Multicenter randomized, non-comparative, phase 2 trial of first-line atezolizumab plus mDCF for advanced anal cancer

The phase 2 SCARCE C17-02 PRODIGE 60 trial at 21 centers in France randomized patients with chemo-naïve, metastatic or unresectable locally advanced squamous cell carcinoma of the anus (aASCC) to atezolizumab every two weeks for a year plus 8 cycles of modified docetaxel, cisplatin, and fluorouracil (mDCF) or mDCF alone. The 12-month progression-free survival rate was 45% in the atezolizumab plus mDCF group versus 43% in de mDCF-alone group. Among participants with a PD-L1 combined positive score of 5 or greater, the 12-month PFS rate was 70% versus 40%. Atezolizumab-related serious adverse events occurred in 14% of patients in the atezolizumab plus mDCF group. There were no treatment-related deaths. The authors conclude that combining atezolizumab with mDCF is feasible. The predictive value of a PD-L1 CPS of 5 or greater needs to be confirmed in future studies.