1stOncology™: Cancer Intelligence Service – Page 465 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA

On October 13, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) (Press release, BeOne Medicines, OCT 13, 2025, View Source [SID1234656592]). Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"Breakthrough Therapy Designation is reserved for medicines with the potential to transform outcomes for patients with serious diseases. This recognition affirms the strength of the emerging data for sonrotoclax and its potential to become a new standard of care for people with relapsed or refractory mantle cell lymphoma," said Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. "Additionally, by participating in Project Orbis, we may be able to accelerate access to sonrotoclax, potentially helping patients faster than previously imagined."

The decision by the FDA to grant sonrotoclax BTD and participation in Project Orbis was based on data from the BGB-11417-201 study, a Phase 1/2 study evaluating sonrotoclax in adult patients with R/R MCL, following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. The recently announced positive topline results for sonrotoclax underscore its potential to deliver deep and durable responses, giving it the potential to be the first and only BCL2 inhibitor approved for use in R/R MCL in the U.S. BeOne plans to present the full data at an upcoming medical meeting. The Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302; NCT06742996) is underway.

The FDA grants BTD to medicines with early data suggesting they may offer significant advances for patients with serious diseases. Project Orbis, established by the FDA Oncology Center of Excellence in 2019, facilitates collaboration across regulatory bodies on the review of oncology medicines with the goal of making promising cancer therapies available to patients more quickly across participating countries.

This is the first BTD for sonrotoclax and the second for BeOne’s hematology program. The FDA has also granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma (MM), and acute myeloid leukemia (AML). These designations help reinforce sonrotoclax’s position as the next major advancement in BeOne’s commitment to redefining care in B-cell malignancies.

About Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL)1 that develops in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally2, affecting an estimated 28,000 people3. MCL is often diagnosed at advanced stages4 and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.5 The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.6

About BGB-11417-201 Study

The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label, Phase 1/2 study, which enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor. In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy of sonrotoclax. The primary endpoint is overall response rate (ORR), as assessed by an independent review committee (IRC). Secondary endpoints include complete response (CR) rate, duration of response (DOR) and progression-free survival (PFS).

About Sonrotoclax (BGB-11417)

Sonrotoclax is a next-generation and potentially best-in-class investigational inhibitor of B-cell lymphoma 2 (BCL2), which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a highly potent and specific inhibitor of BCL2 with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and nearly 2,000 patients have been enrolled to date across the broad global development program.

Daiichi Sankyo Continues to Transform Standards of Care for Patients with Three Landmark Breast Cancer Trials and Additional Data Across Industry-Leading ADC Portfolio at ESMO

On October 13, 2025 Daiichi Sankyo reported data at ESMO (Free ESMO Whitepaper) will spotlight the company’s advances towards creating new standards of care for patients with breast cancer, including back-to-back presentations during Presidential Symposium I featuring data from the DESTINY-Breast11 (291O) and DESTINY-Breast05 (LBA1) phase 3 trials (Press release, Daiichi Sankyo, OCT 13, 2025, https://daiichisankyo.us/press-releases/-/article/daiichi-sankyo-continues-to-transform-standards-of-care-for-patients-with-three-landmark-breast-cancer-trials-and-additional-data-across-industry-leading-adc-portfolio-at-esmo [SID1234656591]). Results of these two landmark trials will showcase the potential of ENHERTU (trastuzumab deruxtecan) to become a foundational treatment in curative-intent settings of HER2 positive early breast cancer.

Late-breaking DATROWAY (datopotamab deruxtecan) data from the TROPION-Breast02 phase 3 trial (LBA21), representing the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option, will be featured in a proffered paper session.

"Data from these three landmark trials demonstrate how the DXd ADC portfolio of Daiichi Sankyo continues to transform standards of care for patients with breast cancer. The findings from DESTINY-Breast11 and DESTINY-Breast05 highlight the potential of ENHERTU to become a foundational treatment in the curative-intent settings of HER2 positive early breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "Additionally, the DATROWAY results from TROPION-Breast02 represent the first time ever that an overall survival benefit has been demonstrated in the first-line setting of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option. Couple these impressive results for DATROWAY with previous results seen with ENHERTU in the HER2 positive, HER2 low and HER2 ultralow disease settings, Daiichi Sankyo will now have two medicines with the potential to treat approximately 90 percent of patients with metastatic breast cancer."

