Datopotamab Deruxtecan

AstraZeneca and Daiichi Sankyo announced Monday that Datroway (datopotamab deruxtecan) demonstrated a significant improvement in both progression-free survival (PFS) and overall survival (OS) versus chemotherapy as a first-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option. The companies noted that high-level results from the TROPION-Breast02 Phase III trial make Datroway — a TROP2-directed antibody-drug conjugate (ADC) — "the first and only therapy to significantly improve overall survival versus chemotherapy in this patient population." Earlier this year, Gilead Sciences' own TROP2-directed ADC Trodelvy (sacituzumab govitecan) significantly improved PFS in a similar patient population in the Phase III ASCENT-03 study. However, the company said at the time of the analysis, OS was not mature, adding that "no…detriment was observed" with the use of Trodelvy. TROPION-Breast02 enrolled 644 patients, including those whose tumours did not express PD-L1 as well as those with PD-L1 expressing tumours who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Participants were randomised to receive Datroway or investigator's choice of chemotherapy. AstraZeneca and Daiichi indicated that for the dual primary endpoints of PFS and OS, Datroway demonstrated a statistically significant and clinically meaningful improvement compared to chemotherapy. The results are expected to be presented at an upcoming medical meeting and shared with regulatory authorities. Datroway is currently approved in a number of markets for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The ADC is also available in the US under accelerated approval for the treatment of adults with locally advanced or metastatic EGFR-mutated non–small-cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

AstraZeneca and Daiichi Sankyos cancer drug Datroway has succeeded in a late-stage trial in an aggressive, tough-to-treat type of breast tumor, the companies said Monday.According to a statement, the therapy, a type of targeted medicine known as an antibody-drug conjugate, slowed tumor progression and extended survival when compared to standard chemotherapy in triple-negative breast cancers. Patients in the Phase 3 trial were ineligible for a commonly used immunotherapy. Their tumors were either metastatic or locally recurrent and inoperable.AstraZeneca and Daiichi didnt provide specifics, but said that Datroway treatment was associated with a statistically significant and clinically meaningful improvement on both measures, and its effects on holding tumors in check were highly significant. The partners added that the findings marked the first time a survival benefit was observed compared to chemotherapy in people unable to receive immunotherapy.Ken Takeshita, Daiichis global head of research and development, said these “landmark“ results have further encouraged the companies to continue advancing Datroway programs for triple-negative breast cancer and other tumor types. Details from the study will be shared at a future medical meeting and submitted to global health regulators as soon as possible, the companies said.Datroway is one of several ADCs AstraZeneca and Daiichi are developing in the hopes of supplanting chemotherapy in many tumor types. The drug is designed to seek out a protein called TROP2 thats overexpressed in multiple cancers.AstraZeneca and Daiichi have had high hopes for Datroway following the clinical and commercial success of Enhertu, another ADC they co-developed and thats helped change the way certain breast cancers are treated. But Datroways benefits have so far been less clear, leading to a narrower-than-expected approval in lung cancer and lower commercial expectations in a common type of advanced breast tumor.In triple-negative tumors, Datroway could face competition from Gileads Trodelvy, another antibody-drug conjugate that targets TROP2. Earlier this year, Gilead said Trodelvy held tumors in check longer than chemotherapy in a trial also involving people ineligible for immunotherapy. Gilead, though, said at the time that the study hadnt been run long enough to detect a survival benefit.According to AstraZeneca, about 70% of people with triple-negative breast cancers cant receive immunotherapy, leaving chemotherapy as the first-line standard of care. We expect todays results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options, said Susan Galbraith, who leads AstraZenecas cancer and blood disease R&D, in the statement.AstraZeneca shares rose by over 1% in Monday morning trading, while Daiichi shares climbed about 4%. '