On October 13, 2025 AstraZeneca reported its ambition to redefine 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, October 17-21, 2025 (Press release, AstraZeneca, OCT 13, 2025, View Source [SID1234656589]).

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More than 95 abstracts will feature nine approved and nine potential new medicines from the Company including two abstracts featured in a late-breaking Presidential Symposium and 26 oral presentations.

Key presentations include:

DESTINY-Breast11 Phase III trial of Enhertu followed by paclitaxel, trastuzumab and pertuzumab (THP) when used in the neoadjuvant setting in patients with high-risk, locally advanced HER2-positive early-stage breast cancer (Presidential Symposium 1 Abstract #291O).
DESTINY-Breast05 Phase III trial of Enhertu (trastuzumab deruxtecan) as post-neoadjuvant therapy in patients with HER2-positive early breast cancer with high risk of disease recurrence (Presidential Symposium 1 Abstract #LBA1).
TROPION-Breast02 Phase III trial of Datroway (datopotamab deruxtecan) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option (Proffered Paper Abstract #LBA21).
POTOMAC Phase III trial of Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) (Proffered Paper Abstract #LBA108).
MATTERHORN: Final overall survival (OS) results from the Phase III trial of perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers (Proffered Paper Abstract #LBA81).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "We are advancing a broad portfolio of new treatments to transform patient care in breast cancer and sharing meaningful progress at ESMO (Free ESMO Whitepaper) with data from TROPION-Breast02, DESTINY-Breast11 and DESTINY-Breast05. We are also sharing data from our next wave of potential new Oncology medicines including saruparib in combination with novel hormonal agents in prostate cancer, our folate receptor targeted antibody drug conjugate torvu-sam in ovarian cancer, and rilvegostomig in non-small cell lung cancer."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The momentum of our industry-leading oncology portfolio continues with presentations of the first data from four major pivotal trials at this year’s ESMO (Free ESMO Whitepaper). Beyond the key data in breast cancer for Enhertu and Datroway, the POTOMAC results for Imfinzi demonstrate the benefits of treating early-stage bladder cancer with immunotherapy and illustrate our strategy to bring novel treatments to early cancer settings where patients can benefit most."

Additional highlights include:

FONTANA Phase I/IIa first-in-human trial of AZD5335, a folate receptor α (FRα)-targeting antibody drug conjugate, in patients with platinum-resistant recurrent ovarian cancer (Mini Oral Abstract #1065MO).
PETRANHA Phase I/II trial of saruparib plus androgen receptor pathway inhibitors in patients with metastatic prostate cancer (Mini Oral Abstract #2384MO).
ARTEMIDE-01 Phase I/II trial of rilvegostomig in patients with checkpoint inhibitor-naïve metastatic NSCLC (Mini Oral Abstract #1853MO).
FLAURA2: Exploratory OS analysis of patients with poor prognostic factors in the FLAURA2 Phase III trial of Tagrisso (osimertinib) plus chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) (Proffered Paper Abstract #LBA77).
CAPItello-281: Phase III trial of Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) in PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC) (Proffered Paper Abstract #2383O).
TROPION-PanTumor03: First results from the bladder cancer cohort of the TROPION-PanTumor03 Phase II trial of Datroway plus rilvegostomig (Mini Oral Abstract #3072MO).
BEGONIA: Final results from the BEGONIA Phase Ib/II trial of Datroway plus Imfinzi in patients with previously untreated unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) (Mini Oral Abstract #555MO).
AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialise Enhertu and Datroway, collaborating with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza (olaparib), and collaborating with HUTCHMED to develop and commercialise Orpathys (savolitinib). Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen’s clinical stage anti-TIGIT antibody, COM902.

Key AstraZeneca presentations during ESMO (Free ESMO Whitepaper) Congress 20251

Lead Author

Abstract Title

Presentation details (CEST)

Antibody drug conjugates

Harbeck, N

DESTINY-Breast11: neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer (eBC)

Abstract #291O

Presidential 1

18 October 2025

4:30 PM

Geyer, C

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients (pts) with high-risk human epidermal growth factor receptor 2–positive (HER2+) primary breast cancer (BC) with residual invasive disease after neoadjuvant therapy (tx): Interim analysis of DESTINY-Breast05

Abstract #LBA1

Presidential 1

18 October 2025

4:52 PM

Dent, R.

