Starlyte phase II study of coltuximab ravtansine (CoR, SAR3419) single agent: Clinical activity and safety in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL; NCT01472887).

Lymphoma and Plasma Cell Disorders
Session Type and Session Title: 
Oral Abstract Session, Lymphoma
Abstract Number: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 8506)
Marek Trneny, Gregor Verhoef, Martin JS Dyer, Dina Ben Yehuda, Caterina Patti, Miguel Canales, Andrés López, Farrukh Awan, Paul Montgomery, Andrea Janikova, Anna Maria Barbui, Kazimierz Sulek, Maria José Terol, John A. Radford, Laure Siraudin, Laurence Hatteville, Sandrine Schwab, Corina Oprea, Alessandro M. Gianni; Charles University Hospital, Department of Hematology, Prague, Czech Republic; UZ Leuven, Leuven, Belgium; Leicester University, Leicester, United Kingdom; Hadassah Medical Center, Jerusalem, Israel; Azienda Ospedali Riuniti Villa Sofia, Palermo, Italy; Hospital Universitario La Paz, Madrid, Spain; Hospital Universitari Vall d'Hebron, Barcelona, Spain; The Ohio State University, Columbus, OH; St. Lukes/Mountain States Tumor Institute, Boise, ID; University Hospital Brno, Brno, Czech Republic; Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy; Military Medical Institute, Warszawa, Poland; Hospital Clínico Universitario de Valencia, Valencia, Spain; University of Manchester/Christie Hospital NHS Foundation Trust, Manchester, United Kingdom; Lincoln, Boulogne-Billancourt, France; Sanofi R&D, Vitry-sur-Seine, France; Sanofi R&D, Chilly-Mazarin, France; Fondazione IRCCS Istituto Nazionale Tumori and Università degli Studi di Milano, Milan, Italy

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Abstract Disclosures


Background: CoR is an anti-CD19 antibody maytansinoid conjugate. CD19 is expressed in the majority of B cell lymphomas. Phase I program showed clinical activity in pts with both indolent and aggressive lymphomas. Methods: Pts withCD19+ R/R DLBCL after at least one standard treatment including rituximab and not candidate for transplantation were eligible. Primary refractory pts were excluded. Biopsy was required at baseline. CoR 55 mg/m² was administered weekly for 4 weeks then bi-weekly until disease progression or other study discontinuation criteria. The primary objective was to demonstrate an overall response rate (ORR) of at least 20% following Cheson 2007 criteria. Tumor assessments were done every 12 weeks. Secondary objectives were: safety, pharmacokinetics (PK), duration of response (DOR), progression free and overall survival (PFS, OS). Assessment of correlation between biomarkers (BM) status and disease outcome was an exploratory objective. Results: 41 pts were evaluable. Median age was 71 (39:85), 53.7% were male; 92.7% had ECOG performance status 0-1. 31.7% had received ≥ 3 prior regimens for DLBCL. The ORR was 43.9% (90% CI: 30.6% to 57.9%, p-value<0.0001) including 5 complete responses (12.2%). DOR, OS and PFS data are not mature (11 pts ongoing). The most common (>10%) all grades (gr) non-hematologic treatment-emergent adverse events (TEAEs) were nausea (23.0%), diarrhea (19.7%), fatigue and cough (18.0%), vomiting and decrease appetite (13.1%), asthenia, abdominal and back pain (11.5%). TEAEs led to treatment discontinuation in 4 pts. Only gr 1-2 eye disorders were reported, including 1 pt with unrelated gr 2 keratitis. Peripheral neuropathies were observed in 5 pts, all were gr 1-2. Hematological toxicity was moderate, with gr 3-4 neutropenia, thrombocytopenia and anemia in 26.4%, 9.9% and 6.6% pts respectively. PK assessment and investigations on BM expression are ongoing. Conclusions: CoR as single agent demonstrated significant activity in R/R DLBCL pts and reached its primary endpoint for ORR, with acceptable safety profile. Trial funded by Sanofi. Clinical trial information: NCT01472887.