Endocyte Pursuing Phase 3 Trial of 177Lu-PSMA-617 in Metastatic PC

Endocyte Pursuing Phase 3 Trial of 177Lu-PSMA-617 in Metastatic PC
Endocyte announced it will move PSMA-617 quickly into Phase 3 development in prostate cancer after it licensed the compound from German ABX. The trial, for which the company has yet to seek approval, likely will launch by early 2018. Although the compound, which is coupled to a radioactive molecule called 177Lu to fight cancer, has yet to enter late-stage clinical testing, it already has been given to hundreds of patients in earlier trials and compassionate use studies because of its potential to treat prostate cancer metastases. “This transaction is transformational to Endocyte, accelerating our path to commercialization,” Mike Sherman, president and CEO of Endocyte, said in a press release, in which he spoke of the potential of 177Lu-PSMA-617 to treat both bone and soft tissue tumors found in patients with metastatic castration-resistant prostate cancer. PSMA-617 originally was developed at the German Cancer Research Center and the Heidelberg University Hospital. ABX held the exclusive license to bring the treatment, which targets prostate-specific membrane antigen (PSMA), through early clinical development. Endocyte said the company will focus its efforts on the upcoming Phase 3 trial with a goal of completing it by 2020. “With the exception of a very targeted effort to generate proof-of-concept data for our CAR T-cell program, we will focus our resources on the development
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  1. Stephen B. Strum, MD, FACP says:

    The use of 68Ga-PSMA PET/CT for imaging and 177Lu-PSMA-617 for treatment is a two armed approach called theranostics. The Germans have led the way on this as well as on most imaging advances in prostate cancer for some time now. I do not know why there is so much of a lag (averaging at least ten years) between what the Germans come out with and our eventually translating this to our patients. I call this process read, digest, assimilate and translate (RDAT) and we here in the USA are failing miserably to do this. I saw this with NaF PET/CT and continue to see patients getting the highly insensitive Tc99 to rule out bone metastases when NaF PET/CT is superior and proven to be so in head-to-head studies in the literature that date back ten years. I see major advances also coming out of China, S. Korea and Japan and wonder what in the world is wrong with imaging studies in the USA.

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