Nicholas Hornstein, Gastrointestinal Medical Oncologist and Assistant Professor at Northwell Health Cancer Institute, shared on LinkedIn:
“Would you like a glimpse of the future? Where solid tumors may be heading?
Look no further.
Agenus may have had some ups and downs in the past (BATMAN -> ROBBIN), but Bot Bal looks like it has the capacity to absolutely change how we manage MSS solid tumors.
UNICORN, now in Nature Medicine. Phase 2, non-randomized, window-of-opportunity. Resectable rT3-4 colon cancer. One dose of botensilimab, two doses of balstilimab, surgery around day 30-40.
Highlights:
- MPR 36% (5/14) in MSS disease, pCR 29%. (compare to FOLFOX in FOxTROT: 8%)
- Bot alone in MSS: 0%. The PD-1 matters.
- dMMR Bot Bal: MPR 100%, pCR 93%
- 12-month EFS 100% in both Bot Bal cohorts
Yes there is tox. irAEs in 54%, mostly flu-like symptoms, and only one grade 3 (hyperthyroidism). No grade 3 diarrhea.
Every MSS responder cleared ctDNA before surgery, that’s a helpful tool for predicting response in a disease that may fibrose and stay visible on imaging.
The holy grail is almost here: melting the majority of rectal cancers away. In MSI-H we have AZUR-1. In MSS, perhaps we have this in the future.”
Title: Neoadjuvant botensilimab with or without balstilimab in pMMR and dMMR colon cancer: the phase 2 UNICORN trial
Authors: Filippo Ghelardi, Margherita Ambrosini, Alessandra Raimondi, Andrei Tyshevich, Federica Palermo, Francesca Bergamo, Vincenzo Nasca, Paolo Manca, Ilaria Mulas, Lisa Derosa, Gina Brown, Claudia Chiodoni, Massimo Di Maio, Samantha Di Donato, Anna Chiaramonte, Lorenzo Castagnoli, Stephanie Ni, Darryl Nousome, Erik Spickard, Antony Tin, Robert Lentz, Adham Jurdi, Giovanna Sabella, Daniele Spada, Stefano Tamberi, Alessandro Passardi, Federica Morano, Emiliano Tamburini, Chiara Rossi, Luca Azzolin, Francesco Cambuli, Antonia Martinetti, Elisa Sottotetti, Andrew Allan Almonte, Valerio Iebba, Chiara Ratti, Riccardo Cerantola, Özlem Kutlu, Eleonora Cristarella, Serenella M. Pupa, Cecilia Villa, Eleonora Perissinotto, Margherita Galassi, Andrea Barina, Fabrizio Vittadello, Marcello Guaglio, Gianluca Baiocchi, Andrea Sartore-Bianchi, Riccardo Rosati, Chiara Cremolini, Isacco Montroni, Sara Lonardi, Andrea Sottoriva, Filippo Pietrantonio.
Read the full article.
Learn more: UNICORN Challenges Immunotherapy Resistance in MSS Colon Cancer
