AstraZeneca to present overall survival data from four pivotal Phase III trials in Presidential Symposia at ESMO 2026 featuring Sone-Ve, Imfinzi, Tagrisso and Orpathys
CLARITY-Gastric01 data will demonstrate potential of Sone-Ve to establish new treatment for broad population of CLDN18.2-positive gastric cancer patients. SAFFRON results will highlight clinical benefit of adding Orpathys to backbone Tagrisso in MET-driven 2nd-line EGFRm lung cancer. VOLGA and DeLLphi-305 data will showcase the transformative potential of combining Imfinzi with novel agents to set new standards of care in bladder and small cell lung cancer.
AstraZeneca advances 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) Congress, 23-27 October 2026.
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 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, 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 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 |
1 More than 100 abstracts at ESMO 2026 will feature AstraZeneca medicines and pipeline molecules
Notes
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.
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