SERENA-6 研究的全体大会报告将聚焦用于晚期 HR 阳性乳腺癌一线治疗的新一代口服 SERD 药物 Camizestrant

MATTERHORN 研究的全体大会报告将展示英飞凡用于早期胃和胃食管结合部腺癌的围手术期治疗方案

DESTINY-Breast09 研究的专场口头报告将强调优赫得在 HER2 阳性转移性乳腺癌更前线治疗的潜力

上海 2025年5月22日 /美通社/ -- 阿斯利康在2025年5月30日至6月3日召开的美国临床肿瘤学会（ASCO）上，凭借行业领先的多样化产品与管线布局的全新研究数据，进一步深化自身让癌症不再成为致死主因的雄心。

会上将有超过80个摘要公布，其中涵盖20款已获得批准的药物和潜在新药，包括两项重磅研究的全体大会报告（plenary presentation），一项特别重磅研究摘要口头报告（late-breaking oral abstract session），以及19项口头报告。其中亮点包括：

  • SERENA-6 ：评估了Camizestrant与广泛获批的细胞周期蛋白依赖性激酶（CDK）4/6抑制剂联合，用于一线治疗激素受体（HR）阳性、HER2阴性且肿瘤出现ESR1突变的晚期乳腺癌患者的III期临床研究（Plenary #LBA4）。Camizestrant是在研的新一代选择性雌激素受体降解剂（SERD）和完全ER拮抗剂。这是首个在一线治疗中取得阳性结果的新一代口服SERD药物III期临床研究，也是Camizestrant的首个III期阳性结果。
  • MATTERHORN：评估了度伐利尤单抗联合FLOT化疗作为可切除的早期和局部晚期的胃和胃食管结合部腺癌（GEJ）患者围手术期治疗方案的III期研究（Plenary #LBA5）。
  • DESTINY-Breast09：评估德曲妥珠单抗联合帕妥珠单抗用于一线治疗HER2阳性转移性乳腺癌患者治疗获益的III期研究（口头报告摘要#LBA1008）。
  • DESTINY-Gastric04 ：评估了德曲妥珠单抗用于二线治疗HER2阳性不可切除和/或转移性胃和胃食管结合部腺癌患者的治疗获益的III期研究（#LBA4002）。
  • NeoADAURA：奥希替尼联合或不联合化疗作为新辅助治疗用于可切除的早期EGFR突变非小细胞肺癌（NSCLC）的III期临床研究（口头报告摘要#8001）。
  • TROPION-Lung02：Datroway联合帕博利珠单抗的联合或不联合铂类一线化疗治疗无驱动基因突变的晚期非小细胞肺癌的Ib期临床研究结果，基于计算病理学生物标志物分析（口头报告摘要#8501）。
  • KOMET：评估司美替尼治疗伴有症状性、无法手术的丛状神经纤维瘤的1型神经纤维瘤病成人患者的III期临床研究（快速口头摘要#3014）。

阿斯利康全球执行副总裁、全球肿瘤研发负责人高书璨（ Susan Galbraith）表示："本次ASCO大会上公布的两项乳腺癌重磅研究数据将凸显我们在以创新药物和产品管线改变肿瘤治疗结局上所取得的进展。SERENA-6是首个采用循环肿瘤DNA检测指导治疗方案切换的一项关键III期临床研究，开创了这一技术在一线治疗中的应用，以延缓HR阳性、HER2阴性晚期乳腺癌的疾病进展。此外，DESTINY-Breast09研究评估了德曲妥珠单抗与帕妥珠单抗的联合治疗方案，这是十年来首次在HER2阳性转移性乳腺癌广泛患者群体中，证明疗效优于目前一线治疗标准方案的试验。"

阿斯利康全球执行副总裁，全球肿瘤研发负责人Dave Fredrickson表示："MATTERHORN的研究数据证明，度伐利尤单抗作为胃和胃食管结合部腺癌患者围手术期的治疗方案，是我们将免疫疗法迁入癌症早期阶段治疗的成功例证，有望实现早期治愈的可能。这是阿斯利康连续第七年登上ASCO全体大会，这一非凡的里程碑彰显出我们在多个癌肿领域已建立行业领先的肿瘤产品组合和强大的研发管线。

阿斯利康与第一三共联合开发和商业化德曲妥珠单抗与Datroway；与默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）联合开发和商业化司美替尼；与和黄医药合作开发和商业化赛沃替尼。

阿斯利康在 2025 年 ASCO 大会期间的重要演讲 1

主要作者

摘要标题

演示文稿详情  (CDT)

抗体偶联药物

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

 

 

肿瘤驱动因素和耐药性

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

 

 

 

免疫肿瘤学与双特异性抗体

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

 

 

 

细胞疗法

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

 

 

 

罕见病药物

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

 

 

 

1  阿斯利康在2025年ASCO大会将公布超过80个摘要，涵盖其产品和管线中的分子药物