ADC Digest - August 2020
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CAR-T Digest - August 2020
ADC Digest - August 2020
AstraZeneca in collaboration with Daiichi Sankyo initiated a Phase 3 study evaluating trastuzumab deruxtecan versus chemotherapy in HER2-low, HR+ breast cancer
20 Aug 2020
Enhertu (Trastuzumab deruxtecan, DNA topoisomerase I inhibitor; AstraZeneca, Daiichi Sankyo)
- This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan (T-DXd) compared to investigator’s choice of chemotherapy in HER2-low, HR+ve breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting
- Study design: Phase 3 (N= 850); PCD: Dec’22 (PFS ~60 months); Randomized, parallel assignment, open label and multi-centered (global) study
- Regimen:
- Arm 1: T-DXd monotherapy, IV infusion
- Arm 2: Investigator’s choice of chemotherapy (capecitabine (oral), paclitaxel (IV), nab-paclitaxel (IV))
- Patient segment:
- Advanced or metastatic HR+, HER2-low or -ve; Never previously HER2+ve
- Should not have had prior chemotherapy and should have progressed on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting or disease progression within 24 months of starting adjuvant endocrine therapy and on at least 1 previous line of endocrine therapy in the metastatic setting
AZ/Daiichi initiated new Phase 3 trial for HER2-low breast cancer
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- As part of a broad development program in multiple HER2 expressing tumors, AstraZeneca and Daiichi are aiming to conduct multiple trials. Over 40% of all breast cancers are HER-low for which there is no approved HER2 therapy
- Most of these patients are treated with endocrine therapy which is a standard of care for HER2- breast cancer. Enhertu showed promising efficacy in the initial Phase 1 study. In patients with HER2-low breast cancer, Enhertu showed the capability to destroy neighboring cells with low HER2 expression
- The companies are conducting two Phase 3 trials in this HER2-low population, DESTINY-Breast04 in chemotherapy treated and DESTINY-Breast06 in chemotherapy naïve subjects
- There was no Phase 2 trial
– Dr. Kowndinya, CI Scientists
Background:
- Enhertu is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. The product got accelerated approval by the FDA for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting
- In Phase 1 study, T-DXd demonstrated promising preliminary antitumor activity in patients with HER2-low breast cancer. Most toxicities were GI or hematologic in nature. Interstitial lung disease (ILD) is an important identified risk and should be monitored and managed proactively
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