Beta test.

This single arm phase 2 trial sought to determine if the addition of galunisertib, a TGF-beta type 1 receptor kinase inhibitor, to neoadjuvant chemoradiation for rectal cancer could improve pathologic complete response rates. Galunisertib was taken twice daily along with fluoropyrimidine-based chemotherapy during radiation. Most patients (66%) went straight to surgery, and 20% of those had a pCR. Just over a quarter (26%) of patients were clinical complete responders after nCRT and elected to have nonoperative management. Ultimately, 7 of these either eventually had surgery with a pCR or had ongoing cCR at 12 months. So, among the 38 patients enrolled, the complete response rate was 32%. That’s encouraging, but comparable clinical response rates have also been reported with the addition of irinotecan and TNT. | Yamazaki, Lancet Oncol 2022