Acceleron/Celgene’s drug was effective across all endpoints in transfusion-dependent beta-thalassemia and myelodysplastic syndromes, but Acceleron CEO Habib Dable notes key secondary endpoints could be most meaningful to doctors treating these patients.
Luspatercept met the primary endpoints in its first two Phase III tests – in transfusion-dependent beta-thalassemia and myelodysplastic syndromes (MDS) in the BELIEVE and MEDALIST studies, respectively – but Acceleron Pharma Inc. CEO Habib Dable pointed to key secondary endpoints in both clinical trials that could be the most important data points to treating physicians.
Results from the two studies were presented on Dec. 1 and 2 at the American Society of Hematology (ASH) annual...
Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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