BiovaxID: An Introduction to Consolidation Therapy (Part 3 of a series)

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You've just finished six rounds of tough CHOP combination chemotherapy plus the immunotherapeutic monoclonal antibody rituximab (R-CHOP) to treat your follicular lymphoma. Scans show that you are in remission.

Now the doctors tell you that it's not over. You will begin consolidation therapy.

Standard treatment guidelines in oncology currently dictate that first-line consolidation therapy means receiving an infusion of rituximab every eight weeks for as long as two years.

Rituximab requires a couple of hours to administer. It has a lot of troubling side effects . The infusion means sitting in a waiting room and exposing one's self to one of the most germ-infested places ever tested—the arm rests on chairs in medical waiting rooms. For those two years you will be immunosuppressed and therefore susceptible to all manner of infections. You might develop the mysterious 'Rituxan cough'. You can't get a flu shot in that time. And the side effects from rituximab can kick in several months after administration.

You could do that, or…

…What if, starting about 9 months after finishing chemotherapy, you received a simple, fast, subcutaneous injection once a month for about five months?

No side effects. No hours lost in waiting rooms and infusion wards. Flu shot, no problem. Immune system, not compromised. Disease-free survival time, pretty much equal to rituximab except your quality of life is significantly better.

Sound too good to be true? Well it is good, it is true. This is Biovest's therapeutic lymphoma vaccine BiovaxID in the consolidation setting.

Consolidation therapy

This is one of many cancer terms that confuses us: consolidation therapy. Often. In the struggle to understand all the terms, it's easy for this one to get lost. Especially when the National Cancer Institute defines consolidation therapy like this:

Consolidation therapy is treatment that is given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. It may include radiation therapy, a stem cell transplant, or treatment with drugs that kill cancer cells. Also called intensification therapy and postremission therapy.

And the NCI defines adjuvant therapy like this:

[Adjuvant therapy] is additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

It doesn't take Webster to see that these definitions express the exact same idea: a therapeutic regimen of some sort that is administered after front line treatment in order to find and kill any remaining cancer cells that are not detectable by scans. A mop-up job, if you will.

Consolidation Strategies in Follicular Lymphoma

Right now, patients with follicular lymphoma who undergo induction chemotherapy—could be R-CHOP—are told that the regimen is not a cure; that the slow-growing lymphoma will slowly grow back. That's just the reality of indolent lymphoma.

In order to put as much time as possible between finishing chemotherapy and the inevitable return of the lymphoma, doctors use consolidation therapy. It begins shortly after the patient finishes chemotherapy.

As mentioned, chemotherapy typically includes Rituxan. When it's finished, patients are immunosuppressed and they have been depleted of B-lymphocytes. Standard treatment guidelines for consolidation therapy right now call for another two years of Rituxan.

For all the profound good that it has done, rituximab nonetheless comes with many potential side effects. Since radioimmunotherapy (RIT, like Zevalin) also includes rituximab and might be used off-label as consolidation therapy, we can compare rituximab, RIT and BiovaxID across several risks:

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BiovaxID's safety profile is virtually spotless by comparison. And the reason is simple: Because BiovaxID is an autologous vaccine product; by autologous that means the vaccine is developed from a protein found on the surface of your tumor cell. Biovest extracts that specific protein expressed on your cancer cells and they make many copies of it, enough to provide for several injections.

But sending the protein back into the body as-is would be pointless. The idea is to generate a response from your immune system that identifies this protein as a foreign substance that needs to be taken out.

Biovest does this by using a common vaccine carrier protein, called KLH.

KLH, bound to your specific cancer protein, elicits a strong immune response. But in order to encourage an even stronger response, Biovest adds GM-CSF, another protein that helps the body develop white blood cells. So these BiovaxID injections are carrying three working parts: the protein representing your cancer, a protein carrier that alerts the immune system to attack it, and another protein that sees to it that your immune system has the goods to execute it.

Coming to a Euro-market Near You

Recently the FDA stated that they want Biovest to conduct another Phase III trial of BiovaxID. This could take a few years. Fortunately, the treatment should be available in the European Union and Canada not too long from now.

Biovest is leading the way in imagining therapeutic vaccines in consolidation therapy. This kind of mop-up work significantly extends disease-free survival times and in some cancers can be the difference between a cure and a recurrence. Chemotherapy puts the body through enough--consolidation therapy shouldn't be as toxic as induction therapy if it doesn't have to.

Now if only the FDA could understand that.

BiovaxID: On the Trail of the Lymphoma Vaccine

Follow the links below to read the rest of this series:

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