR+/HER2− metastatic breast cancer: A two-center NHS audit

Advanced breast cancer, other
Saturday, October 24, 2026
Session: 12-12:45 p.m.

Poster
708P

Clinical and molecular characteristics of leptomeningeal disease in metastatic breast cancer patients: A prospective observational registry study

CNS tumors
Saturday, October 24, 2026
Session: 12-12:45 p.m.

Rapid oral
787RO

ctDNA-guided re-treatment with encorafenib and cetuximab in patients with chemorefractory BRAFV600E mutated metastatic colorectal cancer (mCRC): The proof-of-concept single arm phase II BRICKET trial by GONO

Rapid oral: Gastrointestinal tumors, lower digestive
Saturday, October 24, 2026
Session: 2:45-4:15 p.m.
Presentation: 2:45-2:50 p.m.
Location: Alicante Auditorium – Hall 6

Poster
805P

Baseline ctDNA and the efficacy of staged combination with encorafenib + binimetinib + cetuximab following encorafenib + cetuximab in patients with BRAF V600E-mutant mCRC from BAYONET trial

Colon cancer
Sunday, October 25, 2026
Session: 12-12:45 p.m.

Rapid oral
3718RO

Molecular response in KIT circulating ctDNA from StrateGIST 1: A phase 1/1b study of velzatinib (IDRX-42) in patients with advanced gastrointestinal stromal tumors

Rapid oral: Sarcoma
Monday, October 26, 2026
Session: 8:30-10 a.m.
Presentation: 8:35-8:40 a.m.
Malaga Auditorium – Hall 3

LBA – 4037

ctDNA negative hyperselection as an effect modifier of treatment sequence efficacy in left-sided RAS wild-type mCRC: pre-specified exploratory analysis of the CR-SEQUENCE

TBD

LBA 2882eP

ctDNA assessment in patients with CLDN18.2+, HER2−, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in SPOTLIGHT

TBD

ePoster-2813eP

A decade of ctDNA-NGS in NSCLC: Real-world evolution of actionability and liquid-first clinical use

ePoster: NSCLC, metastatic

ePoster-

4548eP

Combined cfDNA and ctDNA analysis improves prognostic models in patients referred for early-phase clinical trials

ePoster: Translational research and biomarkers

ePoster- 2734eP

Clinical significance of comprehensive genomic profiling after negative initial CDx testing in advanced NSCLC

ePoster: NSCLC, metastatic

ePoster TiP-3584eTiP

Consolidation XELOX plus dostarlimab after chemoradiation with optional adjuvant dostarlimab in pMMR/MSS or MSI-low locally advanced rectal cancer: The IMMUNOSTAR phase II randomized trial (GOIRC-02-2024)

ePoster Trial in progress: Rectal and anal cancer

ePoster-2783eP

Sequential liquid biopsy in advanced NSCLC

ePoster: NSCLC, metastatic

ePoster-4185eP

The value of liquid biopsy in pleural mesothelioma as a biomarker strategy in clinical trials selection

ePoster: Thoracic malignancies, other

The full abstracts for Guardant Health at ESMO (Free ESMO Whitepaper) 2026 can be found on the ESMO (Free ESMO Whitepaper) website.

Since 2020, Guardant has established public-private partnerships (PPPs) with leading healthcare institutions and cancer centers in Europe including The Royal Marsden NHS Foundation Trust (UK), Vall d’Hebron Institute of Oncology (Spain), and Policlinico Gemelli (Italy) to localize advanced diagnostic testing, generate clinical/economic evidence, and ultimately expand reimbursement and adoption. These partnerships make it possible to deliver high quality, clinical grade testing, similar to tests administered in the U.S., with local validation supporting research, delivering faster diagnoses, and increasing access to targeted treatments.

To learn more about the PPPs and Guardant Health during ESMO (Free ESMO Whitepaper), visit the team at Booth #8058.

About Guardant360 Liquid

Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing comprehensive genomic profiling (CGP) to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts.

About Guardant Reveal

Guardant Reveal is a tissue-free liquid biopsy test that detects minimal residual disease (MRD) and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights.

The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures.

About Guardant360 CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer.

(Press release, Guardant Health, OCT 20, 2026, View Source [SID1234673626])

On October 20, 2026 Flatiron Health reported that four research abstracts will be presented as e-posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place October 23–27 in Madrid, Spain. The research examines how cancer treatments are used in everyday practice, how patient outcomes vary, and where additional evidence could help inform care across the United States, Germany, Japan, and the United Kingdom.

