Precision medicine in oncology – the tailoring of treatments to individual patients rather than a one-size-fits-all approach – could perhaps be expressed in philosophical terms as meaning that no patient is an average, and every patient is unique.
That’s the approach Bryce Olson took starting in 2014, when he was diagnosed with prostate cancer and found that one standard-of-care treatment after another failed. “You’re just like a sheep on the long journey to slaughter,” he said in a phone interview, referring to the pitfalls of the one-size-fits-all cancer treatment paradigm.
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Olson will deliver the closing keynote address at the MedCity ENGAGE conference, which takes place in San Diego next week. While the cost of NGS tests can be high, Olson emphasized that paying few thousand dollars for them upfront can avoid greater costs down the road, for drugs that don’t work and for emergency room visits, while also increasing patient engagement by giving them greater hope. “I’m in Cigna – if you look at the cost of care for me over five years, it’s been really cheap for them,” he said. “I’ve had a few diagnostics tests costing $3,000-4,000, but that’s enabling me to take drugs with a high probability of working and pushed me onto clinical trials that barely cost the insurer anything.”
He was able to undergo genomic sequencing, a technology then limited to a few academic cancer hospitals like Oregon Health and Science University’s Knight Cancer Institute, where he was being treated. Working at Intel helped also, given the company’s involvement in a lot of cutting-edge technology, including genomics.
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This was before the advent of widely available next-generation sequencing technology from companies like Foundation Medicine – whose FoundationOne CDx gained Food and Drug Administration approval last year – and the OHSU test could only pick up about 30 or so mutations. But as luck would have it, Olson had one, phosphoinositide 3-kinase, or PI3K, meaning he qualified for a Phase I clinical trial of a PI3K/mTOR inhibitor called VS-5584, made by Needham, Massachusetts-based Verastem Oncology.
The rise in precision medicine, fueled by next-generation sequencing tests and increasingly by liquid biopsy as well, has given rise to treatments targeted not to cancer types, but to oncogenic driver mutations. Last year, Merck & Co.’s PD-1 inhibitor Keytruda (pembrolizumab) was approved for solid tumors with the microsatellite instability-high marker, regardless of where they occur in the body. And the FDA is expected to decide by late November whether to approve Loxo Oncology and Bayer’s larotrectinib, which targets NTRK fusions in solid tumors, also regardless of where they occur.
Initially, the lead investigator at Los Angeles’ Cedars-Sinai Medical Center was going to turn Olson down due to a lack of available slots, but let him in when he told her he had genomic data, as most of patients in the trial were receiving the drug regardless of whether they carried PI3K. Although the drug’s development had to be canceled because many patients experienced serious toxicity, Olson did not despite receiving the highest dose, and his disease responded. Currently approved PI3K inhibitors include Gilead Sciences’ Zydelig (idelalisib), approved in 2014 and used to treat follicular lymphoma and chronic lymphocytic leukemia, and Bayer’s Aliqopa (copanlisib), approved last year for FL. And just last month, Verastem won approval for another PI3K inhibitor, Copiktra (duvelisib), for FL and CLL.
After the VS-5584 study ended, Olson received the remaining supply of drug and was enrolled in a one-patient, FDA-approved study. Around the time he finished taking it, his cancer returned, but once again he was saved by genomics. He underwent a liquid biopsy test from San Diego-based Epic Sciences to see if his circulating tumor cells carried a protein called AR-V7, which is known to render hormone-based prostate cancer therapies ineffective. However, he was negative for it and now takes Johnson & Johnson’s Zytiga (abiraterone acetate) plus the steroid prednisone. Today, he said, he has no evidence of active disease.
Photo: iLexx, Getty Images