First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase 3 TROPION-Breast02 trial

Abstract #LBA21

Proffered Paper Session

19 October 2025

9:25 AM

Loibl, S

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: additional analysis of DESTINY-Breast09 in key subgroups of interest

Abstract #LBA18

Proffered Paper Session

19 October 2025

8:30 AM

Rha, SY

Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase 2 TROPION-PanTumor03 study

Abstract #3072MO

Mini Oral Session

17 October 2025

4:10 PM

Oaknin, A

First-in-human study of AZD5335, a folate receptor α (FRα)-targeted antibody-drug conjugate, in patients with platinum-resistant recurrent ovarian cancer

Abstract #1065MO

Mini Oral Session

19 October 2025

10:53 AM

Schmid, P

Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment (tx) for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Final results from the phase 1b/2 BEGONIA study

Abstract #555MO

Mini Oral Session

20 October 2025

10:50 AM

Raghav, K

Trastuzumab deruxtecan (T DXd) in patients (pts) with HER2-positive (HER2+) metastatic colorectal cancer (mCRC): Final analysis of DESTINY-CRC02, a randomized, phase 2 trial

Abstract #737P

Poster Session

Peng, Z

Trastuzumab deruxtecan (T-DXd) in patients (pts) with HER2+ gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA) who received prior anti-HER2 treatment (Tx) other than / in addition to trastuzumab in DESTINY-Gastric06 (DG-06)

Abstract #2105P

Poster Session

Shen, L

Risk of hepatitis B virus reactivation (HBVr) in patients (pts) with past or resolved HBV or inactive chronic HBV infection treated with trastuzumab deruxtecan (T-DXd) in the DESTINY-Gastric06 (DG-06) trial

Abstract #2175P

Poster Session

Pietrantonio, F

Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) plus paclitaxel (PTX) in second-line (2L) treatment of patients (pts) with HER2+ unresectable/metastatic gastric cancer (GC)/gastroesophageal junction adenocarcinoma (GEJA): Additional data from DESTINY-Gastric04 (DG-04)

Abstract #2099P

Poster Session

Makker, V

Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) Part 1 final analysis

Abstract #957P

Poster Session

Lee, J-Y

Trastuzumab deruxtecan (T-DXd) in pretreated patients (pts) with HER2-expressing solid tumors: exploratory biomarker analysis of DESTINY-PanTumor02 (DP-02) Part 1

Abstract #145P

Poster Session

Immuno-oncology

Tabernero, J

MATTERHORN Phase III trial of Imfinzi (durvalumab) perioperative Imfinzi (durvalumab) plus FLOT chemotherapy in patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers

Abstract #LBA81

Proffered Paper Session

17 October 2025

2:00 PM

De Santis, M

Durvalumab (D) in Combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, High-risk Non-muscle-invasive Bladder Cancer (NMIBC): Results from the Phase 3, Open-label, Randomised POTOMAC Trial

Abstract #LBA108

Proffered Paper Session

17 October 2025

2:10 PM

Larkin, J

First results from RAMPART: An international phase 3 randomised-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL

Abstract #LBA93

Proffered Paper Session

18 October 2025

9:20 AM

Aghajanian, C

Durvalumab + paclitaxel/carboplatin + bevacizumab followed by durvalumab, bevacizumab + olaparib maintenance in patients with newly diagnosed non-tBRCA-mutated advanced ovarian cancer: final overall survival from DUO-O/ENGOT-ov46/GOG-3025

Abstract #LBA44

Mini Oral Session

19 October 2025

11:31 AM

Goss, G

CCTG BR.31: Adjuvant durvalumab (D) in resected non-small-cell lung cancer (NSCLC): final overall survival (OS) and minimal residual disease (MRD) analyses

Abstract #LBA68

Mini Oral Session

20 October 2025

3:20 PM

Heymach, J

Association of radiomic features ± on-treatment ctDNA detection with treatment outcomes in patients with resectable NSCLC: exploratory analyses from AEGEAN

Abstract #LBA70

Mini Oral Session

20 October 2025

3:50 PM

Wermke, M

Tarlatamab with first-line chemoimmunotherapy for extensive stage small cell lung cancer (ES-SCLC): DeLLphi-303 study

