Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘ASCO GU Prostate Cancer’

San Francisco Cable CarWe’re continuing our post-meeting coverage of the 2016 Genitourinary Cancers Symposium (ASCO GU) that took place earlier this month in San Francisco.

In this post we’re taking a look at the results of a clinical trial with a non-invasive liquid biopsy which in a cohort of patients with prostate cancer identified increased risk of death on abiraterone and enzalutamide, but not taxane chemotherapy.

What struck me listening to this presentation was the simple elegance of an approach, which the presenter likened to the equivalent of “facial recognition” of prostate cancer cells.

As the ASCO GU discussant noted, this could have an impact on clinical trial design, potentially leading to more rapid prostate cancer drug approvals.

Subscribers can login to read more about a biomarker approach, that if validated in a prospective trial, could help identify the optimal sequencing of prostate cancer drugs for patients.

This week we turn our focus to the American Society of Clinical Oncology Genitourinary (ASCO GU) symposium being held in San Francisco.

The hottest topic is highly likely to be the Medivation and Astellas data for enzalutamide (Xtandi) in the pre-chemotherapy setting in men with advanced prostate cancer who are asymptomatic or slightly symptomatic and naive to chemotherapy.  Previously, I wrote in detail about the Medivation announcement regarding the interim analysis where the PREVAIL trial was found to meet its primary endpoint (open access).

Dr Tom Beer, OHSU

Dr Tom Beer, OHSU

The company subsequently stated that the data had been accepted as a late breaker for the the ASCO Genitourinary meeting in San Francisco this weekend.  That data is being presented on Thursday morning in the oral prostate cancer session by Dr Tomasz Beer (OHSU), who is the Deputy Director of the Knight Cancer Institute and a prostate cancer specialist.

The ASCO GU 2014 abstracts will be available for perusing as of 5pm ET today.

This week I caught up with Dr Beer to discuss not only the details relating to the PREVAIL data, but also how enzalutamide (Xtandi) potentially fits in the advanced prostate cancer competitive landscape given that he also participated in the abiraterone (Zytiga) COU-AA-302 trial in the same clinical setting.

To read more about Dr Beer’s insights, you can access the article below by signing in or signing up via the box below.

$EXEL Share Price Jan 6 2014The share price of Exelixis ($EXEL) is starting a run-up (after months in the doldrums) in advance of anticipated results from the COMET-1 phase 3 trial in metastatic castrate resistant prostate cancer (mCRPC) for cabozantinib (Cometriq, formerly XL184).

Cabozantinib is a small molecule tyrosine kinase inhibitor of c-Met and VEGFR2. It has been shown to significantly improve bone scans and decrease pain, but the $64,000 questions are will patients taking it live longer and feel better?

The answers will come from the COMET-1 trial that has a primary end point of overall survival (OS). It’s a placebo-controlled trial of 960 men with advanced prostate cancer randomly assigned to cabozantinib 60mg (n=640) or prednisone (5mg twice daily) (NCT01605227) who have disease progression after treatment with docetaxel chemotherapy and abiraterone (Zytiga) or enzalutamide (Xtandi).

Subscribers to premium content can login to read my analysis as to why I thought this trial would be negative.

Update Sep 1, 2014 COMET-1 is a failure

We normally put updates at the end of a post, but we’ve just heard the trial a failure, so I think it’s appropriate to put this upfront. Am glad that our analysis turned out to be correct. Congratulations to those blog subscribers who on the basis of this post sold all or part of their $EXEL position. Commiserations if you held on.


As 2013 comes to an end, rather than look back as many are doing, I’m looking forward to 2014. January is a busy month for cancer meetings with the ASCO organized gastrointestinal cancers symposium (ASCO GI) and genitourinary cancers symposium (ASCO GU) both taking place in San Francisco a few weeks apart.

In fact, looking at the calendar of forthcomings meetings, 2014 looks to have a West Coast focus, with the annual meeting of the American Association for Cancer Research (AACR) taking place in San Diego in April, and the American Society of Hematology (ASH) annual meeting also heading to San Francisco in December.

Transcontinental airfares are notoriously expensive at the last minute so if flying from the East Coast, do make travel plans early!

The ASCO GU symposium takes place at the San Francisco Marriott Marquis from Jan 20 – February 1, 2014. The abstracts for meeting go online at 5pm Eastern Time on Jan 28.

ASCO in a December 19 press release have already announced what will be highlighted on the January 28 press cast, and what many of the media can be anticipated to write about from the meeting.

Perhaps not surprisingly the Medivation PREVAIL trial data (LBA1) is top of the list; the abstract for this presentation has already been published online as Professor Tombal (@BertrandTOMBAL) kindly highlighted on Twitter.

This preview highlights some of the prostate cancer abstracts and presentations to watch out for at the meeting:

Drugs discussed in this post include: enzalutamide (Xtandi), abiraterone (Zytiga), ODM-201, ARN-509, ipilimumab (Yervoy).

Subscribers to premium content can login and read the ASCO GU 2014 prostate cancer preview below:

Galeterone (Tokai Pharmaceuticals) is a new prostate cancer drug in development that has an interesting triple mechanism of action in that like abiraterone (Zytiga) it acts as a CYP17 lyase inhibitor, but it also acts as an androgen receptor (AR) inhibitor and is an AR degrading drug that decreases AR levels.

How effective it is compared to AR antagonists on the market such as enzalutamide (Medivation) or second-generation AR antagonists in development such as ARN-509 (Aragon Pharmaceuticals) or ODM-201 (Orion Pharma) is one of the many unanswered questions with this drug.

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