On October 19, 2026 Riboscience, a clinical-stage biotechnology company developing first-in-class immunotherapies, reported that Phase 1b data for RBS2418, its lead oral ENPP1 inhibitor, will be presented in a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, held October 23–27 in Madrid, Spain.

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ESMO 2026 Poster Presentation Details

Title: Overall survival and intratumoral immune activation in subjects with advanced metastatic solid tumors, by Thomas U. Marron, Jamal G. Misleh, Michael Gordon, Zev A. Wainberg, Christopher T. Chen, Daniel Johnson, Alexander I. Spira, Jordan Berlin, Won Jin Ho, John T. Hamm, Ralph V. Boccia, Seol Hee Im, Stephan Rogalla, Juergen Schanzer, Ningwu Huang, Sayantanee Paul, Edward Pham, Buer Song, Jeffrey S. Glenn, Hirak Der-Torossian, Klaus Klumpp and Aaron J. Scott
Abstract/Poster Number: 1977P
Session: Investigational Immunotherapy
Date/Time: Saturday, October 24, 2026, 12:00 CEST
Location: IFEMA Madrid, Hall 5
The poster will present safety, pharmacokinetic, pharmacodynamic and clinical outcome data, including overall survival, from the Phase 1 study of RBS2418 (NCT05270213) in patients with advanced unresectable, recurrent or metastatic solid tumors (safety population n=89). Results will feature outcomes in the overall population and in RBS2418 monotherapy and colorectal cancer (CRC) cohorts. The study evaluates RBS2418 alone and with approved anti-cancer treatments.

"As the first ENPP1 inhibitor in the clinic, RBS2418 is bringing a new type of immunotherapy to the field. Seeing immune activation in cold tumors from a simple oral monotherapy is very exciting, and we are proud to share our first long-term survival outcomes at ESMO (Free ESMO Whitepaper)." said Klaus Klumpp, Co-founder and President of Riboscience."

About RBS2418

RBS2418 is a first-in-class oral small-molecule inhibitor of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1). It binds ENPP1 with picomolar affinity and high selectivity. The expression of ENPP1 and cGAS is highly prevalent in solid tumors and ENPP1 is associated with effective cGAMP clearance in the tumor microenvironment (TME), a block of dendritic cell activation, a cold tumor phenotype and immune evasion. ENPP1 expression on circulating tumor cells has been associated with an increased risk of metastasis. By blocking ENPP1, RBS2418 is designed to restore anti-tumor immunity. RBS2418 is being studied in a Phase 1a/b trial in advanced solid tumors, as monotherapy in a Phase 2 trial for late-line CRC (NCT06824064), and in combination with the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen for first-line heptaocellular carcinoma (HCC) (NCT07175441).

(Press release, Riboscience, OCT 19, 2026, View Source [SID1234673580])

On October 19, 2026 Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage global radiopharmaceutical company, reported first-in-human imaging data for [111In]In-FL-261, its c-MET-targeted theranostic radionuclide drug conjugate ("RDC") program, in a Top Rated Oral Presentation at the 39th Annual Congress of the European Association of Nuclear Medicine ("EANM"), which is being held October 17 to 21, 2026, in Vienna, Austria.

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The presented data from patients with non-small cell lung cancer ("NSCLC") demonstrated high lesion contrast, no tracer-related serious adverse events and support the continued evaluation of [225Ac]Ac-FL-261 in clinical trials. Full-Life is also presenting an E-Poster, highlighting preclinical data in which [225Ac]Ac-FL-261 produced marked tumor regression in tumor cell-derived and patient-derived xenograft models with varying levels of c-MET expression.

"We are excited to share, for the first time, clinical imaging data showing FL-261’s potential for patients with c-MET-expressing NSCLC," said Debora Barton, MD, Chief Medical Officer of Full-Life Technologies. "These data demonstrate compelling FL-261 uptake in lesions with high contrast, no tracer-related serious adverse events and uptake that rose with c-MET expression in the patients studied, with favorable tumor to normal tissue ratios. Together with the recent regulatory clearances, the data provide strong support to advance [225Ac]Ac-FL-261 into the SumMET Phase 1 trial."

"c-MET is an oncogenic driver and a mediator of resistance to treatment in lung cancer, which makes it a meaningful target for precision therapy," said Prof. Xiaoli Lan, Department of Nuclear Medicine, Union Hospital, Tongji Medical College. "Being able to see c-MET expression across the whole body, noninvasively in this first cohort, is an encouraging step toward matching radioligand therapy to the patients who can benefit."

