Very promising new drug trial - Genentech/Roche ADC

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Very promising new drug trial - Genentech/Roche ADC

Postby Jonathan » Mon May 13, 2013 4:33 pm

Hi folks,

It's been a while, but I've been "doing things," most recently getting over anemia. Apologies - I feel a lot better.

Catherine posted a while ago about this trial of a drug currently called DEDN6526A by Genentech/Roche – details at clinicaltrials.gov, trial NCT01522664. It uses something called ADC technology, which is the hottest wrinkle in cancer therapy these days, and this is the first ADC drug specifically aimed at melanoma. The first ADC drug to be FDA approved "came out" 2 weeks ago, for Her-2 breast cancer, the most aggressive form. Many more ADC drugs are "in the trial pipeline" at present, and you'll likely hear about them soon if you haven't already.

I am just back from visiting Sarah Cannon in Nashville, where I met with Dr. Infante and his group about this, and it is very exciting, but very slowly accruing patients (1 every 3 weeks, there, The Angeles Clinic, and Karmanos in Detroit, I believe - this last needs confirmation - also 2 sites in Australia). It’s been going on for over a year, and response rates look extremely good – comparable or better than anti-PD1 rates (though numbers are really small at this stage, so no truly reliable percentage estimates). Genentech is talking about expanding the trial to other centers – a good sign. The ADC approach is a targeted chemotherapy, not an immunotherapy (so prior use of Ipi, anti-PD1, etc are not exclusions). The nasty killer chemo payload (Auristatin) is linked to an antibody molecule that is specific to a melanoma cell surface target (endothelin-B), so a tiny amount of the chemo is directly delivered to tumors, where it’s taken in and causes tumor cell death - not to normal tissue. Side effects are therefore minimal and responses are clear (or not) by 6 weeks. They have now pretty much ascertained the effective dose, so there’s no worry about getting too little or too much drug, as often is the case in phase 1 trials. It's apparently surprisingly effective for ocular melanoma patients, as well - I was told by an ocular melanoma patient going to Sarah Cannon that both OM patients in the trial had responded well - remarkable if true.

I want to do the trial, especially since I have few other options. It will mean being in Nashville for the first month of the trial (staying gratis at their Hope Lodge), plus weekly visits for the year duration of the trial, assuming I get a response. So that’s a major issue…People who continue to get a response will have access to the drug after the trial.

For more information on ADCs, here are a couple of links – others can be found by googling things like “antibody-drug conjugate cancer review”:

Key research article (Asundi et al. 2011 out of Genentech) - http://clincancerres.aacrjournals.org/c ... /965.short

Visual description of how ADCs work in cancer (put out by Genentech) – http://www.gene.com/stories/understandi ... conjugates

Best,
Jonathan
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby Catherine Poole » Tue May 14, 2013 6:27 am

Thanks for sharing this promising information. The beauty of it is you can be BRAF negative too. I hope this works out well for you! I would try some of the air travel support charities too. Glad you found the Hope Lodge!
Catherine M. Poole, President/Founder
Melanoma International Foundation
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby Cecelia » Tue May 14, 2013 7:55 am

Thank you for posting this, Jonathan. It bolsters everyone to know that there is yet another option for moving forward. And thank you for being such a model of resilience.
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby Angela21 » Wed May 15, 2013 6:04 am

Thank you for researching this. Hopefully it will be widely available.
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby ericw » Fri Jun 28, 2013 8:59 am

Hey Johnathan...was curious if you decided to start this trial? Thanks
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby Catherine Poole » Fri Jun 28, 2013 10:50 am

I heard from Jonathan this week and he started the infusion this week. He said it was amazing how there were no side effects. He is down there for a while but I'll remind him to keep the forum updated.
Catherine M. Poole, President/Founder
Melanoma International Foundation
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby ericw » Fri Jun 28, 2013 11:45 am

Thanks and good luck Johnathan
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby jamesa » Fri Jun 28, 2013 11:52 am

Jonathan,

This is just wonderful news for you. I am thrilled that finally things are working out for you.

