Eugen Leo, Founder and CEO of LEOConsulting, shared a post on LinkedIn:
“The long-term follow-up of the first-in-human Phase 1/2a trial of visugromab (the GDFATHER01 trial) is out!
The brand-new publication in the Journal of Hematology and Oncology by Ignacio Melero et al. reports the long-term outcome of visugromab+nivolumab (V+N) treatment in anti-PD-(L)1 r/r solid tumors, extending substantially the initial results published in Nature in 12/2024.
What the data show in anti–PD-(L)1 relapsed/refractory patients:
(1) Exceptional, unparalleled durability of response with V+N – median DoR now 28.8 months on V+N vs 12.0 months on the patients’ initial, approved anti–PD-(L)1! (2) 7 of 8 CR/CMR responses are ongoing, (3) 46.2% of responders (6/13) achieved a deeper response on V+N than on their initial anti–PD-(L)1 therapy (RECIST v1.1), and (4) continued excellent tolerability of V+N.
A first glimpse into what visugromab can achieve in earlier lines of treatment has recently been shown at ESMO2025 in the GDFATHER_NEO trial led by Andrea Necchi – pCR 33.3% vs 7.1% and MPR 66.7% vs 21.4% (see graph below), and with radiologic ORR approximately 4 x higher in the N+V combination vs N alone in checkpoint-inhibitor-naive patients! Looking forward to more data from this trial coming SOON! The successful journey of visugromab continues!
My sincere gratitude to Ignacio Melero, Andrea Necchi and Martin Reck, and to all the investigators – past and present – of the visugromab trials.”
Title: Long-term follow-up of a phase 1/2 trial of anti-GDF-15 antibody visugromab plus anti-PD-1 antibody nivolumab in anti-PD-1/-L1 relapsed/refractory solid tumors
Authors: Ignacio Melero, María de Miguel, Elena Garralda Cabanas, Guillermo de Velasco, Markus Joerger, Juan Martín-Liberal, Maria Reig, David König, Joerg Trojan, Maria-Elisabeth Goebeler, Martin Schuler, Guzman Alonso, Reinhard Dummer, Maria E. Rodríguez-Ruiz, Ramón Yarza, Giulia Pretelli, Jorge Esteban-Villarubia, Kira-Lee Koster, Paula Sabat Viltro, Marco Sanduzzi-Zamparelli, Heinz Läubli, Christine Koch, Cyrus Sayehli, Tanja Gromke, Fabricio Racca, Egle Ramelyte, Peter R. Galle, Andrea Necchi, Martin Reck, Zlatko Trajanoski, Hubert Hackl, Falk Gogolla, Jaclyn Billing, Teresa Sattmann, Jörg Wischhusen, Christine Schuberth-Wagner, Julia Akdemir, Felix S. Lichtenegger, Alexandra Auckenthaler, Marlene Fox, Kathrin Klar, Petra Fettes, Mara Liebig, Aasim Amin, Sheena Sachdeva, Frank Hermann, Eugen Leo
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