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Spanning colorectal, lung, and prostate cancer, the studies demonstrate how real-world data can help researchers evaluate treatment effectiveness beyond clinical trials and understand differences across healthcare systems. Findings include international variation in the use of metastasis-directed therapy, an association between low serum sodium and poorer outcomes among patients receiving immunotherapy, and gaps in treatment sequencing and diagnostic testing.

"Learning from patients’ experiences across countries helps us answer questions that clinical trials alone cannot fully address," said Emily Castellanos, Head of Research Oncology at Flatiron Health. "The research we’re presenting at ESMO (Free ESMO Whitepaper) examines how treatments perform in everyday care and where practice patterns differ across healthcare systems. These insights can help researchers and clinicians identify gaps, ask better questions, and build evidence that reflects the patients they serve."

Research highlights include:

Understanding international differences in colorectal cancer care. A multinational study using real-world data from Germany, Japan, and the UK found substantial differences in the adoption and timing of metastasis-directed therapy for metastatic colorectal cancer. The findings offer insight into how regional practice patterns influence treatment sequencing and identify areas for further research.
Exploring an accessible prognostic marker in lung cancer. An analysis across three countries found that low serum sodium was associated with poorer outcomes among patients with metastatic non–small cell lung cancer receiving checkpoint inhibitors. The findings support further investigation into serum sodium as a potential marker to help identify patients who may benefit from closer monitoring.
Evaluating colorectal cancer treatment effectiveness in routine practice. A US study found that trifluridine-tipiracil plus bevacizumab was associated with longer survival than trifluridine-tipiracil alone among patients with previously treated metastatic colorectal cancer. The findings add real-world evidence to clinical trial results supporting the combination.
Identifying gaps in prostate cancer treatment and testing. A US study documented use of androgen receptor pathway inhibitor switching in first-line metastatic castration-resistant prostate cancer, particularly among older men, despite limited supporting evidence. The analysis also identified treatment disparities and diagnostic testing gaps, underscoring the need for additional evidence to inform treatment decisions.
To learn more, join us at ESMO (Free ESMO Whitepaper) and follow Flatiron Health on LinkedIn and X for updates from #ESMO26.

Abstracts and E-Poster Presentations

Metastasis-directed therapy in colorectal cancer: a multinational real-world study from Germany, Japan, and the UK
Presentation Number: 907eP
Presentation Format: E-poster

Association of serum sodium and outcomes in patients receiving checkpoint inhibition for metastatic NSCLC
Presentation Number: 2855eP
Presentation Format: E-poster

Real-world comparative effectiveness of trifluridine-tipiracil + bevacizumab vs trifluridine-tipiracil in patients with refractory metastatic colorectal cancer in the United States
Presentation Number: 965eP
Presentation Format: E-poster

Recent US real-world utilization of androgen receptor pathway inhibitor switch in first-line metastatic castration resistant prostate cancer
Presentation Number: 2360eP
Presentation Format: E-poster

(Press release, Flatiron Health, OCT 20, 2026, View Source [SID1234673625])

On October 20, 2026 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, reported it will highlight its latest research insights through more than 85 abstracts and presentations at the annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) conference in Madrid, Spain, from October 23-27.

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

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Each year, ESMO (Free ESMO Whitepaper) brings together thousands of leading researchers, physicians and oncology professionals from around the world to share the latest advances shaping the future of cancer care. SCRI thought leaders are presenting recent findings from several early- and late-phase clinical trials focused on a variety of targeted treatment approaches like antibody drug conjugates (ADCs), immunotherapies and bispecifics.

"Each abstract presented by SCRI investigators at ESMO (Free ESMO Whitepaper) represents our mission to bring cutting-edge cancer research closer to patients," said David R. Spigel, MD, President and Chief Medical Officer, SCRI. "Our investigators are helping answer critical questions across a wide range of tumor types and treatment approaches, all with the goal of accelerating progress for patients. We’re honored to share these findings and contribute to conversations that will help define the next generation of cancer care."

Notable presentations include:

Benjamin Garmezy, MD, SCRI, will present "Safety and efficacy of JNJ-6143, a first-in-class oral AR-targeted RIPTAC at the optimal dose for further development in patients with mCRPC/mAPMR, including high-risk molecular features" in an oral presentation on October 24, 2026, from 10:35 a.m. to 10:45 a.m., during a session in the Barcelona Auditorium (Hall 9).

Meredith McKean, MD, MPH, SCRI, will present "Patritumab Deruxtecan (HER3-DXd) in Melanoma After Anti-PD-(L)1 Therapy: Primary Analysis From HERTHENA-PanTumor01" in an oral presentation on October 25, 2026, from 10:20 a.m. to 10:25 a.m., during a session in the Bilbao Auditorium (Hall 3).

