Slide 1: IMMUNOCERV Phase II Trial Combining PDS0101 with Chemoradiation for Cervical Cancer
IMMUNOCERV Phase II Trial Combining the HPV-specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer Adam J Grippin1, Kyoko Yoshida-Court1, Madison O’Hara1, Olsi Gjyshi2, Geena Mathew1, Maliah Domingo1, Lilie Lin1, Anuja Jhingran1, Melissa Joyner1,
Slide 2: Disclosure
Disclosure Employed by The University of Texas MD Anderson Cancer Center. Inventor on a patent application related to cancer vaccines This presentation discusses investigational use of PDS0101 in a clinical trial sponsored by PDS Biotechnology.
Slide 3: Rationale
Rationale Although they express virus-associated antigens, there are currently no HPV-targeted therapies to treat HPV-related cancers.1 PDS0101 is a novel, subcutaneously administered Type I interferon and CD8 T-cell activating immunotherapy containing peptide pools encoding HPV antigens E6/E7.2 The
Slide 4: Trial Design
Trial Design Primary Endpoint: Clinically significant grade ≥3 acute toxicities from first vaccine injection up to 30 days following completion of chemoradiation (Day -10 to day 80) Prespecified secondary endpoints: Complete metabolic response (CMR) on Day 170 PET CT (± 14 days) ≥90% gross tumor vol
Slide 5: Patient Enrollment and Demographics
Patient Enrollment and Demographics n (%) Age, median (range), years Age, median (range), years 40 (26-79) Ethnicity Native Hawaiian or Other Pacific Islander 1 (5.8) White or Caucasian 11 (64) Other 1 (5.8) Patient Refused 1 (5.8) Black or African American 2 (11) Clinical Stage IB3 1 (5.8) IIB 4 (2
Slide 6: PDS0101 was well-tolerated
PDS0101 was well-tolerated Acute grade 3+ adverse events occurred in eight patients (47%), approximating the expected rate of Grade 3+ adverse events among patients receiving chemoradiation and brachytherapy boost of 46% (Rose, NEJM 1999; Rose, JCO 2007; Keys, NEJM 1999; Morris, JCO 1999; Eifel, JCO
Slide 7: Complete metabolic response and GTV reduction at Day 35 MRI
Complete metabolic response* at 4 months** GTV Reduction at Day 35 MRI Radiographic Response *Maximum SUV<4 on PET. ** CMR ultimately achieved in 15/17 (88%) patients
Slide 8: Patients in this high-risk cohort demonstrated promising survival outcomes
Patients in this high-risk cohort demonstrated promising survival outcomes 36 month OS = 84.4% 36 month PFS = 74.9% *Both deaths occurred in patients with Stage IVA disease. One death was related to disease and the other was caused by cardiac arrest in a disease-free patient.
Slide 9: Receipt of all five planned doses of PDS0101 was associated with improved PFS
Receipt of all five planned doses of PDS0101 was associated with improved PFS
Slide 10: >75% volume reduction at Day MRI was associated with improved PFS
>75% volume reduction at Day 35 MRI was associated with improved PFS
Slide 11: Conclusions
Conclusions In this final report of the IMMUNOCERV clinical trial, PDS0101 was safe and well-tolerated, and receipt of all prescribed doses of PDS0101 was associated with improved PFS. Further investigation of PDS0101 in cervical cancer in combination with pembrolizumab is warranted.
Slide 12: Acknowledgements
Acknowledgements MD Anderson Department of Radiation Oncology Kyoko Yoshida-Court, PhD Kathleen Schmeler Geena Mathew Erica Lynn Maliah Domingo Aaron Seo, MD, PhD Lilie Lin, MD, PhD Sage Copling Anuja Jhingran, MD Lauren Colbert, MD Melissa Joyner, MD Ann Klopp, MD Tatiana Cisneros Napravnik Saint E