Wellness Profile: Dr. Gary Onik

Over the past 40 years, Dr. Gary Onik has created and implemented multiple methods to detect and treat challenging malignancies.

And when Dr. Onik himself was faced with metastatic prostate cancer, he successfully used his own technique.

Five years later, Dr. Onik has personally celebrated something he has given to hundreds of patients before him—another anniversary of being cancer-free.

A Novel Cancer Vaccine

Dr. Onik was diagnosed with metastatic prostate cancer in 2018.

"I had prostate cancer with a very high PSA, and eventually I was going to die from it," said Dr. Onik. "I refused to go on hormone treatment that would chemically castrate me. Instead, I knew of something else that could help: my own treatment."

Three years earlier, Dr. Onik had pioneered a new therapy called intra-tumor immunotherapy.

Or, as Dr. Onik calls it, the first cancer vaccine of its kind.

Intra-tumor immunotherapy involves freezing a small portion of the tumor in a special way, which releases tumor proteins that the immune system can recognize. This is different from traditional cryosurgery, where freezing kills the tumor completely. The tumor is then directly injected with a checkpoint inhibitor* drug.¹

"We treat one small area of one tumor. After that, the patient’s immune system can recognize that tumor, go to other sites where metastatic tumors reside, and often kill those tumors as well," said Dr. Onik. "We only have to do a procedure on one tumor, and all of them often go away."

This patented process arms the immune system to create its own cancer vaccine out of the patient’s tumor without the side effects of systemic checkpoint inhibitor drugs or CAR T**.

While Dr. Onik himself had successfully treated many cancer patients using his intra-tumor immunotherapy, no one else knew how to perform the procedure when he received his own cancer diagnosis.

But Dr. Onik wasn’t fazed by this roadblock.

Dr. Onik decided to have spinal anesthesia so that he could be awake to guide a colleague through the procedure.

"He thought I was out of my mind," laughed Dr. Onik.

But eight weeks and two procedures later, Dr. Onik was cancer-free.

"On December 4, I reached my five-year anniversary with no metastatic disease," said Dr. Onik.

40% Success Rate

Dr. Onik’s success story has been repeated in patients whose lives have been saved by his innovative cancer discoveries.

One of the first patients to undergo intra-tumor immunotherapy was Joe Lee, who was dying from metastatic prostate cancer. After undergoing a radical prostatectomy, the cancer had recurred, and he had tumors throughout his body.

"Lee was going to hospice. He only had weeks to live because he was essentially bleeding to death from a tumor invading his bladder," said Dr. Onik.

He had a dramatic response to intra-tumor immunotherapy.

After the first month, Lee’s PSA went down by almost two-thirds. After the second month, his tumors vanished.

Nine years later, Lee remains cancer-free.

Dr. Onik has since treated nearly 200 patients with every kind of tumor using intra-tumor immunotherapy.

A preliminary retrospective analysis of 27 patients showed that this treatment has a complete response of 40% in metastatic cancers including prostate, bladder, colon, and breast.2 A complete response means that all signs of cancer have disappeared in response to treatment.

"These results are unheard of in patients previously deemed untreatable—and this is just the beginning," said Dr. Onik.

Dr. Onik is currently working with Nova Southeastern University on sophisticated immune tests to identify which patients respond to the immune therapy and which do not.

Many types of cancers respond to intra-tumor immunotherapy.

A Track Record of Success

Dr. Onik has been revolutionizing the cancer industry since his days in radiology residency training in 1982, when he pioneered a new approach to cancer treatment called image-guided tumor ablation.

This radical new approach utilized ultrasound guidance in real-time to allow the doctor to guide a probe directly into the tumor, and then to destroy it with either freezing or heating. The tumor is left in place to be removed naturally by the body.

This procedure is especially useful for treating liver cancers that can’t be surgically removed (called unresectable tumors) due to their location.

"Image-guided tumor ablation changed that scenario. Finally, we had a method that could reliably destroy a tumor that couldn’t be surgically removed or destroyed by radiation or chemotherapy," said Dr. Onik. "Patients with these unresectable tumors had no hope. Since then, data has shown that by using liver cryosurgery, we could benefit many patients."