October 25 at 4:30 p.m., "Krascendo 1: efficacy and safety of divarasib (diva) vs sotorasib (soto) or adagrasib (ada) in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC" will be presented in Hall 6 of the Alicante Auditorium. This research was co-authored by Bo Wang, MD, SCRI at Willamette Valley Cancer Institute and Research Center | The US Oncology Network.

Dax Kurbegov, MD, Sarah Cannon Cancer Network, will present "Efficiency and Safety of Cancer Signal Origin (CSO)-Guided Diagnostic Workups Following Multi-Cancer Early Detection (MCED) Testing: Results from PATHFINDER 2 (PF2)" in an oral presentation on October 26, 2026, from 3:22 p.m. to 3:27 p.m., during a session in the Salamanca Auditorium (Hall 10).

Erika Hamilton, MD, SCRI, will deliver a presentation on Next Generation Therapies during the Novel Concepts for Metastatic Breast Cancer session on October 24 at 4:45 p.m. in Hall 9 of the Barcelona Auditorium.

October 25, Melissa Johnson, MD, SCRI, will also take part in a panel discussion on non-small cell lung cancer at 10:15 a.m. in Hall 6 of the Alicante Auditorium.

Additional SCRI First-Author Poster Presentations

Breast Cancer

Dr. Erika Hamilton will present "Efficacy, safety, and biomarker analysis of DB-1310 (HER3-targeted ADC) in pretreated HR+/HER2- breast cancer: Updated global phase 1/2a trial" on October 24, 2026, from 12:00 p.m. to 12:45 p.m.
Nina Balanchivadze, MD, SCRI at Virginia Oncology Associates | The US Oncology Network, will present "Real world (RW) outcomes in HR+/HER2- metastatic breast cancer (mBC) patients, by second-line (2L) treatment" on October 24, 2026.
Judy S. Wang, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network will present "First-in-class Rac/Cdc42 inhibitor MBQ-167 in patients with metastatic breast cancer (MBC): safety and preliminary efficacy" on October 24, 2026, from 12:00 p.m. to 12:45 p.m.
Genitourinary Cancer

Dr. Benjamin Garmezy will present "A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. in Hall 5.
Gynecologic Cancer

Noelle Cloven, MD, SCRI at Texas Oncology | The US Oncology Network will present "Defining the Molecular Landscape of HRD Negative Ovarian Cancer: A Real World Data Set to Enable Synthetic Control Arm Generation" on October 25, 2026 from 12:00 p.m. to 12:45 p.m.
Head & Neck Cancer

Cesar Perez, MD, SCRI at Florida Cancer Specialists & Research Institute | The US Oncology Network will present "A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients with advanced solid tumors that express CA19-9" on October 24, 2026, from 3:15 p.m. to 4:00 p.m.
Lung Cancer

David Spigel, MD, SCRI, will present "Deep-Learning Serial CT Imaging Predictions of Survival Compared with RECIST 1.1 Objective Response Rate in Immunotherapy-Treated NSCLC."
Dr. Melissa Johnson will present "First-line (1L) Olomorasib + Pembrolizumab in KRAS G12C-Mutant NSCLC: Updated Results from LOXO-RAS-20001 and SUNRAY-01" on October 26, 2026, from 12:00 p.m. to 12:45 p.m.
Dr. Bo Wang will present "TeLuRide-005: Phase 2 study of EIK1001 (TLR7/8 dual agonist) plus pembrolizumab and chemotherapy in patients with stage IV NSCLC: results from the squamous cohort and updated pooled results" on October 26, 2026, from 12:00 p.m. to 12:45 p.m.
Elisa Fontana, MD, SCRI at HCA Healthcare UK, will present "Prospective validation of artificial intelligence (AI)-assisted RECIST 1.1 in a phase 1 study of fetrastobart vedotin in patients with non-small cell lung cancer (NSCLC)" on October 25, 2026, from 12:00 p.m. to 12:45 p.m.
Skin Cancer

Dr. Meredith McKean will present "Darovasertib and Crizotinib for HLA-A02–Positive Metastatic Uveal Melanoma: Results from the Phase 2 OptimUM-01 Study" on October 24, 2026, from 12:00 p.m. to 12:45 p.m.
Additional Presentations

Dr. Melissa Johnson will present "Preliminary safety and pharmacokinetics of TJ101, an EGFR × B7-H3 bispecific antibody-drug conjugate, in patients with advanced solid tumors: results from an ongoing global Phase I study" on October 23, 2026, from 3:15 p.m. to 4:00 p.m.
Gerald Falchook, MD, SCRI at HCA HealthONE, will present "AXL inhibitor AB801 in patients with advanced malignancy: Dose escalation results from the phase 1/1b ARC-27 study" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. Additionally, Dr. Falchook will present "Dose optimization of ragistomig (ABL503/TJ-L14B), a PD-L1 x 4-1BB Bispecific Antibody" on October 23, 2026, from 3:15 p.m. to 4:00 p.m. and "Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors" on October 23, 2026, from 3:15 p.m. to 4:00 p.m.

