Tag: Enhertu

Results from a global Phase 3 trial demonstrated that trastuzumab deruxtecan (T-DXd; Enhertu®; Daiichi Sankyo and AstraZeneca) can delay disease progression longer than standard...

Triple-negative breast cancer (TNBC) remains one of the most challenging and most malignant subtypes of breast cancer to treat. TNBC represents a heterogeneous group...

August 2026 was a busy month for the antibody-drug conjugate (ADC) field, with activity spanning the full arc of development. Highlights included early discovery partnerships, manufacturing alliances, a practice-changing phase 3 readout in lung cancer, and the first dosing of a novel Treg-depleting ADC.

Advances, Sequencing Challenges, and Real-World Integration of ADCs in Breast Cancer: Insights from ASCO 2026

Economy: Failure to Reshore Pharmaceutical Manufacturing: US Approved Drug Manufacturing Shifts to Europe as US Deal Volume Drops

Compelling evidence presented at the European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025, in Berlin, Germany, has shown that a new generation of antibody-drug conjugates (ADCs) can dramatically improve outcomes for patients with early-stage HER2-positive breast cancer.

The international phase 3 DESTINY-Gastric04 clinical trial (NCT04704934), sponsored  by Daiichi Sankyo, found that second-line treatment with trastuzumab deruxtecan (Enhertu®; also known as T-DXd; DS-8201; Daiichi Sankyo and AstraZeneca, See ADC Drugmap) can help people with advanced human epidermal growth factor receptor 2 (HER2-) positive (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or gastroesophageal junction adenocarcinoma (GEJA) that have grown during first-line treatment live about 3 months longer. The study outcomes demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to ramucirumab (Cyramza®; Eli Lilly and Company) plus paclitaxel (Taxol®; Bristol-Myers Squibb).

Now positive topline results from a new study, the DESTINY-Breast11 phase 3 trial (NCT05113251), confirmed that trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca)**, followed by paclitaxel, trastuzumab and pertuzumab (THP), demonstrated a statistically significant and clinically meaningful improvement in pCR rate versus Standard-of-Care (SoC; dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting in patients with high-risk, locally advanced HER2-positive early-stage breast cancer.

Positive topline results from a planned interim analysis of the phase 3 DESTINY-Breast09 (NCT04784715) trial showed trastuzumab deruxtecan (Enhertu®; Daiichi Sankyo and AstraZeneca)* in combination with pertuzumab (Perjeta®; Genentech/Roche) demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to taxane, trastuzumab (Herceptin®; Genentech/Roche) and pertuzumab (THP) as a first-line treatment for patients with human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer.

20-Hour Conjugation Bottlenecks – Confronting ADC Development Challenges with CDMOs