Additional breast cancer data at ESMO (Free ESMO Whitepaper) includes a mini oral presentation of data from Arm 7 and Arm 8 of the BEGONIA phase 1/2 trial (555MO) evaluating DATROWAY plus durvalumab in patients with first-line metastatic TNBC. The efficacy and safety of this combination strategy is being further investigated in three phase 3 trials – TROPION-Breast03, TROPION-Breast04 and TROPION-Breast05 – across stages and treatment settings of TNBC.

Trials Supporting Three Recent Breakthrough Therapy Designations Showcased
Data from additional late-stage trials – DESTINY-Breast09, REJOICE-Ovarian01 and IDeate-Lung01 – that supported three recent Breakthrough Therapy Designations (BTD) in the U.S. for ENHERTU, raludotatug deruxtecan (R-DXd) and ifinatamab deruxtecan (I-DXd) will be showcased at ESMO (Free ESMO Whitepaper).

Two late-breaking proffered paper sessions will highlight the primary analysis from the phase 2 part of the REJOICE-Ovarian01 phase 2/3 trial (LBA42) of raludotatug deruxtecan in patients with previously treated platinum-resistant ovarian cancer, and additional analyses of key subgroups of interest from the DESTINY-Breast09 phase 3 trial (LBA18) evaluating ENHERTU plus pertuzumab versus THP (taxane, trastuzumab, pertuzumab) for the first-line treatment of patients with HER2 positive metastatic breast cancer. Results of DESTINY-Breast09 formed the basis for a supplemental Biologic License Application in the U.S. for ENHERTU, which was recently granted Priority Review under the Real-Time Oncology Review program.

Detailed results highlighting the intracranial activity of ifinatamab deruxtecan from the IDeate-Lung01 phase 2 trial (2760MO) in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) and baseline brain metastases will be highlighted during a mini oral session. The primary results of IDeate-Lung01 were presented last month at the 2025 World Conference on Lung Cancer (#WCLC25).

Progress Continues in Multiple Cancers Across the DXd ADC Portfolio of Daiichi Sankyo
Additional mini oral sessions at ESMO (Free ESMO Whitepaper) will feature the first presentation of data from two early phase trials from the DXd ADC portfolio of Daiichi Sankyo. These include preliminary results from the first-in-human phase 1/2 trial of DS-3939 (917O), the sixth DXd ADC in clinical development, in patients with previously treated advanced solid tumors refractory to standard treatment, as well as initial results from a sub-study of the TROPION-PanTumor03 phase 2 trial (3072MO) evaluating DATROWAY plus rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, in patients as first-line or second-line locally advanced or metastatic urothelial carcinoma.

Final analyses from two trials – DESTINY-CRC02 and DESTINY-PanTumor02 – that supported the tumor agnostic indication of ENHERTU, which is now approved in more than 10 countries/regions worldwide, will be presented. A mini oral session will feature the final analysis from the DESTINY-CRC02 phase 2 trial (737MO) of ENHERTU in patients with previously treated HER2 positive metastatic colorectal cancer while two poster presentations will highlight the final results (957P) and an exploratory biomarker analysis (145P) from part 1 of the DESTINY-PanTumor02 phase 2 trial in patients with previously treated HER2 expressing solid tumors. Additional regulatory submissions seeking a tumor agnostic approval in patients with HER2 positive metastatic solid tumors currently are under review in the EU and Japan.

Further sub-analyses from the DESTINY-Gastric04 phase 3 trial of ENHERTU versus ramucirumab plus paclitaxel in the second-line treatment of patients with HER2 positive metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma will be presented as a poster presentation (2099P) reporting the concordance of central HER2 testing with local HER2 testing along with additional efficacy and safety analyses. Data from DESTINY-Gastric06, a phase 2 trial in patients from China with HER2 expressing advanced gastric or GEJ adenocarcinoma who have received at least two prior regimens including a fluoropyrimidine agent and a platinum agent, will be presented in two poster presentations. The first poster (2105P) will feature an analysis of patients that received prior anti-HER2 treatment other than or in addition to trastuzumab. The second poster (2175P) will report the risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with ENHERTU.

