Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Effect of encorafenib plus cetuximab with or without binimetinib for people with metastatic colorectal cancer

Date of summary: September 2019

Study number: NCT02928224

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Study start date: October 2016

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Estimated study end date: August 2020

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The full title of this abstract is: Encorafenib plus Cetuximab With or Without Binimetinib for BRAF V600E–Mutant Metastatic Colorectal Cancer: Expanded Results from a Randomized, 3-Arm, Phase III Study vs. the Choice of Either Irinotecan or FOLFIRI plus Cetuximab (BEACON CRC)

This combination of study drugs is not approved to
treat the condition under study that is discussed in this
summary.

 

Researchers must look at the results of many types of
studies to understand whether a study drug works, how
it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study.
The results of this study might be different from the
results of other studies that the researchers look at.

 

More information can be found in the scientific
abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Colorectal cancer (CRC for short) is cancer of the large bowel (colon and rectum).
    • Metastatic colorectal cancer (mCRC for short) is cancer that has spread from the colon or rectum to other areas of the body.
  • Cetuximab (CETUX for short) is an approved treatment for people with mCRC.
    • CETUX blocks a receptor called the epidermal growth factor receptor on the surface of colorectal cancer cells. This helps to stop the cancer cells from growing.
  • Some people have colorectal cancer with a faulty gene called BRAF. Faulty BRAF genes make altered versions of the BRAF protein, which helps cancer cells to grow.
  • Colorectal cancer cells may have other changes in related proteins, such as MEK proteins. These proteins help cancer cells to divide.
  • Encorafenib (ENCO for short) and binimetinib (BINI for short) are investigational treatments for colorectal cancer.
    • ENCO blocks the activity of BRAF.
    • BINI blocks the activity of MEK proteins.
  • This study looked at the following 3 combinations of study drugs in people who had mCRC with a specific type of faulty BRAF gene known as BRAF V600E:
    1. 1. ENCO + BINI + CETUX
      • This treatment is known as a triplet treatment as there are 3 drugs.
    2. 2. ENCO + CETUX
      • This treatment is known as a doublet treatment as there are 2 drugs.
    3. 3. Doctor’s choice of chemotherapy (irinotecan or a combined treatment called FOLFIRI) + CETUX
      • These treatments are widely used for colorectal cancer, so they are called the current standard of care.
  • In the overall study, people who had the triplet treatment lived for longer and were more likely to have their tumor shrink compared with people who had the current standard of care.
  • This summary looks at the results in people who received the triplet compared to people who received the doublet.

Who took part in this study?

  • Overall, 665 people with mCRC took part in this study.
  • Around 1 in 3 people received the triplet, around 1 in 3 people received the doublet, and the remaining 1 in 3 people were on the doctor’s choice of chemotherapy + CETUX.

What were the results of the study?

  • On average, people who received the triplet lived for 9 months, while people who received the doublet lived for 8.4 months.
  • 26 in 100 people receiving the triplet had tumors that shrank, compared with 20 in 100 people who received the doublet.
    • For people who had received one previous treatment for their cancer:
      • 34 in 100 people receiving the triplet had tumors that shrank
      • 22 in 100 people who received the doublet had tumors that shrank.
  • 58 in 100 people who received the triplet had serious medical problems, compared with 50 in 100 people who received the doublet.
  • A similar number of people left the study because of a medical problem with the triplet or the doublet (7 compared with 8 people in 100).
  • People who received the triplet had a similar quality of life to people who received the doublet.

More results from this study can be found here:
View ESMO Scientific Abstract

What were the main conclusions reported by the researchers?

  • In this study, people who received the triplet lived longer, on average, and were more likely to have their
    tumors shrink than people who received the doublet.
  • People who received the triplet were slightly more likely to have medical problems than people who
    received the doublet. In general, these medical problems were manageable and did not greatly affect people’s overall quality of life.

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY, NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the
people who took part in this study.

 

Array BioPharma Inc (a subsidiary of Pfizer Inc)
3200 Walnut Street
Boulder, CO 80301
Phone (United States): +1 303-381-6600

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