Biotech Strategy Blog

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

Posts tagged ‘Dr Chris Parker’

Radium-223 (Alpharadin) is a novel bone targeted treatment for advanced prostate cancer.

At the recent European Multidisciplinary Cancer Congress in Stockholm (EMCC 2011), Dr Chris Parker from The Royal Marsden Hospital presented results of the phase 3 ALSYMPCA trial that showed both delayed time to first skeletal-related event (SRE) AND an overall survival (OS) benefit for those men with advanced prostate cancer taking radium-223.  This is the first time a product in the bone category has shown such a survival benefit – neither denosumab or zoledronic acid can claim that distinction.

Unlike the recent regulatory approvals for cabazitaxel (Jevtana) and abiraterone acetate (Zytiga), which focused on the post-docetaxel setting, the ALSYMPCA trial included not only those who had already received cytotoxic therapy, but also pre-docetaxel patients, who were unable to take chemotherapy.

As Dr Parker mentions in the interview that he kindly gave in Stockholm (the first video interview on Biotech Strategy Blog), radium-223, assuming it gains regulatory approval, will provide a new treatment option for the considerable population of men with bone metastases who may be too weak, too old or otherwise unable to take chemotherapy such as docetaxel.

Radium-223 is, therefore, potentially good news for this “neglected” population of prostate cancer patients.

In the video interview, Dr Parker talks about why he believes combining radium-223 with abiraterone acetate (Zytiga) makes sense.

He also talks about some of the challenges that radium-223 still faces, such as how to monitor treatment and work out the optimal dose.  It is hard to believe that Algeta/Bayer would undertake a phase 3 registration study of a novel bone targeted agent without any bone imaging in the protocol!

As Cora Sternberg mentioned in the educational session at EMCC 2011, in advanced prostate cancer, “80% of the disease is in the bone.radium-223 is an exciting radiopharmaceutical that is likely to be “practice changing” once approved.

That’s not to say there are not going to be challenges and issues with its commercialization.  Algeta/Bayer have a lot of work to do now that it is clearly on fast track for FDA approval next year.

Dr Parker also mentions in his interview that radium-223 is a weak alpha emitter and the radiation can be blocked by paper or glass. It therefore requires no special facilities, such as lead lined rooms, for its administration, unlike beta emitters.  The latter have been challenging commercially in the past for this reason.

However, it does require a radiopharmaceutical license, which means that community based oncologists and urologists in the United States will most likely have to refer patients to receive their injection at an approved facility where there is a nuclear medicine/radiology department or equivalent expertise.  In Europe, this is less of an issue given most cancer patients are treated in outpatient clinics associated with hospitals, whereas in the US, the majority of patients are seen in the community setting.

Despite that, it is hard to believe that radium-223 (Alpharadin) will not have a major impact on the advanced prostate cancer market if it can be commercially supplied without difficulty and the details are worked out on how to use it optimally and monitor progress. I am sure we will hear more on these issues at cancer conferences next year.

Looking at the other indications for bone targeted agents such as denosumab and zoledronic acid, radium-223 or a similar radiopharmaceutical could offer potential benefits in other tumor types such as breast cancer, were there are also skeletal related events (SRE’s) associated with treatment.

The video interview I did with Dr Chris Parker is well worth watching, and I am grateful to him for taking the time out of his busy schedule at the recent Cancer Congress in Stockholm. Since this is a first for Biotech Strategy Blog, do let me know if this is something you’d like to see more of moving forwards.

Challenges & opportunities for radium-223 (Alpharadin) in advanced prostate cancer – an interview with Dr Chris Parker 

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Radium-223 (Alpharadin) will be “Practice Changing” is how Michael Baumann, President of the European CanCer Organisation (ECCO) and Jean-Charles Soria, Co-Scientific chair of the 2011 Stockholm Multidisciplinary Cancer Congress described the prostate cancer clinical trial data to be presented in the Presidential (plenary) session on Saturday September 24, 2011.

Alpharadin is the first bone targeted therapy to show an overall survival (OS) advantage in metastatic castration-resistant prostate cancer (mCRPC). To date, none of the other therapies targeting bone in prostate cancer such as zoledronic acid (Zometa), denosumab (Xgeva) or cabozantinib (XL184) have shown any overall survival benefit.

The Alphardin data from the phase 3 ALSYMPCA trial that will be presented in Stockholm shows an increase in overall survival of 2.8 months compared to placebo (median OS of 14 months with Alpharadin versus median OS of 11.2 months with placebo, p=0.00185, HR=0.695).

What is big news is that Alpharadin also significantly prolongs time to first skeletal related event (p=0.00046; HR=0.610). This is tremendous news for prostate cancer patients given the number that experience bone metastases.

It is not, however, good news for Amgen and denosumab (Xgeva). Amgen have tried to associate the improvement in symptoms and decline in skeletal related events with survival, but have failed to obtain any overall survival data (OS). This is something that Alphardin achieves as well as a significant reduction in time to first skeletal related event (SRE).

What Alpharadin has effectively shown is that by nuking bone metastases using a weak alpha emitting radium-223, overall survival (OS) can be prolonged in a way that targeting rank ligand does not. This is ground breaking news and the 2011 Stockholm Multidisciplinary Congress have rightly recognized the importance of this data with a plenary session. For further information on how Alpharadin works – see my previous blog post about the ASCO 2011 phase 2 data.

At the press briefing late friday afternoon in Stockholm, Dr Chris Parker of the Royal Marsden Hospital and PI of the ALSYMPCA study said that “Radium-223, a novel alpha-pharmaceutical, may provide a new standard of care for the treatment of  CRPC patients with bone metastases.”

There is no doubt in my mind that it will lead to a new standard of care. What’s more as Dr Parker speculated in the press briefing, there is no reason why Alphardin could not be combined with androgen receptor antagonists such as the recently approved abiraterone acetate (Zytiga).

Both are well tolerated and operate by different mechanisms of action.  It’s hard not to believe that the overall survival of CRPC patients will be increased by such a combination.

When approved, Alpharadin and any possible combination with Zytiga, may further delay the use of sanofi-aventis’ cabazitaxel (Jevtana) in the post-doctaxel CRPC setting. It may also potentially have an impact on the use of sipuleucel-T (Provenge) in the asymptomatic population.

The Alpharadin phase 3 trial results is exciting news from the 2011 Stockholm Multidisciplinary Cancer Congress. I will be writing more after Dr Parker presents the data in the Presidential session later today.

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