(Press release, Sarah Cannon Research Institute, OCT 20, 2026, View Source [SID1234673624])

On October 20, 2026 BostonGene, developer of the leading AI model for tumor and immune biology, reported a new research collaboration with the Medical University of South Carolina (MUSC). The collaboration will leverage BostonGene’s biologically grounded AI platform to model longitudinal immune system dynamics and identify the biological mechanisms associated with treatment response, resistance, toxicity, and durability in patients receiving an innovative CAR-T cell therapy.

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The ongoing phase Ib clinical trial (NCT05702853) is evaluating a novel metabolically programmed and purified CAR-T cell therapy designed to optimize T-cell fitness, persistence, and safety in patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma. To evaluate the therapy’s impact, BostonGene is performing comprehensive immune system profiling on longitudinal blood samples using high-throughput multi-color flow cytometry and bulk RNA sequencing. By integrating these multiomics layers into biologically grounded AI models, researchers can map real-time immune dynamics and identify predictive biomarkers of CAR-T efficacy, persistence, treatment response, and adverse events. These analyses will help connect molecular and cellular changes with critical clinical outcomes while providing deeper insight into the biological mechanisms driving long-term remission and resistance.

Presented at ASCO (Free ASCO Whitepaper) 2026, preliminary data demonstrated a 67% complete remission rate alongside a favorable safety profile, characterized by a complete absence of immune effector cell-associated neurotoxicity syndrome and no grade 3+ cytokine release syndrome (CRS), and minimal intervention required for low-grade CRS (only two patients received a single low dose of corticosteroids). Correlative analyses further revealed that treatment response was associated with CD8 effector memory cells, whereas progressive disease was linked to baseline T-cell exhaustion, highlighting the power of advanced computational modeling to uncover mechanisms of response and resistance.

"Improving CAR-T cell fitness and purifying the cellular product represent critical steps toward making these life-saving therapies safer and more durable," said Brian Hess, MD, Principal Investigator at the Medical University of South Carolina’s Hollings Cancer Center. "Collaborating with BostonGene gives us unprecedented, high-resolution clarity into the systemic immune shifts occurring in our patients, helping us validate our metabolic programming approach and identify why certain patients achieve long-term remission."

"Understanding the intricate dynamics of the immune system during CAR-T therapy is paramount to overcoming therapeutic resistance and predicting adverse events," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By applying our biologically grounded AI and multimodal immune system modeling capabilities to this innovative cellular therapy, we aim to identify predictive biomarkers and biological mechanisms that can improve patient selection, anticipate toxicity, and ultimately improve outcomes for patients battling aggressive blood cancers."

(Press release, BostonGene, OCT 20, 2026, View Source [SID1234673623])

On October 20, 2026 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard of care to cure cancer and infectious diseases, reported their upcoming Phase 1/Phase 2 clinical updates at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (Madrid, Spain, 23-27 October). During the event, Debiopharm will highlight clinical updates on its pipeline targeting the DNA Damage Response (DDR), featuring single-agent data on zedoresertib (Debio 0123) as well as rational combination strategies, with both temozolomide in glioblastoma and with lunresertib (Debio2513) in solid tumors.

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Debiopharm’s planned activities at ESMO (Free ESMO Whitepaper) 2026 include:

Rapid Oral Presentation (Debio 0123-GBM-105 / NCT05765812): Presenting dose escalation data evaluating zedoresertib in combination with temozolomide in patients with recurrent or progressive glioblastoma.
Poster Presentation (Debio 0123-102 / NCT05109975): Presenting Phase 1 expansion data evaluating single-agent zedoresertib in advanced solid tumors, including uterine serous carcinoma and Cyclin E1-overexpressing high-grade ovarian cancer.
Meet-the-Expert Event (MYTHIC Study): An invitation-only session alongside the congress during which leading international oncology experts will discuss emerging data from the MYTHIC clinical trial (Debio 0123-106 / NCT04855656), dual WEE1/PKMYT1 checkpoint inhibition, and precision biomarker selection.
"The data to be presented at ESMO (Free ESMO Whitepaper) 2026 reinforce our belief that zedoresertib has the potential to become a breakthrough therapy in oncology in combination with key agents across multiple tumor types," expressed Esteban Rodrigo Imedio, Executive Medical Director, Oncology at Debiopharm. "From establishing single-agent disease control in solid tumors and confirming blood-brain barrier penetrance in glioblastoma to advancing dual WEE1/PKMYT1 targeting in the MYTHIC trial, we are committed to unlocking the benefits of synthetic lethality for patients battling hard-to-treat cancers."

