Ewa E. Kalinka

78P Patient-reported outcomes (PROs) of cemiplimab plus chemotherapy in advanced non-small cell lung cancer (aNSCLC): A focus on age subgroups from EMPOWER-Lung 3

A. Baramidze, M. Gogishvili, T. Makharadze, T. Melkadze et autres

In EMPOWER-Lung 3 (NCT03409614), cemiplimab (CEMI) plus chemotherapy (CHEMO) improved overall survival versus placebo (PBO) plus CHEMO, with a consistent safety profile. Here we report post hoc exploratory analyses of PROs by age (<65 and ≥65 years).

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VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor–Positive/HER2−/PIK3CA Wild-Type Advanced Breast Cancer

Sara A. Hurvitz, Rachel M. Layman, Giuseppe Curigliano, Fabrice André et autres

PURPOSE Gedatolisib potently targets all four class I PI3K isoforms and mTORC1 and mTORC2 to comprehensively block the PI3K/AKT/mTOR pathway and has shown compelling activity in early clinical trials with palbociclib and fulvestrant. METHODS This phase III randomized trial (VIKTORIA-1; ClinicalTrials.gov identifier: …

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Abstract LB-A005: DAREON-8: A Phase I trial of first-line obrixtamig plus chemotherapy and atezolizumab in extensive-stage small cell lung carcinoma (ES-SCLC)

Solange Peters, Rafal Dziadziuszko, Ewa E. Kalinka, Anas Gazzah et autres

Abstract Background Obrixtamig (BI 764532) is a DLL3/CD3 IgG-like T-cell engager. We report the first safety and efficacy data for the dose-escalation part of the Phase I DAREON-8 (NCT06077500) trial investigating obrixtamig + first-line (1L) standard of care (SOC; carboplatin + etoposide …

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Real-World Outcomes of Primary Versus Interval Debulking Surgery in a Multicenter Cohort of Advanced Ovarian Cancer Patients Treated with Bevacizumab

Kaja Michalczyk, Lubomir Bodnar, Marta Czeluścińska-Murawiec, Anna Dańska-Bidzińska et autres

Background: With an ongoing debate concerning the optimal timing of advanced ovarian cancer surgical treatment, primary debulking surgery (PDS) versus neoadjuvant chemotherapy followed by interval debulking surgery (IDS), this study aimed to compare survival outcomes between PDS and IDS populations and evaluate …

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Cemiplimab plus chemotherapy versus chemotherapy in advanced non-small cell lung cancer with PD-L1≥1%: 5‑year update of EMPOWER-Lung 3 results

Petra Hoffknecht, M Gogishvili, T Makharadze, T Melkadze et autres

Background: In EMPOWER-Lung 3 Part 2 (NCT03409614), a randomised, double-blind, placebo-controlled phase 3 study, cemiplimab+chemotherapy (chemo) showed significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) vs chemo and an acceptable safety profile in patients with squamous/non-squamous …

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First-Line Cemiplimab for Locally Advanced NSCLC: Updated Subgroup Analyses From the EMPOWER-Lung 1 and EMPOWER-Lung 3 Trials

Ewa E. Kalinka, Igor Bondarenko, Miranda Gogishvili, Tamar Melkadze et autres

Introduction: Patients with unresectable locally advanced NSCLC who are not candidates for concurrent chemoradiation represent an unmet medical need. We report long-term results for this patient subgroup from two phase III trials. Methods: We analyzed data from patients with locally advanced NSCLC …

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Immune-Related Adverse Events of Checkpoint Inhibitors and Human Leukocyte Antigen System: A Review

Kamil Kośmider, Agata Kozakiewicz, Paweł Krawczyk, Robert Kieszko et autres

Kamil Kośmider,1,2 Agata Kozakiewicz,3 Paweł Krawczyk,1 Robert Kieszko,1 Katarzyna Szklener,2 Magdalena Skórzewska,2 Kamila Wojas-Krawczyk,1 Ewa Kalinka,4 Janusz Milanowski1 1Department of Pneumonology, Oncology and Allergology, Medical University of Lublin, Lublin, Poland; 2Department of Clinical Oncology and Chemotherapy, Medical University of Lublin, Lublin, Poland; …

Randomized Multicenter Trial of Cladribine Alone (C) or in Combination with Cyclophosphamide (CC), and COP in Previously Untreated Low Grade B-Cell Non-Hodgkin Lymphoma Patients: The First Interim Analysis.

Ewa E. Kalinka, Jarosław Wajs, Kazimierz Sułek, Tadeusz Robak et autres

Abstract To comparatively assess first-line treatment with cladribine alone (C) or in combination with cyclophosphamide (CC), and COP (cyclophosphamide, vincristine, prednisone) in low grade B-cell non-Hodgkin lymphoma (NHL), previously untreated patients (pts) with Ann Arbor stage II–IV were randomly allocated to receive …

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