Another kinase inhibitor shows only “modest” activity in men with mCRPC

A relatively small Phase II trial, carried out in France and Germany, has suggested that a new kinase inhibitor called nintedanib has only “modest” activity in the treatment of post-chemotherapy, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Sunday morning’s news from the ASCO annual meeting

We commented earlier on several of the prostate cancer presentations given this morning at the American Society for Clinical Oncology (ASCO) meeting — see here and here. However, there was another important paper presented this morning. … READ MORE …

Decision about enzalutamide in chemo-naive mCRPC

According to a joint media release, issued yesterday by Medivation and Astellas, the U.S. Food & Drug Administration (FDA) has granted a priority review for the supplementary New Drug Application (sNDA) for the use of enzalutamide in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Custirsen does NOT significantly extend survival in men with mCRPC

OncoGenex and Teva stated earlier today that the addition of custirsen (OGX-011) to docetaxel + prednisone did not demonstrate any significant effect on the overall survival of men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Ketoconazole vs. abiraterone acetate in mCRPC? Never gonna happen!

In a commentary in this week’s New England Journal of Medicine, Mailankody and Prasad use abiraterone acetate vs. ketoconazole in the treatment of metastatic, castration-resistant prostate cancer (mCRPC) as an example of the type of comparative effectiveness trial that should — but probably never will — be done. … READ MORE …

OncoGenex gets addditional “fast track” designation for custirsen

According to a media release from OncoGenex, the U.S. Food & Drug Administration has granted a “fast track” designation to the evaluation of data from the so-called AFFINITY trial of custiren + carbazitaxel + prednisone as a second-line treatment for men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Palliative (and non-palliative) radiation therapy in late-stage prostate cancer today

The role of radiation therapy in the management of men with advanced (i.e., metastatic and castration-resistant) forms of prostate cancer has been evolving over the past 5 years or so. … READ MORE …

Is AR-V7-positive status a contraindication to enzalutamide therapy?

According to a media release issued by the American Association for Cancer Research (AACR), it may be possible to identify some men with advanced prostate cancer who are highly likely to be resistant to treatment with enzalutamide. … READ MORE …

The potential of metformin in prostate cancer treatment: an update

We have previously commented (more than once) on the perception that metformin may have some value in the management of prostate cancer. A recently reported (albeit small), prospective Swiss study, has added to our knowledge in this regard. … READ MORE …

COMET-1 trial does not show survival benefit … yet

Some in the investment community (and probably many in Exelixis itself) had been hoping that an interim analysis of an ongoing Phase III trial of cabozantinib (Cometriq) in the treatment of late-stage prostate cancer would show a positive outcome and allow the trial to be stopped early. … READ MORE …

AB Science initiates Phase III trial of masitinib in mCRPC, but …

A French company called AB Science has initiated a Phase III clinical trial of masitinib (yet another tyrosine kinase inhibitor) in the treatment of metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

To prednisone or not to prednisone? Is that the question?

The past couple of years have seen a resurgence of academic (and clinical) interest in the value of the corticosteroid prednisone in combination with other drugs in the treatment of men with advanced forms of prostate cancer. … READ MORE …

Results of Phase III trial of custirsen (OGX-011) in mCRPC coming soon

According to a media release issued early this morning by OncoGenex Pharmaceuticals, the Phase III SYNERGY trial of custirsen (originally known as OGX-011) has reached its pre-specified endpoint in terms of the number of events required for final analysis of the trial data. … READ MORE …

Evaluating the risks and benefits of prednisone

Over the past 20 years or so, the oral corticosteroid prednisone has been used regularly in combination with drugs like mitoxantrone, docetaxel, cabazitaxel, ketoconazole, and abiraterone acetate in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Phase II trial of tasquinimod shows overall survival benefit

A paper in Clinical Cancer Research has reported an overall survival (OS) benefit of the investigational drug tasquinimod compared to a placebo in men with castration-resistant prostate cancer after treatment with docetaxel-based chemotherapy.

These data come from the long-term follow-up of the randomized Phase II trial of tasquinimod, and we shall have to wait for the results of the ongoing Phase III trial to confirm these results, but, according to this paper by Armstrong et al.:

  • Patients taking tasquinimod had a median OS of 33.4 months compared to 30.4 months for men treated with a placebo.
  • Patients whose cancer had already metastasized to their bones survived an average of 34.2 months, compared to 27.1 months for men treated with a placebo.

Additional information about this study can be found in a media release from the Duke University Health System; in an article on the OncLive web site; and in the actual paper by Armstrong et al.

It is worth remembering that few of the patients originally enrolled in this Phase II trial would have received either abiraterone acetate or enzalutamide prior to their initial treatment with either tasquinimod or the placebo, and that some of these patients may well have received abiraterone acetate or enzalutamide (or both) after their treatment with tasquinimod. It may be difficult, as a consequence, to know how much of the survival benefit shown in this trial is a direct consequence of treatment with tasquinimod itself. This is one of the reasons that the outcome of the later Phase III trial will be very important.

Median OS was 33.4 months in the tasquinimod group versus 30.4 months for those taking placebo, investigators Armstrong et al reported. Results were best for the subgroup of 136 men in the study who had bone metastases; they experienced a 34.2 month OS as compared to 27.1 months for those who took placebo, the authors wrote.PFS lasted an average 7.6 months for men taking tasquinimod, as compared with 3.3 months for those on placebo; among men with bone metastases, those numbers rose to 8.4 months in the experimental group versus 3.4 months in the control group, Duke reported in an announcement about the findings.2 – See more at: http://www.onclive.com/publications/urologists-in-cancer-care/2013/December-2013/Tasquinimod-Improves-OS-PFS-in-CRPC-Data-Show?utm_source=Informz&utm_medium=OncLive&utm_campaign=Prostate%20eNews%20Zytiga%2001-22-14#sthash.impQwIoj.dpuf

Median OS was 33.4 months in the tasquinimod group versus 30.4 months for those taking placebo, investigators Armstrong et al reported. Results were best for the subgroup of 136 men in the study who had bone metastases; they experienced a 34.2 month OS as compared to 27.1 months for those who took placebo, the authors wrote.PFS lasted an average 7.6 months for men taking tasquinimod, as compared with 3.3 months for those on placebo; among men with bone metastases, those numbers rose to 8.4 months in the experimental group versus 3.4 months in the control group, Duke reported in an announcement about the findings.2 – See more at: http://www.onclive.com/publications/urologists-in-cancer-care/2013/December-2013/Tasquinimod-Improves-OS-PFS-in-CRPC-Data-Show?utm_source=Informz&utm_medium=OncLive&utm_campaign=Prostate%20eNews%20Zytiga%2001-22-14#sthash.impQwIoj.dpuf

Median OS was 33.4 months in the tasquinimod group versus 30.4 months for those taking placebo, investigators Armstrong et al reported. Results were best for the subgroup of 136 men in the study who had bone metastases; they experienced a 34.2 month OS as compared to 27.1 months for those who took placebo, the authors wrote.PFS lasted an average 7.6 months for men taking tasquinimod, as compared with 3.3 months for those on placebo; among men with bone metastases, those numbers rose to 8.4 months in the experimental group versus 3.4 months in the control group, Duke reported in an announcement about the findings.2 – See more at: http://www.onclive.com/publications/urologists-in-cancer-care/2013/December-2013/Tasquinimod-Improves-OS-PFS-in-CRPC-Data-Show?utm_source=Informz&utm_medium=OncLive&utm_campaign=Prostate%20eNews%20Zytiga%2001-22-14#sthash.impQwIoj.dpuf

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