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NCI-MATCH to assess treatments based on genetic abnormalities, not cancer type
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The ECOG-ACRIN Cancer Research Group has opened the largest precision medicine cancer trial to date.
The phase 2 National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) trial will evaluate the efficacy of targeted therapies in patients whose tumors share specific gene abnormalities. Treatment choice will be made based on these abnormalities rather than the site of origin of the malignancy.
Keith T. Flaherty
“The primary underpinning of the trial comes from genetic characterization of various cancer types, which has become increasingly common place but is not yet routine,” Keith T. Flaherty, MD, an oncologist at Massachusetts General Hospital, associate professor at Harvard Medical School and ECOG-ACRIN chair of the NCI-MATCH trial, told HemOnc Today. “When looking at cancers as defined by their site of origin, there are threads of continuity across those cancer types. Within a cancer type, there also is heterogeneity, and understanding what this patchwork looks like was really the main motivator for setting up a trial like this.”
The trial — also known as EAY131 — is expected to enroll nearly 3,000 patients aged 18 years and older from community hospitals and large cancer centers nationwide. The trial is open to patients with any type of solid tumor, as well as those with lymphoma, whose cancer recurred or progressed after standard systemic therapy.
“We essentially aimed to include every cancer type in this trial and only ended up excluding those that we just simply could not operationalize within the context of a single-arm study,” Flaherty said.
The researchers will use four molecular diagnostics laboratories to assess 143 genes associated with cancer identified with a single DNA sequencing test developed specifically for this trial.
“We’ll aim to perform deep genetic characterization of patients regardless of cancer type and [use that information] to assign them targeted therapies that we think would be the optimal potential match for their genetic makeup,” Flaherty said.
Researchers expect to perform initial analysis on 3,000 patients, all of whom will undergo a new biopsy. All biopsy samples will undergo genetic testing to see if tumors harbor a genetic abnormality. From that group, the investigators hope to identify 1,000 eligible participants whose tumors harbor a genetic abnormality that can be targeted by one of the treatments being assessed in the trial.
The trial launched with 10 treatment arms, and another dozen are expected to open in the next several weeks, Flaherty said.
The trial will assess the effectiveness of each treatment independently. It is not designed to compare regimens.
Cost can be a barrier to precision medicine in the real-world setting, but NIH funding will cover the cost of the NCI-MATCH trial.
“I see a lot of inefficiency in terms of doctors and patients seeking personalized medicine approaches, but only having partial access to parts of what we all think is the vision for personalized medicine,” Flaherty said. “Performing next-generation sequencing is increasingly feasible but challenges remain, particularly in terms of payers covering it.”
The trial also is designed to overcome another challenge, Flaherty said.
“When patients do have this genetic testing done in routine clinical practice, often times there is not much that they can do with the information,” he said. “There are relatively few drugs that are FDA approved for a specific cancer type and genotype, but there are dozens and dozens of drugs in clinical trials aiming to target some of these cancer cells. With NCI-MATCH, we are trying to create a ‘one-stop shopping’ opportunity where patients can have their diagnostic characterization, but then also have the therapy brought to them.”
Patients with a rare type of cancer for which no standard treatment is currently available also are eligible to enroll. The trial is designed so individuals with rare cancers account for at least one-quarter of enrolled participants.
“We ultimately hope for this trial to uncover the efficacy of drugs in populations with rare cancers and provide at least the initial evidence to get moving toward subsequent trials to finally get these drugs approved in these populations,” Flaherty said. – by Jennifer Southall
FOR MORE INFORMATION
Physicians or patients who want more information about NCI-MATCH may call the NCI Cancer Information Service at (800) 4-CANCER or go to ecog-acrin.org/nci-match-eay131.
Keith T. Flaherty, MD, can be reached at Massachusetts General Hospital, 10 N. Grove St.; LH 202, Boston, MA 02114; email: kflaherty@mgh.harvard.edu.
Disclosure: Flaherty reports a consultant role with Novartis.