Ruta Arays, MD

This final segment consists of expert clinicians offering key takeaways to help pharmacists prepare for potential approvals and integrate new TNBC therapies into practice.

This segment summarizes early DB-1305 data showing promising efficacy and manageable toxicity in pretreated TNBC, along with ongoing investigation of combination strategies such as anti-PD-L1 × VEGF bispecific therapy.

If datopotamab deruxtecan (Dato-DXd) is approved for first-line metastatic TNBC, it could significantly influence clinical practice by providing an effective option for patients, particularly those ineligible for immunotherapy or with PD-L1–negative disease.

Pharmacists play a critical role in educating patients about potential side effects, monitoring for early signs of toxicity, and coordinating supportive care measures, including growth factor support for hematologic events.

Studying antibody–drug conjugates (ADCs) in patients ineligible for immunotherapy addresses a critical unmet need in PD-L1–negative metastatic TNBC, where targeted treatment options are limited.

If sacituzumab govitecan (SG) is approved for first-line metastatic TNBC, it could meaningfully shift clinical practice by providing an effective option for patients ineligible for immunotherapy or with PD-L1–negative disease.

Because ASCENT-03 allowed crossover and more than half of patients received subsequent therapy, overall survival is unlikely to show a statistically significant difference, even if a clinical benefit exists.

The ASCENT-03 trial, presented at ESMO and published in NEJM, evaluated sacituzumab govitecan (SG) versus physician’s-choice chemotherapy—including paclitaxel, nab-paclitaxel, or gemcitabine/carboplatin—in patients with metastatic TNBC who were either PD-L1–negative or not candidates for immunotherapy.

If SG plus pembrolizumab becomes approved in the first-line metastatic TNBC setting, many clinicians anticipate shifting practice patterns to favor this regimen, given its promising efficacy.

From a pharmacologic standpoint, the adverse events associated with sacituzumab govitecan (SG)—particularly neutropenia and diarrhea—are consistent with the mechanism of its payload.

In clinical practice, the approach to G-CSF use with sacituzumab govitecan (SG) is typically individualized based on patient-specific risk factors and prior tolerance.

This section compares the adverse-event patterns of SG plus pembrolizumab versus chemotherapy plus pembrolizumab, emphasizing differences in hematologic and non-hematologic toxicities that inform clinical monitoring.

This segment explains how ASCENT-04 assessed whether moving sacituzumab govitecan into the first-line setting with immunotherapy could improve outcomes for a population with historically limited options.

This segment summarizes the challenges of metastatic TNBC and highlights how current treatment decisions rely on biomarkers and evolving molecular profiling to guide a personalized therapeutic approach.