Sarah Cannon Research Institute (SCRI) believes personalized medicine—tailoring treatment to the individual patient’s cancer—is critical for drug development and offering the right treatment, to the right patient, at the right time. SCRI’s Personalized Medicine Program brings together experts in cancer research and the latest technology to help physicians determine the best treatments for their patients by surveying the genetic makeup of a patient’s individual cancer.

In this article, Andrew McKenzie, PhD, vice president of personalized medicine at SCRI and scientific director of Genospace, SCRI’s precision medicine platform, and Mick Correll, president of Genospace, share insights on how precision medicine has evolved over the past decades and what the future looks like.

The evolution of precision medicine

“We have come a long way in the realm of precision oncology and personalized medicine,” says Dr. McKenzie.

Initially, personalized medicine in oncology was used to classify different tumor types by their tissue of origin and assign therapies to those tumors. But over time, precision medicine has evolved to classify different molecularly defined subtypes of any given tumor type. This has allowed researchers to build personalized therapies specific to a tumor molecular subtype.

“For instance, lung cancer can be treated today not just as lung cancer defined by a specific histology like adenocarcinoma, but as a specific molecular subtype of lung cancer, such as EGFR-mutated, MET-altered, or BRAF-mutated,” says Dr. McKenzie. “Because we can now target the underlying biology specific to a patient’s tumor, these targeted therapies work better, there are fewer side effects, and we’re able to finely tune a therapy regimen to a specific patient rather than just to a broad disease type like lung cancer.”

This means more treatment options and better outcomes for patients.

“The number of options patients have access to today is incredible compared to 10 or 15 years ago when the standards of care were limited to a small number of different chemotherapy regimens,” he explains.

Dr. McKenzie says the advances in precision medicine center around two areas: molecular diagnostic technologies and the advancement of the precision therapeutics themselves.

 The evolution of diagnostic technology

Molecular diagnostic technology – including next-generation sequencing (NGS) – allows oncologists to survey a patient’s cancer for specific molecular abnormalities that can be targeted with therapeutics. These abnormalities can be detected from tissue biopsies or, in some cases, in simple, relatively noninvasive blood draws—some of which can even be done in the patient’s home through mobile phlebotomy.

“When the Human Genome Project first started, the cost to sequence a human genome was estimated at one billion dollars,” says Dr. McKenzie. “The evolution sequencing technology and its integration into cancer treatment has evolved from something that was unattainable to something that’s a routine part of cancer care.”

He adds, “Now, a patient doesn’t even have to leave their local oncologist to get answers about whether or not their cancer has these molecular targets. We’ve been able to democratize the technology so much that a once billion-dollar project is now one that can be done at their own oncologist’s office for a few hundred dollars. It’s really amazing.”

Advancements in precision medicine treatments

Previously, the standard of care for many cancers was cytotoxic chemotherapy. While this therapy targets rapidly dividing cancer cells, it can also affect normal, healthy cells, which can lead to significant side effects.

“We’ve moved away from cytotoxic chemotherapy and into the world of using one’s own immune system to fight against cancer and to strategically build molecules and therapeutics that are designed against the molecular drivers an individual’s cancer,” he says. “The science behind that and our ability to understand cancer biology at such a deep level over the past decade has opened up a plethora of tools we can use from a pharmaceutical standpoint to target these cancers in brand new ways.”

Researchers can also use precision medicine technology to monitor resistance to therapies.

“We know that many of these targeted therapies only work for a specific amount of time before tumors develop mechanisms of resistance to those therapies,” says Dr. McKenzie. “It’s only through the work of experts doing these types of genomic analyses to understand how those tumors evolved and evaded therapy that we’re able to build the next generation of therapies that target those resistance mechanisms.”

He also notes that if a precision medicine treatment works for one patient’s tumor subtype, it will likely work for patients with similar diseases.

“We can build therapies that are specific to a patient and then extrapolate that and say, ‘I know patients are more similar than they are different. And so maybe that one type of therapy can be used for any patient who has a similar molecular alteration,’” he says. In fact, multiple tissue-agnostic targeted and immune therapies have been approved by the U.S. Food and Drug Administration (FDA) that target specific molecular alterations including NTRK fusions, microsatellite instability, high tumor mutation burden, and BRAF V600E mutations. These approvals indicate that identifying the molecular drivers of certain cancers can be more important than the tissue of origin when treating disease.

Earlier molecular testing

One major paradigm shift, Dr. McKenzie notes, is the transition from performing molecular diagnostics once a patient has metastatic disease to performing these tests earlier in care.

