PDS Biotechnology Corporation (NASDAQ: PDSB) has announced interim data from the Phase 2 trial led by the National Cancer Institute (NCI) evaluating PDS0101 (Versamune-HPV16) in combination with two investigational immune-modulating agents - bintrafusp alfa and NHS-IL12 for HPV16 positive cancers.
Data were presented at the American Society of Clinical Oncology 2021 Annual Meeting.
83% (5/6) of the patients demonstrated an objective response in relapsed or refractory checkpoint inhibitor naïve advanced cancer patients.
The reported objective response rate with the current standard of care checkpoint inhibitor treatment is 12-24%.
100% (6/6) are still alive at eight months.
80% (4/5) of patients with an objective response still have an ongoing response at eight months. One patient had a complete response.
In patients who have also failed checkpoint inhibitor therapy, tumor reduction was observed in 58% (7/12), with an overall objective response rate of 42% (5/12) already achieved.
83% (10/12) of patients are still alive at eight months.
Also, in patients with HPV16-negative cancer, 0% (0/7) experienced tumor reduction was observed.
80% (4/5) of checkpoint inhibitor naïve patients are still alive at eight months. 0% (0/2) checkpoint inhibitor refractory patients are still alive at eight months.
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