FAQ

Cancer has historically been treated using standard, single-drug therapies to target specific cancers, and even when using personalized cancer therapy, the vast majority of treatments are performed using targeted monotherapies. Though far superior to standard therapies in that a tumor’s genetic mutation is matched to a specific drug therapy, monotherapies are also deficient in that it is rare that a cancerous tumor has only one mutation that requires a matching therapy. Recently, it has been shown that when the right combination of multiple drugs is used to match multiple mutations, cancer treatment is more effective.

Each drug is able to target individual cancer mutations to improve treatment, and each drug can be used with the right dose to reduce side effects. Until now, matched combination therapy was not available outside of research, mainly because there are millions of possible drug combinations that are difficult for doctors to analyze. That is where CureMatch comes in. Our goal is to make matched combination therapy a clinical reality for oncologists and patients worldwide.

CureMatch’s personalized combination therapy approach can be illustrated using a simple example, using cancer cell lines derived from the tumors of patients. In a simple example, we show cell lines from human pancreatic adenocarcinoma tumors with eight mutations, two of which were “actionable” – meaning that these two mutations were known to be responsive to a specific drug.

Although the standard of care for this type of cancer is treatment with gemcitabine—the most commonly used chemotherapy in the treatment of pancreatic adenocarcinoma—the CureMatch platform instead recommended a combination of two specific drugs (“Drug A” and “Drug B”)* to simultaneously target the two actionable mutations.

In order to assess the efficacy of the recommended treatment, four scenarios were compared: (1) standard chemotherapy (gemcitabine); (2) personalized monotherapy using Drug A only; (3) personalized monotherapy using Drug B only; and (4) personalized combination therapy using both Drug A and B (the CureMatch-recommended therapy). A graphic representation of these four scenarios is shown below, with the two actionable mutations shown on the DNA strands as blue and white circles.

The effects of the drug treatments were measured using a cell viability assay, which measures the number of living cells remaining after treatment. Personalized Combination Therapy (the CureMatch-recommended therapy), at 1:1 concentrations of Drug A:Drug B, not only resulted in a significant increase in cell death compared to the matched monotherapies (3-5 fold increase), but also in a significant increase in cell death when compared to standard chemotherapy (>20-fold increase).

This in vitro data supports the notion that combinations of drugs specifically “matched” to actionable mutations present in a patient’s tumor have the potential to provide greatly improved outcomes compared not only to standard chemotherapy but to matched monotherapy. This the basis of the CureMatch approach.

Doctors and patients have traditionally relied upon “one-size-fits-all” treatments and procedures, including chemotherapy, radiation therapy and surgery, aimed largely at fighting a particular type or origin of cancer (e.g. breast, prostate, pancreatic, etc) rather than target the unique nature of an individual patient’s cancer. This is despite one’s genotype having a profound influence on clinical responses to targeted anticancer therapies.

In fact, patients with the same cancer diagnosis not only are unlikely to share the same specific genetic variants but also unlikely to have similar reactions to identical treatments. Thus cancer must be viewed as a personal disease, with personalized treatments to best counter the disease.

Today, doctors are able to target the unique nature of an individual patient’s tumor, by matching treatments at the molecular level; resulting in improved outcomes. A recent study conducted by the CureMatch team found that patients with advanced cancers treated using the traditional or standard of care, which is based on their type or origin of cancer rather than their molecular tumor profile, had a mere 5% response rate to their treatment.

When patients with advanced cancers were treated using a personalized approach, matching them at the molecular level, there was a 27% response rate. This is personalized medicine. And it is available now.

The CureMatch PreciGENE™ analysis is available for patients with all types of cancer, at all stages of the disease, and at any time during the treatment course. In many cases, patients will have already undergone surgery, radiation therapy, and/or one or more lines of chemotherapy.

CureMatch is ideally suited to patients who have incurable cancers, have failed standard-of-care treatment, or patients with rare, incurable tumors for which there is no standard of care. A CureMatch PreciGENE™ Report can be obtained even after a patient’s tumor has progressed or while a patient is on a clinical trial or under treatment, especially if the physician is concerned that the clinical trial or treatment may not result in a durable response.

CureMatch itself does not focus on acquisition of genomic and proteomic data or next-generation sequencing (NGS) – 3rd party tumor profiling services perform these tests. When we have your lab data, we then analyze it against more than 4.5 million different drug combinations to find the most advanced cancer treatment combinations customized just for you.

Many of these lab tests are covered by insurance.

There are many personalized medicine companies that perform tumor profiling (such as DNA sequencing) of a patient’s tumor or blood, and generate a report that identifies tumor mutations and drugs that can be used to target individual mutations.