In September 2026, Full-Life announced that the U.S. Food and Drug Administration had cleared the Investigational New Drug application for [225Ac]Ac-FL-261 and that the program had also received regulatory clearances in Australia and China. Together, the clearances allow the Phase 1 SumMET trial (NCT07873450) of [²²⁵Ac]Ac-FL-261 to proceed at sites in these countries for patients with non-squamous NSCLC that expresses c-MET.

First-in-human imaging data (Top Rated Oral Presentation, OP-442)

The Top Rated Oral Presentation reports results from a prospective clinical trial of [111In]In-FL-261 in 10 patients with histologically confirmed NSCLC, designed to evaluate safety, biodistribution and diagnostic performance. Patients underwent SPECT/CT imaging 4, 24 and 72 hours after injection, and had a baseline [18F]FDG PET/CT for comparison.

Mean patient age was 65.3 years (range 59 to 71), and nine of 10 patients were male. Histology was adenocarcinoma in five patients, squamous cell carcinoma in four and NSCLC not otherwise specified in one. One patient had MET exon 14 skipping and two had no MET alteration detected, and seven were not tested.

Key findings

c-MET-specific lesion uptake: Tumor SUVmax at 4, 24, and 72 hours was 13.8, 25.7 and 43.2 respectively for a patient with high c-MET immunohistochemistry (IHC) score and 12.7, 22.9 and 20.7 respectively for a patient with moderate IHC score. The ratio of tumor SUVmax versus kidney and bone marrow SUVmean was in the range of 2.8-20.3 and 17.4-72.4 respectively for these two patients at all acquired time points.
Potential of c-MET diagnostic: Across six patients with available c-MET IHC scores, [111In]In-FL-261 uptake in the lesions showed a positive trend with c-MET expression (Spearman rho 0.82, P = 0.034), whereas [18F]FDG uptake did not (rho -0.13, P = 0.80).
Normal organ biodistribution: The uptake of the tracer in normal organs was generally low and all with rapid washout. The organs with highest uptake were liver, spleen and kidneys.
Safety: [111In]In-FL-261 was well tolerated in all patients, with no tracer-related serious adverse events.
Preclinical data (E-Poster #0035)

Full-Life is also presenting E-Poster #0035 "Development of FL-261 as a theranostic RDC vector for the diagnosis and treatment of c-MET positive cancers" at EANM.

The E-Poster describes the discovery and preclinical characterization of FL-261. [111In]In-FL-261 showed potent, c-MET-specific binding and rapid internalization in c-MET-overexpressing cells and in tumor-bearing mice. Tumor uptake exceeded that of normal organs and was nearly completely blocked by unlabeled FL-261. [225Ac]Ac-FL-261 produced marked tumor regression in xenograft models with varying levels of c-MET expression, including a model derived from a patient previously treated with a c-MET-targeted antibody-drug conjugate, with no notable changes in body weight.

Presentation details

Top Rated Oral Presentation

Title: First-in-human translation of the c-MET-targeting theranostic ligand FL-261 for imaging in NSCLC
Number: OP-442
Session: Clinical Oncology Track – Lung (Session 1006)
Date and time: Monday, October 19, 2026, 16:10 – 16:20
Location: Hall C
E-Poster

Title: Development of FL-261 as a theranostic RDC vector for the diagnosis and treatment of c-MET positive cancers
Number: #0035
Session: EP-03
Dates: October 17 – 21, 2026
About [225Ac]Ac-FL-261

[225Ac]Ac-FL-261 is Full-Life’s first-in-class c-MET-targeted alpha radioconjugate for multiple solid tumor indications. It is designed to selectively bind c-MET-expressing tumor cells and deliver alpha-particle radiation directly to tumor lesions while sparing key normal tissues. It is currently being studied in Phase 1 trials in the U.S., Australia and China in patients with Non-Small Cell Lung Cancer (NSCLC). [225Ac]Ac-FL-261 is one of the various radiopharmaceutical assets discovered utilizing Full-Life’s proprietary UniRDC discovery platform.

(Press release, Full-Life Technologies, OCT 19, 2026, View Source [SID1234673579])

On October 19, 2026 Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a global, clinical-stage biopharmaceutical company focused on creating innovative cancer treatments that leverage the patient’s own immune system, reported that final results from the metastatic melanoma cohort of its Phase 1/2 MATINS study have been accepted as an ePoster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026, taking place in Madrid, Spain, 23–27 October 2026.

