Tag: SCLC
Daiichi Sankyo and Merck & Co/MSD Withdraw BLA for Ifinatamab Deruxtecan...
Daiichi Sankyo and Merck & Co/MSD have voluntarily withdrawn the Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd; DS-7300a), a B7-H3-directed antibody-drug conjugate (ADC), for adults with previously treated extensive-stage small cell lung cancer (ES-SCLC). The withdrawal follows discussions with the U.S. Food and Drug Administration (FDA), which concluded that the data submitted with the application, including results from the Phase 2 IDeate-Lung01 trial, did not satisfy the requirements for accelerated approval in the proposed indication.
First-in-Patient Phase I Combination Study of IDE849 and IDE161 in DLL3...
The first patient (FIP) has been dosed in a Phase 1 clinical trial combining IDE849 (also known as SHR-4849), a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topoisomerase I (Topo-I-) payload antibody drug conjugate (ADC), with IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor. Both drugs are being developed by IDEAYA Biosciences. The Phase 1 combination study will be evaluated in DLL3 upregulated solid tumor indications, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), neuroendocrine carcinomas (NECs), and melanoma.
Independent Data Monitoring Committee Recommends Enrollment to be Stopped for Study...
An Independent Data Monitoring Committee (IDMC) responsible for ongoing review of study data of the TAHOE study, a Phase III study evaluating Rovalpituzumab Tesirine...
Phase II Study Evaluating Rovalpituzumab Tesirine Announced – AbbVie will Not...
After consulting with the U.S. Food and Drug Administration (FDA), AbbVie, a global research and development-based biopharmaceutical company, announced that the company will not...
Researchers Find SCLC-biopsy Specimen Reliable for Evaluating DLL3 Expression
High levels of delta-like protein 3 or DLL3 in small-cell lung cancer or SCLC are correlated with poor survival trends. Li-Xu Yan, MD, a...
Sacituzumab govitecan (IMMU-132) Demonstrates Therapeutic Potential in the Treatment of Metastatic...
Two prominent cancer journals have published phase II clinical trial results with sacituzumab govitecan (IMMU-132; Immunomedics) in a total of 104 patients with lung...
Collaboration to Explore the Safety and Efficacy of Combining Rova-T +...
A new Phase I/II clinical program in which Bristol-Myers Squibb collaborates with AbbVie will evaluate the safety, tolerability and efficacy of the investigational biomarker-specific...
Rovalpituzumab Tesirine Shows Early Promise in Small Cell Lung Cancer
Rovalpituzumab tesirine (Rova-T or SC16LD6.5; AbbVie), a novel biomarker-specific 'smart-bomb' antibody-drug conjugate or ADC targeting the delta-like protein 3 or DLL3 protein, expressed in more...
Sacituzumab govitecan (IMMU-132) Shows Positive Interim Phase II Results
Sacituzumab govitecan also known as IMMU-132, an antibody-drug conjugate being developed by Immunomedics, a clinical-stage biopharmaceutical company, continues to produce durable responses in patients with...
Novel Targeted Lung Cancer Therapies are Expected to Replace Current Conventional...
Lung cancer, which is mostly a disease of the elderly*, is defined as the uncontrolled growth of abnormal cells in one or both lungs. Approximately 60%...
