Biotech Strategy Blog

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

Posts tagged ‘wet AMD’

This afternoon at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Fort Lauderdale saw the long-awaited briefing on the National Eye Institute Lucentis v Avastin comparative effectiveness trial in AMD.

I wrote in a previous post about the CATT results published in the New England Journal of Medicine.

I also tweeted from the briefing, but must add the disclaimer that live tweeting is tough and none of my tweets should be relied upon for accuracy.

What did I learn from the briefing (aside from the fact that ARVO’s technology vendors have real challenges in not being able to light a room properly, set up wifi and get a projector to work):

  • The CATT study was set-up before anyone knew what the price for Lucentis was.
  • No mention was made in the briefing today about comparative cost – but isn’t that what everyone thinks this study is about?
  • No mention was made of how you balance the cost benefits against the trade-off of the higher risk of serious adverse events that was seen.
  • When asked what they would give to a relative, most of the panel answering Q&A “punted” and said they would discuss the data with the patient, and try and get them to make an informed decision.
  • Only Dan Martin from Cleveland Clinic stuck his neck out and said if the patient asked him to make the choice of what to take, he would use Avastin over Lucentis – this statement clearly resonated with the audience (he received a big round of applause)
  • Two year data is already available and some of it was shown today, with no difference in death rate at 2 years between Lucentis or Avastin. The two year data will be published this time next year.
  • The study was not adequately powered to look at the serious adverse events (SAE), which means the statistically significant difference in SAEs may never be truly understood.

Overall, my impression from the briefing is that Lucentis is not identical to Avastin, although functionally the benefits from both appear broadly comparable with no statistical significance between them in terms of visual acuity gains. No mention was made of when you might use one drug over the other (if at all).

Lucentis did have some benefits over Avastin such as a lower retinal thickness at one year compared to the other three treatment groups, which was statistically significant. Both drugs produced an immediate and substantial decrease in retinal fluid, but more eyes were completely dry with Lucentis.

My thoughts are that the debate over Lucentis v Avastin is like the difference between a brand versus a generic, they are similar in terms of efficacy but not identical. While that’s perhaps an over-simplification given that in this case one drug is FDA approved and the other is not, those who want a brand and can afford it will buy a brand, while others may prefer the “generic” for cost reasons.

Will the Lucentis v Avastin decision be any different? If you can afford Lucentis through your insurance you may choose to take that, otherwise Avastin is another option for AMD.  Weighing cost versus slightly higher risk of SAE’s (for which there’s no adequate explanation showing causality) is how I would approach this decision.

It was interesting to note that the follow-up will continue and two year results will be published this time next year. They may shed further light on the serious adverse event differences, but I suspect that given the way the study is powered, this issue may not be resolved any further.

My overall take is that there is nothing compelling in the data to suggest that any ophthalmologist that is using bevacizumab off-label will switch patients to ranibizumab. Off-label Avastin use in wet AMD received an official NEI endorsement from the CATT study and will continue.

Equally those who are happy with Lucentis will not switch to Avastin on the back of this study, given that the Lucentis data appeared slightly better in places.  The controversy will no doubt continue and other studies comparing Lucentis v Avastin will add further insight.

 

This weekend I will be at the annual meeting of The Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale.

I’m excited about attending because earlier in my career I worked at Alcon Laboratories on European IDE clinical trials for three novel intra-ocular lenses.

ARVO is the ophthalmology equivalent of AACR and is where scientists involved in drug, device research meet to discuss new findings and early stage research.

The title of meeting is “Visionary Genomics.”  After listening to the plenary session at the recent AACR annual meeting by Lynda Chin on how insights from cancer genomics are translating into personalized medicine, I’m looking forward to seeing the impact of genomics on vision research.

Sunday’s ARVO/Alcon keynote presentation is from Roderick McInnes who is the Canada Research Chair in Neurogenetics at McGill University in Montreal.

A presentation that is already generating some advance interest is Sunday’s presentation of the results from the Comparison of Age Related Macular Degeneration Treatments Trials (CATT).

Age related macular degeneration (AMD) is the leading cause of vision loss in those over 65 in the United States, with over 7 million people estimated to be at risk.  Once you have AMD in one eye, you have a 43% risk of developing it in the other eye over a  five year period, a scary statistic!

The first CATT clinical trial is between bevacizumab (Avastin®) and ranibizumab (Lucentis®), both similar anti-VEGF inhibitors that are derived from the same monoclonal antibody.  It will be interesting to see whether the data supports the current practice of off-label use of bevacizumab given its lower cost compared to ranibizumab.

The findings from this data will also potentially impact aflibercept (VEGF-Trap) that is being co-developed by Bayer and Regeneron.  In February, Regeneron submitted a biologics license application (BLA) to the FDA for the use of VEGF-Trap in wet AMD.

The initial results from the aflibercept phase III AMD trial announced late last year showed a non-inferiority to ranibizumab.  If aflibercept is approved and comes to market in 2012, depending on the CATT results, it may have to compete on price against off-label bevacizumab in AMD.  Whether a more convenient injection once every two months for VEGF-Trap (compared to monthly for Lucentis) is sufficient to justify a price premium, it will be interesting to watch the market dynamics in this space.

You can find more about the meeting on the ARVO conference website and they have also put up a blog for the meeting.   The theme of my blog posts over the next few days will be ophthalmology related, and I expect to be live tweeting from ARVO 2011 on Sunday and Monday.  I’ll also be aggregating tweets from the meeting (hashtag #ARVO11) on this blog.

 

error: Content is protected !!