PDS Biotech Announces Publication of VERSATILE-002 Phase 2 Clinical Trial Results of PDS0101 with pembrolizumab in HPV16-Positive Recurrent and/or Metastatic (R/M) Head and Neck Cancer in JAMA Oncology
PDS Biotech published Phase 2 VERSATILE-002 results in JAMA Oncology showing PDS0101 plus pembrolizumab produced 39.3 months median overall survival (95% CI, 23.9 to NE) in HPV16-positive recurrent/metastatic head and neck cancer, versus a best published 17.9 months for standard-of-care pembrolizumab regimens. Objective response rate was 36% by investigator review (34% by central review) among 53 ICI-naive patients, with 5-6 complete responders, against a published 19% ORR for pembrolizumab alone; Grade ≥ 3 treatment-related adverse events ran 13.8% versus 17% for standard of care.
Key figures
- Drug Name
- PDS0101
- Phase Of Trial
- Phase 2
- Trial sites
- 26
- Median os ci
- 95% CI, 23.9 to NE
- Mitt population
- 75
- Median os months
- 39.3
- Orr investigator
- 36%
- Orr soc benchmark
- 19%
- Patients enrolled
- 88
- Safety population
- 87
- Ici naive patients
- 53
- Orr central review
- 34%
- Pipe financing usd
- 22300000
- Grade3plus trae rate
- 13.8%
- Ici resistant patients
- 22
- Grade3plus trae soc benchmark
- 17%
- Median os soc benchmark months
- 17.9
- Complete responses investigator
- 5/53
- Complete responses central review
- 6/53
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