KENNEBUNK — Michael Delia calls himself a GMO, a genetically modified organism. It’s a play on words equating GMO-produced food to how a cutting-edge immune therapy procedure may have saved Delia’s life.

Delia’s T-cells were “genetically engineered” and re-inserted back into him to fight an aggressive form of non-Hodgkin lymphoma. The experimental treatment soon will be more widely available to patients.

Delia, 73, a Kennebunk retiree, has been in full remission for more than a year. He participated in a clinical trial, and the therapy, called CAR T, was approved on Wednesday by the Food and Drug Administration.

“I’m a GMO,” Delia said, smiling. “They inserted the good cops into me, and they’ve gone in my body and taken out the bad guys.”

Doctors removed his T-cells, which were genetically engineered in a lab in California and re-injected back into him during a procedure at Dana-Farber Cancer Institute in Boston in July 2016.

After eight days in the hospital to recover from extreme fatigue and other side effects, Delia has been cancer free for more than a year. He went golfing about two months after he got out of the hospital, and spent last winter skiing.

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“I’ve been feeling completely normal, saying a lot of prayers,” said Delia, a former U.S. Air Force colonel and helicopter pilot during the Vietnam War. Delia said he was exposed to Agent Orange while in Vietnam and the Veterans Administration has considered him disabled from the chemical. He said he can’t prove that it’s what caused his cancer, but he believes it did.

Delia had tried chemotherapy and radiation in 2014 and 2015 to treat a tumor on his right leg and cancerous cells that were in a lymph node. But the cancer kept coming back, and in 2016 he and his doctors decided to try something different.

“I was told that they could keep trying chemotherapy, but that it probably wouldn’t get good results,” Delia said.

Video: Doctors using patients’ genes to guide cancer care

Delia said Maine Medical Center doctors told him that he would be a candidate for a clinical trial at Dana-Farber. Maine Med and Dana-Farber deepened their partnership in 2015, including giving Maine Med patients more access to Dana-Farber clinical trials.

“I consider myself very fortunate,” Delia said. “Maine Med just happened to have this association with Dana-Farber. I said, ‘Let’s do it and see what happens. Let’s kick this thing.’”

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About 20,000 patients each year are diagnosed with the type of non-Hodgkin lymphoma Delia had, said Dr. Caron Jacobson, the Dana-Farber physician who headed up the clinical trial. Of that group, Jacobson said a few thousand do not respond well to traditional cancer treatment, and for those patients the immune therapy now has proven to be a viable choice.

“This is really changing the way we treat these patients who otherwise would have very few resources,” Jacobson said. She said the results of the clinical trial are “incredibly encouraging.”

The clinical trial involved 101 patients across the country, with 82 responding positively to treatment and 54 percent in “complete” recovery, according to a Dana-Farber news release.

The FDA approval of the Kite Pharma therapy is a major step toward getting the treatment in broader use. The next steps would be to get Medicare to cover the procedure and private insurance companies to then follow suit.

While it’s not yet known how much it would cost, a similar CAR T immune therapy to treat a form of pediatric leukemia costs $475,000, raising alarms among consumer health advocates.

But Gary Claxton, co-director of the program for the study of health reform and private insurance at the Kaiser Family Foundation, a Washington-based think tank, said that there’s a difference in paying high costs to fund for research for new therapies and funding disputes over existing treatments, such as a controversy over a spike in costs for EpiPen, a life-saving device for allergies.

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And Claxton said that as exclusive patents expire and more companies develop therapies that are as effective or better, the prices will likely come down.

“Things that are expensive now tend to become less expensive later,” he said.

Also, a highly specialized drug can be extremely expensive, but if it’s not in wide use, it won’t have much of an overall effect on the cost of health care in comparison to a drug or medical device that would be used by millions.

“When a new drug comes out and it’s expensive, some might say it costs too much. In this country, we don’t have any way to mediate these prices. This can be a problem,” Claxton said.

But he said that when the drug or therapy is approved by the FDA, it clears an important hurdle. If the doctor can prove that the new therapy is medically necessary, backed up by FDA approval they can usually get Medicare to agree to pay for it, and it’s also easier to get an insurance company to pay for it. Claxton said the patient may have to file appeals with insurance. But he said over time, if the therapy continues to prove it’s effective, the barriers to access will lessen.

Delia said that the high cost for the leukemia immune therapy does make him worry about access for people who are not able to participate in a clinical trial and have their costs covered as he did.

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But Delia, who moved to Maine 20 years ago with his wife, Bettianne, said he sees the results as a positive step and hopes that others like him with aggressive non-Hodgkin lymphoma soon can try the immune therapy.

Bettianne said her husband is “brave” and “never had one negative word” during the trying time.

Jacobson said Delia was “incredibly fit and saw the bright side of everything. That’s a good recipe for going through any kind of treatment.”

Delia said he has good health, and his father and uncles lived into their 90s, and that’s his goal as well.

“We got through this, so I intend to be skiing into my 80s and I plan to live well into my 90s,” he said.

Joe Lawlor can be contacted at 791-6376 or at:

jlawlor@pressherald.com

Twitter: @joelawlorph


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