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These are the final results from the melanoma cohort of MATINS and the first report of complete survival data for all 25 patients, following interim results presented in 2022 and 2023.

The melanoma cohort comprised 25 patients with checkpoint inhibitor-refractory metastatic melanoma who received single-agent bexmarilimab at doses of 0.3 to 10 mg/kg every three weeks. All patients had failed prior anti-PD-1 therapy and 48% had also failed anti-CTLA-4 therapy. Patients had received a median of three prior lines of treatment, with a range of one to seven.

The disease control rate was 20% and median overall survival was 7.6 months (95% CI 5.3–14.9). Patients who achieved disease control had a median overall survival of 15.2 months, compared with 6.2 months in patients who did not (p=0.1545), and 12-month survival rates of 80% and 35% respectively. The duration of the previous line of therapy before entering the trial was similar in both groups (p=0.7275). Treatment-emergent adverse events were reported in 96% of patients, including grade 3 or higher events in 56% and serious events in 44%, consistent with a heavily pretreated metastatic population. Events assessed as related to bexmarilimab occurred in 36% of patients, most commonly fatigue (20%), with one patient (4%) experiencing a related event of grade 3 or higher.

Exploratory biomarker analyses showed lower baseline serum interferon gamma (sIFNγ) in patients who achieved disease control than in those who did not (3.5 versus 13.5 pg/mL, p=0.002). Low baseline sIFNγ was associated with a trend toward longer overall survival (10.1 versus 5.2 months, p=0.1971), and patients with disease control showed a median peak increase in sIFNγ of 181% on treatment, consistent with treatment-induced immune activation. These analyses are exploratory and the survival differences did not reach statistical significance in a cohort of this size.

Petri Bono, MD, PhD, Chief Medical Officer of Faron, stated, "These are the complete survival data for bexmarilimab in melanoma, in patients who had run out of options. One in five achieved disease control on a single agent, and those patients lived longer, although in 25 patients we cannot call that difference statistically significant. What interests us most is the biology underneath it. The patients who benefited started with lower interferon gamma and their levels rose on treatment, which is what we would expect if bexmarilimab is reactivating an immune response that had been switched off. That is the question the BLAZE trial is now asking in combination with a checkpoint inhibitor."

MATINS evaluated bexmarilimab as a single agent. The BLAZE trial, led by The Institute of Cancer Research, London, operating in partnership with The Royal Marsden NHS Foundation Trust, is the first clinical evaluation of bexmarilimab in combination with a checkpoint inhibitor in patients with acquired resistance to immunotherapy. BLAZE enrolls patients with metastatic non-small cell lung cancer (NSCLC) and melanoma who have progressed on prior anti-PD-1 therapy, and uses a sequential priming design in which patients receive an initial run-in dose of bexmarilimab, aiming to reprogram the immunosuppressive tumor microenvironment, before transitioning to the combination of bexmarilimab and nivolumab. Faron announced the first patient dosed in BLAZE on 01 October 2026. Its Principal Investigator, Dr Anna Minchom, is also the presenting author of the MATINS melanoma data. For more information on the BLAZE trial: NCT07718243.

Abstract details:

Title: Activity of bexmarilimab, a novel macrophage checkpoint inhibitor, in PD-1 refractory metastatic melanoma: final results from the phase I/II MATINS study
Abstract number: FPN 1091eP
Category: Developmental therapeutics
Presenting author: Dr. Anna Minchom, The Institute of Cancer Research, London
Presentation type: ePoster, available on the ESMO (Free ESMO Whitepaper) congress platform and on the ePoster screens in Hall 5
Clinical trial identification: NCT03733990
About bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes by targeting myeloid cell function. It binds to Clever-1, a receptor on immunosuppressive macrophages that helps cancer evade the immune system. By targeting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

About MATINS

The MATINS study was a first-in-human open label phase 1/2 clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumor cohorts, which are all known to host a significant number of Clever-1 positive tumor-associated macrophages (TAMs). The completed Part 1 of the trial dealt with tolerability, safety and dose escalation. The completed Part 2 focused on identifying patients who show an increased number of Clever-1 positive TAMs and exploring safety and efficacy. Data from MATINS showed bexmarilimab to be safe and well-tolerated, and demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

(Press release, Faron Pharmaceuticals, OCT 19, 2026, View Source [SID1234673578])

On October 19, 2026 AstraZeneca reported its ambition to revolutionise cancer care with new data across its diverse, industry-leading portfolio and pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, 23-27 October 2026.

