What is a Tumor Agnostic Therapy?

In May 2017, the U.S. Food and Drug Administration (FDA) approved the first tumor/tissue agnostic therapy. These drugs are approved for use for any tumor that has a specific mutation, regardless of where the tumor started. Since then, two more tumor/tissue agnostic therapies have been approved. The drugs that have been approved are:

 Pembrolizumab (Keytruda®), for metastatic cancers that have microsatellite instability-high (MSI-H) or DNA mismatch repair deficiency (dMMR). It is rare in breast cancer.
Larotrectinib (Vitrakvi®) and Entrectinib (Rozlytrek®), for metastatic cancers that have certain NTRK gene mutations. These mutations are found in about 2% of breast cancers.

Although these mutations aren’t common in breast cancer, more tumor/tissue agnostic therapies are in clinical trials which could potentially expand breast cancer treatment options.

Below you can learn more about the drugs that have been approved and how these tumor/tissue agnostic therapies are pushing the field of precision medicine forward. These drugs are often studied in basket trials, which enroll patients with many different types of cancer that all share a common mutation. You can read more about basket trials from BreastCancerTrials.org: All Open Basket Trials

Overview of Tumor Agnostic Therapy:

Tumor Agnostic Therapies:

OS vs. PFS: What You Need to Know

Clinical trials are set up to look at specific outcomes. Click to read about how progression-free survival (PFS) and overall survival (OS) are used to measure treatment effectiveness.

What Are Master Protocols?

Master protocols are clinical trials that are specifically designed to allow researchers to study several molecular markers and targeted therapies simultaneously. These protocols also allow researchers to introduce new therapies into a trial that is already underway.

Researchers are still learning the best way to design these protocols and choose the proper statistical methods for evaluating their findings. Here you can read about how master protocols are being used in breast cancer and other clinical trials.

Want to learn more? The February issue of MTT discussed two types of master protocols: basket trials and umbrella trials.

All about Basket and Umbrella Trials

Basket trials and umbrella trials were created to help researchers study how tumors respond to targeted therapies.

Basket trials, also known as bucket trials, enroll patients whose tumors have a specific genetic mutation, regardless of where their cancer started.

Umbrella trials enroll patients with one type of cancer and have many different treatment arms. Patients are assigned to a specific arm based on the biomarkers seen in their tumor.

The articles below explain the goals of these trials. They also discuss potential challenges and concerns.

You can find all the basket trials enrolling breast cancer patients from BreastCancerTrials.org

Understand Basket and Umbrella Trials

Basket and Umbrella Trials: Past and Now

Basket Trials: Advantages, Challenges and Opportunities

Current Basket Trials: