![]() Like other breast cancers, TNBC is biologically heterogeneous, leading to diverse clinical and epidemiological behaviors, however, unlike the other clinical subtypes, in TNBC we still lack tumor-specific targeted therapy. TNBC is overrepresented among Black and pre-menopausal women and is associated with significant psychological and treatment-related burdens, including financial toxicity. ![]() It accounts for 10–15% of incident breast cancers and carries the worst prognosis. Accessed July 5, 2023.Triple negative breast cancer (TNBC) is characterized by the lack of estrogen and progesterone receptor expression and lacks HER2 overexpression or gene amplification. Study of DS-1062a versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer with or without actionable genomic alterations (TROPION-LUNG01).Datopotamab deruxtecan met dual primary endpoint of progression-free survival in patients with advanced non small cell lung cancer in TROPION-Lung01 phase 3 trial.“These first phase 3 trial results from the datopotamab deruxtecan clinical program provide compelling evidence for the potential role this TROP2 directed ADC can play in treating patients with lung cancer.” References “With TROPION-Lung01, we met the dual primary end point of PFS, challenging the entrenched standard of care in a previously treated and unselected patient population that has long deserved an alternative to chemotherapy,” Susan Galbraith, MBBChir, PhD, executive vice president of Oncology R&D at AstraZeneca, stated in a news release. Patients were randomly assigned to receive 6.0 mg/kg of datopotamab deruxtecan once every 3 weeks or 75 mg/m 2 of docetaxel once every 3 weeks.Īlong with the dual primary end points of PFS per blinded independent central review (BICR) and OS, secondary end points included investigator-assessed PFS, objective response rate, duration of response, time to response, disease control rate per BICR and investigator assessment, and safety. The study enrolled approximately 600 patients at sites in Asia, Europe, North America, and South America. Patients were excluded if they had mixed small cell and non–small cell histology, had spinal cord compression or clinically active central nervous system metastases, had leptomeningeal carcinomatosis or metastasis, or received prior treatment with an antibody-drug conjugate (ADC) featuring a chemotherapeutic agent targeting topoisomerase I, a Trop-2–targeted therapy, or docetaxel. Other key inclusion criteria included documented radiographic disease progression on or after the most recent treatment for advanced NSCLC measurable disease per RECIST v1.1 criteria an ECOG performance status of 0 or 1 adequate bone marrow, hepatic, and renal function and a life expectancy of at least 3 months. Those with a known genomic alteration, including EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET, were required to have received prior platinum-based chemotherapy and an approved targeted therapy, and those without these alterations needed to have received concurrent or sequential platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The global, randomized, multicenter, open-label TROPION-Lung01 study enrolled patients at least 18 years of age with pathologically documented stage IIIB, IIIC, or IV NSCLC with or without actionable genomic alterations. “We plan to share these data with regulatory authorities to discuss next steps.” “We are encouraged by the statistically significant results of the dual primary end point of PFS seen with datopotamab deruxtecan and look forward to the final OS analysis,” Ken Takeshita, MD, global head of Oncology R&D at Daiichi Sankyo, stated in a news release. Assessment of OS is ongoing, and the study is still blinded. ![]() However, a trend in favor of datopotamab deruxtecan did not reach a prespecified threshold for statistical significance at the time of this interim analysis. 1ĭata for the other primary end point of overall survival (OS) remained immature. Datopotamab deruxtecan (Dato-DXd DS-1062a) provided a statistically significant improvement in progression-free survival (PFS) compared with standard-of-care docetaxel in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who received at least 1 prior line of therapy, meeting a primary end point of the phase 3 TROPION-Lung01 trial (NCT04656652).
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