Clinical Progression: Monotherapy, Glioblastoma, and Combination Strategies

Zedoresertib (Debio 0123) is a potent, oral, brain-penetrant, and highly selective WEE1 kinase inhibitor. In the monotherapy expansion study (Debio 0123-102), continuous daily administration of zedoresertib at the recommended Phase 2 dose demonstrated a manageable safety profile alongside evidence of target engagement and signals of activity in heavily pretreated solid tumors, particularly uterine serous carcinoma and ovarian cancer. In parallel, the Debio 0123-GBM-105 clinical trial in recurrent glioblastoma confirmed early signals of antitumor activity, central nervous system penetration and a manageable safety profile in combination with temozolomide, supporting ongoing evaluation in randomized cohorts.

Supported by this favorable tolerability profile and single-agent foundation, Debiopharm has expanded zedoresertib’s clinical evaluation into rational combination regimens. The ongoing MYTHIC trial evaluates zedoresertib in combination with lunresertib, a first-in-class, selective oral PKMYT1 inhibitor, in patients with advanced solid tumors, particularly ovarian cancer.

Therapeutic Rationale: Exploiting Synthetic Lethality in DDR

The scientific rationale underlying Debiopharm’s DDR pipeline focuses on targeted cell-cycle checkpoint disruption. Combining WEE1 and PKMYT1 inhibition creates a dual-checkpoint blockade within the G2/M transition, preventing cancer cells from repairing DNA damage and inducing mitotic catastrophe. Early clinical data from the MYTHIC study indicate promising signs of synthetic lethality and tumor regression in biomarker-selected populations, notably patients harboring CCNE1 amplification as well as FBXW7 or PPP2R1A alterations. Clinical development continues to refine combination dosing and biomarker selection in the MYTHIC trial for solid tumors, while advancing randomized expansion cohorts to evaluate zedoresertib with temozolomide in glioblastoma.

ESMO 2026 Presentation Details

Session Type

Date & Time

Presentation Title / Location

Presenter / Host

Rapid Oral
(CNS Tumours)

Friday, Oct 23 14:07 – 14:12

699RO: Dose Escalation of Debio 0123 Plus Temozolomide in Recurrent/Progressive Glioblastoma

Dr. Maria Vieito
(Vall d’Hebron)

Poster Presentation
(Gynecological Cancers)

Monday, Oct 26
12:00 – 12:45

1273P (Abstract #3519): Expansion data disclosure of the Phase 1 trial of WEE1 inhibitor zedoresertib

Dr. Maria M. Rubinstein
(MSKCC)

Meet-the-Expert
(Closed Session)

Saturday, Oct 24
16:30 – 18:00

Beyond Biomarkers: Advancing DDR-Targeted Therapy in Ovarian Cancer and Solid Tumors

ABOUT DNA DAMAGE REPAIR (DDR)

When cells have damaged DNA, they must undergo a repair process known as DDR to survive. Cancer cells rely heavily on DDR as they divide and grow uncontrollably. Inhibition of DDR, particularly in combination with other anticancer agents, prevents cancer cells from repairing their DNA, ultimately activating a programmed cell death process. DDR inhibitors such as zedoresertib (Debio 0123), Debiopharm’s WEE1 inhibitor, are currently being investigated in clinical and preclinical studies.

ABOUT PKMYT1 INHIBITION

Lunresertib (Debio2513) is a first-in-class, oral PKMYT1 inhibitor designed to exploit specific genetic vulnerabilities in solid tumors, such as CCNE1 amplification. PKMYT1 acts as a key regulator at the G2/M checkpoint, and its inhibition reduces CDK1 activity, thereby preventing cancer cells from properly repairing DNA damage and forcing them into programmed cell death. As the most advanced PKMYT1 inhibitor in clinical development, lunresertib has shown encouraging proof-of-concept results both as monotherapy and in combination therapies within the ongoing MYTHIC trial.

(Press release, Debiopharm, OCT 20, 2026, View Source [SID1234673622])