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Experimental Vic-Trastuzumab Duocarmazine Better Than Doctors’ Treatment Choices for Pre-treated Advanced-Stage HER2-Positive Breast Cancer

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The experimental targeted therapy vic-trastuzumab duocarmazine improved progression-free survival and overall survival more than doctors’ treatment choices for people diagnosed with advanced-stage HER2-positive breast cancer that had been previously treated with anti-HER2 medicine, according to a study.

The research was presented on Sept. 19, 2021, at the European Society for Medical Oncology (ESMO) Congress 2021. Read the abstract of “Primary outcome of the phase III SYD985.002/TULIP trial comparing [vic-]trastuzumab duocarmazine to physician’s choice treatment in patients with pre-treated HER2-positive locally advanced or metastatic breast cancer.”

Advanced-stage breast cancer is either locally advanced or metastatic. Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from the breast. Metastatic breast cancer is breast cancer that has spread to parts of the body away from the breast, such as the bones or liver.

Progression-free survival is how long people live without the cancer growing. Overall survival is how long people live, whether or not the cancer grows.

About vic-trastuzumab duocarmazine
About the TULIP trial
What this means for you

About vic-trastuzumab duocarmazine

Vic-trastuzumab duocarmazine, also called SYD985, is a type of targeted therapy called an antibody-drug conjugate made up of two parts:

  • the monoclonal antibody Herceptin (chemical name: trastuzumab), an anti-HER2 medicine
  • valine-citrulline-seco-duocarmycin-hydroxybenzamide-azaindole, a cleavable linker drug

Cleavable linker drugs contain a chemotherapy molecule and attach (conjugate) it to a monoclonal antibody.

In the case of vic-trastuzumab duocarmazine, the linker drug contains the chemotherapy molecule duocarmycin, as well as molecules that link the chemotherapy to the Herceptin.

The Herceptin carries the vic-trastuzumab duocarmazine to the HER2-positive cancer cells. Then enzymes activate the chemotherapy to kill the cancer cells.

Vic-trastuzumab duocarmazine is given intravenously, which means that it’s delivered directly into the bloodstream through an IV or a port.

Vic-trastuzumab duocarmazine is not currently approved by the U.S. Food and Drug Administration (FDA) to treat breast cancer.

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About the TULIP trial

Called the TULIP trial, the phase III study included 437 people from 11 countries. All the people were diagnosed with advanced-stage HER2-positive breast cancer that had been previously treated with either:

  • two or more lines of anti-HER2 therapy
  • Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine) for metastatic disease

Overall, 383 people in the study had previously received Kadcyla. The number of previous treatments ranged from one to 16.

The researchers randomly assigned the people to one of two treatment groups:

  • 291 people received vic-trastuzumab duocarmazine
  • 146 people received their doctors’ treatment choices

The doctors’ treatment choices were:

  • Tykerb (chemical name: lapatinib) plus Xeloda (chemical name: capecitabine)
  • Herceptin plus Xeloda
  • Herceptin plus Navelbine (chemical name: vinorelbine)
  • Herceptin plus Halaven (chemical name: eribulin)

Progression-free survival was:

  • 7.0 months for people who received vic-trastuzumab duocarmazine
  • 4.9 months for people who received their doctors’ treatment choices

This difference was statistically significant, which means that it was likely due to the difference in treatment and not just because of chance.

Overall survival was:

  • 20.4 months for people who received vic-trastuzumab duocarmazine
  • 16.3 months for people who received their doctors’ treatment choices

This difference was not statistically significant.

Vic-trastuzumab duocarmazine is known to cause eye problems. About 78% of people who received the medicine reported eye problems. Nearly 21% of the people in the vic-trastuzumab duocarmazine treatment group stopped treatment and about 23% had a dose reduction because of eye problems.

Vic-trastuzumab duocarmazine also is known to cause interstitial lung disease and pneumonia. Interstitial lung disease is a general term for disorders that cause inflammation and scarring in the lungs. The scarring makes the lung tissue stiff, which makes it difficult to breathe. Of the people who received the medicine, 7.6% reported lung problems. About 5% of the people in the vic-trastuzumab duocarmazine treatment group stopped treatment and about 2% had a dose reduction because of lung problems.

The most common side effects reported by people who received vic-trastuzumab duocarmazine were:

  • pink eye
  • inflammation of the cornea
  • fatigue
  • dry eye

The most common side effects reported by people who received their doctors’ treatment choices were:

  • diarrhea
  • nausea
  • fatigue
  • low white blood cell counts

About half the people in each treatment group reported a grade 3 or higher side effect.

The most common grade 3 or higher side effects reported by people who received vic-trastuzumab duocarmazine were:

  • inflammation of the cornea
  • pink eye
  • low white blood cell counts

The most common grade 3 or higher side effects reported by people who received their doctors’ treatment choices were:

  • low white blood cell counts
  • hand-foot syndrome
  • diarrhea

Four people in the vic-trastuzumab duocarmazine treatment group died from side effects during the study:

  • one person died from respiratory failure
  • one person died from pneumonia
  • two people died from lung inflammation

No one who received their doctors’ treatment choices died from side effects.

“[Vic-trastuzumab duocarmazine] can provide a new treatment option for patients with pretreated, locally advanced or metastatic HER2-positive breast cancer,” said Cristina Saura Manich, M.D., Ph.D., of the Vall d’Hebron University Hospital in Barcelona, who presented the research.

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What this means for you

If you’ve been diagnosed with locally advanced or metastatic breast cancer that has grown during treatment with Kadcyla or two or more other anti-HER2 medicines, the results of this study are encouraging.

Still, vic-trastuzumab duocarmazine is not approved by the FDA to treat breast cancer. It’s also important to know that the study’s early results didn’t show a significant overall survival benefit for the medicine. The TULIP trial continues to collect information, and the researchers plan to do another overall survival analysis when more information becomes available.

As you and your doctor discuss next treatments, you may want to bring up this study. If you’re willing to enroll in a clinical trial, vic-trastuzumab duocarmazine may be an option for you. Ask your doctor if there are any clinical trials that may be a good fit for your unique situation. Learn more about Clinical Trials.

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Written by: Jamie DePolo, senior editor


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