Michigan college student fights to keep melanoma drug in production

Josh Oleksiak has stage four melanoma

LANSING, Mich. – Josh Oleksiak is focused on college, living away from home and achieving his career goals. He tries really hard not to think about cancer.

Oleksiak, 20, has stage-four melanoma. He was first diagnosed at age 16 and has gone through several surgeries and treatments to fight the disease. Often times, the treatments took their toll on his body with difficult side effects.

He is currently participating in a clinical trial that requires him to take three different drugs every day. Oleksiak said he feels great on this treatment and is able to focus on having a normal life, including going away to school at Lansing Community College, where he is studying business management.

"To be on what I'm on now is kind of a blessing for me to be able to feel as good as I do right now," Oleksiak said.

It's not just about feeling good. He said the cancer has stopped growing in his body.

"They basically stopped the cancer in its tracks," Oleksiak said. "They really have helped me take that ease of mind off of that something could be growing inside my body to where every scan that I have shows that there is no new results on anything."

Oleksiak has been part of the clinical trial since October 2015. Under it, he takes two drugs that are FDA approved and a third one that's investigational.

According to SWOG, a worldwide network of researchers that design and conduct cancer clinical trials, nine people in this trial have experienced tumors that did not grow under treatment. It's unclear if it's the investigational drug or the combination of the other two that halted tumor growth.

"He's felt the best he's felt since all of this happened. He is able to go away to school, living life, feeling great," said Okeksiak's mother, Jennifer Oleksiak.

But the clinical trial has to stop because the investigational drug is no longer produced by Novartis and any existing supply expires April 30.

Patients in the trial can still take the two FDA approved drugs. Oleksiak has already tried that treatment.

"Being on those two pills the cancer had actually gone to my brain so wondering with removal of this pill if that could be a potential to happen again and that's just something that's in the back of my mind," Oleksiak said.

Novartis told Local 4 it discontinued manufacturing the drug due to lack of clinical benefit observed in early studies. Oleksiak and his family wants the company to reconsider its decision.

"I would tell them they don't know how big an impact they're making by removing this pill. Whether it's one person like myself or a million people on this trial, what they have shown through scans ... is that this pill is working," Oleksiak said.

Researchers and doctors, including Oleksiak's doctor at the University of Michigan Hospital, have been working hard to find a solution for patients in the trial.

"It's obviously very difficult to think that something that's benefiting someone would just ... stop," said Dr. Christopher Lao. "If I had complete control of that ... it wouldn't happen

Oleksiak's mom has worked tirelessly to find a solution for her son, too, reaching out to Novartis, the FDA and other agencies for help.

"I would like to think that if the head of the company or the person or persons committee that made the decision to discontinue this drug, that if you knew the stories, that if you saw my child, that you would think again," Jennifer Oleksiak said. "If you had a cure for your child, that you would make it even if your child was the only one."

"I think that's what honestly is difficult is because he has been through multiple therapies and finally not only (does) something seem to be working but he's tolerating it well," Lao said. "He had a lot of problems with side effects with some of these different treatments and we had to stop sometimes just for the side effects. So to be on something he actually can tolerate and seemingly live a normal life, we (would) love to be able to keep that going."

Novartis tells Local 4 it has found additional limited supply of the drug and released the following statement.

"Novartis is working with the study sponsors National Cancer Institute (NCI) and SWOG regarding their study of an investigational compound AKT795. In 2015, it was decided to discontinue manufacturing the investigational compound due to lack of clinical benefit observed in early studies. At that time, clinical trial investigators were informed of the situation and were advised to transition their patients to alternative treatment options.  

Novartis is aware of the patient situation and is committed to working with NCI and SWOG on solutions. We have alerted NCI that we have been able to identify additional limited supply of AKT795. This may allow more time for the study center to determine an appropriate, long-term treatment approach for the patient.

We will not be producing additional AKT795 because the treatment has not demonstrated efficacy in clinical trials."

The new limited supply was supposed to arrive at the National Cancer Institute Tuesday where it will be evaluated. NCI funds SWOG research and holds the user agreement for the drug from Novartis.

SWOG tells Local 4 they are working quickly to determine how much of the drug they have, how long it will last and if testing is required. Since the drug supply is unlabeled, it must be tested for patient safety. There are six patients still on the trial taking the investigational drug.

"Novartis, SWOG, and the NCI have made a major effort to help our patients, and I am so grateful for their partnership and fast action.," said Wendy Lawton, communications and public rRelations manager for SWOG.

No matter what happens, Oleksiak remains positive and that's his advice to other people with cancer.

"Just live every day to the fullest with a smile on your face because there is nothing you can do. Just treat it and God's will is God's will," Oleksiak said.

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