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Methodological considerations in the interpretation of ASCENT-03

Francesca Poggio1, Daniele Generali2

  • 1Clinica di Oncologia Medica, AOM - IRCCS Ospedale Policlinico San Martino, Genova, Italy.

European Journal of Cancer (Oxford, England : 1990)
|July 28, 2026
PubMed

Insights

Sacituzumab govitecan improved progression-free survival in previously untreated metastatic triple-negative breast cancer (mTNBC) patients ineligible for PD-(L)1 inhibitors. Further overall survival data are needed to confirm its role as a first-line standard of care for mTNBC.

Area of Science:

  • Oncology
  • Medical Oncology
  • Clinical Trials

Background:

  • Metastatic triple-negative breast cancer (mTNBC) without PD-(L)1 inhibitor eligibility presents a significant unmet need.
  • A substantial proportion of mTNBC patients have tumors with PD-L1 CPS < 10.
  • Many mTNBC patients do not receive subsequent lines of therapy.

Purpose of the Study:

  • To evaluate the efficacy of sacituzumab govitecan (SG) compared to chemotherapy as a first-line treatment for patients with previously untreated metastatic triple-negative breast cancer (mTNBC) ineligible for PD-(L)1 inhibitors.

Main Methods:

  • The ASCENT-03 trial compared sacituzumab govitecan (SG) with chemotherapy in this patient population.
  • Progression-free survival (PFS) was a primary endpoint.

Main Results:

  • Sacituzumab govitecan demonstrated a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy.
  • This benefit was observed in a patient group with limited treatment options.

Conclusions:

  • Sacituzumab govitecan shows promise as a first-line treatment for previously untreated mTNBC patients ineligible for PD-(L)1 inhibitors.
  • Mature, crossover-adjusted overall survival analyses are required to establish SG as a definitive first-line standard of care.
Keywords:
breast cancerchemotherapysacituzumab govitecantriple negative

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