Abstract #2757O

Proffered Paper Session

18 October 2025

8:30 AM

Loibl, S

Durvalumab in Combination with Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer (TNBC) – Long-term Analysis from the GeparNuevo Trial

Abstract #292MO

Mini Oral Session

19 October 2025

10:15 AM

Van der Heijden, M

Health-related quality of life (HRQoL) from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC)

Abstract #3069MO

Mini Oral Session

17 October 2025

4:00 PM

Sangro, B

Pooled efficacy and safety outcomes with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the combined China extension and global cohorts in the Phase 3 HIMALAYA study

Abstract #1494P

Poster Session

Westin, S

Durvalumab plus carboplatin/paclitaxel followed by durvalumab for endometrial cancer: Tumour mutational burden-high subpopulation efficacy analyses from the DUO-E trial

Abstract #1117P

Poster Session

Leal, TA

Global quantitative assessment of multidisciplinary team (MDT) care in early-stage NSCLC

Abstract #1794P

Poster Session

Reck, M

Neoadjuvant durvalumab (D) + chemotherapy (CT) followed by either surgery (Sx) and adjuvant D or CRT and consolidation D in patients (pts) with resectable or borderline resectable stage IIB–IIIB NSCLC: interim analysis (IA) of the phase 2 MDT-BRIDGE study

Abstract #LBA65

Proffered Paper Session

18 October 2025

9:15 AM

Maruki, Y

CELEBRATE Study (JCOG2107E): A Multicenter, Open-label, Phase III Trial of Etoposide, Carboplatin, and Durvalumab in First-line Treatment of Unresectable or Recurrent Digestive NEC

Abstract #1734TiP

Poster Session

Oudard, S

A phase IIIb, open-label, single-arm, global study of perioperative durvalumab (D) with neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) or gemcitabine/cisplatin (gem/cis) in patients with muscle-invasive bladder cancer (MIBC) (NIAGARA-2)

Abstract #3133eTiP

ePoster Session

IO Bispecifics

Chul Cho, B

Efficacy and Safety of Rilvegostomig, an Anti-PD-1/TIGIT Bispecific Antibody, for Checkpoint Inhibitor (CPI)-Naïve Metastatic Non-Small-Cell Lung Cancer (mNSCLC): ARTEMIDE-01

Abstract #1853MO

Mini Oral Session

20 October 2025

10:25 AM

Slomovitz, BM

A randomized Phase 3 study of first-line (1L) trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2-expressing, mismatch repair-proficient (pMMR), primary advanced or recurrent endometrial cancer (EC): DESTINY-Endometrial01/GOG-3098/ENGOT-EN24

Abstract #1223TiP

Poster Session

Naidoo, J

ARTEMIDE-Lung04: A Phase 3, randomised, double-blind, global study of rilvegostomig or pembrolizumab monotherapy as first-line (1L) treatment for patients with metastatic non-small cell lung cancer (mNSCLC) and programmed cell death ligand-1 (PD-L1) expression ≥50%

Abstract #2025TiP

Poster Session

Tumour drivers and resistance

Jänne, PA

FLAURA2: exploratory overall survival (OS) analysis in patients (pts) with poor prognostic factors treated with osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) as first-line (1L) treatment for EGFR-mutated (EGFRm) advanced NSCLC

Abstract #LBA77

Proffered Paper Session

17 October 2025

4:56 PM

Mayer, E

Patient-reported outcomes (PROs) from the SERENA-6 trial of camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) for emergent ESR1m during first-line (1L) endocrine-based therapy and ahead of disease progression in patients (pts) with HR+/HER2- advanced breast cancer (ABC)

Abstract #486MO

Mini Oral Session

20 October 2025

10:25 AM

Arriola, E

Molecular residual disease (MRD) analysis from the LAURA study of osimertinib (osi) in unresectable (UR) stage III EGFR-mutated (EGFRm) NSCLC

Abstract #1817MO

Mini Oral Session

20 October 2025

2:55 PM

Park, YH

Visual symptom questionnaire results from SERENA-6, a Phase 3 study of switch to camizestrant (CAMI) + CDK4/6 inhibitor (CDK4/6i) at emergence of ESR1m during first-line (1L) therapy for patients (pts) with HR+/HER2- advanced breast cancer (ABC)

Abstract #528P

Poster Session

Chu, Q

SAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osi

Abstract #1955P

Poster Session

Rotow, J

MET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): Interim analysis of a global real world (rw) study

