Antibody-drug conjugate outperforms chemotherapy

The antibody-drug conjugate becotatug vedotin improved both objective response rate (ORR) and progression-free survival (PFS) in participants with heavily pretreated nasopharyngeal carcinoma (NPC) compared to chemotherapy, according to results from a randomised, phase 2 study.

A standard-of-care for patients with recurrent/metastatic NPC who failed on systemic chemotherapy and immunotherapy is currently lacking. Previously, phase 1 and 2 studies demonstrated promising antitumour activity of becotatug vedotin, an EGFR-targeted antibody-drug conjugate, in patients with recurrent/metastatic NPC who had failed after ≥1 line of platinum-based chemotherapy with or without inhibitors for programmed cell death protein-1 (PD-1) or its ligand PD-L1 [1,2]. From this, the efficacy and safety of becotatug vedotin were explored in a phase 2, randomised, open-label study (NCT05126719); Prof. Fei Han (Sun Yat-sen University Cancer Center, China) presented the outcomes [3].

A total of 172 heavily pre-treated (median prior treatment lines 3) participants were 1:1 randomised to receive becotatug vedotin or chemotherapy (capecitabine, docetaxel) until disease progression or intolerable toxicity. Participants in the chemotherapy arm were allowed to cross over to becotatug vedotin at disease progression.

The study met both primary endpoints, defined as ORR and PFS. The objective response rate was 30.2% (95% CI 20.8–41.1%) in the becotatug vedotin arm versus 11.5% (95% CI 5.7–20.1%) in the chemotherapy arm (odds ratio 3.3; P=0.0025). Median PFS reached 5.82 months (95% CI 4.21–6.24) versus 2.83 months (95% CI 2.00–5.45), respectively (HR 0.63; 95% CI 0.43–0.91; P=0.0146). “Becotatug vedotin promoted a 37% reduction in the risk of disease progression or death”, highlighted Prof. Han. The benefit of becotatug vedotin was observed across all subgroups (age, sex, liver/lung metastases, EGFR status). Overall survival, as a secondary endpoint, was not yet mature, and the follow-up is ongoing.

Becotatug vedotin showed a manageable safety profile with no unexpected adverse events and a low rate of discontinuation (3.5% vs 3.4% in the chemotherapy arm). “These findings support becotatug vedotin as a new treatment option for patients with recurrent/metastatic NPC after failing on chemotherapy and immunotherapy”, concluded Prof. Han.

1. Qui MZ, et al. JAMA Oncol. 2022;8(7):1042–1046.
2. Han F, et al. Ann Oncol. 2023;34 (suppl_2):S559.
3. Han F, et al. Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: a randomized-controlled, multicenter, open-label study. Abstract LBA6005, ASCO Annual Meeting 2025, May 30–June 3, Chicago, IL, USA.

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Posted on 30 July 2025