PDS Biotech Reports P-II Clinical Trial Results of Triple Combination Therapy for Human Papillomavirus-Positive Cancers
- The interim results from the P-II trial evaluating the triple combination of PDS0101 + M9241 (tumor-targeting IL-12 fusion protein) & bintrafusp alfa (bifunctional fusion protein targeting PD-L1 & TGF-β) in 40 CPI-naïve & CPI-refractory patients with advanced HPV+ anal, cervical, head & neck, vaginal, and vulvar cancers
- The results showed m-OS (21mos.) in 29 CPI refractory patients with ORR (63%) who received the optimal dose of the triple combination. In CPI naïve, 75% were alive at a median follow-up of 27mos., m-OS not reached, ORR (88%), historically m-OS was 3-4mos & 7-11mos. in CPI refractory & naïve disease
- Grade 3 TRAEs (48%) and grade 4 AEs (4%) over 70% received the combination of CPIs and CT reporting grade ≥3 TRAEs
Ref: Globe Newswire | Image: PDS
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