Safety and efficacy of CS2009, a first-in-class PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced non-small cell lung cancer: Results from a phase 1/2 study.
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Le résumé fourni par la source
8558 Background: CS2009 is a novel PD-1/VEGF/CTLA-4 trispecific antibody. An ongoing phase 1/2 study is evaluating its safety, tolerability, PK, PD, and anti-tumor activity as a single agent and in combination with systemic treatment in patients (pts) with advanced solid tumors. This study comprises a phase 1 dose escalation and phase 2 dose expansion. Here, we report the initial efficacy and safety data from advanced non-small cell lung cancer (NSCLC) pts treated in first-line and later-line settings. Methods: The study enrolled both treatment-naïve (1L) and heavily pre-treated later-line (≥2L) NSCLC pts. The ≥2L group included previously treated pts without known actionable oncogenic alterations (AGA) who had progressed on at least one prior line containing an anti-PD-1/L1 antibody and platinum-based chemotherapy; these pts received CS2009 at 10, 20, 30, or 45 mg/kg, i.v., Q3W, until disease progression or intolerance. The 1L cohort enrolled treatment-naïve pts with PD-L1 TPS ≥1% NSCLC without known AGA; these pts were randomized 1:1 to receive CS2009 at 20 or 30 mg/kg, i.v., Q3W, until disease progression or intolerance. Safety was assessed in all treated pts. Efficacy was assessed in pts who had at least one post-baseline tumor assessment per RECIST v1.1. Results: As of Jan. 4, 2026, 40 pts with ≥2L NSCLC were treated with CS2009 across four dose levels (10 mg/kg, n=3; 20 mg/kg, n=12; 30 mg/kg, n=20; 45 mg/kg, n=5). Median age was 67 (range 37-78) years; 72.5% were Asian, 27.5% were White; 77.5% were male; 77.5% had ECOG PS 1 at baseline. Among 30 efficacy-evaluable pts, ORR was 20.0% (6 PRs); in 16 pts treated at 30 mg/kg, ORR was 25.0% (4 PRs). Any-grade and grade ≥3 treatment-related adverse events (TRAEs) occurred in 27 (67.5%) and 8 (20.0%) pts, respectively. The most common TRAEs were proteinuria (12.5%), hypertension (12.5%), bilirubin conjugated increased (10.0%), and fatigue (10.0%), which were mostly grade 1 or 2, except for grade ≥3 hypertension in two pts. No treatment-related deaths were reported. TRAEs led to discontinuation in 3 (7.5%) pts. More mature ≥2L efficacy data with additional evaluable pts will be presented at the conference. As of Jan. 4, 2026, 19 pts with 1L NSCLC (PD-L1 TPS ≥1%) were randomized to receive CS2009 at 20 mg/kg (n=10) or 30 mg/kg (n=9). Median age was 69 (range 52-82) years; 84.2% were male; 89.5% had ECOG PS 1 at baseline. Preliminary encouraging efficacy and favorable safety signals were observed. Updated efficacy and safety data in approximately 50 1L pts will be disclosed at the conference. Conclusions: CS2009, as a first-in-class trispecific antibody targeting PD-1, VEGF, and CTLA-4, demonstrated a favorable safety profile and clinically meaningful anti-tumor activity in advanced NSCLC pts without known AGA. These findings warrant further investigation of CS2009 in this population. Clinical trial information: NCT06741644 .
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Safety and efficacy of CS2009, a first-in-class PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced non-small cell lung cancer: Results from a phase 1/2 study.
- Date Crossref
- 01/06/2026
- 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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Shanghai East Hospital Department of Medical Oncology pays non établi dans la noticeÉtablissement de santé
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Nanchang University Department of Respiratory and Critical Care Medicine pays non établi dans la noticeUniversité ou école supérieure
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First Affiliated Hospital of Nanchang University pays non établi dans la noticeÉtablissement de santé
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Harbin Medical University Department of Medical Oncology 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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First Affiliated Hospital of Zhengzhou University Department of Oncology pays non établi dans la noticeÉtablissement de santé
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Peking University Department of Thoracic Oncology II 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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Blacktown & Mount Druitt Hospital pays non établi dans la noticeÉtablissement de santé
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Shanghai Pulmonary Hospital Department of Thoracic Surgery pays non établi dans la noticeÉtablissement de santé
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Fujian Medical University pays non établi dans la noticeUniversité ou école supérieure
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Jilin Province Tumor Hospital pays non établi dans la noticeÉtablissement de santé
Department of Medical Oncology — Shanghai East Hospital, Department of Respiratory and Critical Care Medicine — Nanchang University et First Affiliated Hospital of Nanchang University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.