You are truly a "educator" so if you can, please post a description of the protocol that you are going through (ie: how often & how long are the infusions, how often lab work, side effects,etc)

Best of Luck on the trial. Please keep us posted on how you are doing.

Catherine, if you know anything about the protocol(ie: how often & how long are the infusions, how often lab work, side effects,etc) for this trial, please post. Everyone can benefit by learning about this exciting trial.

James
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby Shirley Z » Fri Jun 28, 2013 11:56 am

Good Luck Jonathan! My thoughts and prayers are
with you as always.
You strength and courage are remarkable.
Shirley Z
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Re: Very promising new drug trial - Genentech/Roche ADC

Postby Jonathan » Fri Jun 28, 2013 12:22 pm

Hi folks,
I just wanted to give an update on this promising phase I trial I'm just starting in Nashville (Sarah Cannon).
Bottom line - it's extremely hopeful, drug companies are falling over themselves getting similar drugs going on different cancers, their share prices are going up, and everyone involved is very optimistic. However, it's still in very early development, and I doubt it will be widely available in trials for a number of months yet (but who knows?). You can see the earlier post in this thread of mine describing these ADC (antibody-drug conjugate) drugs. This one, which is the only one specific for melanoma, doesn't have a weird name yet - just numbers with DEDN as a prefix (Genentech/Roche). The name will come, however. Genentech alone has 8 ADC drugs in trial development (15 under study), and one ADC drug for an aggressive form of breast cancer is the first to be FDA approved, a couple of months ago.

My situation and the regimen - I had my first infusion on Wednesday (the regimen is 1 IV infusion for 1 1/2 hours every 3 weeks, probably for ever if you respond, which will be established within the first 6 weeks). I am here for a month because of all the scans and associated follow-up blood work the company demands - scans and bloodwork on Monday, infusion Wednesday, then bloodwork at 24 and 48 hours. Next Wednesday additional bloodwork, then another PET scan that Friday, bloodwork the following Wednesday, and finally the second infusion the following Wednesday. After that, I'm due for blood work weekly (plus the 3-week infusions) for a few months, and then I'll be here a day for 2 out of 3 weeks, and finally at the half-year mark, just for the infusions every 3 weeks - the major draw-back, but hey, if I'm a responder, it will be manageable, right? Side-effects are apparently almost totally infusion-related, so they gave me 20 mg steroids the night before plus benadryl the day of, and watched me like hawks every 15 minutes during the infusion. No problem at all, not even a little tired (this is now usual - they now expect no side-effects with the steroid premeds). The trial director, Dr. Jeffrey Infante, doesn't want to cite percentage responses, but it's clear he's most enthusiastic about this particular drug among all the ones they're doing trials on at Sarah Cannon (that's all they do - drug development). The clinical trial nurses, however, have said things to me that suggest that the response rate is somewhere around 50% (including achieving stable disease), and of course the lack of side-effects is an incredible plus.
It is especially hopeful for ocular melanoma, and the gossip is that the trial may be expanded first for those patients - apparently there are 2 or 3 ocular patients among the first 30 or so who've been taken into the trial, and they all have responded.

Everyone (nurses, doctors) speaks of the trial inevitably expanding in numbers and to other locations because it's so promising, and I fervently hope that is true, because otherwise, IF I am a responder, I will be condemned to fly down to Nashville a great deak - crazy company requirements.

I must warn you that I do tend to be an optimistic person (Polyannaish perhaps?), but this is clearly something to keep in mind if you hear about it down the line. I am not sure that there are any new seats on this trial available (it's only at Sarah Cannon, The Angeles Clinic, and 2 sites in Australia), and the original phase I plan was for a total of 50 patients altogether - about 20 already at Sarah Cannon, 1 taken in every 3 weeks for the past year, and about 10 still continuing treatment (meaning responders). Apparently, however, the company (Genentech) will suddenly call up and say something like "We want you to take in another 3 patients at a slightly lower dose" or some such, so if you are interested, do contact them. The people here have no idea if/when the trial will be expanded (again company business), but they all are confident it will be, so it won't hurt to notify them of your interest.

So I will let you know in a month whether I'm a responder or not - I'm very hopeful.

Best,

Jonathan
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