Michigan college student, family celebrate after new supply of melanoma drug is found

Josh Oleksiak has stage 4 melanoma

The Oleksiak family is heading into summer joyful, celebrating the good news they received at their son Josh's last doctor's appointment.

Josh 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.

As Local 4 first told you in May, he is 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.

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

Patients in the trial could 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.

Jennifer Oleksiak, Josh's mom, fought hard to try to keep her son in the trial and on the three drugs. That included calling the Local 4 Defenders to help get their story out.

"This is my son and I think any mother in my shoes would do what I'm doing," Jennifer Oleksiak said.

Novartis told Local 4 it discontinued manufacturing the drug in 2015 due to lack of clinical benefit observed in early studies.

After we started asking questions about the investigational drug and the trial, Novartis told us it had 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."

Local 4 has followed developments since the new limited supply arrived at the National Cancer Institute to be evaluated. NCI funds SWOG research and holds the user agreement for the drug from Novartis.

"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 relations manager for SWOG.

SWOG said the drug arrived unlabeled and had to be tested and labeled to make sure it was ready for clinical distribution. By May 8, the drug was ready for shipping and could be ordered by research staff and hospitals and clinics taking part in the trial. 

Oleksiak was able to receive the new supply of the drug at his most recent doctor's appoint at the University of Michigan Health System in early May. He will be able to stay on the three drugs and in the trial for another year.

"That's huge. At the age of 16, we had no idea if he'd even be here today so to be able to have this now, for him, he is home right now for the summer, which I am so thankful for, for him to be able to hang out with us, and go out on the boat and just be with us for dinner time, he is working a full time job," Jennifer Oleksiak said.

 

The Oleksiak family is grateful to Novartis for finding the additional supply.

"Thank you, thanks for listening," Josh Oleksiaksaid.

"Thank you for being able to do what you needed to get done to supply us for this next year," Jennifer Oleksiak said.

While the family is celebrating Josh's continued health, they are still focused on his future.

"A year is going to go by and Joshua is going to continue doing well and continue living life and we need the next step, we need to know what's next," Jennifer Oleksiak said. "Once this supply is gone, then what? Because the type of drug that this is, I would hope this company, because if they are no longer going to make it, they've got to have something in the background, something that I'm hoping they'll be able to provide for us.  If not this company, maybe another company."

Local 4 checked back with Novartis. The company does not plan to manufacture the investigational drug "at this time due to minimal efficacy in earlier clinical trials."

Novartis said it "is continuing to work with NCI and SWOG as they determine the best solutions for this patient and others on their trial."

"Trial volunteers make new cancer treatments possible, and they are our highest priority. SWOG was pleased to work with the NCI and Novartis to find a fast, temporary solution for our patients, who have more time to determine with their physicians and families the best continuing treatment," said SWOG in a statement.

As for Josh Oleksiak, he and his doctor are already looking into other options for future treatments. He is also thankful his cancer fight is helping others. He is one of six people who can continue taking the investigational drug since Novartis found the additional supply.

"That really means a lot to me too. that I can help out a lot more than just myself," Josh Oleksiak said.


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