“We’re asking ‘How do we intervene with these technologies and new therapies earlier in care?’  The earlier we can intervene with targeted therapies or immune-based therapies, the better the chance of survival for those patients – it’s an exciting landscape in oncology.”

New FDA approvals have emerged in the early disease or adjuvant setting that require the knowledge of particle molecular alterations. For example, patients with non-small cell lung cancer (NSCLC) with certain EGFR mutations are now eligible to receive osimertinib – an EGFR inhibitor – in the adjuvant setting and patients with early stage breast cancers with mutations in BRCA1 or BRCA2 who are at a high risk of recurrence are eligible for PARP inhibitor therapy. Surveying the mutational landscape of cancers earlier in care will continue to provide new insights into how to better treat cancer at their most vulnerable state.

Advancing personalized medicine through clinical trial matching

As precision medicine creates more therapeutic options for patients, SCRI and Genospace are harnessing the power of technology to get precision medicine treatments into the hands of more clinicians and patients.

“Our partners in the biotech and pharma industry have made great advances in developing new therapies, and SCRI sits right at that intersection of when these new therapies are being studied and investigated and then getting those therapies into the hands of the clinicians and patients in our communities,” says Dr. McKenzie. “Personalized medicine is not something that is only offered in an academic medical center or reserved for a specific type of patient anymore. Personalized medicine is now democratized at scale so patients can get access to these therapies and technologies that were inaccessible 10 years ago.”

 Dr. McKenzie believes the key now is closing the gap between which patients to test and which patients get which therapies once oncologists get the test results. This affects both the standard of care and clinical trial spaces, he adds. That’s where technology like Genospace comes in.

A part of McKesson, Genospace is a specialized data science and technology company that has developed cloud-based software to advance precision medicine in the field of oncology. From early-stage drug development to approved therapies, Genospace is the fully-integrated personalized medicine engine for SCRI.

“Genospace significantly impacts care. With data accessible at a clinician’s fingertips, oncologists can more easily make data-drive decisions, reducing decision fatigue and de-mystifying complex molecular data,” says Dr. McKenzie. “The convergence of complex molecular diagnostics, precision therapeutics, and a deeper understanding of the molecular mechanisms of disease over the past 10 years has greatly benefited our cancer patients.”

Today, Genospace has tools in partner clinics that help providers use genomics to guide therapy and clinical trial selection. Behind these tools is an enormous database of information.

Genomics is not only a feat of chemistry, but, just as importantly, a feat of computation, notes Mick Correll.

“In the past, we used to look at one or two factors like a patient’s age and tumor type,” he says. “Now we have the ability to simultaneously investigate thousands of data points about a patient and, eventually, millions or even billions of factors. Genomics is a powerful molecular microscope that enables us to observe an individual’s cancer,” says Correll. “Looking ahead, with the advent of blood-based early cancer detection tests, we expect these tools will bring tremendous insight into the progression and evolution of the disease. This is a huge change happening right now.”

Correll also believes that cancer treatment will evolve into an engineering discipline.

“We’re going to stop discovering drugs and start engineering them on a truly personal scale,” he says. “Look at personalized cancer vaccines or the COVID-19 vaccine mRNA technology. That was an engineered vaccine. I think the same thing is going to start happening with personalized medicine. We’re literally talking about making a therapy just for you, just for your unique cancer. We’re going to engineer cells that will recognize and kill an individual’s cancer cells.”

Dr. McKenzie adds, “There’s nothing more personalized than that kind of therapy.”

What’s next

A significant part of personalizing medical care is helping patients know their options for both standard-of-care treatments and clinical trials.

A missing piece of the cancer treatment puzzle, says Dr. McKenzie, is simply awareness – educating patients on which clinical trials are available to them. Currently, only about 5% of people with cancer in the United States enroll in a clinical trial.

“Clinical trial participation is abysmally low,” he says. “We know and believe that cancer care delivered as a part of a clinical trial is the best cancer care a patient can get. It makes clinical and scientific sense for us to figure out how to get more patients involved in these trials.”

Clinical trials are a crucial component in developing and advancing new therapies that benefit patients today as well as patients in the future.

SCRI is a leader in drug development. It has conducted nearly 700 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. In 2022, SCRI formed a joint venture with US Oncology Research to enhance clinical trial access and availability across the country. The combined research network brings together more than 1,300 physicians who are providing access to clinical trials at more than 250 locations in 24 states across the U.S. SCRI is actively enrolling patients on 1,000+ trials.