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More than 100 abstracts will be presented, including data from five pivotal Phase III trials, four of which will be featured in Presidential Symposia. This breadth of data will demonstrate how AstraZeneca is redefining the way cancer is treated with innovative combinations, precision medicine and antibody drug conjugates (ADCs) across bladder, lung and gastric cancers. Highlights include:

CLARITY-Gastric01: Phase III trial of sonesitatug vedotin (Sone-Ve), a wholly owned Claudin-18.2 (CLDN18.2) ADC, in 2nd and later-line CLDN18.2-positive (≥25%) advanced gastric or gastroesophageal junction (GEJ) cancers versus investigator’s choice of therapy. This is the first Phase III trial to show a statistically significant and clinically meaningful overall survival (OS) benefit with an anti-CLDN18.2 ADC in this setting. Approximately 60% of patients have CLDN18.2 expression ≥25% in this setting. (Presidential Symposium 2 Abstract #LBA7).
SAFFRON: Phase III trial of Tagrisso (osimertinib) plus Orpathys (savolitinib) in patients with MET-driven, epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who progressed on prior treatment versus platinum-based chemotherapy (Presidential Symposium 2 Abstract #LBA6).
DeLLphi-305: Amgen-led Phase III trial of Imfinzi (durvalumab) plus tarlatamab as a 1st-line maintenance treatment for extensive-stage small cell lung cancer versus Imfinzi alone (Presidential Symposium 1 Abstract #LBA3).
VOLGA: Phase III trial of perioperative Imfinzi in combination with neoadjuvant enfortumab vedotin in patients with muscle-invasive bladder cancer who are ineligible for or have refused cisplatin-based chemotherapy, versus surgery with or without approved adjuvant treatment (Presidential Symposium 1 Abstract #LBA2).
SANOVO: Hutchmed-led Phase III trial of Tagrisso plus Orpathys in treatment-naïve patients with MET-overexpressed, EGFRm locally advanced or metastatic NSCLC versus Tagrisso alone in China (Proffered Paper Abstract #LBA69).
NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase II perioperative trial of Imfinzi combinations with Datroway (datopotomab deruxtecan), oleclumab and monalizumab in NSCLC (Rapid Oral Session Abstract #4244RO).
FONTANA: Phase I/IIa trial of torvutatug samrotecan (Torvu-Sam), a folate receptor α (FRα)-targeting ADC as monotherapy in patients with platinum-resistant recurrent ovarian cancer (Rapid Oral Session Abstract #1245RO).
AZD7003: Updated results from a Phase I trial of C-CAR031, a Glypican 3 (GPC3) CAR-T, in advanced hepatocellular carcinoma (Rapid Oral Session Abstract #1680RO).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "AstraZeneca’s portfolio of scientific data at ESMO (Free ESMO Whitepaper) is our strongest to date, showcasing transformative combinations including emerging modalities. Findings from VOLGA, DeLLphi-305 and SAFFRON demonstrate the potential of combination regimens with complementary mechanisms to improve on today’s standards of care, extend treatment benefit and meaningfully improve survival outcomes for more patients. These data, alongside practice-changing results for our first wholly owned ADC Sone-Ve from CLARITY-Gastric01 underscore how AstraZeneca is transforming cancer care."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "At ESMO (Free ESMO Whitepaper), we are presenting pivotal data that demonstrate how we are advancing new standards of care by adding novel medicines to AstraZeneca’s proven backbone therapies. Results from VOLGA, DeLLphi-305 and SAFFRON highlight the potential of innovative Imfinzi- and Tagrisso-based regimens to improve outcomes for patients across bladder and lung cancers, reinforcing our commitment to continually raising the bar for patients with cancer across the treatment landscape."

