Small, Phase I combo trial suggests 3-year overall survival in men with mCRPC

A media release issued earlier today by Barvarian Nordic (the developer of Prostvac®) gives us an inkling of where we may be headed in the development of combination therapies for the management of late stage (and maybe even earlier stage) forms of prostate cancer.

GTx forced to stop development of Capesaris (GTx-758)

The US Food & Drug Administration (FDA) has advised GTx to stop development of GTx-758 (also known as Capesaris), its oral drug intended for the treatment of men with advanced prostate cancer, after it became apparent that there was an increase in risk for blood clots in men taking active drug compared to those being [...]

The potential of MVA-5T4 as treatment for advanced prostate cancer

Early data have suggested that a modified vaccinia Ankara (MVA) virus that expresses a tumor-associated glycoprotein called 5T4 may have activity in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) — among other forms of cancer. We will refer to this agent as MVA-5T4; the brand name is TroVax®.

Problems with enrollment into ongoing Phase III trials of new drugs for men with mCRPC?

Has the clinical success of some new drugs started to affect enrollment in trials of others for advanced forms of prostate cancer?

Advisory panel does NOT recommend approval of Xgeva for prevention of bone mets

According to an online report in The Washington Post earlier this afternoon, an advisory panel to the U.S. Food and Drug Administration (FDA) has voted 12 to 1 not to recommend the approval of denosumab (Xgeva®) for the prevention of bone metastasis in men with non-metastatic, castrate-resistant prostate cancer.

Will denosumab gain approval for prevention of onset of metastasis to bone?

The U.S. Food and Drug Administration (FDA) has questioned the value of denosumab (Xgeva®) as an agent capable of delaying the onset of metastatic disease to bone in men with progressive, castration-resistant prostate cancer.

Long-term use of abiraterone acetate at 250 mg/d: is this really viable?

It has been suggested that, after an initial “loading dose” for a period of time, abiraterone acetate could potentially be used to treat metastatic, castration-resistant prostate cancer (mCRPC) at a much lower daily maintenance dose than that currently approved.

Other interesting presentations from the GU Oncology meeting: Part I

We promised to give a summary of other interesting prostate cancer-related data presented at the Genitourinary Cancer Symposium out in San Francisco. Here is an an initial commentary on some of the presentations that seemed (to us) to be of particular interest:

Educational updates from the GU Oncology Symposium

One of the most useful elements introduced this year at the Genitourinary Cancer Symposium still ongoing in San Francisco is the summary papers from the educational reviews presented at the meeting.

Side effect profile of MDV3100 appears highly promising in mCRPC

According to a number of media reports today, Medivation’s investigational drug MDV3100 appears to have a relatively good safety profile, although five patients who received MDV3100 in the completed Phase III trial did have seizures.

Full agenda and abstracts for Genitourinary Cancer Symposium now available

The full meeting agenda and abstracts for the upcoming Genitourinary Cancers Symposium (co-sponsored by ASCO and others) are now available on line. The prostate cancer session will start tomorrow morning in San Francisco; unfortunately we have not been able to send a reporter to this meeting this year.

Expanded access trial in development for radium-223 chloride (Alpharadin) in mCRPC

We have heard from one of our contacts that Bayer Healthcare (presumably in combination with their business partner, Algeta) is initiating an expanded access (compassionate use) trial of injectable radiation therapy with radium-223 chloride (Alpharadin®) for men with metastatic, castration-resistant prostate cancer (mCRPC).

Tasquinimod + cabazitaxel in heavily pre-treated men with mCRPC

According to media information from Active Biotech this morning, the company has initiated an early stage, combination therapy trial (the so-called CATCH trial) of their investigational agent tasquinimod + cabazitaxel (Jevtana®) for the treatment of men with heavily pre-treated, metastatic, castration-resistant prostate cancer (mCRPC).

Sequencing of treatment with new therapeutic agents for advanced prostate cancer

The January 2012 issue of Oncology contains an open access, full-text article on the future sequencing of the recently approved and potentially new drugs that are or should soon be available for the treatment of advanced prostate cancer.

Full results of the AFFIRM trial at GU Oncology meeting next month

According to a joint media release from Medivation and Astellas Pharma earlier today, the full results of the Phase III AFFIRM trial — of MDV3100 in men with metastatic castration-resistant prostate cancer (mCRPC) who have received docetaxel chemotherapy — will be presented at the ASCO Genitourinary Oncology meeting on February 2, 2012.

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