Full data presented at ESMO from a closely watched trial of Seagen/Astellas’s Padcev and Merck & Co’s Keytruda should support regulatory approval of the combination in cisplatin-ineligible first-line metastatic urothelial cancer patients but concerns over duration of treatment remain.
The chances of the much-touted combination of Seagen Inc./Astellas Pharma, Inc.'s Padcev and Merck & Co., Inc.'s Keytruda getting approval in first-line urothelial cancer would appear to have improved on the back of more positive data presented at the European Society for Medical Oncology conference in Paris.
Cohort K of the Phase Ib/II EV-103/KEYNOTE-869 trial compared a combination of the antibody-drug conjugate Padcev (enfortumab vedotin) and the...
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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