FoRT 05-BEAT: A phase II randomized trial comparing atezolizumab versus atezolizumab + bevacizumab as first-line treatment in patients with PD-L1 high advanced/metastatic NSCLC.

Authors

null

Rita Migliorino

Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy

Rita Migliorino , Lorenza Landi , Domenico Galetta , Daniela Soregaroli , Serena Ricciardi , Gabriele Minuti , Michele Montrone , Ilaria Marech , Rossana Berardi , Silvia Novello , Danilo Rocco , Sara Pilotto , Francesca Zanelli , Carmelo Bengala , Angelo Delmonte , Michele Aieta , Diego Luigi Cortinovis , Federico Cappuzzo , Alessandro Morabito

Organizations

Pulmonary Oncology Unit, San Camillo-Forlanini Hospital, Rome, Italy, Istituto Nazionale Tumori Regina Elena, Roma, Italy, Medical Oncology Department, Clinical Cancer Center Giovanni Paolo II, Bari, Italy, Hospital San Camillo-Forlanini, Rome, Italy, A.O. San Camillo-Forlanini, Rome, Italy, UOC Oncologia Medica 2 Istituto Nazionale Tumori "Regina Elena", Roma, Italy, Clinical Cancer Center Giovanni Paolo II, Bari, Italy, Istituto Tumori “Giovanni Paolo II” IRCCS, National Cancer Research Center Onc, Bari, Italy, Clinical Oncology, Polytechnic University of Marche, AOU Ospedali Riuniti, Ancona, Italy, University of Turin, Department of Oncology, S. Luigi Hospital, Torino, Italy, Pneumology and Oncology Department, AORN dei Colli, Naples, Italy, U.O.C. Oncology, University of Verona, Azienda Ospedaliera Universitaria Integrata, Verona, Italy, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy, Misericordia Hospital, Grosseto, Italy, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori-RCCS, Meldola, Italy, IRCCS Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture (Potenza), Italy, Medical Oncology Unit, ASST San Gerardo Hospital Monza, Monza, Italy, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy

Research Funding

Pharmaceutical/Biotech Company

Background: Several ongoing phase III studies are evaluating the efficacy of first-line atezolizumab in combination with chemotherapy in patients with non small-cell lung cancer (NSCLC). Among angiogenesis inhibitors, bevacizumab is approved as first-line therapy in combination with chemotherapy or in combination with erlotinib in patients with NSCLC harboring activating EGFR mutations. Recent evidence (Wallin 2016) suggests that the combination of atezolizumab and bevacizumab increases intra-tumoral CD8+T cells, suggesting that dual VEGF and PD-L1 inhibition improves antigen-specific T-cell migration. In addition, preliminary clinical data suggested a strong synergistic effects of bevacizumab with immune checkpoint inhibitors. There is therefore a strong rationale for investigating the combination of atezolizumab and bevacizumab in patients with advanced/metastatic NSCLC. The FoRT 05-BEAT is a multicenter, Italian, phase II, randomized study comparing atezolizumab monotherapy versus the combination of atezolizumab and bevacizumab in patients with chemo-naive metastatic NSCLC and high levels of PD-L1 expression. Methods: The trial was conducted in 35 Italian centers: chemotherapy naive metastatic NSCLC patients, with high levels of PD-L1 expression (PD-L1 TPS ≥50% or TC/IC 3 scoring) were randomly assigned to atezolizumab monotherapy (1200 mg every 3 weeks) or to the combination of atezolizumab (1200 mg every 3 weeks) and bevacizumab (15 mg/kg every 3 weeks).The primary endpoint is overall survival (OS) rate at 18 months. Secondary endpoints include response rate (RR), PFS, OS according to presence of bone and/or hepatic metastases. Safety considerations will be considered. Exploratory analysis of predictive biomarker on tumor tissue and blood samples has been planned. Sample size has been calculated assuming a 18 months OS of 50% in the atezolizumab arm. Therefore, a total of 186 patients is needed to detect an absolute improvement of 20%, thus obtaining a 18mOS of 70% in the combination arm, with a power of 80% at a significance level of 5%. Taking into account the percentage of patients lost-to-follow-up, the sample size has been increased by 10% (N = 206 patients, 103 per arm). At the drafting of this abstract, 57 patients have already been enrolled (47 randomized). Clinical trial information: NCT03896074.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Metastatic

Track

Lung Cancer

Sub Track

Metastatic Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT03896074

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr TPS9145)

DOI

10.1200/JCO.2022.40.16_suppl.TPS9145

Abstract #

TPS9145

Poster Bd #

127a

Abstract Disclosures

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