Need To Know

  • FDA approves Trodelvy earlier in treatment: Patients with unresectable or metastatic triple-negative breast cancer now have a new first-line treatment option with Trodelvy, either alone or combined with Keytruda, depending on PD-L1 status and whether they are candidates for immunotherapy.
  • Studies support using Trodelvy upfront: Results from the ASCENT-03 and ASCENT-04 trials showed that starting Trodelvy as first-line therapy improved outcomes compared with standard chemotherapy—even when most patients later received Trodelvy after their cancer progressed.
  • Potential for longer-lasting responses: Researchers also found that combining Trodelvy with the immunotherapy Keytruda led to longer periods before the cancer worsened and more durable responses, highlighting the promise of pairing antibody-drug conjugates with immunotherapy.

The treatment landscape for metastatic triple-negative breast cancer (TNBC) continues to evolve following the FDA’s new approval of sacituzumab govitecan (Trodelvy) as both a standalone first-line treatment for certain patients and in combination with pembrolizumab (Keytruda) for eligible patients. The approval builds on findings from the pivotal ASCENT-03 and ASCENT-04 trials, where researchers found that introducing the antibody-drug conjugate earlier in treatment improved outcomes compared with standard chemotherapy.

“This approval supports the growing body of evidence that antibody drug conjugates are a preferred treatment over chemotherapy,” says Dr. Tiffany Traina, Breast Medical Oncologist at Memorial Sloan Kettering Cancer Center in New York.

The FDA’s approval of sacituzumab govitecan (Trodelvy) in the first-line setting marks an important shift, allowing eligible patients to receive the antibody-drug conjugate either alone or in combination with pembrolizumab (Keytruda) earlier in the course of their disease.

The approval also reinforces the importance of obtaining PD-L1 testing at the diagnosis of metastatic TNBC, as PD-L1 expression now plays a key role in determining whether eligible patients receive first-line Trodelvy alone or Trodelvy in combination with pembrolizumab.

Data Continue to Support Earlier Use of Trodelvy

Following the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, SurvivorNet spoke with Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and a co-author of both the ASCENT-03 and ASCENT-04 studies, about what the latest data means for patients.

“We’ve now seen further data from both ASCENT-03 and ASCENT-04,” Tolaney said. “The data that we’re seeing really continue to confirm that sacituzumab govitecan should be a first-line standard-of-care option for our patients with metastatic triple-negative breast cancer.”

Benefit Was Seen Across Multiple Biomarkers

One important finding was that patients benefited regardless of biomarkers, including TROP2 expression, BRCA mutation status, or HER2 expression, suggesting that TROP2, BRCA, and HER2 status did not appear to be required to identify benefit in these analyses.

The studies also examined progression-free survival after second-line treatment (PFS2), helping researchers understand the long-term impact of using Trodelvy first. Despite more than 8 out of 10 patients in the chemotherapy groups later crossing over to receive Trodelvy, those who received the drug first still experienced longer PFS2.

“I thought that was very confirmatory of the fact that SG should really be used upfront,” Tolaney said.

ASCENT-04 also demonstrated the promise of pairing Trodelvy with immunotherapy. Patients receiving Trodelvy plus pembrolizumab experienced longer progression-free survival and a substantially longer duration of response than those receiving chemotherapy plus pembrolizumab, raising the possibility that antibody-drug conjugates and immunotherapy may work together to produce more durable responses.