Updates of progress in lung cancer include a mini oral session reporting updated results from a phase 1/2 trial of gocatamig (2758MO), a DLL3 targeting T-cell engager being jointly developed by Merck, in patients with small cell lung cancer and other neuroendocrine cancers, as well as a poster presentation that will highlight the initial safety results from a phase 1b trial of valemetostat (2023P), a dual EZH1 and EZH2 inhibitor, in combination with DATROWAY in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC).

Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio
Several trials-in-progress poster presentations at ESMO (Free ESMO Whitepaper) further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with cancer.

A trial-in-progress poster will highlight the design of the DESTINY-Endometrial01 phase 3 trial (1223TiP) evaluating ENHERTU in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.

Three phase 2 trials-in-progress will include the HERTHENA-Breast03 trial (463eTiP) evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; the REJOICE-GI01 trial (1001TiP) evaluating the efficacy and safety of raludotatug deruxtecan in patients with gastrointestinal cancers, including pancreatic ductal adenocarcinoma, gastroesophageal adenocarcinoma, biliary tract and colorectal cancer; and, the KEYMAKER-U01 sub-studies 01H/01I (2081eTiP) evaluating ifinatamab deruxtecan, raludotatug deruxtecan or docetaxel in patients with stage IV NSCLC.

The design of two additional early phase trials will be shared, including the phase 1/2 trial (2792TiP) evaluating ifinatamab deruxtecan and gocatamig in patients with relapsed/refractory ES-SCLC and a phase 1b trial (977P) of valemetostat in combination with ipilimumab in patients with refractory genitourinary tumors, including prostate cancer, urothelial carcinomas and renal clear cell carcinoma.

Investor Briefing During ESMO (Free ESMO Whitepaper)
Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 21, 2025 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the ESMO (Free ESMO Whitepaper) data.

Daiichi Sankyo Oral Presentations at ESMO (Free ESMO Whitepaper)

Presentation Title

Author

Abstract

Presentation (CEST)

Breast

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

C. Geyer

LBA1

Presidential Symposium I

Saturday, October 18

4:30 – 6:15 pm

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

N. Harbeck

291O

Presidential Symposium I

Saturday, October 18

4:30 – 6:15 pm

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

S. Loibl

LBA18

Proffered Paper Session

Sunday, October 19

8:30 – 10:00 am

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

R. Dent

LBA21

Proffered Paper Session

Sunday, October 19

8:30 – 10:00 am

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

P. Schmid

555MO

Mini Oral Session

Monday, October 20

10:15 – 11:45 am

Lung

Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer and baseline brain metastases: primary analysis of IDeate-Lung01

P. Rocha

2760MO

Mini Oral Session

Saturday, October 18

4:30 – 6:00 pm

Updated results from a phase 1/2 study of gocatamig for small cell lung cancer and other neuroendocrine cancers

H. Beltran

2758MO

Mini Oral Session

Saturday, October 18

4:30 – 6:00 pm

Ovarian

Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: primary analysis of the phase 2 dose- optimization part of the REJOICE-Ovarian01 study

I. Ray-Coquard

LBA42

Proffered Paper Session

Sunday, October 19

2:45 – 4:15 pm

Bladder

Datopotamab deruxtecan (Dato-DXd) + rilvegostomig in patients with locally advanced or metastatic urothelial cancer: results from the phase 2 TROPION-PanTumor03 study

S. Rha

3072MO

Mini Oral Session

Friday, October 17

4:00 – 5:30 pm

CRC

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

K. Raghav

737MO

Mini Oral Session

Sunday, October 19

2:45 – 4:15 pm

PanTumor

DS-3939, a tumor-associated mucin 1 (TA-MUC1)-directed antibody drug conjugate (ADC), in patients with advanced/metastatic solid tumors: initial results from a first-in-human study

M. Patel

917O

Proffered Paper Session

Sunday, October 19

2:45 – 4:20 pm

Daiichi Sankyo Poster Presentations at ESMO (Free ESMO Whitepaper)

Presentation Title

Author

Abstract

Presentation (CDT)

Breast

Final real-world safety and effectiveness results of REALITY-01 study: trastuzumab deruxtecan (T-DXd) in patients received ≥2 prior treatment lines for HER2+ metastatic or unresectable breast cancer

J. Pierga

539P

Poster Session

The effectiveness of post-trastuzumab deruxtecan (T-DXd) treatment regimens and the incidence of recurrent interstitial lung disease (ILD) in patients with HER2+ metastatic breast cancer who discontinued T-DXd due to ILD