Marsha Sawyer was one of those patients.

* Some of the checkpoint inhibitor drugs that Dr. Onik injects directly into the tumor include pembrolizumab (Keytruda®) and ipilimumab (Yervoy®). These drugs can cause serious side effects when systemically administered, but not when injected directly into a tumor.

** CAR T-cell therapy, or chimeric antigen receptor therapy, is a type of immunotherapy that helps the immune system identify and destroy cancer cells. It's a complex treatment that can only be performed at registered hospitals with specialized healthcare professionals.

At only 33 years old, this mother of two young children was diagnosed with a rare form of liver cancer called hepatic leiomyosarcoma. She was told that her cancer was inoperable and 100% fatal.

Dr. Onik performed liver cryosurgery using image-guided tumor ablation on Marsha in 1987. Now, 37 years later, she is alive and cancer-free.

Many more followed, with overwhelmingly positive results.

"At five years after the procedure, the majority of patients who have undergone cryosurgery for liver cancer have no evidence of disease," said Dr. Onik. "This procedure is done tens of thousands of times every year. It’s a part of the cancer treatment landscape now."

Prostate Cancer

Another innovation of Dr. Onik’s that is widely used today, called image-guided focal ablation, has been shown to improve disease-free survival in prostate cancer while dramatically reducing side effects.

Until recently prostate cancer was treated as if the whole gland was involved, either by irradiation, freezing, or complete removal. All of these treatments come with complications like incontinence and impotence.

Adding insult to injury, in approximately 30% of cases, the cancer returns anyway.³

Dr. Onik improved prostate cancer treatment in two ways: first by creating 3D prostate mapping, a new biopsy technique that is more accurate than the traditional biopsy, and second, by utilizing image-guided focal ablation to selectively destroy the cancer while leaving the rest of the prostate unharmed.

A study published in the Journal of Men’s Health followed 70 men who underwent optimized focal therapy to treat their prostate cancer.⁴

Maintaining potency and preventing incontinence were the main concerns. After 10 years, overall disease-free survival was 89%. There was no urinary incontinence after the first treatment and 94% of the study participants remained potent.

Focal therapy is also effective in men who have recurrent prostate cancer whose options would otherwise be limited to radical prostatectomy, chemical castration chemotherapy and/or radiation.

The treatment has also been found to be effective in liver, skin, lung, breast, and head and neck cancers.

Working Toward FDA Approval

Dr. Onik’s goal is to achieve the same level of widespread integration with intra-tumor immunotherapy as he has had with image-guided tumor ablation and focal therapy.

He is working to obtain funding for clinical trials. After that, he hopes to obtain a breakthrough designation from the FDA. This is a process that fast-tracks the development and review of treatments that can save lives.

While each individual component of the therapy is approved by the FDA, the novel combination of methods utilized in intra-tumor immunotherapy is not.

Because of that, insurance companies don’t cover the procedure, and as of now, only Dr. Onik and a handful of doctors he has trained are capable of performing it.

Without insurance coverage, anyone electing to undergo intra-tumor immunotherapy will pay somewhere in the range of $100,000.

Dr. Onik is optimistic that intra-tumor immunotherapy could receive approval in as little as three years.

"Right from the very beginning, we were treating patients that nobody else could treat," said Onik. "We were offering hope, and that’s what we’re continuing to offer now."

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References

1. Brito-Orama S, Sheth RA. The Contemporary Landscape and Future Directions of Intratumoral Immunotherapy. J Immunother Precis Oncol. 2023 May;6(2):84-90.
2. Onik, G. Abstract 6540: Regression of metastatic cancer and abscopal effects following in situ vaccination by cryosurgical tumor cell lysis and intratumoral immunotherapy: A case series. Cancer Research. Cancer Res (2020) 80 (16_Supplement): 6540.
3. Available at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/prostate-cancer/prostate-cancer-prognosis. Accessed May 24, 2024.
4. Long-Term Results of Optimized Focal Therapy for Prostate Cancer: Average 10-Year Follow-Up in 70 Patients. Journal of Men’s Health. 2014;11(2):64-74.