Genentech’s Kadcyla Cut the Risk of Disease Recurring by Half Compared to Herceptin in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment

– At three years, 88.3 percent of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0 percent treated with Herceptin, an 11.3 percent improvement

– People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease –

– Data from the Phase III KATHERINE study will be submitted to health authorities globally, including the U.S. Food and Drug Administration and European Medicines Agency –

– Results are being presented at the 2018 San Antonio Breast Cancer Symposium, featured in the press program and simultaneously published in the New England Journal of Medicine on Wednesday, December 5 –

SOUTH SAN FRANCISCO, CA, USA I December 5, 2018 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla® (ado-trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival; iDFS) by 50 percent (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin® (trastuzumab) as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (EBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment. At three years, 88.3 percent of people treated with Kadcyla did not have their breast cancer return compared to 77.0 percent treated with Herceptin, an 11.3 percent improvement. Kadcyla improved iDFS irrespective of hormone receptor status, lymph node status and prior HER2-targeted treatment regimen received in the neoadjuvant setting. The safety profile of Kadcyla was consistent with that seen in previous studies, and no unexpected or new safety signals were identified.

“The KATHERINE results demonstrate a significant reduction in the risk of recurrence of HER2-positive early breast cancer in people with residual disease after neoadjuvant therapy, and we look forward to submitting these data to health authorities as soon as possible,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure with every advance in reducing disease recurrence.”

The goal in treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. While we come closer to this goal with each advance, many people still have a disease recurrence in the long-term. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and is aimed at eliminating any remaining cancer cells in the body to help reduce the risk of the cancer returning.

These results are being presented in an oral session today at the 2018 San Antonio Breast Cancer Symposium (SABCS) at 11:00 a.m. CST (abstract GS1-10) and featured in the official SABCS press program at 7:15 a.m. CST. These results will simultaneously be published in the New England Journal of Medicine.

About the KATHERINE study

KATHERINE is an international, multi-center, two-arm, randomized, open-label, Phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive EBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which in this study is defined as the time from randomization free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.

KATHERINE Study Results






Median follow-up     41 months
Invasive disease-free survival (iDFS)
Risk reduction     HR=0.50, 95% CI 0.39-0.64, p<0.0001
3-year iDFS     88.3%     77.0%
    11.3% improvement
Overall survival (OS)
Risk reduction    

HR=0.70, 95% CI 0.47-1.05, p=0.0848

Data immature at this interim analysis

Adverse events (AEs)
Grade ≥3 AE     25.7%     15.4%
Serious AE     12.7%     8.1%
Most common Grade ≥3 AEs
Thrombocytopenia (decreased platelet count)     5.7%     0.3%
Hypertension (high blood pressure)     2.0%     1.2%
Radiation-induced skin injury     1.4%     1.0%
Peripheral neuropathy (numbness, tingling or pain in the hands or feet)     1.4%     0.0%
Neutropenia (decreased neutrophil count)     1.2%     0.7%
Hypokalemia (low blood potassium level)     1.2%     0.1%
Fatigue     1.1%     0.1%
Anemia (decrease in red blood cells)     1.1%     0.1%

About HER2-positive breast cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 269,000 people in the United States will be diagnosed with breast cancer, and more than 41,000 will die from the disease in 2018. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20 percent of breast cancers are HER2-positive based on the result of a diagnostic test.

About Kadcyla

Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells. It is designed to limit damage to healthy tissues, although it can still affect them. Kadcyla can cause serious side effects. It combines two anti-cancer agents using a stable linker: the HER2-targeting trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the only ADC approved for the treatment of HER2-positive metastatic breast cancer. In the U.S., Genentech licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

Kadcyla Indication Statement

Kadcyla® (ado-trastuzumab emtansine), as a single agent, is indicated for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

  • Received prior therapy for metastatic disease, or
  • Developed disease recurrence during or within six months of completing adjuvant therapy.

About Genentech in breast cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit

SOURCE: Genentech

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