China's NMPA Approves Dato-DXd for Metastatic TNBC Ineligible for PD-(L)1 Inhibition

China's National Medical Products Administration (NMPA) has approved datopotamab deruxtecan (Dato-DXd; Datroway) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.¹

The decision was based on findings from the phase 3 TROPION-Breast02 trial (NCT05374512), which were presented at the 2025 ESMO Congress and subsequently published in Annals of Oncology.^1,2

In the trial, Dato-DXd (n = 323) generated a median overall survival (OS) of 23.7 months (95% CI, 19.8-25.6) compared with 18.7 months (95% CI, 16.0-21.8) for investigator's choice of chemotherapy (n = 321; HR, 0.79; 95% CI, 0.64-0.98; P = .0291).^1,2 The median progression-free survival (PFS) by blinded independent central review (BICR) was 10.8 months (95% CI, 8.6-13.0) vs 5.6 months (95% CI, 5.0-7.0), respectively (HR, 0.57; 95% CI, 0.47-0.69; P < .0001). The objective response rate (ORR) was 63% with Dato-DXd deruxtecan vs 29% with chemotherapy.¹

“One of the greatest challenges in my clinical practice is treating patients at their first metastatic TNBC diagnosis who are not candidates for immunotherapy since there [have] been limited treatment options available,” Zhimin Shao, MD, director of the Fudan University Cancer Institute and Breast Cancer in China and China lead investigator of TROPION-Breast02, said in the news release.¹ “The approval of [Dato-DXd] in China introduces an important new treatment option, which is supported by clinically meaningful improvements in OS and PFS, and offers a significant advancement over the current standard of care.”

In May 2026, the FDA approved datopotamab deruxtecan-dlnk for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.⁴ That decision was also supported by data from TROPION-Breast02.

How was the TROPION-Breast02 trial designed?

The global, randomized, open-label, multicenter phase 3 trial enrolled patients with previously untreated, locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option.² Eligible patients included those with PD-L1–negative tumors as well as those with PD-L1–positive tumors who could not receive immunotherapy because of prior exposure in the early-stage setting, comorbidities, or lack of access. Patients with de novo or recurrent disease were eligible regardless of disease-free interval, and patients with stable brain metastases were permitted.

A total of 644 patients were randomly assigned 1:1 to receive Dato-DXd at 6 mg/kg intravenously every 3 weeks or investigator's choice of paclitaxel, nab-paclitaxel (Abraxane), capecitabine, carboplatin, or eribulin. Randomization was stratified by geographic location, disease-free interval, and PD-L1 status.

The dual primary end points were PFS by BICR per RECIST 1.1 criteria and OS.

What is the safety profile of Dato-DXd?

Grade 3 or higher treatment-related adverse effects (TRAEs) occurred in 33% of patients who received Dato-DXd deruxtecan vs 29% of those who received chemotherapy. TRAEs led to treatment discontinuation in 4% and 7% of patients, respectively, and no treatment-related deaths were reported in either arm.

In the safety population used to support the approval (n = 319), the most common AEs, including laboratory abnormalities, reported in at least 20% of patients comprised stomatitis, increased amylase level, nausea, alopecia, decreased hemoglobin level, decreased white blood cell count, constipation, decreased calcium level, fatigue, decreased lymphocyte count, decreased neutrophil count, increased alanine aminotransferase level, increased aspartate aminotransferase level, dry eye, decreased albumin level, vomiting, decreased sodium level, and increased blood alkaline phosphatase level.¹

Serious AEs occurred in 5.6% of patients given Dato-DXd; those reported in more than 1% of patients were vomiting and anemia. One patient death was attributed to interstitial lung disease/pneumonitis.¹

References

1. Datroway approved in China as first and only TROP2 directed antibody drug conjugate with overall survival benefit for treatment of patients with metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. News release. Daiichi Sankyo. October 8, 2026. Accessed October 8, 2026. https://www.daiichisankyo.com/files/news/pressrelease/pdf/202610/20261008_E2.pdf
2. Dent R, Shao Z, Schmid P, et al. Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial. Ann Oncol. 2026;37(8):1066-1080. doi:10.1016/j.annonc.2026.03.008
3. Dent RA, Shao Z, Schmid P, et al. First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: primary results from the randomised, phase 3 TROPION-Breast02 trial. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA21.
4. Datroway approved in the U.S. as first TROP2 directed antibody drug conjugate for first-line treatment of patients with metastatic triple negative breast cancer who are not PD-1/PD-L1 inhibitor candidates. News release. Daiichi Sankyo. May 22, 2026. Accessed October 8, 2026. https://daiichisankyo.us/web/dsi/press-releases/-/article/datroway-approved-in-the-us-as-first-trop2-directed-antibody-drug-conjugate-for-first-line-treatment-of-patients-with-metastatic-triple-negative-breast-cancer-who-are-not-pd-1pd-l1-inhibitor-candidates