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Experimental Drug Turns Off Leukemia Cells

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COLUMBUS, Ohio (Ivanhoe Newswire) - Medical experts said every year about 12,000 patients in the United States are diagnosed with chronic lymphocytic leukemia, but a new drug has shown promise for patients who have lost all hope of beating the disease.

It's the simple things, like enjoying the outdoors and taking family vacations that 73-year-old Dennis Hickey can look forward to once again.

"I'm very fortunate, I'm excited about life.  I can do my job, I sell houses, I can enjoy the grandkids," Hickey told Ivanhoe.

Hickey has chronic lymphocytic leukemia, or CLL, a common and deadly form of leukemia affecting older adults.

"The prognosis was not good, but I was going to see it through no matter what," Hickey said.

With six months to live, Hickey got to take an experimental drug called Ibrutinib as part of a clinical trial for CLL patients.  John Byrd, MD, and professor of medicine at the Ohio State University, co-led the study.

"We have seen a drug come into the clinic that has really helped patients with CLL and related diseases that have been at the end of their life," Dr. Byrd explained.

The drug works by targeting the protein in CLL cells. Without the protein, the cancer can't grow.  Doctors say 90 percent of patients have had success with Ibrutinib and side effects are minimal compared to chemotherapy.

"The patients tolerate it very, very well. Many patients say they feel like they did before they had CLL," Dr. Byrd said.

Researchers said Ibrutinib is a game-changer. Hickey says it's a life-saver.

"I'm still here and I'm so thankful," Hickey said.

Researchers said Ibrutinib is not a cure, but if patients follow treatment, they can manage CLL the same way they would manage diabetes or high blood pressure.

The drug is expected to be approved by the FDA in early 2014.

RESEARCH SUMMARY

BACKGROUND: Chronic lymphocytic leukemia (CLL) is a type of cancer of the blood and bone marrow. The term "chronic" comes from the fact that it typically progresses more slowly than other types of leukemia  and "lymphocytic" comes from the cells affected by the disease — a group of white blood cells called lymphocytes, which help your body fight infection.  (SOURCE:http://www.mayoclinic.com/health/chronic-lymphocytic-leukemia)

SYMPTOMS: Many people with CLL have no early symptoms. Those who develop signs and symptoms may experience:

  • Enlarged, but painless, lymph nodes
  • Pain in the upper left portion of the abdomen, which may be caused by an enlarged spleen
  • Frequent infections

(SOURCE: http://www.mayoclinic.com/health/chronic-lymphocytic-leukemia)

TREATMENT: A new drug application has been submitted to the FDA for the investigational agent Ibrutinib as a therapy for previously treated chronic lymphocytic leukemia (CLL) and previously treated mantle cell lymphoma (MCL) after the positive results observed in two clinical trials, which showed high response rates to the drug.

The filing for the indication for CLL was based on the results of a phase Ib/II trial, in which 85 patients with relapsed or refractory CLL or small lymphocytic lymphoma (SLL) received Ibrutinib orally once daily, with 51 patients receiving a 420 mg dose and 34 patients receiving an 840 mg dose.

The overall response rate (ORR) in both treatment groups was 71%, with an additional 20% of patients in the 420 mg dose arm and 15% of patients in the 840 mg dose arm experiencing a partial response with lymphocytosis. After 26 months of follow-up, the estimated rate of progression-free survival (PFS) was 75%, and the rate of overall survival (OS) was 83% for all patients, irrespective of the dose. Side effects were minimal and consisted mostly of grade 1 or 2 transient diarrhea, fatigue, and upper respiratory tract infection. (SOURCE:http://www.onclive.com/web-exclusives/NDA-Filed-for-Ibrutinib-in-CLL-and-MCL)

INTERVIEW

John C. Byrd, MD, Professor of Medicine and Medicinal Chemistry at The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, talks about a new drug to treat Leukemia.

How exciting is this drug?

Dr. Byrd: Ibrutinib has been very exciting. This drug has really helped patients with CLL and related diseases; that have been at the end of their life. We've been able introduce a very well tolerated therapy that's giving patients back their life. How can one not be excited about that?

Can you explain how it works? Does it attack the protein within the leukemia cell?

Dr. Byrd:  Ibrutinib works in a unique way and it's a targeted therapy. So leukemia cells, CLL cells, and related leukemia have a protein called Brutons Tyrosine Kinase. Without this protein, malignant B cells, the leukemia cells can't propagate. They can't grow and they can't get stimuli to stay alive. The drug works very uniquely by just affecting predominately the leukemia cells.  It's a targeted therapy that doesn't affect the rest of the body, which really contrasts it from chemotherapy, that's been used for decades for the treatment of cancer where you're giving something that's toxic to the whole body. It's just a little bit more toxic to the cancer cells. So the patients can take this medicine for a long period of time and not have the adverse side effects that people would have with chemotherapy.

What about side effects with this drug?

Dr. Byrd: Any drug that we give is going to have side effects. Some nuisance side effects at the beginning of treatment, loose stools, rash, heartburn, but then those generally disappear and then patients often will go back to feeling very well. Many patients will say they feel like they did before they had CLL.

What cancer patients are typically good candidates for this particular drug, is it only leukemia patients?

Dr. Byrd:  Thus far the drug has been shown to work in CLL, chronic lymphocytic leukemia and a variety of different B cell lymphomas. The target of ibrutinib is present, the drug has a chance of working and it's worked across several different types of blood cancers at this point.

This isn't approved yet by the FDA, but it's on the road to being approved, is that correct?

Dr. Byrd:  That's correct. When it will be approved will more than likely be soon, we hope. It can't be soon enough because we're seeing patients every day that would benefit from this drug and right now the only access to it is on clinical trials.

How many on average are patients out there with CLL?

Dr. Byrd: Approximately twelve thousand new patients with CLL are diagnosed a year in the United States.  The prevalence is over a hundred thousand because patients with CLL live for an extended period of time.

The good thing with this drug is although they are still living with it their quality of live does improve?

Dr. Byrd: Yeah, it's a disease that mainly affects the elderly, so patients can live with it for a period of time. However, when it causes the symptoms, the big lymph nodes, the spleen enlarging, the fatigue and other things that's when we treat it. That's sort of when outcome becomes much less favorable where quality of life goes down and that's really where the drug impacts most, because we're giving something that's targeted. It doesn't have the adverse side effects of chemotherapy and produces durable remissions with just taking a pill daily.

It comes in a pill form right?

Dr. Byrd: It's a pill.

Any thoughts about the folks at home that are going to see this and may not have hope or know this is available?

Dr. Byrd:  Ibrutinib in CLL has given a lot of hope to patients, to physicians, and to the care givers that care for them. The success of this project has come from pharmaceutical companies, universities and the FDA really working hard to bring forth a – a very exciting and active drug and it's happened very quickly. And I think that's a credit—that's a credit to everybody you know including the regulatory agencies that have really moved this agent very quickly through the pipeline.

Is this a cure?

Dr. Byrd: Ibrutinib does not appear to cure CLL, but it is medicine that patients can go on and potentially convert their disease to being one like high blood pressure or diabetes where they can take an oral medicine and control their disease and live with the symptoms of their disease. 

Would you even use the product or give it to someone in your family?

Dr. Byrd: If I had CLL and were at the point that it was time to be treated, I would travel around the world, mortgage my house, do whatever to be able to get on this medicine, because it's really a game changing medicine and it's going to likely eliminate chemotherapy from the treatment of CLL in the future.

FOR MORE INFORMATION, PLEASE CONTACT:

The Ohio State University
614-293-9869
Lab website: www.cll.osu.edu

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