TROP2 ADC for Breast Cancer Succeeded In Phase III Clinical Trials

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TROP2 ADC for Breast Cancer Succeeded In Phase III Clinical Trials

TROP2 ADC for Breast Cancer Succeeded In Phase III Clinical Trials.

Daiichi Sankyo and AstraZeneca’s TROP2 ADC Achieves Success in Phase III Clinical Trials for Breast Cancer – Global Market Expansion Plan Underway.

On September 22nd, Daiichi Sankyo and AstraZeneca jointly announced that the Phase III clinical trial, TROPION-Breast01, for TROP2 ADC Dato-DXd (DS-1062) has successfully met the primary endpoint of progression-free survival (PFS) for advanced, unresectable, or metastatic hormone receptor-positive (HR+), HER2 low-expressing, or HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer patients who had previously received hormonal therapy and at least one systemic therapy.

Dato-DXd demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to the chemotherapy regimens chosen by investigators. Additionally, there is a trend toward improvement in the dual primary endpoint of overall survival (OS), although the data at the interim analysis are not yet mature, and OS will continue to be evaluated as planned.

This marks the first release of results for a Phase III breast cancer clinical trial for Dato-DXd. With these positive results, both companies intend to submit corresponding regulatory applications for global market approval. There are also two additional Phase III clinical trials ongoing for Dato-DXd in the breast cancer field: TROPION-Breast02 for first-line treatment of triple-negative breast cancer and TROPION-Breast03 for adjuvant therapy in triple-negative breast cancer.

TROP2 ADC for Breast Cancer Succeeded In Phase III Clinical Trials

Notably, in July of this year, Dato-DXd achieved its first positive results in a Phase III clinical trial for advanced NSCLC, TROPION-Lung01, meeting the primary endpoint of PFS. Additionally, there are two Phase III clinical trials, TROPION-Lung07 and TROPION-Lung08, covering first-line NSCLC. These studies explore combination regimens of Dato-DXd with the K drug, pembrolizumab, and hold great promise.

TROP2 ADC for Breast Cancer Succeeded In Phase III Clinical Trials

Dato-DXd is a TROP2 ADC developed jointly by Daiichi Sankyo and AstraZeneca, with a payload consisting of a topoisomerase I inhibitor linked via a tumor-specific cleavable linker, with a DAR value of ~4.

TROP2 ADC for Breast Cancer Succeeded In Phase III Clinical Trials

Regarding Dato-DXd, Daiichi Sankyo and AstraZeneca’s strategic approach is to initially focus on NSCLC.

Daiichi Sankyo & AstraZeneca's TROP2 ADC Succeeds in Phase III Breast Cancer Trial

Breast cancer is another key area of focus, and by targeting breast cancer with Dato-DXd, Daiichi Sankyo aims to strengthen the advantage established by Enhertu and expand comprehensive coverage for various breast cancer subtypes.

The antibody industry has experienced rapid and significant development over the past few decades, becoming a rapidly growing and highly regarded field in the biopharmaceutical sector. Since the approval of the first monoclonal antibody drug (Muromonab-CD3) in the 1980s, many antibody drugs have been approved for the treatment of various diseases, including cancer, autoimmune diseases, and infectious diseases. There are already dozens of successful antibody drugs on the market, and many more candidate drugs are in clinical development and research, with expectations for more new drugs to enter the market in the future.

Today, in addition to traditional monoclonal antibodies, various new antibody technologies have been developed, including bispecific antibodies, polyclonal antibodies, humanized antibodies, recombinant antibodies, antibody-drug conjugates, and more. These new technologies enhance the specificity, affinity, stability, and producibility of antibody drugs, expanding their applications.