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Datopotamab Deruxtecan's Role in HR+/HER2- Breast Cancer Treatment: Sequencing and Safety Considerations

4 months ago

• Datopotamab deruxtecan (Dato-DXd) is poised to become a standard treatment for metastatic hormone receptor-positive, HER2-negative breast cancer after prior systemic therapy. • Optimal sequencing of antibody-drug conjugates (ADCs) like Dato-DXd, sacituzumab govitecan, and trastuzumab deruxtecan remains uncertain, especially considering overlapping toxicities. • Real-world toxicity profiles suggest sacituzumab govitecan may cause more cytopenias and diarrhea, while Dato-DXd and trastuzumab deruxtecan are linked to interstitial lung disease. • The lack of overall survival difference in the TROPION-Breast01 trial raises questions about efficacy issues or the impact of crossover between treatment arms.

ARX788 Demonstrates Significant PFS Benefit in HER2-Positive Breast Cancer

4 months ago

• A phase III trial of ARX788 showed a significantly longer median progression-free survival (PFS) of 11.3 months compared to 8.2 months with lapatinib plus capecitabine (LC) in HER2-positive advanced breast cancer patients. • The objective response rate (ORR) was higher in the ARX788 group (63.8%) compared to the LC group (52.7%), with a significantly longer duration of response (DoR) of 12.5 months versus 8.3 months. • ARX788 demonstrated a manageable safety profile, with the most frequent treatment-related adverse events (TRAEs) including hepatic enzyme increase, dry eye, blurred vision, alopecia, and interstitial lung disease (ILD). • The study suggests ARX788 could be an alternative second-line treatment option for HER2-positive advanced breast cancer patients who have progressed on trastuzumab and taxane.

Imlunestrant Shows Promise in Advanced ER+/HER2- Breast Cancer Treatment

5 months ago

• Imlunestrant monotherapy significantly improved progression-free survival (PFS) in advanced breast cancer patients with ESR1 mutations compared to standard endocrine therapy. • The combination of imlunestrant and abemaciclib demonstrated a statistically significant improvement in PFS compared to imlunestrant alone, regardless of ESR1 mutation status. • The EMBER-3 trial results suggest imlunestrant, particularly in combination with abemaciclib, could offer a new all-oral targeted therapy option for pre-treated advanced breast cancer. • Safety data from the trial indicated that imlunestrant, both as a monotherapy and in combination, was generally well-tolerated, with manageable adverse events.

SHR-A1811 Demonstrates Promising Activity in HER2-Expressing Breast Cancer Subtypes

5 months ago

• SHR-A1811, a novel anti-HER2 ADC, shows promising anti-tumor activity and acceptable safety in HR-positive/HER2-low breast cancer in a phase 2 trial. • In HR-positive/HER2-low breast cancer, SHR-A1811 achieved an objective response rate of 74.3% in the first stage of a phase 2 trial. • The FASCINATE-N trial showed SHR-A1811 monotherapy had similar pathological complete response rates compared to standard chemotherapy in HER2-positive breast cancer. • Common treatment-related adverse events with SHR-A1811 include neutropenia, leukopenia, anemia, nausea, asthenia, and vomiting, with manageable safety profiles.

Prevalence and Profiles of Treatment-Related Adverse Events in Metastatic Breast Cancer Patients Receiving Antibody-Drug Conjugates

6 months ago

A meta-analysis of 23 clinical trials reveals the prevalence and distinct toxicity profiles of treatment-related adverse events (TRAEs) associated with currently approved antibody-drug conjugates (ADCs) for metastatic breast cancer. Gastrointestinal disorders were highly prevalent across all treatments, with Trastuzumab Deruxtecan and Sacituzumab Govitecan showing higher symptom burdens compared to Trastuzumab Emtansine. The study underscores the importance of understanding these TRAEs to enhance supportive care and develop personalized risk-stratified care pathways.

Robust Clinical Trial Pipeline Fuels Hope for Renal and Breast Cancer Advances

8 months ago

• The renal cancer clinical trial pipeline is robust, with over 70 companies developing more than 75 therapies, including novel immunotherapies and targeted agents. • Breast cancer research is also thriving, with over 100 companies exploring 120+ new drugs, such as antibody-drug conjugates and PARP inhibitors, in clinical trials. • Recent FDA actions, including Fast Track and Breakthrough Therapy designations, highlight the potential of emerging therapies for both renal and breast cancer. • Advances in diagnostics, such as PET imaging agents for clear cell renal cell carcinoma, are also contributing to improved management of these diseases.

J&J Acquires Ambrx for $2B to Expand Antibody-Drug Conjugate Portfolio in Oncology

a year ago

• Johnson & Johnson has announced a $2 billion acquisition of Ambrx Biopharma, gaining access to a promising pipeline of antibody-drug conjugates for cancer treatment. • Ambrx's lead candidate ARX517, targeting PSMA in prostate cancer, shows promising clinical results and aligns with J&J's strategic focus in prostate cancer therapeutics. • The deal represents a significant premium of over 100% to Ambrx's previous share price and follows a trend of major pharmaceutical companies investing heavily in ADC technology.