I wonder how this compares to Novartis/Endocyte's 177LU-psma-617:
Progenics Pharma (PGNX) Advances 1095 into Phase 2 Clinical Development Following Discussions with the FDA
October 11, 2018 4:03 PM EDT
Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX), an oncology company developing innovative medicines and imaging analysis technology for targeting and treating cancer, today announced plans to advance I-131 1095, its PSMA-targeted therapeutic, into a Phase 2 clinical study.
I-131 1095 is a small molecule radiotherapeutic designed to selectively bind to the extracellular domain of prostate specific membrane antigen (PSMA), a protein that is highly expressed on prostate cancer cells. Once 1095 binds to the prostate cancer cells, the drug is internalized and the beta radiation kills the tumor cells. Data from compassionate use of I-131 1095 indicates it was well tolerated and demonstrated markedly reduced PSA levels and bone pain in a group of heavily-pretreated advanced prostate cancer patients following a single cycle of treatment.1
“We are pleased, following our discussions with FDA, to move this important therapeutic agent into a phase 2 study in combination with enzalutamide in chemo-naïve patients with mCRPC,” stated Vivien Wong, Ph.D., Executive Vice President Development at Progenics. “1095 delivers a targeted radiation dose to prostate cancer cells utilizing iodine-131 as the payload. Iodine 131 is an attractive agent to use because its physical properties of longer range and higher energy could potentially improve efficacy for bulky lesions and lesions that have lower PSMA expression. Iodine has been used widely in other cancer therapeutics, is broadly available with a ready supply and known safety profile. We look forward to evaluating the safety and efficacy of 1095 in this Phase 2 study.”
The multicenter, randomized, controlled trial will evaluate the efficacy and safety of 1095 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who are PSMA-avid, chemotherapy naïve, and progressed on abiraterone. 1095 radiotherapy represents a new mechanism of action that may overcome resistance developed to novel androgen axis drugs (NAADs), such as abiraterone and enzalutamide. In addition, recent preclinical research reported that enzalutamide can sensitize cells to radiotherapy induced cell death, suggesting that 1095 in combination with enzalutamide has the potential to be an effective treatment paradigm for patients with mCRPC who are resistant to NAADs.2
The study’s primary endpoint will be prostate specific antigen (PSA) response rate according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria defined as a confirmed 50% or greater decline from baseline of 1095 and enzalutamide compared to enzalutamide alone. Secondary endpoints will evaluate radiographic response based on Response Evaluation Criteria In Solid Tumors (RECIST), Progression Free Survival (PFS) and overall survival (OS). Tumor avidity will be determined utilizing PyLTM (18F-DCFPyL), the Company’s PET imaging agent designed to visualize prostate cancer.
“The design of this trial highlights our differentiated PSMA-targeted theranostic approach which utilizes iodine as the tumor ablator, treats metastatic patients at an earlier stage, is used in combination with enzalutamide, a standard of care NAAD treatment, as well as uses our advanced PyL imaging to select patients most likely to benefit from this treatment,” said Mark Baker, CEO of Progenics. "This Phase 2 development program reflects our commitment to developing PSMA-targeted candidates that have the potential to transform how prostate cancer is detected, managed and treated."
Progenics expects to begin enrollment of approximately 120 evaluable patients in the study in early 2019. Patients will be followed for one year after their first treatment for all efficacy endpoints. Survival and safety data will be collected for an additional year.