AbbVie’s Venclexta failed to show a significant improvement in the primary endpoint of overall survival in the Phase III VIALE-C for AML, but there was numerical improvement. Its setback is good news for Pfizer’s rival Daurismo, analysts said.
Prospects for AbbVie Inc.’s Venclexta (venetoclax) becoming a fully approved treatment for acute myeloid leukemia (AML) were thrown into doubt when the B-cell lymphoma-2 inhibitor failed to show a significant improvement in the primary endpoint of overall survival (OS) in the ongoing VIALE-C Phase III study, although it did demonstrate numerical improvement.
AbbVie on 28 February said that the VIALE-C trial evaluating Venclexta in combination with low-dose cytarabine (LDAC) versus LDAC in...
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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