CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase 3 study.
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Le résumé fourni par la source
LBA8502 Background: Anti-PD-(L) 1 monotherapy has been the standard first-line treatment for PD-L1 positive NSCLC, but its clinical benefit remains unsatisfactory. Benmelstobart (TQB2450) is a humanized monoclonal antibody against PD-L1 and anlotinib is a multikinase inhibitor that has been approved as the standard of care in the third-line treatment of NSCLC in China. This phase 3 study aimed to compare the efficacy of benmelstobart in combination with anlotinib and pembrolizumab as first-line treatment of PD-L1 positive aNSCLC. Methods: This is a randomized, single-blind, multicenter phase Ⅲ study (NCT04964479). Eligible patients (pts) were previous systemic treatment naïve, diagnosed with locally advanced or recurrent/metastatic NSCLC and had PD-L1 positive expression (defined as TPS ≥1%). Pts were randomized in a 2:1 ratio to receive either benmelstobart plus anlotinib (benmel+ anlo) or pembrolizumab plus placebo (pem+placebo). Anlotinib or placebo was administered orally at a dose of 12/0mg QD on days 1-14 of a 21-day cycle, while benmelstobart or pembrolizumab was given intravenously at a dose of 1200mg or 200mg on the first day of each cycle. The primary endpoint was progression-free survival (PFS) assessed by independent review committee (IRC). Results: Between August 2021 and December 2022, 531 pts were randomized (528 treated). At the data cutoff date of 20 May 2023, the median follow-up for PFS was 11.4 months for the benmel+anlo arm and 10.6 months for the pem+placebo arm. The study met its primary endpoint that the median PFS was significantly prolonged to 11.0 months (95% CI 9.2-12.6) in the benmel+anlo arm compared with 7.1 months (95% CI 5.8-9.5) in the pem+placebo arm (P = 0.007). The hazard ratio (HR) was 0.70 (95% CI 0.55-0.91). The HR for pts with squamous cell carcinoma and PD-L1 expression ≥50% was 0.63 (95% CI 0.46-0.86) and 0.60 (95% CI 0.41-0.88). The confirmed objective response rate was also obviously higher with combination therapy (57.3% vs. 39.6%; P < 0.001). The data for overall survival (OS) was immature. In total, 98.3% of pts in the benmel + anlo arm and 88.1% in the pem + placebo arm experienced at least one treatment-related adverse event (TRAE). The incidence of grade ≥3 TRAE was 58.5% and 29.0% in each group, respectively. Only 5.7%/3.7% of pts permanently discontinued benmelstobart/anlotinib since TRAE, while termination of pembrolizumab/placebo due to TRAE occurred in 8.0%/2.3% of pts. Conclusions: To our knowledge, this is the first phase III study to demonstrate the significant PFS benefit of a multikinase inhibitor plus an anti-PD-L1 mAb in the first-line treatment of PD-L1-positive aNSCLC compared to pembrolizumab. Tolerability is favourable with a lower incidence of treatment discontinuation due to TRAE. The data support this combination as a new option for these pts. Clinical trial information: NCT04964479 .
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC)—A randomized, single-blind, multicenter phase 3 study.
- 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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Shanghai Chest Hospital 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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Kunming Medical University Internal Medicine Department 2 pays non établi dans la noticeUniversité ou école supérieure
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Central South University pays non établi dans la noticeUniversité ou école supérieure
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Hunan Cancer Hospital pays non établi dans la noticeÉtablissement de santé
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Nanchang University 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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Shandong First Medical University pays non établi dans la noticeUniversité ou école supérieure
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Affiliated Hospital of Chengde Medical College pays non établi dans la noticeÉtablissement de santé
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Northern Jiangsu People's Hospital pays non établi dans la noticeÉtablissement de santé
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Harbin Medical University Respiratory Medicine Ward 3 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
Shanghai Chest Hospital, Tianjin Medical University Cancer Institute and Hospital et Internal Medicine Department 2 — Kunming Medical University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.