Key AstraZeneca presentations during ESMO (Free ESMO Whitepaper) 20261

Lead Author

Abstract Title

Presentation details (CEST)

Antibody drug conjugates

Xu, R-H

CLARITY-Gastric01 (CG-01): a Phase III trial of Sone-Ve in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC)

Abstract #LBA7

Presidential Symposium 2

25 October 2026

4:30 PM

Meric-Bernstam, F

Updated results from FONTANA: Torvutatug samrotecan (torvu-sam), a folate receptor α (FRα)-targeted antibody-drug conjugate (ADC), in patients (pts) with platinum-resistant ovarian cancer (PROC)

Abstract #1245RO

Rapid Oral Session

24 October 2026

Dent, R

First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients (pts) with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Exploratory analysis of pts with brain metastases in TROPION-Breast02 (TB-02)

Abstract #LBA96

Proffered Paper Session

24 October 2026

8:30 AM

Boileau, JF

DESTINY-Breast11 (DB-11): MRI-assessed objective responses during neoadjuvant treatment (NAT) with trastuzumab deruxtecan (T-DXd) followed by paclitaxel + trastuzumab + pertuzumab (THP) vs dose-

dense doxorubicin + cyclophosphamide followed by THP (ddAC-THP) in HER2+ early breast cancer (eBC)

Abstract #543RO

Rapid Oral Session

23 October 2026

4:15 PM

Novello, S

First-line (1L) trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2-mutant (HER2m) NSCLC: Patient-reported outcomes (PROs) from DESTINY-Lung04 (DL-04)

Abstract #LBA74

Rapid Oral Session

24 October 2026

9:00 AM

Manich, S

A DESTINY-Breast09 (DB-09) analysis of trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for patients (pts) with HER2+ advanced/metastatic breast cancer (a/mBC) and baseline (BL) brain metastases (BMs)

Abstract #LBA49

Rapid Oral Session

26 October 2026

10:15 AM

Immuno-oncology

Powles, T

Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: results from the Phase 3 VOLGA trial

Abstract #LBA2

Presidential Symposium 1

24 October 2026

4:30 PM

Sands, J

Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 DeLLphi-305 trial

Abstract #LBA3

Presidential Symposium 1

24 October 2026

4:30 PM

Kudo, M

Liver function trajectory and post-progression outcomes in the Phase III EMERALD-3 trial of tremelimumab (T) + durvalumab (D) ± lenvatinib

(L) + transarterial chemoembolisation (TACE) in participants (pts) with

embolisation-eligible hepatocellular carcinoma (eeHCC)

Abstract #LBA48

Proffered Paper Session

24 October 2026

10:15 AM

Westin, S

Durvalumab (D) plus carboplatin/paclitaxel (CP) followed by D with or without olaparib (O) in advanced/recurrent endometrial cancer (a/rEC): interim overall survival (OS) and safety from the randomised Phase III DUO-E/GOG-3041/ENGOT-EN10 trial

Abstract #LBA37

Proffered Paper Session

24 October 2026

2:45 PM

De Santis, M

Durvalumab (D) in Combination With BCG Induction and Maintenance (I+M) for BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC): Early Recurrence and Cystectomy-Free Survival in Patients (pts) With Papillary Only Tumours From POTOMAC

Abstract #4737RO

Rapid Oral Session

24 October 2026

10:15 AM

Cascone, T

NeoCOAST-2: Association of ctDNA clearance with clinical outcomes in a global platform Phase III perioperative trial

Abstract #4244RO

Rapid Oral Session

25 October 2026

8:30 AM

Spicer, J

ctDNA clearance (CL) during neoadjuvant treatment (neoadj Tx) and its association with outcomes in patients (pts) with resectable/borderline resectable stage IIB–IIIB NSCLC from MDT-BRIDGE

Abstract #LBA69

Rapid Oral Session

26 October 2026

10:15 AM

Lorenza, R

Seven-year overall survival (OS) and OS by tumour response measures from the Phase III HIMALAYA trial of tremelimumab plus durvalumab in first-line (1L) unresectable hepatocellular carcinoma (uHCC)

Abstract #1683P

Poster Session

25 October 2026

12:00 PM

Tumour drivers and resistance

Lu, S

Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase III primary results

Abstract #LBA6

Presidential Symposium 2

25 October 2026

4:30 PM

Wu, YL

Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase III SANOVO trial

Abstract #LBA69

Proffered Paper Session

26 October 2026

8:30 AM

Fizazi, K

Capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN-deficient metastatic hormone sensitive prostate cancer (mHSPC): updated overall survival (OS) from CAPItello-281

Abstract #LBA56

Rapid Oral Session

23 October 2026

1:30 PM

Cell therapy

Liang, T

Phase I trial of C-CAR031, a GPC3-targeted TGFβRIIDN armored autologous CAR-T, in advanced hepatocellular carcinoma (aHCC): Updated Results