J. Tsurutani

540P

Poster Session

HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR low+/HER2− breast cancer

M. Danso

463eTiP

ePoster

Lung

Phase 1b study of valemetostat in combination with datopotamab deruxtecan (Dato-DXd) in advanced non-squamous non-small cell lung cancer: initial safety results

A. Spira

2023P

Poster Session

A phase 1b/2 study of gocatamig (MK-6070; HPN328) and ifinatamab deruxtecan for relapsed/refractory extensive-stage small cell lung cancer

J. Sun

2792TiP

Poster Session

KEYMAKER-U01 phase 2 substudies 01H/01I: ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) or docetaxel in stage IV non-small cell lung cancer

E. Nadal

2081eTiP

ePoster

Gastrointestinal

Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma: additional data from DESTINY-Gastric04

F. Pietrantonio

2099P

Poster Session

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

Z. Peng

2105P

Poster Session

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

L. Shen

2175P

Poster Session

Raludotatug deruxtecan in participants with gastrointestinal cancers: phase 2 REJOICE-GI01 trial

M. Ueno

1001TiP

Poster Session

Endometrial

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

B. Slomovitz

1223TiP

Poster Session

PanTumor

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

V. Makker

957P

Poster Session

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

D. Oh

145P

Poster Session

DS3201 (valemetostat), an EZH1/2 inhibitor, with ipilimumab in patients with refractory genitourinary tumors

S. Goswami

977P

Poster Session

Transgene and BioInvent to Present
Translational Data and Updated Clinical Results on Armed Oncolytic Virus BT-001, at ESMO 2025

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]).

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.

AstraZeneca furthers ambition to redefine cancer care with first data from four major pivotal trials at ESMO

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]).

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

Theolytics to Present Ongoing Phase I/IIa OCTOPOD-IV Trial of THEO-260 in Ovarian Cancer at ESMO 2025

On October 13, 2025 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported it will present a Trials in Progress Poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21 (Press release, Theolytics, OCT 13, 2025, View Source [SID1234656586]). Dr Margaret Duffy, CSO and Dr Matilde Saggese, CMO will be attending and will showcase the OCTOPOD-IV Phase I/IIa clinical trial of THEO-260, a novel oncolytic immunotherapy, given by intravenous delivery in patients with ovarian cancer.

Details of the ESMO (Free ESMO Whitepaper) presentation are:

Phase I/IIa, open-label, dose finding, safety and exploratory trial of THEO-260, a novel oncolytic immunotherapy, by intravenous delivery in patients with high grade serous or endometrioid ovarian cancer
· Presenter: Matilde Saggese, MD, MD (Res), CMO at Theolytics
· Presentation Number: 1238eTiP
· Session: Trials in Progress: – eTrial in Progress
· Session Time/ Place: Poster Session 2, Saturday 18 October 2025 [Messe Berlin]

The abstract is available online on the ESMO (Free ESMO Whitepaper) website.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase II dose and demonstrate THEO-260’s differentiated cancer-associated fibroblast ‘CAF-lytic’ mechanism of action in patients through comprehensive biomarker analysis.

Recruitment at UK clinical sites is ongoing and expansion into further international sites is planned (including Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

Matilde Saggese, MD, MD (Res), Theolytics’ CMO, said, "Recruitment is now well under way for our first ever clinical trial with THEO-260. Ovarian cancer remains a leading cause of cancer-related death amongst women, but with THEO-260’s differentiated mechanism of action in targeting and eliminating ovarian patient cancer cells and cancer-associated fibroblasts, whilst triggering immunogenic cell death and promoting T-cell activation, we hope that we can deliver a therapy that transforms outcomes for women with this devastating disease."

Patients with epithelial ovarian cancer almost invariably develop platinum-resistant disease, for which the prognosis is very poor. Treatment in this setting is challenging due to the complexity of the tumour microenvironment (TME) and most immunotherapies including checkpoint blockade have not proven effective. This may be attributed to an immune suppressed and stromal rich TME, with up to 60% of the tumour volume comprising cancer-associated fibroblasts (CAFs). THEO-260 is a novel oncolytic immunotherapy specifically evolved to target stromal rich tumours. In preclinical studies, THEO-260 has been shown to kill cancer cells and CAFs, trigger immunogenic cell death, and promote T-cell activation.