The company plans to initiate a P-III trial to evaluate PDS0101 + Keytruda vs Keytruda monotx. in patients with unresectable, recurrent/metastatic HPV 16+ HNSCC at ~90-100 sites globally. The trial is expected to be initiated in Q4’23
In the previous studies, patients treated with the combination therapy achieved ORR (41%) and an overall survival rate of 87% @9mos. in 17 evaluable patients with HPV16 & PD-L1+ recurrent or metastatic HNSCC, was well tolerated with no treatment-related grade 3 or 4 AEs
PDS0101 + Keytruda received FTD for HPV16+ HNSCC. The company has completed tech transfer, scale-up, and manufacturing activities required to initiate the trial & plans to submit an amended IND application to the US FDA in Q3’23
Ref: GlobeNewswire | Image: PDS
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