The median survival time of patients was 12 months compared with 7 in the control group, the analysis demonstrates.
An assessment of monotherapies with sacituzumab govitecan (Trodelvy, Gilead) showed an early benefit for patients with non-surgically removable or metastatic triple-negative breast cancer who have had 2 or more prior systemic therapies, including at least 1 for advanced disease, new study results show.
In the sacituzumab govitecan group, the median survival time of individuals was 11.8 months compared with 6.7 months in the control group, according to the German Institute for Quality and Efficiency in Health Care (IQWiG), which conducted the study.
IQWiG’s early assessment is based on the ASCENT study, a controlled, open-label, randomized trial that included 529 individuals for whom monotherapy with capecitabine, eribulin, gemcitabine, or vinorelbine, should be suitable.
Given that gemcitabine is not an appropriate comparator therapy, just 445 individuals in the subpopulation of the remaining therapies were chosen for the assessment.
The risk of bias in the study and its outcomes were high, because of ambiguities in the evaluation, so no other hints of greater benefit or harm can be derived from the results, IQWiG said in a statement.
Overall, the analysis determined that the ASCENT study showed more positive than negative effects for sacituzumab govitecan compared with the appropriate comparator therapy.
Additionally, the treatment with sacituzumab govitecan caused fewer adverse effects (AEs). In terms of symptoms, the positive effects predominate, though individuals did experience diarrhea more frequently. This was offset by benefits in terms of pain and respiratory disorders.
When health-related quality of life was examined, only the advantages sacituzumab govitecan were shown by comparison with the appropriate comparator therapy.
However, the effects observed for the AEs, health-related quality of life, and symptoms refer exclusively to the period until the end of treatment, plus 30 days, and not until the end of the study or the time point of death..
Breast cancer is divided into subtypes depending on how many estrogen receptors and progesterone receptors or human epidermal growth factor receptors 2 (HER2) are present on the surface of the cancer cells.
The 3 receptors promote the growth of breath cancers, and drugs that block this activity are a staple in treatment.
However, triple-negative breast cancer has low levels of the 3 receptors, but there are high concentrations of trop-2.
Sacituzumab govitecan is an antibody-drug conjugate that binds directly to trop-2 on the surface of the cancer call.
When the antibody and trop-2 interact, the drug is drawn into the cancer cell, where it links to the antibody and releases the chemotherapeutic agent to kill the cancer.
Triple-negative breast cancer: survival advantage with sacituzumab govitecan. EurekAlert. News release. March 7, 2022. Accessed March 9, 2022. https://www.eurekalert.org/news-releases/945608