Abstract #1680RO

Rapid Oral Session

26 October 2026

2:45 PM

(Press release, AstraZeneca, OCT 19, 2026, View Source [SID1234673577])

On October 19, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that data from across its rapidly progressing solid tumor portfolio will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 on October 23-27 in Madrid. Presentations will highlight an accelerating pipeline of differentiated targeted therapies, alongside a broad body of evidence for TEVIMBRA (tislelizumab), including a late-breaking rapid oral presentation on TEVIMBRA in combination with ZIIHERA (zanidatamab) in HER2+ gastroesophageal adenocarcinoma (GEA). Priority pipeline data include an oral proffered paper presentation on BeOne’s GPC3x4-1BB bispecific antibody, currently being studied in hepatocellular carcinoma (HCC) and first-in-human data for two investigational lung cancer assets, a CEA targeting antibody-drug conjugate (ADC), in CEA-expressing non-small cell lung cancer (NSCLC), and a brain-penetrant PRMT5 inhibitor in MTAP-deleted tumors, including NSCLC. A trial-in-progress (TiP) abstract of KANDELA-302 will be presented for the Company’s CDK4 inhibitor, in front-line metastatic HR+/HER2-negative breast cancer (BC).

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Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne, said:

"2026 has been an inflection year for our solid tumor portfolio. Across major medical congresses, we have demonstrated proof of concept for five priority programs, while rapidly advancing these assets toward pivotal development. At ESMO (Free ESMO Whitepaper), that progress is visible in pipeline data spanning our three strategically focused disease areas, breast, lung, and gastrointestinal cancers, alongside further evidence supporting TEVIMBRA, including updated Phase 3 data in combination with ZIIHERA in HER2+ gastroesophageal adenocarcinoma. Together, the reach of TEVIMBRA and a pipeline advancing at scale position BeOne to change the game in solid tumor oncology."

Pipeline at scale: advancing priority programs with new data at ESMO (Free ESMO Whitepaper)

The latest evidence of the progress of BeOne’s solid tumor pipeline will be presented at ESMO (Free ESMO Whitepaper) with abstracts being published across four investigational assets, demonstrating the speed and scale of BeOne’s global development superhighway.

Priority pipeline presentations at ESMO (Free ESMO Whitepaper) include:

BGB-B2033 (GPC3x4-1BB bispecific antibody): An oral proffered paper presentation with updated Phase 1 dose-escalation and first dose-optimization results in previously treated patients with advanced HCC.
BG-C477 (CEA targeting ADC): First-in-human Phase 1 data in heavily pretreated, locally advanced NSCLC, with further analysis provided in patients with CEA-high expressing tumors.
BGB-58067 (PRMT5 inhibitor): First-in-human data evaluating BeOne’s brain-penetrant, MTA-cooperative PRMT5 inhibitor in MTAP-deficient advanced tumors.
BGB-43395 (CDK4 inhibitor): Trial-in-progress presentation of KANDELA-302, a global Phase 3 study evaluating BGB-43395 plus letrozole compared with investigator’s choice of a CDK4/6 inhibitor plus letrozole as first-line treatment for advanced or metastatic HR+/HER2-negative BC.
Strengthening evidence base for TEVIMBRA in lung and gastrointestinal cancers

In addition to pipeline data, seven abstracts at ESMO (Free ESMO Whitepaper) will further characterize TEVIMBRA across lung and gastrointestinal cancers, including a late-breaking, rapid oral presentation with new data from the Phase 3 HERIZON-GEA-01 trial in HER2+ gastroesophageal adenocarcinoma.

Key TEVIMBRA presentations include:

HERIZON-GEA-01: Second interim analysis of the Phase 3 trial of ZIIHERA plus chemotherapy, with and without TEVIMBRA, in first-line HER2-positive locally advanced or metastatic GEA.
RATIONALE-312: Exploratory analysis evaluating the effect of TEVIMBRA plus platinum-etoposide on brain disease progression in first-line extensive stage small-cell lung cancer (ES-SCLC).
RATIONALE-315: Analysis of clinical outcomes by adjuvant treatment cycles with perioperative TEVIMBRA plus chemotherapy in patients with resectable NSCLC.
RATIONALE-305 and RATIONALE-302: New analyses further evaluating outcomes with TEVIMBRA in gastric/gastroesophageal junction (GEJ) adenocarcinoma and esophageal squamous cell carcinoma (ESCC), respectively.
Full list of BeOne’s presentations at ESMO (Free ESMO Whitepaper):

