Sacituzumab Govitecan Receives FDA Approval Across 2 TNBC Indications

The FDA has approved sacituzumab govitecan-hziy (Trodelvy) across 2 indications for patients with triple-negative breast cancer (TNBC).¹ The first indication is supported by results from the phase 3 ASCENT-03 trial (NCT05382299) with sacituzumab as a single agent as first-line treatment for those with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.² The ASCENT-04/KEYNOTE-D19 (NCT05382286) supported the second indication of sacituzumab plus pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) as first-line treatment for those with unresectable locally advanced or metastatic TNBC with PD-L1 with a combined positive score of 10 or more.³ This is determined by an FDA authorized test.

Results from both trials were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

While the biomarker analysis of ASCENT-03 was presented at ASCO, full efficacy data were reported at the European Society of Medical Oncology 2025.⁴ The progression-free survival (PFS) by blinded independant central review was 9.7 months (95% CI, 8.1-11.1) in the sacituzumab arm vs 6.9 months (95% CI, 5.6-8.2) in the control arm (HR, 0.62; 95% CI, 0.50-0.77; P <.001).

The ASCENT-04 trial had a median PFS after next line of treatment (PFS2) that was not reached (NR) in the combination arm vs 21.0 months (95% CI, 16.0-NR) in the chemotherapy arm (HR, 0.67; 95% CI, 0.48-0.95).

The recommended dosage of sacitizumab alone or in combination with pembrolizumab is 10 mg/kg given intravenously on days 1 and 8 of each 21 day cycle. Treatment with sacituzumab should be continued until progression or unacceptable toxicity.

The approval press release highlighted a boxed warning for sacitizumab for diarrhea and neutropenia. There are also warnings and precautions for hypersensitivity and infusion-related reactions, nausea, vomiting, reduced UGT1A1 activity, and embryo-fetal toxicity. For pembrolizumab, the warnings and precautions include immune-mediated adverse effects, infusion-related reactions, complications of allogeneic hematopoietic cell transplantation, and embryo-fetal toxicity.

References

1. FDA approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer. News release. June 24, 2026. Accessed June 24, 2026. https://tinyurl.com/2symm8fx
2. Cortés JC, Bardia A, Punie K, et al. Primary results from ASCENT-03: a randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i). Ann Oncol. 2025;36(suppl 2):S1565-S1566. doi:10.1016/j.annonc.2025.09.030
3. Kalinsky K, Schmid P, de Azambuja E, et al. Progression-free survival after next line of treatment (PFS2) and subsequent therapies in the ASCENT-04 study of participants with previously untreated PD-L1+ metastatic triple-negative breast cancer treated with sacituzumab govitecan plus pembrolizumab vs chemotherapy plus pembrolizumab. Presented at: 2026 ASCO Annual Meeting; May 29-June 2, 2026; Chicago, IL. Abstract LBA1000.
4. Barrios C, Hurvitz SA, Tolaney SM, et al. ASCENT-03: Efficacy by biomarker subgroup with sacituzumab govitecan (SG) vs chemotherapy (chemo) in participants (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors (PD-[L]1i). J Clin Oncol. 2026;44(suppl 16):1014. doi:10.1200/JCO.2026.44.16_suppl.1014