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Clinical Trials

mystery molecule


Date: June 29, 2004

by Chaya Venkat

Meeting With Berlex Labs

Related Articles:
Campath Therapy;

Last week PC and I met with Berlex Labs in Seattle, at their request. Berlex is the U.S. distributor of Campath, fludarabine and Leukine (GM-CSF). I am sure they make or distribute other great stuff, but these days I am not ashamed to admit I have tunnel vision: if the drug has nothing to offer CLL patients, I am not interested. And for those of you with "inquiring minds", yes, Berlex did offer us an honorarium for our time. Both PC and I chose to have their entire check made out to Mayo Clinic, earmarked for CLL research and Project Alpha. So both of us are still as pure as the driven snow, no taint of pharmaceutical money to cloud our judgment.

We met with Berlex's marketing and clinical team. They wanted our input and perspective as patient advocates, and we were happy to give it to them. We also participated in a CLL patient focus group discussion. All in all, nice folks, great town, very interesting conversations, tiresome airports and flights. I have tried to capture much of what we discussed with Berlex, as well as a little background information where I though it might be useful to you.

Fludarabine and Campath: Major Drugs on the CLL Landscape

Let's face it, like it or not chemotherapy is an important weapon in our arsenal against CLL and fludarabine is as big as they come in the list of chemotherapy agents for CLL. It has long been the "gold standard" for CLL, and even now it plays a major role in combination therapies such as FRC and RF. But please do read our recent article on the use of single agent fludarabine as front line therapy: Fludarabine Monotherapy No Longer the Gold Standard. The Ohio State clinical trial of (Rituxan + fludarabine) combination has demonstrated clear survival advantage over single agent fludarabine. At this point in time, the other Berlex CLL-specific drug, Campath, is the only monoclonal antibody that has been approved for CLL as single agent therapy. Rituxan has not been approved in this role. And yet, more and more patients are choosing Rituxan-based therapies, either as single agent or in combinations, and oncologists are going along with that, sometimes prescribing Rituxan for off-label use. For many patients, the line-up of escalating therapy intensity goes something like this right now:

Obviously, this list is an oversimplification, and does not fit all cases. There are other drugs such as Pentostatin (purine analog similar to fludarabine), older generation drugs like chlorambucil, new stars that are yet to prove their worth such as flavopiridol, disappointments like Genasense, double helping of monoclonal scenarios like (Rituxan + Campath), the odd "gene therapy" and externally grown armies of killer T-cells thrown in for good measure. A few well-constructed clinical trials have addressed frontline and second-line therapy with Campath, but this is hardly setting the patient community buzzing with excitement. What gives? No wonder Berlex's Campath team wanted to meet with us. 

Here Is Why We Think Patients May Be Voting With Their Feet for Rituxan-Based Therapy

However, It Is Not In Patients' Interest to Let This Become a One-horse Race:

Let me get my personal opinion right on the table, so you can judge what I have to say in the context of my acknowledged bias. I think Campath is a very important monoclonal in our fight against CLL, and it is in our interest to support research and clinical development of this and other such drugs. Here are my reasons: 

I hate to see a one-horse race. It really takes at least two players to keep our capitalist system working right. Where would be the incentive for improvements in Rituxan and related products, if Genentech had no competition?

FluCam 106

Berlex is interested in a clinical trial that compares head-to-head the Ohio State type (Rituxan + fludarabine) combination against Campath + fludarabine. This trial is called "FluCam 106" (some of these guys should go back to marketing 101. Personally, I think the "Round Headed Kid" or RHK protocol is a lot cuter name. But then, I admit I am biased). Here is a link to the official trial announcement at the NCI website. Here are some of the details of FluCam 106:

It is no secret the average community-based oncologists make much of their annual income based on difference between the "bulk discount price" they pay for expensive oncology drugs, and the much larger figure they are permitted to bill insurance companies or Medicare. This is a huge financial disincentive for referring patients to clinical trials.  That is the single biggest reason why cancer clinical trials in this country are doing so poorly at recruiting volunteers. Patients just don't hear about them from their community-based oncologists! The solution is simple: recruit patients directly, without going through the local oncologist as middleman. This is where the Internet and patient advocacy groups like CLL Topics can make a huge difference. We are interested in the clinical research, we will participate and help the process. But only if we are taken seriously as legitimate partners in the process, our voices heard, our input sought. It seems this is a "novel" idea, to have patients considered as something more than passive cancer victims in the clinical trial process. Well, time to change that outmoded paradigm, don't you think? 

Recruit Where the Interest Is, Among Patient Communities

Here is the advice we gave the Berlex team. They listened very politely and we even think we convinced them on some of the issues. But if I have learned one thing in my business career, no deal is a done deal, not until it is really done. As some guy said, at this point the fat lady is just humming and a lot can change. 

In summary, I think it was a very fruitful meeting. It says a lot that this company is actually soliciting our opinion and advice (OK, PC and I might have gone a little over the top on the advice bit, but hey you get nothing unless you ask for it, right?). I hope this is a trend and the empowerment that goes with the development of on-line patient communities will finally get us a seat at the table. We have the most at stake in these clinical trials, our lives and our children's lives. Full disclosure and good faith recruitment that takes the patients' perspective into account when designing clinical trials just may work, cut through the so-called patient apathy and distrust.

If Berlex comes through with formal acceptance of any of these recommendations, we will publish their letter on our website as well. Patients sign very formal contractual documents when they volunteer for clinical trials, we ask for no less from the sponsors of the trials.

Editor's Note: The following letter was received from Berlex on October 21, 2004

Closure of FluCam 106 Trial

New Clinical Trial in the Works to Test Important Combination Therapy

Letter from Dr. Andrew Sandler of Berlex

Dear Friends at CLL Topics: 

Berlex has decided to close the study FluCam 106, “A Phase II Study Comparing Fludarabine/Campath to Fludarabine/Rituximab.” This decision was reached as a result of low enrollment on the current study and strong feedback that indicated that the scientific question asked continues to be of interest. Comments from many of the investigators indicated that the stringent  inclusion / exclusion criteria, rigorous schedule of events and overall protocol complexity made it difficult to enroll patients. Therefore, based on this feedback, we will be developing a new study which asks a similar scientific question, however the overall complexity of the study design will be greatly reduced - a benefit to both the investigator and the patient. Berlex will continue to keep CLL Topics apprised of the progress on this new study and the sites that will be participating.  We expect the new trial to be up and running by March of 2005. 

Best regards,

double drip

Andrew S. Sandler, M.D.
Associate Director
Berlex Oncology



Editor's Note 2:

An Update

As of July 2007, we have not seen a re-launch of FluCam-106 or a successor protocol comparing F+Campath versus FR in a side-by-side study. If such a trial is announced in the future, we will certainly look into it.

In the meantime, a multinational phase III study comparing the combination of fludarabine and Campath versus fludarabine alone has been recruiting patients since July 2004. This study (CAM314), sponsored by Genzyme Corporation, has a total targeted enrollment of 300. On December 21, 2004 Genzyme acquired the rights to Campath through its corporate acquisition of Ilex Oncology — but the distribution agreement with Berlex (Schering AG) seems to have continued at least for a while after that. The scorecard gets a bit confusing as the recombinant corporate jockeying continues. We will report on this important therapeutic combination as results become available.




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