Primary-source record
Decision-gradeTopline results
PDSB: VERSATILE-002 Phase 2 PDS0101 + pembrolizumab JAMA Oncology publication reports 39.3-mo mOS in 1L HPV16+ R/M HNSCC
Publication of VERSATILE-002 Phase 2 results shows 39.3-month median overall survival and 36% ORR (including complete responses) for PDS0101 plus pembrolizumab in ICI-naïve CPS≥1 patients, substantially exceeding historical pembrolizumab benchmarks of 17.9 months mOS and 19% ORR. The combination was well tolerated. PDS Biotech is prioritizing PDS0301 in mCRC and seeking partners for Phase 3 development of PDS0101.
Key facts
- Filed
- Sep 22, 2026, 12:05 PM
- Event
- Topline results
- Direction
- Positive
- Company
PDSBPDS Biotechnology- Asset
- PDS0101
- Source
- SEC 8-K
- Confidence
- Sourced
- ORR
- 36%
- mOS
- 39.3 months (95% CI, 23.9 to NE)
- TRAEs Grade3+
- 13.8%
- CR rate central
- 6/53
- CR rate investigator
- 5/53
Source excerpt
EX-99.1 2 ef20082545_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 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 39.3 months median overall survival in first-line (1L) R/M immune checkpoint inhibitor naïve patients Company continues to prioritize PDS0301 in metastatic colorectal cancer (mCRC) while pursuing partnership strategy for PDS0101 PRINCETON, N.J., September 22, 2026 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced the publication of results from a Phase 2 trial evaluating PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology , a peer reviewed journal of the American Medical Association . The data were published in an article titled “ VERSATILE-002 – A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Trial. ” Key findings ● 62.3% of the ICI-naïve participants in the mITT cohort (n = 53) had low CPS of 1-19, and 37.7% had high CPS ≥ 20. In the overall CPS ≥ 1 population, the mOS was 39.3 months (95% CI, 23.9 to NE); The best published result with st