Two-year follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-b and PD-L1, for second-line (2L) treatment of non-small cell lung cancer (NSCLC)
Abstract No : 9558
Abstract Type : Poster Session
Indication : Non-Small Cell Lung Cancer
Intervention : Bintrafusp alfa (M7824)
Company : Merck KGaA, Darmstadt, Germany, Pharmaceutical/Biotech Company
Technology : Bifunctional fusion protein
As of October 15, 2019, a total of 40 patients received bintrafusp alfa at the recommended phase 2 dose of 1200 mg Q2W for a median of 17 (range, 2-136) weeks, with a median follow-up of 128 weeks; 18 patients were still alive, 3 patients had an ongoing response, and 1 patient remained on treatment. Results for the 1200 mg dose cohort showed an ORR of 27.5%, and a median duration of response of 18 months. The 18- and 24-month progression-free survival and OS rates were 18.4% and 11.0%, and 49.7% and 39.7%, respectively. Duration of response rates at 18 and 24 months were 42.4% and 21.2%, respectively. Median OS in patients with positive ($1%) PD-L1 expression was 21.7 months; 6 of 7 patients with high ($80% with Ab clone 73-10, which is equivalent
to $50% with 22C3) PD-L1 expression were still alive. The overall safety profile has remained consistent since the interim analysis, with no new safety signals or deaths and 1 additional treatmentrelated discontinuation (blood alkaline phosphatase increased)
After two years of follow-up, bintrafusp alfa continues to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression. A study evaluating bintrafusp alfa vs pembrolizumab as first-line treatment for NSCLC is ongoing in patients with high PD-L1 expression (NCT03631706).
After two years of follow-up, bintrafusp alfa continues to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression. Median OS was 21.7 months in PD-L1 positive patients and median DoR was 18.0 months.