Dataset Information

Economic Evaluation of Sacituzumab Govitecan for the Treatment of Metastatic Triple-Negative Breast Cancer in China and the US

ABSTRACT:

Background

The effectiveness of Sacituzumab Govitecan (SG) for metastatic triple-negative breast cancer (mTNBC) has been demonstrated. We aimed to evaluate its cost-effectiveness on mTNBC from the Chinese and United States (US) perspective.

Methods

A partitioned survival model was developed to compare the cost and effectiveness of SG versus single-agent chemotherapy based on clinical data from the ASCENT phase 3 randomized trial. Cost and utility data were obtained from the literature. The incremental cost-effectiveness ratio (ICER) was measured, and one-way and probabilistic sensitivity analyses (PSA) were performed to observe model stability. A Markov model was constructed to validate the results.

Results

In China, SG yielded an additional 0.35 quality-adjusted life-year (QALY) at an additional cost of Chinese Renminbi ¥2257842. The ICER was ¥6375856 ($924037)/QALY. In the US, SG yielded the same additional QALY at an extra cost of $175393 and the ICER was $494479/QALY. Similar results were obtained from the Markov model. One-way sensitivity analyses showed that SG price had the greatest impact on the ICER. PSA showed the probability of SG to be cost-effective when compared with chemotherapy was zero at the current willing-to-pay threshold of ¥217341/QALY and $150000/QALY in China and the US, respectively. The probability of cost-effectiveness of SG would approximate 50% if its price was reduced to ¥10.44/mg in China and $3.65/mg in the US.

Conclusion

SG is unlikely to be a cost-effective treatment of mTNBC at the current price both in China and the US.

SUBMITTER: Chen J

PROVIDER: S-EPMC8581633 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan (IMMU-132) is an antibody-drug conjugate that contains the irinotecan active metabolite, SN-38, linked to a humanized monoclonal antibody targeting trophoblast cell surface antigen 2, which is overexpressed in many solid tumors. In a basket design phase I/II study, sacituzumab govitecan demonstrated promising single-agent therapeutic activity in multiple cancer cohorts, leading to accelerated approval by the U.S. Food and Drug Administration of sacituzumab govitecan-hziy (TRODELVY) for the treatment of patients with metastatic triple-negative breast cancer who had received at least two prior therapies in the metastatic setting. Recently, results of the phase III trial, ASCENT, were confirmatory. There is limited available information on the adverse event management with sacituzumab govitecan needed to maximize the dose and duration of effective therapy while maintaining patient quality of life. This review summarizes the clinical development and the practical management of patients receiving sacituzumab govitecan. Sacituzumab govitecan has a well-defined and manageable toxicity profile, and rapid recognition and appropriate early and proactive management will allow clinicians to optimize sacituzumab govitecan treatment for patients. IMPLICATIONS FOR PRACTICE: Sacituzumab govitecan (TRODELVY) is a novel antibody-drug conjugate composed of the active metabolite of irinotecan (SN-38) conjugated to a monoclonal antibody targeting trophoblast cell surface antigen 2, an epithelial cell surface antigen overexpressed in many cancers. Because of the rapid approval of sacituzumab govitecan, there is limited available information on adverse event (AE) management with this agent. As such, this article reviews the clinical development of the drug, the AE profile, and provides recommendations regarding AE management to help optimize therapy with sacituzumab govitecan.

Project description:BackgroundTwo new antibody-drug conjugates (ADCs) containing a topoisomerase I inhibitor payload have recently emerged in the breast cancer (BC) treatment landscape. Sacituzumab govitecan-hziy (SG) is a first-in-class anti-trophoblast cell-surface antigen 2 ADC approved for pretreated metastatic triple-negative breast cancer (mTNBC) and trastuzumab deruxtecan (T-DXd) gained approval for human epidermal growth factor receptor-2 (HER2)-positive advanced BC (aBC). We aim to provide a contemporary review and the current clinical trial landscape of SG and T-DXd in BC.Materials and methodsWe conducted a literature search from Medline database through PubMed, major conference proceedings [abstracts from European Society for Medical Oncology (Breast) Congress, American Society of Clinical Oncology annual meeting, San Antonio Breast Cancer Symposium] and ClinicalTrials.gov with search terms 'sacituzumab govitecan', 'IMMU-132', 'trastuzumab deruxtecan' and 'DS-8201a' up to 21 March 2021.ResultsWe assessed 293 records for eligibility, of which 153 were included in this review after screening and exclusion. For SG, efficacy and safety data are available from a phase III trial in pretreated mTNBC and from a phase I/II basket study in mTNBC and hormone receptor-positive/HER2-negative aBC. Thirteen trials with pending primary analysis are ongoing with SG as single agent or in combination, of which 11 are enrolling (2/11 in the early setting). For T-DXd, efficacy/safety data are available as single agent in pretreated HER2-positive (phase Ib and phase II) and in HER2-low aBC (phase Ib), and in combination with nivolumab in HER2-low/positive aBC (phase Ib). Of 23 ongoing trials with T-DXd, 12 are open for enrollment and 3 phase III trials have completed recruitment. The distinct safety profiles of both drugs and their management are discussed.ConclusionGiven their robust single-agent activity, SG and T-DXd are expected to substantially impact treatment standards, both in and far beyond the currently approved indications. Several trials are investigating new treatment settings for both drugs, including a transition to earlier lines and combinations with other anticancer treatments such as immune checkpoint inhibitors.