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Pr Ajay Gopal: News in refractory indolent non-Hodgkin’s lymphoma

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Pr. Ajay Gopal, Seattle

 

Breakthrough in refractory indolent non-Hodgkin’s lymphoma

 

 

CLEMENTINE:

Hello! You’re on MD-FM INSIGHT, the first medical web radio. Today we’ll be devoting our "Question & Answer" program to the treatment of patients with refractory indolent non-Hodgkin’s lymphoma.

 

Slow-growing, or indolent, non-Hodgkin lymphomas are difficult to treat, with most patients relapsing repeatedly and the disease becoming increasingly resistant to therapy over time. However, it has been more than ten years since a treatment with a new mechanism of action has been approved for this condition.

 

At the 2013 annual meeting of the American Society of Hematology, which took place last December in New Orleans, we interviewed Pr. Ajay Gopal, from the University of Washington School of Medicine in Seattle, who presented the results of a phase 2 study evaluating the investigational agent idelalisib in patients with indolent B-Cell non-Hodgkin’s lymphoma that’s refractory to standard treatment with both rituximab and chemotherapy containing alkylating agents.

 

 

CLEMENTINE:

Hello Dr. Gopal, first of all, give us an overview on indolent non-Hodgkin’s lymphoma:

 

GOPAL:

“So an indolent B-cell lymphoma is an incurable disease and, though we have many improved therapies now, inevitably these therapies eventually stop working and patients die of their disease. So there’s a desperate need for better therapies, safe therapies, in patients that have disease that has become refractory to standard alkylating chemotherapy and also refractory to rituximab.”

 

CLEMENTINE:

What is this new agent idelalisib, why is theoretically interesting for indolent non-Hodgkin’s lymphoma?

 

GOPAL:

“The specific target is the delta isoform of the P-I-3 kinase enzyme, which mediates several key biochemical pathways within the malignant B-cell, including mediates B-cell receptor signaling. So there’s preclinical data suggesting that, by targeting and inhibiting this specific enzyme you can induce cell death in malignant B-cells.”

 

CLEMENTINE:

Can you tell us just a few words on the design of your study?

 

GOPAL:

“It was a phase II study, a single arm study of 125 patients who had to meet the definition of double refractory indolent B-cell lymphoma, so they had to have disease that was refractory to both rituximab and refractory to alkylating agents, such as bendamustine or cyclophosphamide or chlorambucil. So this was the inclusion criteria.”

 

CLEMENTINE:

Ok so how effective was idelalisib in these patients?

 

GOPAL:

“So the main results, first, just noting that this was an oral agent, it’s a pill, patients take 150 mg twice a day and they take it continuously, until they have disease progression, or unacceptable side effects. So the main result in this population was the overall response rate of 57 percent in this group of patients with a double refractory disease.”

 

CLEMENTINE:

So it’s a very good result isn’t it?

 

GOPAL:

“Right we’re very encouraged, there’s very little data in this population because most drugs don’t work. So we were certainly very encouraged and 90 percent of patients had reduction in their lymph node size.”

 

CLEMENTINE:

What about the safety data, what did they show?

 

GOPAL:

“The safety: this was actually very well tolerated, relative to other therapies, there was some transaminase elevation early on but, in the vast majority of patients, we just noted the lab abnormality and they continued taking the drug and it resolved on its own. There is some late diarrhea in a minority of patients, after being on the drug for 6 to 12 months, which also can be treated either by pausing the drug or treating with anti-inflammatories.”

 

CLEMENTINE:

So what is your take home message?

 

GOPAL:

“I think the whole community is very excited with this because we all have numbers of patients in our clinic really with very few options and so, with such a low toxicity oral therapy, we’re hopeful that this will provide meaningful benefit to them.”

 

 

Clementine:

This show is over. By visiting the MD-FM website, you can check out the themes of the programs we will be offering you regularly.

See you soon on MD-FM.

 

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