CureMatch takes this to the next level:

• We input the data provided by such companies and look at the mutations together instead of individually.
• We rank the top drug combinations (out of more than 4.5 million options) that are customized for the patient.
• We integrate multiple types of tumor profiling results (DNA/RNA sequencing, protein expression, etc.) to get a more complete picture, when available.
• We consider all of the latest advances in cancer care, including immunotherapy, targeted therapy, hormone therapy, and newly approved cancer drugs, in addition to standard drug therapies.
• We consider “off-label” cancer drugs in our analysis (i.e., drugs that have been approved for a different type of cancer, but that may be relevant to the patient’s specific tumor mutations based on data from prior clinical studies).

Therefore, a CureMatch PreciGENE™ report provides a more comprehensive analysis, both in terms of mutations and treatment options, and is provided in a ranked format that provides actionable knowledge and insight to the oncologist.

Molecular profiling data from the patient’s tumor is required prior to a CureMatch PreciGENE™ analysis. CureMatch is able to process various types of molecular profiling data, all listed in the table below. The most common type is DNA sequencing data, specifically using Next-Generation Sequencing methods. Additional data types are shown below.

Several companies offer molecular profiling services. These include, but are not limited to, Ambry Genetics, Cancer Genetics, Caris, Clarient, Foundation Medicine, GenomeDX, Genomic Health, Guardant, InterMountain, NantOmics, NeoGenomics, Perthera, and Trovagene. The specific molecular profiling service that a patient uses depends on a number of factors. Talk to your oncologist to decide which test is best for you, or contact us if you would like us to refer you to an oncologist who can help you decide.

A solid biopsy is taken directly from within a tumor, whereas a liquid biopsy analyzes the circulating DNA (cfDNA) from cells that are shed into the bloodstream by all tumors present in a patient with metastatic cancer. Therefore, a solid biopsy generally provides a picture of the mutations found directly within an individual tumor, whereas a liquid biopsy generally provides a picture of all mutations found in all tumors, if the cancer has spread. Because of this, solid biopsies and liquid biopsies can present different results.

There are also disadvantages to each:

• A solid biopsy may miss some mutations that are found only in a small area of a tumor, or it may not provide a complete picture of all of the mutations, especially in cases where cancer has spread beyond the organ of origin.
• With a liquid biopsy, all mutations may not be equally represented by cfDNA, since it may not pick up mutations from tumors that do not shed enough cells into the bloodstream, or mutations that are found only in a small area of a tumor.

CureMatch can integrate data from both solid and liquid biopsies in its analysis and ranking of personalized combination therapy options.

Foundation Medicine is best known for analyzing solid biopsies, whereas Guardant Health is best known for analyzing liquid biopsies. However, there are many other companies who analyze solid and/or liquid biopsies. Talk to your oncologist to determine which choice is right for you.

Visit this blog post (Testing for Tumor Mutations: Liquid Biopsy Versus Traditional Biopsy) on https://www.cancercommons.org for a more detailed explanation.

Depending of the complexity of the case (i.e., the type of molecular aberrations that have been identified), our PreciGENE™ software analysis usually takes between 48 and 72 hours.

If molecular profiling has not yet been performed, additional time will be required. A solid biopsy typically takes up to 4 weeks for biopsy, sample processing, and profiling; a liquid biopsy typically takes up to 2 weeks for this process. After biopsy and molecular profiling are completed, results need to be sent to CureMatch.

The CureMatch PreciGENE™ analysis only includes FDA-approved drugs. These drugs can be used on- or off-label, depending on the recommendation of the oncologist. If one of our scored combinations is available via clinical trial, we will include that information on the report

Yes. CureMatch’s PreciGENE™ analysis uses all FDA-approved drugs and pharmacology classes, including immunotherapies. When relevant (i.e., when the molecular profile includes a marker of response for immunotherapy), immunotherapies are proposed alone or in combination with any additional drug of interest.

Immunotherapy, also called biologic therapy, is a type of cancer treatment that boosts the body’s natural defenses to fight the cancer. It uses substances made by the body or in a laboratory to improve or restore immune system function. Immunotherapy may work in these ways:

• Stopping or slowing the growth of cancer cells
• Stopping cancer from spreading to other parts of the body
• Helping the immune system work better at destroying cancer cells

There are several types of immunotherapy, including:

• Monoclonal antibodies
• Non-specific immunotherapies
• Oncolytic virus therapy
• T-cell therapy
• Cancer vaccines

You can talk to your oncologist about the CureMatch report, and your oncologist can request the report. Please contact us if you want us to refer you to an oncologist familiar with our Personalized Combination Therapy reports.

CureMatch’s services are not reimbursable by health insurance providers at this time.

You may be able to reimburse yourself for the costs of CureMatch’s services in a tax-advantaged way if your oncologist orders the CureMatch report and documents that request and you have either a Flexible Spending Account (FSA) or Health Savings Account (HSA), regardless of whether the services are reimbursable under your health insurance coverage. You may also inquire about CureMatch’s financial assistance program.

Note that molecular diagnostic tests (such as Next-Generation Sequencing), which are performed by a 3rd party service provider may be covered by insurance.

Yes. While our nGENE software platform uses U.S. FDA-approved drugs, the analysis can be customized and restricted to the list of approved drugs in other countries.