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• W3088693805 abstract "Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1. Results from a global phase 1 study (NCT02517398) found an objective response rate (ORR) of 27.5%, median overall survival (OS) of 17.1 months, and a manageable safety profile in patients who received bintrafusp alfa 1200 mg every 2 weeks (Q2W) in the 2L setting at 2 years of follow-up. Here we present efficacy and safety data for 3 years of follow up. Patients with advanced NSCLC, unselected for PD-L1 expression, who had disease progression after platinum-based 1L treatment with no prior immunotherapy were randomized to receive bintrafusp alfa at the recommended phase 2 dose of 1200 mg (n=40) Q2W until disease progression, unacceptable toxicity, or trial withdrawal. The primary objective was best overall response per RECIST 1.1. Secondary and exploratory objectives included safety, duration of response (DOR), and OS. As of March 31, 2020, 40 patients received bintrafusp alfa 1200 mg Q2W for a median of 16.9 (range, 2-160) weeks. The median follow-up was 153.3 weeks, and 16 patients were still alive; 2 patients had an ongoing response, and 1 patient remained on treatment. The median DOR was 18 months and 21.2% (n=2) of patients had responses lasting ≥24 months. The 12-, 24-, and 36-month OS rates were 66.2%, 39.7%, and 23.2%, respectively. By subgroups of PD-L1 expression, the median OS was 21.7 months in PD-L1 positive (≥1%) patients and not reached in patients with high PD-L1 expression (≥80% by 73-10 assay). The 36-month OS rate was 33.6% in PD-L1 positive patients and 66.7% in patients with high PD-L1 expression. No new safety signals were observed. After 3 years of follow-up, bintrafusp alfa at 1200 mg Q2W as 2L therapy continues to show durable responses and long-term survival with a manageable toxicity profile in patients with advanced NSCLC. A phase 3 study evaluating bintrafusp alfa vs pembrolizumab as 1L treatment for patients with advanced NSCLC that has high PD-L1 expression is ongoing (NCT03631706)." @default.
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• W3088693805 date "2020-09-01" @default.
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• W3088693805 title "1272P Three-year follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, for second-line (2L) treatment of non-small cell lung cancer (NSCLC)" @default.
• W3088693805 doi "https://doi.org/10.1016/j.annonc.2020.08.1586" @default.
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