- PDS Biotechnology Corporation (NASDAQ:PDSB) announced interim data from the VERSATILE-002 Phase 2 trial of PDS0101 in combination with Merck & Co Inc’s (NYSE:MRK) Keytruda (pembrolizumab), in patients with unresectable, recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
- The estimated 12-month overall survival rate was 87.1%. Published results are 36-50%, with approved Immune Checkpoint Inhibitors (ICI) used alone.
- Median progression-free survival was 10.4 months. Published results are a median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.
- Related: PDS Biotech, Merck Germany Enter Licensing Pact For Investigational Cancer Treatment.
- A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34).
- The confirmed and unconfirmed objective response rate was 41.2% (14/34 patients), identical to the preliminary response rate data PDS Biotech reported at ASCO 2022 (7/17 patients).
- These responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.
- 15/34 patients (44.1%) had stable disease.
- 9/34 patients (26.5%) had progressive disease.
- “The interim data showed an estimated 12-month survival rate of 87% and a progression-free survival of 10.4 months, which is very encouraging given the poor prognosis these patients face,” stated Lauren V. Wood, M.D., PDS Biotech’s Chief Medical Officer and a co-author of the study.
- The company said that PDS0101, in combination with Keytruda, was associated with 8% of patients experiencing a Grade 3 treatment-related adverse event without more serious Grade 4 or 5 events.
- Price Action: PDSB shares are up 26.96% at $8.53 during the premarket session on the last check Friday.
Meteorological Service Singapore Advances Weather Forecasting With New Supercomputer From Hewlett Packard Enterprise
New supercomputer will speed up weather predictions and bolster climate research into Singapore's tropical climate trends with up to 2X more performance and advanced modeling and simulation capabilities
Hewlett
