PF-06753512 / Pfizer - LARVOL DELTA

First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). (PubMed, J Immunother Cancer) - P1 | "PrCa VBIR overall demonstrated safety signals similar to other ICI combination trials; significant side effects were seen in some patients with BCR. It stimulated antigen-specific immunity across all cohorts and resulted in modest antitumor activity in patients with BCR without using ADT."

Journal • Metastases • P1 data • P1 data • Endocrine Disorders • Fatigue • Genito-urinary Cancer • Immune Modulation • Infectious Disease • Influenza • Oncology • Prostate Cancer • Respiratory Diseases • Solid Tumor • PSCA

First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC) (J Immunother Cancer) - P1 | N=91 | NCT02616185 | Sponsor: Pfizer | "Ninety-one patients were treated in dose escalation (mCRPC=38) and expansion (BCR=35, mCRPC=18)....In patients with mCRPC, the objective response rate (ORR, 95% CI) was 5.6% (1.2% to 15.4%) and the median radiographic progression-free survival (rPFS) was 5.6 (3.5 to not estimable) months for all; the ORR was 16.7% (3.6% to 41.4%) and 6-month rPFS rate was 45.5% (24.9% to 64.1%) for those who received RP2D with measurable disease (n=18). 7.4% of patients with mCRPC achieved a ≥50% decline in baseline PSA (PSA-50), with a median duration of 4.6 (1.2–45.2) months. In patients with BCR, 9 (25.7%) achieved PSA-50; the median duration of PSA response was 3.9 (1.9–4.2) and 10.1 (6.9–28.8) months for Cohorts 5B-BCR and 1B-BCR."

P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=91; Terminated; Sponsor: Pfizer; Completed ➔ Terminated; Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.

Clinical • Trial termination • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

[VIRTUAL] First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2021) - P1 | "PrCa VBIR consists of: 1) priming immunization with a replication-deficient adenoviral vector (AdC68) expressing PSA, prostate-specific membrane antigen and prostate stem cell antigen; 2) boosts with plasmid DNA (pDNA) encoding the same antigens by IM electroporation; 3) ICI given subcutaneously, including anti CTLA-4 antibody tremelimumab (TRM) and anti PD-1 antibody sasanlimab (SSL) . Vaccination with PrCa VBIR had a manageable safety profile . TRAEs increased when 2 ICIs were given . Some pts with BCR experienced durable PSA-50 responses without ADT; patients with mCRPC had few objective tumor responses, but had prolonged median rPFS ."

P1 data • Cardiovascular • CNS Disorders • Complement-mediated Rare Disorders • Genito-urinary Cancer • Immune Modulation • Inflammation • Myasthenia Gravis • Oncology • Prostate Cancer • Pulmonary Embolism • Respiratory Diseases • Solid Tumor • PSCA

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=91; Completed; Sponsor: Pfizer; Active, not recruiting ➔ Completed; N=62 ➔ 91

Clinical • Enrollment change • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=62; Active, not recruiting; Sponsor: Pfizer; Recruiting ➔ Active, not recruiting; N=160 ➔ 62

Clinical • Enrollment change • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=160; Recruiting; Sponsor: Pfizer; N=91 ➔ 160; Trial completion date: Feb 2023 ➔ Feb 2021; Trial primary completion date: Feb 2023 ➔ Feb 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=91; Recruiting; Sponsor: Pfizer; N=160 ➔ 91

Clinical • Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=133; Recruiting; Sponsor: Pfizer; Trial completion date: Sep 2021 ➔ Mar 2021

Trial completion date • Biosimilar • Prostate Cancer

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=133; Recruiting; Sponsor: Pfizer; Trial completion date: Dec 2021 ➔ Feb 2023

Trial completion date

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=133; Recruiting; Sponsor: Pfizer; Trial completion date: Oct 2022 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date

A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) (clinicaltrials.gov) - P1; N=133; Recruiting; Sponsor: Pfizer; Trial completion date: Mar 2021 ➔ Oct 2022; Trial primary completion date: Sep 2020 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date