On May 21, 2025 AstraZeneca reported its ambition to eliminate cancer as a cause of death with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 30 May to 3 June 2025 (Press release, AstraZeneca, MAY 21, 2025, View Source [SID1234653255]).
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More than 80 abstracts will feature 20 approved and potential new medicines from the Company including two plenary presentations, one special late-breaking oral abstract session and 19 additional oral presentations. Highlights include:
SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation (Plenary #LBA4). Camizestrant is an investigational, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist. This is the first positive Phase III trial for a next-generation oral SERD in this 1st-line setting and the first positive Phase III trial for camizestrant.
MATTERHORN 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 (Plenary #LBA5).
DESTINY-Breast09 Phase III trial of Enhertu (trastuzumab deruxtecan) in combination with pertuzumab in the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Oral Abstract #LBA1008).
DESTINY-Gastric04 Phase III trial of Enhertu in patients with 2nd-line HER2-positive unresectable and/or metastatic gastric and GEJ cancers (#LBA4002).
NeoADAURA Phase III trial of neoadjuvant Tagrisso (osimertinib) with or without chemotherapy in resectable, early-stage EGFR-mutated non-small cell lung cancer (NSCLC) (Oral Abstract #8001).
TROPION-Lung02: Computational pathology biomarker analyses of the TROPION-Lung02 Phase Ib trial of Datroway (datopotamab deruxtecan) plus pembrolizumab with or without platinum chemotherapy as 1st-line treatment for patients with advanced NSCLC without actionable genomic alterations (Oral Abstract #8501).
KOMET Phase III trial of Koselugo (selumetinib) in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas (Rapid Oral Abstract #3014).
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Two key breast cancer presentations at ASCO (Free ASCO Whitepaper) will highlight the progress we are making with our innovative medicines and pipeline to change the treatment landscape. For camizestrant, SERENA-6 is the first pivotal Phase III trial to use circulating tumour DNA to inform a treatment switch, pioneering this technology in the first-line setting to delay disease progression in HR-positive, HER2-negative advanced breast cancer. In addition, DESTINY-Breast09 for Enhertu in combination with pertuzumab is the first trial in more than a decade to demonstrate superiority over first-line standard of care across a broad HER2-positive metastatic patient population."
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "The MATTERHORN data for perioperative Imfinzi in gastric and gastroesophageal junction cancers are a further example of our successful strategy to move immunotherapy into early stages of cancer where cure is the treatment goal. This is the seventh consecutive year AstraZeneca medicines will be featured in an ASCO (Free ASCO Whitepaper) plenary session, an extraordinary milestone which underscores the strength of our industry-leading oncology portfolio and pipeline across many types of cancer."
AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and Datroway, with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Koselugo (selumetinib), and with HUTCHMED to develop and commercialise Orpathys (savolitinib).
Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 20251
Lead Author
Abstract Title
Presentation details (CDT)
Antibody drug conjugates
Shitara, K
Trastuzumab deruxtecan (T-DXd) vs ramucirumab (RAM) + paclitaxel (PTX) in second-line treatment of patients (pts) with human epidermal growth factor receptor 2-positive (HER2+) unresectable/metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJA): Primary analysis of the randomized, phase 3 DESTINY-Gastric04 study.
Abstract #LBA4002
Oral Abstract Session
31 May 2025
3:24pm
Tolaney, SM
Trastuzumab deruxtecan (T-DXd) + pertuzumab (P) vs taxane + trastuzumab + pertuzumab (THP) for first-line (1L) treatment of patients (pts) with human epidermal growth factor receptor 2–positive (HER2+) advanced/metastatic breast cancer (a/mBC): Interim results from DESTINY-Breast09.
Abstract #LBA1008
Oral Abstract Session
2 June 2025
7:30am
Dent, R
Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy (TPC) in HER2-low/-ultralow, hormone receptor-positive (HR+) metastatic breast cancer (mBC) in DESTINY-Breast06 (DB-06).
Abstract #1013
Oral Abstract Session
31 May 2025
3:23pm
Levy, BP
TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).
Abstract #8501
Oral Abstract Session
1 June 2025
8:12am
Waqar, SN
First-line (1L) datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer (a/mNSCLC): Results from TROPION-Lung04 (cohort 5).
