Interim results analysis of the PERFECTION observational study in patients with metastatic non-small cell lung cancer

• DOI: 10.26442/18151434.2024.4.203109
• Publication Date: 2025-02-18T07:42:26Z
• Authors: Konstantin K. Lak...; Mikhail Fedyanin; Daniil L. Stroyak...; Anastasiia S. Moc...; Aishat R. Iasieva; Natal'ia V. Fadeeva; Iuliia S. Shapova...; Oleg V. Mironov; Aleksandr S. Derg...; Sergey V. Orlov; Leonid A. Vasilev; El'vira A. Bobrova; Svetlana A. Orlova; Antonina A. Kosuk...; Natal'ia I. Polshina; Sergei G. Vardanian; Aleksei Iu. Fedoseev; Karina Sh. Tumasian; Anastasiia E. Dan...; Tatiana V. Krashi...; Ekaterina I. Tsyg...; Dmitrii E. Staritsyn; Ol'ga V. Toporkova; Mira V. Boskhomdz...; Alexander V. Sult...; Margarita V. Edam...; Vadim N. Dmitriev; Aleksandr V. Shkr...; Konstantin A. Shkret; Oxana N. Prosiani...; Evgeny V. Svechnikov; Semyon Yu. Grigor...
• Keywords: Interim analysis; Interim

Aim. To evaluate the efficacy and safety profile of pembrolizumab biosimilar, Pembroria, in patients with advanced lung cancer routine clinical practice. Materials methods. The eligible for therapy based on standard indications without contraindications participated multicenter, multicohort, post-marketing, prospective, non-interventional study. primary endpoint was best objective response rate (ORR) assessed within six months treatment initiation. This report presents interim analysis non-squamous non-small cell (nsNSCLC) squamous (sNSCLC) using Fleming’s two-stage single-arm design (stages g1 g2). Thresholds hypothesis testing sample size determination were established literature benchmarks. Results Non-squamous NSCLC. Stage enrolled 20 a median age 64 years. follow-up period assessing 2.57 months. An achieved 55% (11/20) patients, meeting predefined criteria at stage g1. Squamous included 23 results g1, study proceeded to g2 enrollment an additional g2, yielding total 46 participants 66 ORR 47.8% (22/46) observed, confirming pembrolisumab biosimilar g2. assessment 2.88 Across six-month period, nine adverse events (AEs) reported among seven (8.4%) NSCLC cohort. Four AEs considered therapy-related classified as Grade 2 per CTCAE v5.0. No 4/5 recorded. Conclusion. In cohort, (Pembroria) has demonstrated comparable that reference trials both nsNSCLC sNSCLC, regardless PD-L1 expression levels or regimens. These findings support real-world Pembroria diverse patient population.