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Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced an update on the Phase III [email protected] Lung 037 study and the extensive [email protected] clinical trial program for the potential first-in-class investigational bifunctional immunotherapy bintrafusp alfa, in difficult-to-treat cancers, including biliary tract cancer (BTC) and cervical cancer.
The comprehensive [email protected] program is designed to assess the impact of bintrafusp alfa across distinct cancers and settings where TGF-β is thought to play a driving role. TGF-β is a cytokine that is known to be associated with tumor propagation and metastatic potential such as local immunosuppression, fibrosis, growth of tumor blood vessels and chemo- or radiotherapy resistance through several mechanisms. Trapping TGF-β in the tumor microenvironment on top of PD-L1 blockade is thought to be transformative in different clinical settings.
BERLIN (dpa-AFX) - Science and technology company Merck KGaA (MKGAY.PK) announced Wednesday that the Independent Data Monitoring Committee (IDMC) recommended on Tuesday to discontinue the bintrafusp
(GlaxoSmithKline)
A drug that Pfizer passed over but saw a revitalized cancer R&D-focused GlaxoSmithKline jump on for $4.2 billion has come up as a dud in a key trial pitting it against U.S. Merck’s blockbuster Keytruda.
That drug, originally known as M7824, now bintrafusp alfa, works as a bifunctional fusion protein immunotherapy.
It is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein and to combine co-localized blocking of the two immuno-suppressive pathways: Targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses.
Early data showing a strong objective response rate (ORR) appeared to be enough for GSK to pen a deal with Germany’s Merck. (Though Pfizer, already partnered with Merck KGaA for their also-ran checkpoint inhibitor Bavencio, appeared to have passed on the med.)
Epidermal growth factor receptor (
EGFR) mutations are seen in approximately 10-20% of patients with non-small cell lung cancer (NSCLC), with a higher percentage observed among Asian patients. But considering that over 200,000 people a year are diagnosed with lung cancer, that seemingly small percentage represents a lot of patients, said Roy Herbst, MD, PhD, chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital in New Haven, Connecticut.
Over the past 2 decades, tyrosine kinase inhibitors (TKIs) targeting
EGFR have emerged, beginning with the two first-generation EGFR-TKIs, gefitinib (Iressa) and erlotinib (Tarceva).
A series of trials evaluating first- and second-generation EGFR TKIs found that erlotinib, gefitinib, and afatinib (Gilotrif) were the best first-line treatment options for patients with advanced NSCLC with
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