Abstract #1967P

Poster Session

Yu, Y

ctDNA analysis in phase 3 SACHI trial: Savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI)

Abstract #1954P

Poster Session

DNA Damage Response

Azad, AA

First interim efficacy analysis of the Phase 1/2 PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC)

Abstract #2384MO

Mini Oral Session

17 October 2025

2:35 PM

Fizazi, K

A Phase 3 study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281

Abstract #2383O

Proffered Paper Session

19 October 2025

11:19 AM

Rugo, HS

Capivasertib with fulvestrant as first- and second-line endocrine therapy in PIK3CA/AKT1/PTEN-altered hormone receptor-positive advanced breast cancer: Subgroup analysis from the Phase 3 CAPItello-291 trial

Abstract #526P

Poster Session

Gao, Q

Final overall survival (OS) analysis of L-MOCA: olaparib maintenance monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC)

Abstract #1090P

Poster Session

AI Trials

Gonuguntla, HK

Real-World Validation of AI-defined Lung Nodule Malignancy Score (qXR-LNMS) in Predicting Risk of Lung Cancer: Interim results from Phase 2

Abstract #2978P

Poster Session

On October 13, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported it will share initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS trial in a poster presentation at the 37th AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 22-26, 2025 in Boston, MA (Press release, Repare Therapeutics, OCT 13, 2025, View Source [SID1234656605]).

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The LIONS clinical trial (NCT06232408) is a first-in-human, multicenter, open-label Phase 1 study to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a potential first-in-class, highly selective, oral PLK4 inhibitor, for the monotherapy treatment of adult and adolescent patients with TRIM37-high solid tumors.

Poster Presentation Details:

Title: Preliminary safety and antitumor activity of RP-1664, a first-in-class PLK4 inhibitor, as monotherapy in advanced solid tumors with and without TRIM37 amplification
Presenter: Benjamin Herzberg, MD, Columbia University
Abstract Number: LB-C002
Session: Poster Session C
Session Date and Time: Saturday, October 25 | 12:30 p.m. – 4:00 p.m. ET
Session Location: Level 2, Exhibit Hall D

A copy of the poster presentation will be available on the Scientific Resources page of the Repare Therapeutics website at the start of the poster presentation session.

About RP-1664

RP-1664 is a potential first-in-class, highly selective, oral PLK4 inhibitor designed to harness the synthetic lethal relationship with TRIM37 amplification or overexpression in solid tumors. Tumors rely on PLK4 for centriole biogenesis in S-phase of the cell cycle when TRIM37, an E3 ligase that reduces pericentriolar material, is high. Preclinical studies demonstrate that RP-1664 selectively inhibits PLK4 and drives potent synthetic lethality in TRIM37-high tumor models, both in vitro and in vivo. Elevated TRIM37 is a feature found across a range of solid tumors and in approximately 80% of all high-grade neuroblastomas. RP-1664 is the only selective PLK4 inhibitor known to be in the clinic.

On October 13, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will present a wide range of data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025.

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The data, which will be presented at an oral session, will include two-year clinical efficacy, immunogenicity and safety data. More specifically, data will be presented on best overall response, deepened response/conversion rates and durability of response. Furthermore, the presentation will include data on the breadth, magnitude and duration of T-cell response upon booster immunization as well as data on the vaccine’s safety profile.

"We are eagerly anticipating the presentation of the data and the subsequent discussions with medical and scientific colleagues as well as potential partner companies. We are excited to have been selected for oral presentation at an event as important as the ESMO (Free ESMO Whitepaper) Congress, one of the most prestigious medical oncology conferences in the world. This is a testament to the interest in EVX-01 and the field of personalized cancer vaccines in general," says Birgitte Rønø, CSO and interim CEO of Evaxion.

Evaxion will be present and available for discussions at a booth (#3035) throughout the conference to allow for interactions and discussions of the data with all interested stakeholders.

Convincing data
Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO (Free ESMO Whitepaper) Congress last year.

Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Further, the most recent immune data demonstrates that 80% of EVX-01 vaccine targets triggered a tumor-specific immune response.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Presentation details
Abstract Title: EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up
Abstract#: #6308
Presentation#: 1516MO
Track: Mini oral session: Investigational immunotherapy
Location: Nuremberg Auditorium – Hall 5.2
Booth: n#3035
Date/Time: October 17 at 14:10 – 14:15 CEST
Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia

Webinar on October 22, 2025

Evaxion will be hosting an online webinar featuring key opinion leader and trial investigator, Dr. Muhammad Adnan Khattak, on October 22, 2025, at 16.30 CEST/10.30am EDT.

The webinar can be attended through registration via this link.

In the webinar, Dr. Khattak will present the two-year phase 2 data and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions.

About EVX-01
EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

(Press release, Evaxion Biotech, OCT 13, 2025, View Source [SID1234656637])

On October 13, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported it will jointly present a poster on translational data and updated clinical results from the Phase I study of BT-001 at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting. ESMO (Free ESMO Whitepaper) will take place in Berlin, Germany, from October 17 to 21, 2025 (Press release, Transgene, OCT 13, 2025, View Source [SID1234656590]).

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Key findings of the abstract include:

– Intra-tumoral (IT) BT-001 injection in combination with intravenous (IV) pembrolizumab was well tolerated with a manageable safety profile.

– The data show encouraging and sustained anti-tumor activity in patients with advanced refractory tumors. One patient with PD(L)-1 resistant melanoma and one patient with heavily pretreated and Immune Checkpoint Inhibitor (ICI)-naive leiomyosarcoma showed partial response (iPR) lasting 6 and 16 months respectively, among the 13 patients who received the combination of IT BT-001 (at 107 pfu/mL and 108 pfu/mL) and IV pembrolizumab.

– Tumor shrinkage was observed in both injected and non-injected lesions.

– BT-001 could be an effective option to improve the response to ICI in refractory patients.

The abstract is available on the ESMO (Free ESMO Whitepaper) website (here). The poster will be presented on October 20 during ESMO (Free ESMO Whitepaper) 2025 and will also be available to view on Transgene’s website.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine.

BT-001 is being co-developed as part of a 50/50 collaboration between Transgene and BioInvent. In the Phase I part of this study, BT-001 was well tolerated both as monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab)*.

The Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation study evaluating BT-001 as a single agent and in combination with pembrolizumab*. The last patient in the Phase I part was enrolled in August 2024.

Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, as well as PD(L)-1 expression in the tumor microenvironment (ESMO 2024, access press release here).

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

On October 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci), formerly known as ZL-1310, has been selected for an oral presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 22-26, 2025, in Boston, Massachusetts (Press release, Zai Laboratory, OCT 13, 2025, View Source [SID1234656606]). The presentation will include additional follow-up from patients from the ongoing trial.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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Zoci is the Company’s potential first- and best-in-class, Delta-like ligand (DLL3)-targeted antibody-drug conjugate (ADC) being developed for patients with extensive-stage small cell lung cancer (ES-SCLC). The ongoing Phase 1 study is evaluating the safety and antitumor activity of zoci at various doses in patients who have progressed after at least one prior platinum-based chemotherapy regimen. The study is being conducted across multiple global sites.

"The critical need for expanded treatment options for patients with small cell lung cancer propels our strategy to advance zoci as a novel therapeutic option as quickly as possible," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "We remain on track to initiate our Phase 3 registrational study in previously treated SCLC by year-end. We look forward to sharing updated results demonstrating zoci’s continued potential at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference."

Zai Lab will hold an investor conference call and webcast to highlight updated zoci data at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference and outline next steps in clinical development.

Details regarding the webcast and conference call are as follows:

Date/Time: October 24, 2025, at 11 a.m. ET / 11 p.m. HKT, please register at:
Webcast presentation (preferred): View Source
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President and Head of Global Research and Development, Zai Lab

Details regarding the zoci oral presentation are as follows:

Title: Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer
Presenter: Grace K. Dy, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY
Session Title: Plenary Session 3: Antibody Drug Conjugates
Date/Time: Friday, October 24, 2025, 9:17 a.m. – 9:27 a.m. ET (presentation), 9:27 a.m. – 9:45 a.m. ET (panel discussion)
Location: Hynes Convention Center, Level 3, Ballroom AB

About Small Cell Lung Cancer and Zocilurtatug Pelitecan (zoci)

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage3.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. Zocilurtatug pelitecan (zoci), formerly known as ZL-1310, comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

Zoci received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.