Meeting
2016 ASCO Annual Meeting
Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced unresectable mesothelioma from the JAVELIN solid tumor phase Ib trial: Safety, clinical activity, and PD-L1 expression.
Authors
Raffit Hassan
Thoracic and Gastrointestinal Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD
Raffit Hassan , Anish Thomas , Manish R. Patel , John J. Nemunaitis , Jaafar Bennouna , John D. Powderly II, Matthew H. Taylor , Afshin Dowlati , Franklin Chen , Joseph Leach , Ulka N. Vaishampayan , Claire F. Verschraegen , Jean-Pierre Delord , Hans Juergen Grote , Anja von Heydebreck , Jean-Marie Cuillerot , James L. Gulley
Organizations
Thoracic and Gastrointestinal Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, Sarah Cannon Research Institute/Florida Cancer Specialists, Sarasota, FL, Mary Crowley Cancer Research Centers, Dallas, TX, Institut de Cancérologie de l'Ouest – site René Gauducheau, Saint Herblain, France, Carolina BioOncology Institute, Huntersville, NC, Knight Cancer Institute, Oregon Health and Science University, Portland, OR, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, Novant Health Oncology Specialists, Winston-Salem, NC, Virginia Piper Cancer Institute, Minneapolis, MN, Karmanos Cancer Institute, Detroit, MI, University of Vermont, Burlington, VT, Institut Claudius Regaud, Toulouse, France, Merck KGaA, Darmstadt, Germany, EMD Serono, Billerica, MA, Genitourinary Malignancies Branch, National Cancer Institute at the National Institutes of Health, Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD
Research Funding
Pharmaceutical/Biotech Company
Background: Avelumab* is a fully human anti-PD-L1 IgG1 antibody under clinical investigation in multiple cancers. We report safety and clinical activity of avelumab in patients (pts) with unresectable mesothelioma (NCT01772004). Methods: Pts with unresectable pleural or peritoneal mesothelioma, progressed after a platinum-pemetrexed-containing regimen and unselected for PD-L1 expression, were treated with avelumab 10 mg/kg IV Q2W until progression, unacceptable toxicity, or withdrawal. Tumors were assessed every 6 wks (RECIST 1.1). Objective response rate (ORR) and progression-free survival (PFS) were evaluated. Adverse events (AEs) were graded by NCI CTCAE v4.0. PD-L1 expression was assessed by IHC. Results: As of Oct 23, 2015, 53 pts were treated with avelumab and followed for a median of 46 wks (range 11-59). Median age was 66 y (range 32-84), ECOG PS was 0 (26.4%) or 1 (73.6%), median number of prior treatments was 1.5 (range 0-7). Histology was epithelial (81.1%), mixed (11.3%), sarcomatoid (3.8%), or unknown (3.8%). Treatment-related (TR) AEs occurred in 41 pts (77.4%); most common (>10%) were infusion-related reaction (20 [37.7%]), fatigue (8 [15.1%]), chills (8 [15.1%]), and pyrexia (6 [11.3%]), all of grade 1/2. Grade ≥3 TRAEs occurred in 4 pts (7.5%; colitis, decreased lymphocytes, and increased GGT or CPK [each 1 event]); there were no treatment-related deaths. Unconfirmed ORR was 9.4% (5 PRs; 95% CI: 3.1, 20.7); 4 were ongoing. Stable disease was observed in 25 pts (47.2%); disease control rate was 56.6%. Median PFS was 17.1 wks (95% CI: 6.1, 30.1), and PFS rate at 24 wks was 38.4% (95% CI: 23.3, 53.4). Using a ≥5% cutoff for tumor cell staining, 14/39 evaluable (35.9%) were PD-L1+, ORR was 14.3% in PD-L1+ (2/14) vs 8.0% in PD-L1– pts (2/25), and median PFS was 17.1 wks (95% CI: 5.4, ne) in PD-L1+ vs 7.4 wks (95% CI: 6.0, 30.1) in PD-L1− pts. Conclusions: Avelumab showed an acceptable safety profile and clinical activity in PD-L1+ and PD-L1− pts with advanced unresectable mesothelioma, a dataset representing the largest study to date of an all-comer population in this tumor type treated with anti-PD-(L)1. *Proposed INN. Clinical trial information: NCT01772004
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Abstract Details
Session Type
Oral Abstract Session
Session Title
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Track
Lung Cancer
Sub Track
Mesothelioma
Clinical Trial Registration Number
NCT01772004
Citation
J Clin Oncol 34, 2016 (suppl; abstr 8503)
DOI
10.1200/JCO.2016.34.15_suppl.8503
Abstract #
8503
Abstract Disclosures
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