Pipeline data

Abstract Title

Presentation Details (CET)

Lead
Author

Phase 1 study of BGB-B2033 monotherapy: First disclosure of dose optimization and dose escalation update in advanced HCC

Proffered paper 1679O; Gastrointestinal tumour, upper digestive; Oct. 24, 10:15-11:45AM

Hong Jae Chon

First-in-human study of BG-C477, a novel CEA-targeting ADC, in advanced solid tumors: initial results in NSCLC

Poster: 2567P; NSCLC, locally advanced; Oct. 26, 12:00-12:45

Matthew Lee

First-in-human trial of BGB-58067, an MTA-cooperative PRMT5 inhibitor, in MTAP-deficient advanced tumors

Poster: 1043P; Translational Research and Biomarkers; Oct. 23, 3:15-4:00 PM

Jordi Rodon

KANDELA-302: A Phase 3, global, open-label, randomized study of the selective CDK4 inhibitor BGB-43395 + letrozole vs CDK4/6 inhibitors + letrozole for first-line treatment of advanced or metastatic HR+/HER2− breast cancer

Poster: 1885TiP; HR+ Breast Cancer; Oct. 24, 12:00-12:45

Sara M. Tolaney

TEVIMBRA data

Abstract Title

Presentation Details (CET)

Lead
Author

Zanidatamab + chemotherapy ± tislelizumab for first-line HER2+ advanced/metastatic GEA: second interim analysis from HERIZON-GEA-01

Rapid oral: LBA79; Gastrointestinal tumour, upper digestive Oct 23, 4:15-5:45 PM

Kohei Shitara

Phase 1b/2 trial of BGB-A445 (OX40 agonist) with or without tislelizumab in urothelial carcinoma, renal cell carcinoma, and melanoma

Poster: 1980P; Investigational Immunotherapy; Oct. 24, 12:00-12:45

Bin Lian

Impact of progressive disease patterns on post-progression overall survival in ESCC: A post hoc analysis of RATIONALE-302

Poster: 2950P; Oesophagogastric cancer; Oct. 25, 12:00-12:45

Jhe-Cyuan Guo

RATIONALE-305: Post-treatment immuno-oncology adjustment analysis to assess tislelizumab treatment effect vs placebo

Poster: 2931P; Oesophagogastric cancer; Oct. 25, 12:00-12:45

Markus Moehler

RATIONALE-312: Exploratory analysis of tislelizumab plus platinum-etoposide on brain disease progression in first-line ES-SCLC

Poster: 3839P; SCLC; Oct. 26, 12:00-12:45

Francesco Passiglia

RATIONALE-315: Clinical outcomes by adjuvant treatment cycles in perioperative tislelizumab plus chemotherapy in resectable NSCLC

Poster: 2594P; NSCLC, locally advanced; Oct. 26, 12:00-12:45

Ernest Nadal

Exposure-adjusted analyses of safety patterns in HERIZON-GEA-01: Zanidatamab with and without tislelizumab and chemotherapy in 1L HER2+ metastatic GEA

Poster: 2946P; Oesophagogastric cancer; Oct. 25, 12:00-12:45

Sun Young Rha

About ZIIHERA (zanidatamab-hrii)

ZIIHERA (zanidatamab-hrii) is a bispecific human epidermal growth factor receptor 2, or HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab with HER2 results in internalization leading to a reduction in HER2 expression of the receptor on the tumor cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is approved in China for the treatment of patients who have unresectable, locally advanced, or metastatic HER2-high expression (IHC 3+) biliary tract cancer (BTC) and who have received prior systemic therapy. ZIIHERA has also been granted accelerated approval in the U.S. and conditional marketing authorization in the European Union for eligible BTC patients. Zanidatamab is being developed by Jazz and BeOne under license agreements from Zymeworks, which first developed the molecule. BeOne has licensed zanidatamab from Zymeworks in Asia (excluding India and Japan), Australia and New Zealand. Jazz Pharmaceuticals has rights in all other regions.

ZIIHERA is a registered trademark of Zymeworks BC Inc.

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the cornerstone asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 15,000 patients enrolled to date in 30+ countries and regions across 71 trials, including 21 registration-enabling studies. TEVIMBRA is approved for various solid tumors (see prescribing information) in over 50 countries, and more than 2.2 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, OCT 19, 2026, View Source [SID1234673576])