Abstract #8521
Poster Session
31 May 2025
1:30pm
Tumour drivers and resistance
Turner, NC
Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial.
Abstract #LBA4
Plenary Session
1 June 2025
2:41pm
Lu, S
Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.
Abstract #LBA8505
Oral Abstract Session
1 June 2025
9:48am
Levy, BP
Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).
Abstract #8513
Rapid Oral Abstract Session
2 June 2025
8:06am
Chaft JE
Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.
Abstract #8001
Oral Abstract Session
2 June 2025
3:12pm
Immuno-oncology & bispecifics
Janjigian, YY
Event-free survival in MATTERHORN: a randomized, phase 3 study of durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel chemotherapy (FLOT) in resectable gastric/gastroesophageal junction cancer (GC/GEJC).
Abstract #LBA5
Plenary Session
1 June 2025
3:13pm
Powles, T
Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA
Abstract #4503
Oral Abstract Session
1 June 2025
10:45am
Reck, M
Associations of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.
Abstract #8009
Rapid Oral Abstract Session
1 June 2025
4:30pm
Barbie, DA
Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).
Abstract #8014
Rapid Oral Abstract Session
1 June 2025
5:12pm
Mayadev, J
Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.
Abstract #5502
Oral Abstract Session
2 June 2025
8:48am
Westin, SN
Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA.
Abstract #5512
Rapid Oral Abstract Session
3 June 2025
8:30am
Erinjeri, JP
Outcomes by baseline tumor burden using the 6-and-12 score in EMERALD-1: a phase 3 study of durvalumab (D) ± bevacizumab (B) with transarterial chemoembolization (TACE) in embolization-eligible unresectable hepatocellular carcinoma (uHCC).
Abstract #4083
Poster Session
31 May 2025
9:00am
Cascone, T
Neoadjuvant durvalumab (D) + chemotherapy (CT) + novel anticancer agents and adjuvant D ± novel agents in resectable non-small-cell lung cancer (NSCLC): Updated outcomes from NeoCOAST-2.
Abstract #8046
Poster Session
31 May 2025
1:30pm
Zhou, J
First-line rilvegostomig (rilve) plus chemotherapy (CTx) in advanced biliary tract cancer (BTC): Primary analysis of GEMINI-Hepatobiliary substudy 2 Cohort A.
Abstract #4080
Poster Session
31 May 2025
9:00am
Xu, R
ARTEMIDE-Gastric01: a phase 3 randomized study of rilvegostomig with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) as first-line (1L) treatment for locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer (GC/GEJC).
Abstract #TPS4204
Poster Session
31 May 2025
9:00am
Mathias, C
ARTEMIDE-Lung03: a phase 3, randomized, double-blind, multicenter, global study of rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy as first-line treatment for patients with metastatic non-squamous non-small-cell lung cancer whose tumors express PD-L1.
Abstract #TPS8653
Poster Session
31 May 2025
1:30pm
Cell therapy
Yoo, C
RHEA-1: First-in-human (FIH) study of AZD9793, a first-in-class CD8-guided T cell-engager (TCE) for glypican-3-positive (GPC3+) advanced or metastatic hepatocellular carcinoma (HCC).
Abstract #TPS4215
Poster Session
31 May 2025
9:00am
Kim, TM
Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma.
Abstract #7046
Poster Session
1 June 2025
9:00am
Shadman, M
TITANium: An open-label, global multicenter Phase 1/2 study of AZD5492, a first-in-class subcutaneous CD8-guided tri-specific T-cell engager (TCE), in patients (pts) with relapsed or refractory (r/r) B-cell malignancies.
Abstract #TPS7091
Poster Session
1 June 2025
9:00am
Le Gouill, S
SOUNDTRACK-E: A Phase 1/2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or Combination Therapy in Patients With Mature B-cell Malignancies.
Abstract #TPS7083
Poster Session
1 June 2025
9:00am
Rare disease medicines
Chen, AP
Efficacy and safety of selumetinib in adults with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibroma (PN): Primary analysis of KOMET (NCT04924608), a Phase 3, international, randomized, placebo-controlled study.
Abstract #3014
Rapid Oral Abstract Session
2 June 2025
8:00am