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The FDA has granted accelerated approval to Immunomedics’ Trodelvy (sacituzumab govitecan-hziy), the first antibody-drug conjugate that targets the Trop-2 antigen. Trodelvy is indicated for treatment of relapsed or refractory metastatic triple-negative breast cancer (TNBC).

Chemotherapy has been the standard treatment for TNBC, and patients who take Trodelvy must have received at least 2 previous therapies for the cancer. Further clinical trials are required to verify and describe the treatment’s clinical benefit.

The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease,” stated Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and Assistant Professor of Medicine at Harvard Medical School. Dr. Bardia was the lead investigator of the Phase 2 study. “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.”

In the single-arm Phase 2 study, Trodelvy demonstrated an ORR of 33.3 percent (95 percent CI: 24.6, 43.1) and a median DoR of 7.7 months (95 percent CI: 4.9, 10.8), as determined by local assessment, in 108 adult TNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting (range: 2-10).1

“We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer,” said Dr. Loretta M. Itri, Chief Medical Officer of Immunomedics. “This approval highlights the potential of our unique ADC platform and strengthens the premise that the Trop-2 antigen found in many solid cancers is an important target for drug delivery. We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need.”

Trodelvy carries a black box warning for severe neutropenia and severe diarrhea. The most common adverse reactions occurring in 25 or more percent of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash and abdominal pain. The most common Grade 3 or 4 adverse events occurring in more than 5 percent of patients were neutropenia, white blood cell count decreased, anemia, hypophosphatemia, diarrhea, fatigue, nausea and vomiting.  Two percent of patients discontinued treatment due to adverse events. There were no deaths related to treatment and no severe cases of neuropathy or interstitial lung disease.1

“Trodelvy’s approval is a major milestone in our transformation from a research-based organization to a fully-integrated biopharmaceutical company, underscoring our commitment to bring innovative therapies to patients with hard-to-treat cancers,” said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. “We are grateful to all of the patients, their families, physicians, and nurses who participated in our clinical trials and played a significant role in making this moment possible.”

Immunomedics recently announced that the Phase 3 confirmatory ASCENT study of Trodelvy in metastatic TNBC, with over 500 patients enrolled, will be stopped early due to compelling efficacy across multiple endpoints, based on the unanimous recommendation of the DSMC. The Company remains on track to achieve topline results from the ASCENT study by mid-2020.

Triple Negative Breast Cancer Disparities

A George State University Study funded by the National Institute on Minority Health and Health Disparities of the National Institutes of Health found that Black and Hispanic women have a higher incidence of triple negative breast cancer. Compared with non-Hispanic white women, non-Hispanic black women and Hispanic women had higher odds of being diagnosed with triple-negative breast cancer, respectively. More than 21 percent of non-Hispanic black women were diagnosed with triple-negative breast cancer, compared with less than 11 percent for all other types of breast cancer. Women younger than 40 years of age had twice the odds of being diagnosed with triple-negative breast cancer than women aged 50-64 years.


Study Confirms Disparities In Triple Negative Breast Cancer Diagnoses

FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple Negative Breast Cancer