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Genentech Announces Positive Results from Phase II Study of Trastuzumab-DM1 (T-DM1) in Advanced HER2-Positive Breast Cancer

Strategic Insights

— 2 min read

Genentech, Inc., a wholly owned member of the Roche Group, has announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1) in women with advanced HER2-positive breast cancer. The study, known as TDM4374g, found that T-DM1 shrank tumors in 33 percent of women with metastatic HER2-positive breast cancer that had worsened following previous treatment. Women in the study had already received an average of seven drugs for metastatic disease prior to receiving T-DM1, highlighting the need for new treatment options in this population. The study's results demonstrate the potential of T-DM1 as a new treatment option for women with advanced HER2-positive breast cancer.

Key Takeaways:

  • T-DM1 shrank tumors in 33 percent of women with advanced HER2-positive breast cancer that had worsened following previous treatment.
  • Women in the study had already received an average of seven drugs for metastatic disease prior to receiving T-DM1.
  • The study's primary endpoint, objective response rate, was met with 33 percent of women experiencing a complete or partial tumor shrinkage of at least 30 percent.
  • The most common severe adverse events included thrombocytopenia (5.5 percent) and back pain (3.6 percent).
  • No severe (Grade 3 or higher) cardiac-specific side effects were observed.
  • One patient with pre-existing, non-alcoholic fatty liver disease died with hepatic failure.
  • The Phase II study (TDM4374g) is a single-arm, multi-center trial designed to assess T-DM1 as a single agent in 110 women with HER2-positive advanced breast cancer.
  • The study's secondary endpoints include safety, clinical benefit rate, duration of response, and progression-free survival (PFS).
  • T-DM1 is a novel, antibody-drug conjugate (ADC) in development for HER2-positive advanced breast cancer, combining two approaches in one medicine: the anti-cancer activity of the trastuzumab antibody and the targeted delivery of the potent cytotoxic DM1.

Statistics:

  • 33 percent of women with metastatic HER2-positive breast cancer achieved a complete or partial tumor shrinkage of at least 30 percent.
  • Women in the study had received an average of 7 drugs for metastatic disease prior to receiving T-DM1.
  • 5.5 percent of women experienced a severe adverse event of thrombocytopenia.
  • 3.6 percent of women experienced a severe adverse event of back pain.
  • 59.1 percent of women experienced fatigue.
  • 37.3 percent of women experienced nausea.
  • No severe (Grade 3 or higher) cardiac-specific side effects were observed.

Sources:

  • Genentech, Inc.
  • American Cancer Society
  • NewsRx.com
  • Blood Weekly via NewsRx.com

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