Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer.
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LBA4012 Background: DV+T showed encouraging efficacy with manageable safety for pts with HER2-expressing gastric or gastroesophageal junction (G/GEJ) cancer in the second- and later-line setting in a phase 1 trial (Wang et al, eClinicalMedicine, 2024). Here, we first report the efficacy and safety of 1L DV+Tor+C/Tra in pts with HER2-postive or HER2-low la/m G/GEJ cancer from the randomized phase 2 part of a seamless phase 2/3 trial. Methods: Pts with previously untreated HER2-positive (IHC 3+, or IHC 2+/FISH+) la/m G/GEJ cancer were randomized (1:1:1) to receive DV (2.5 mg/kg, Q2W) + Tor (3.0 mg/kg, Q2W) + CAPOX (oxaliplatin [OX]: 130 mg/m 2 , day 1; capecitabine [CAP]: 1000 mg/m 2 , days 1-14; Q3W) (experimental group [EG] 1), or DV + Tor +Tra (staring dose of 8 mg/kg followed by 6 mg/kg, Q3W) (EG2), or Tor + Tra + CAPOX (control group [CG] 1). For pts with HER2-low (IHC 1+, or IHC 2+/FISH-) la/m G/GEJ cancer, they were initially randomized (1:1) to receive DV (2.5 mg/kg) + Tor + CAPOX (EG1), or Tor + CAPOX (CG1) in stage 1; based on the safety data from stage 1, stage 2 was designed to randomize pts (1:1:1) to receive DV (2.5 mg/kg) + Tor + CAPOX (reduced dose: OX 100 mg/m 2 ; CAP 750 mg/m 2 ) (EG2), or DV (2.0 mg/kg) + Tor + CAPOX (reduced dose) (EG3), or Tor + CAPOX (CG2). The primary endpoint was objective response rate (ORR). Results: By date cutoff (Feb 7, 2025), 51 HER2-positive pts (mostly being HER2 IHC 3+) and 93 HER2-low pts (mostly being HER2 IHC 1+) were enrolled. In HER2-positive pts, superior ORR of 82.4% was observed in EG2. In HER2-low pts, the ORR was 70.8% in EG1 and the hazard ratio (HR) for PFS was 0.67 compared to CG1 in stage 1, which favored the experimental group; the highest ORR was 76.9% in EG2 in stage 2. Main outcomes are listed in the Table. Data will be updated during presentation. Conclusions: In pts with HER2-positive la/m G/GEJ cancer, DV + Tor + Tra demonstrated a superior ORR, offering a potential chemo-free treatment option. In pts with HER2-low la/m G/GEJ cancer, DV + Tor + CAPOX showed superior ORR and PFS with a manageable safety profile; lowering the CAPOX dose improved tolerability of the combination therapy while maintaining high efficacy. Clinical trial information: NCT05980481 . HER2-positive pts HER2-low pts / Stage 1 Stage 2 (dose optimization) EG1 (n=18) EG2 (n=17) CG1 (n=16) EG1 (n=25) CG1 (n=23) EG2 (n=14) EG3 (n=15) CG2 (n=16) Confirmed ORR*, % (95% CI) 66.7(41.0-86.7) 82.4(56.6-96.2) 68.8(41.3-89.0) 70.8(48.9-87.4) 47.8(26.8-69.4) 76.9(46.2-95.0) 60.0(32.3-83.7) 46.7(21.3-73.4) Median PFS follow-up, months 11.2 12.2 12.2 9.7 5.6 Median PFS (95% CI), months Immature 9.7(5.8-NE) 7.2(5.4-11.3) Immature HR / 0.67 / Any-G/G ≥3 TRAEs, % 100/94.4 100/82.4 100/75.0 100/100 100/87.0 100/85.7 100/73.3 100/75.0 *In pts with ≥1 post-baseline tumor assessment. PFS, progression-free survival; NE, not estimable; G, grade; TRAE, treatment-related adverse event.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Disitamab vedotin (DV) plus toripalimab (Tor) and chemotherapy (C)/trastuzumab (Tra) as first-line (1L) treatment of patients (pts) with HER2-expressing locally advanced or metastatic (la/m) gastric cancer.
- Date Crossref
- 10/06/2025
- Éditeur
- American Society of Clinical Oncology (ASCO)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Peking University pays non établi dans la noticeUniversité ou école supérieure
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Peking University Cancer Hospital pays non établi dans la noticeÉtablissement de santé
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Shandong Tumor Hospital pays non établi dans la noticeÉtablissement de santé
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Shandong First Medical University pays non établi dans la noticeUniversité ou école supérieure
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Huawei Technologies (China) pays non établi dans la noticeEntreprise
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Xuzhou Central Hospital pays non établi dans la noticeÉtablissement de santé
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Ruijin Hospital pays non établi dans la noticeÉtablissement de santé
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Harbin Medical University pays non établi dans la noticeUniversité ou école supérieure
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Third Affiliated Hospital of Harbin Medical University pays non établi dans la noticeÉtablissement de santé
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Tianjin Medical University Cancer Institute and Hospital pays non établi dans la noticeÉtablissement de santé
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Jinan Central Hospital pays non établi dans la noticeÉtablissement de santé
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Wuxi Fourth People's Hospital pays non établi dans la noticeÉtablissement de santé
Peking University, Peking University Cancer Hospital et Shandong Tumor Hospital, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.