More negative data for checkpoint inhibition in treatment of mCRPC

Alas … once again we hear that the combination of  androgen receptor blockade (with enzalutamide/Xtandi) + a checkpoint inhibitor (the PD-L1 inhibitor atezolizumab/Tecentriq) has had no clinically meaningful impact on the overall survival (OS) of men with metastatic, castration-resistant prostate cancer (mCRPC) compared to enzalutamide alone. … READ MORE …

FDA approves enzalutamide for treatment of metastatic HSPC

Yesterday the U.S. Food and Drug Administration (FDA) approved the use of enzalutamide (Xtandi) for the treatment of metastatic, hormone-sensitive prostate cancer (mHSPC) — also known as metastatic, castration-rsensitive prostate cancer or mCSPC. … READ MORE …

ARCHES study data reported in JCO, and related issues

The initial data from the ARCHES study of standard ADT + enzalutamide versus standard ADT + a placebo in men with metastatic, hormone-sensitive prostate cancer were reported earlier this year at the Genitourinary Cancers Symposium in San Francisco. … READ MORE …

Enzalutamide extends OS compared to an standard antiandrogen in ENZAMET trial, but …

The randomized, double-blind, Phase III ENZAMET trial was designed to investigate whether the combination of enzalutamide + standard androgen suppression had superior outcomes than a non-steroidal antiandrogen + standard androgen suppression in men with metastatic, hormone-sensitive prostate cancer (mHSPC). … READ MORE …

The treatment of mCRPC with a combination of docetaxel + enzalutamide

We know that both abiraterone acetate (Zytiga) and enzalutamide (Xtandi) can be used to extend the survival of men with mCRPC who have already been treated with docetaxel + prednisone. However, … READ MORE …

Results from the ARCHES trial presented yesterday in San Francisco

On Thursday, here in San Francisco, Dr. Andrew Armstrong first presented the results of the so-called ARCHES trial of enzalutamide (Xtandi) + standard androgen deprivation therapy (ADT) in the treatment of men with metastatic, “hormone-sensitive” prostate cancer (mHSPC). … READ MORE …

ADT + enzalutamide in mHSPC … outcome of the ARCHES trial

Pfizer and Astellas have, this morning, announced that the addition of enzalutamide to standard androgen deprivation (ADT) has led to improved outcomes in men with metastatic, hormone-sensitive prostate cancer (mHSPC). … READ MORE …

Is there a subset of CRPC patients who may respond well to checkpoint inhibition?

A paper in the journal Oncotarget has suggested that patients who have progressed on treatment with enzalutamide (Xtandi) may be good candidates for treatment with one of the checkpoint inhibitors like pembrolizumab (Keytruda), nivolumab (Opdivo), or even ipilimumab (Yervoy). … READ MORE …

Results of PLATO trial published in JCO

The results of the PLATO trial have just been published in the Journal of Clinical Oncology (JCO). … READ MORE …

The potential for use of enzalutamide in HSPC: an update

We note that Pfizer and Astellas have recently modified the protocols for two large, international, randomized, Phase III clinical trials to see if they can get earlier results that might affect the potential for use of enzalutamide (Xtandi) in some groups of men with hormone-sensitive prostate cancer (HSPC). … READ MORE …

Evolution in the management of nmCRPC

With the relatively recent approvals of apalutamide (Erleada) and enzalutamide (Xtandi) for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), we are seeing intense discussion within the urologic oncology and medical oncology communities about the appropriate treatment of patients with this category of prostate cancer. … READ MORE …

Evolutions in the treatment of nmCRPC — redux

So at the Genitourinary Cancers Symposium in San Francisco today we were presented with full reports on the SPARTAN trial and the PROSPER trial by Drs. Eric Small and Maha Hussain, respectively. … READ MORE …

Evolutions in the treatment of nmCRPC

So we now have news reports and abstracts telling us what the top-line results of the SPARTAN trial and the PROSPER trial are in the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

FDA gives priority review status to NDA for apalutamide

Apparently the US Food and Drug Administration (FDA) will give a priority review to apalutamide (formerly known as ARN-509), based on data from the Phase III SPARTAN  trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC). … READ MORE …

Enzalutamide treatment and risk for seizures

The “Warnings and Precautions” section of the product prescribing information for enzalutamide (Xtandi) includes the following statement: … READ MORE …