This month has brought a flurry of regulatory activity in the prostate cancer landscape with several companies seeing noticeable action in the new product development area:
The big cancer news that hit the news wires this morning was not entirely surprising:
“Janssen Research & Development, LLC today announced that it has unblinded the Phase 3 study of ZYTIGA (abiraterone acetate) plus prednisone for the treatment of asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC) who have not received chemotherapy.”
Source: Press Release
Given the accelerated approval of abiraterone in the post-chemotherapy setting last year, the results in the pre-chemotherapy setting were widely expected to:
- Be even better in earlier stage than the 3.9 months OS advantage already seen
Amazingly, it’s been a year since I started doing conference highlight videos, with the first one rolling out at EAU meeting in Vienna last March. They’ve proven to be much more popular than expected! The good news is that the video recording, production and presentation skills have improved along the way.
Unlike last year, the 2012 EAU Congress wasn’t lit up with excitement about new data (abiraterone and MDV3100 dominated last year). Instead, there were more reflective discussions about how to consider sequencing and combinations in a more crowded castrate resistant prostate cancer market going forward as well as some mention of new up and coming targets outside the androgen receptor (AR) such as ERG and Src.
Here at the European Association of Urology (EAU) congress in Paris, there are some interesting debates amongst delegates attending the meeting regarding new therapies either recently – or about to be approved – for castrate-resistant prostate cancer (CRPC).
- How should abiraterone and MDV3100 be sequenced pre or post chemotherapy?
- Would combining the two drugs post chemo be a better strategy that leads to superior outcomes?
- Where does chemotherapy fit into this emerging paradigm? Do we need chemotherapy in an new era of oral therapies? If yes, which patients should be considered eligible?
Many readers will have noticed that the advanced prostate cancer market is rapidly becoming crowded with three new therapies (cabazitaxel, sipuleucel-T and abiraterone) already approved and several more in late stage development, including Alpharadin (radium-223) and MDV3100, both likely to file this year. In addition, others are focused on bone complications, such as denosumab, which is expected to have a tough ODAC meeting this month, and cabozantinib, a multikinase inhibitor currently in phase III trials.
This weekend heralds the annual American Society of Clinical Oncology (ASCO) Genitourinary (GU) meeting in San Francisco, although ASCO held their press briefing today to provide an update on some of the key topics.
For those of you interested in Alpharadin (radium-225) in castrate-resistant prostate cancer (CRPC), check out the update of Dr Oliver Sartor’s presentation, which is covered on Biotech Strategy Blog.
The key topic that most interested me though, was Dr Howard Scher’s update on Medivation’s Androgen Receptor antagonist, MDV3100, in CRPC. Previously, Medivation announced that the data showed an improvement in median overall survival (OS) of 4.8 months and this is still solid (Note: J&J’s abiraterone was approved by the FDA based on an OS of 3.9 months in the same population and must be taken with prednisone).
“Fully 71% of online Americans use video-sharing sites such as YouTube and Vimeo, up from 66% a year earlier. The use of video-sharing sites on any given day also jumped five percentage points, from 23% of online Americans in May 2010 to 28% in May 2011.”
Pew Internet (2011)
This is a trend I’ve also noticed amongst my friends over the past year, largely driven by more of them using smartphones and iPads, which make sharing and watching video a whole lot easier.
After attending numerous basic research and clinical updates at the American Urologic Association (AUA) annual meeting in Washington DC, it is clear that the new and emerging therapies are not going to stop at the three grand crus from 2010.
Recently, abiraterone acetate (Zytiga) was approved, but there are a number of critical issues that need to considered, including:
- Patient selection
As we learn more about the molecular mechanisms behind resistance to androgen receptor signaling (up and downstream) and new targets emerge, so it may be possible to improve patient outcomes in castration-resitant prostate cancer.
Today it’s Friday 13th and we’re heading off on the road again, this time to Washington DC for the much anticipated annual meeting of the American Urology Association (AUA).
We’ll be covering the hot topics on urologic cancers, including bladder and prostate cancers and renal cell carcinoma (RCC). I’m particularly interested in castrate resistant prostate cancer and updates on the abiraterone (Zytiga) data following the recent approval post chemotherapy in the US, and also the long term data for Medivation/Astellas’ MDV3100 from their phase I/II trial. It’s always important to know how patients in the early trials are doing.
The interview with Dr Charles Sawyers from Memorial-Sloan Kettering recently, talking about his role in Medivation’s MDV3100, turned out to be rather good timing. On Friday, Medivation announced their 1Q earnings and clinical progress.
The big news is that aside from the ongoing phase III trials in castrate-resistant prostrate cancer (CRPC) before (PREVAIL) and after failure of docetaxel (AFFIRM), the company are seeking to explore the use of MDV3100 earlier in the disease. This makes a lot of sense, both clinically and strategically. A phase II trial is already open in the pre-chemotherapy setting, comparing MDV3100 to bicalutamide (TERRAIN).
- The first phase II trial evaluates the combination of MDV3100 with bicalutamide in the treatment of advanced prostate cancer patients who have progressed while on LHRH analogue therapy or following surgical castration. TERRAIN is expected to enroll approximately 370 patients in North America and Europe. The primary endpoint of the trial is progression-free survival. This trial is ongoing and patients are enrolling.