The annual meeting of the American Association for Cancer Research (AACR) will be held on April 5-10, 2024, local time in San Diego, USA. As one of the world’s most influential academic events in the field of oncology, the AACR Annual Meeting focuses on all aspects of oncology research and innovation, and releases cutting-edge research results in the field of global oncology. Recently, AACR officially released the information of selected studies, and five studies of two innovative drugs, namely, Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor) and TQB2916 (CD40 agonist) from Chiatai Tianqing Pharmaceutical Group, have been selected. Clinical Studies ALTER-G-001 A Multicohort, Multicenter, Phase II Study – Cohort C Results Update: Anlotinib in Combination with Chemotherapy for First-Line Treatment of Digestive Tract Tumors with Unresectable Liver Metastases CT213/13 – Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, ...
Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
BeiGene’s Brukinsa (zanubrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma. The BTK inhibitor has specifically been authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy. The FDA’s decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone. An 18-month duration of response of 69% for the Brukinsa combination was also observed, BeiGene said, adding that safety results were consistent with previous studies of both medicines. Mehrdad Mobasher, chief medical officer, haematology at BeiGene, said: “This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not ...
Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States. The summary of the poster is shown as below: Title: First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial Method: This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed. Background: ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de ...
TransThera, a clinical-stage biopharmaceutical company dedicated to innovating differentiated drugs globally, today announced that the randomized, controlled, global multicenter Phase 3 trial (FIRST-308) of tinengotinib versus physician’s choice to evaluate the efficacy and safety in subjects with FGFR-altered, chemotherapy- and FGFR Inhibitor-refractory/relapsed cholangiocarcinoma (CCA), has been authorized by regulatory agencies in the European Union (EU) after the authorizations from US, South Korea and Taiwan region. Furthermore, European Medicines Agency (EMA) granted the Orphan Drug Designation(ODD) for tinengotinib for the treatment of biliary tract cancer (BTC) . Tinengotinib, a next-generation FGFR inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical benefit in subjects with FGFR-altered metastatic CCA who were heavily pretreated with chemotherapy and refractory/relapsed to FGFRi(s). The results of tinengotinib in CCA from the phase I/II clinical trials were presented orally at 2023 ESMO and 2024 ASCO GI conferences. The FRIST-308 clinical trial ...
Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that the latest results from three preclinical studies of the company’s novel drug candidates olverembatinib, MDM2-p53 inhibitor alrizomadlin, FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and EED inhibitor APG-5918, have been selected for presentations at the 2024 American Association of Cancer Research Annual Meeting (AACR 2024). These abstracts are now available on the AACR’s official website. The AACR annual meeting is one of the world’s largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year’s AACR annual meeting will be held from April 5-10 2024, in San Diego, California, USA. These three preclinical abstracts from Ascentage Pharma include: ...
Researchers from Johns Hopkins Kimmel Cancer Center and the Johns Hopkins University School of Medicine have developed an algorithm to identify high-risk precancerous lesions that lead to ovarian high-grade serous carcinoma (HGSC). Published in Clinical Cancer Research, researchers aimed to develop a tool that could detect and stratify serous tubal intraepithelial carcinomas (STICs) based on key genetic alterations and mutations. STICs are lesions that are presumed to be the main precursors of HGSC, the most common form of ovarian cancer in women. Using a technique called Repetitive Element AneupLoidy Sequencing System (RealSeqS), researchers sequenced 150 DNA samples and analysed the level of aneuploidy, missing or extra DNA chromosomes, in STIC versus HGSC and normal-appearing samples. Results showed that STIC samples had more non-random genetic alterations, including whole and partial deletions of chromosome 17 in the tumour suppressor p53 proteins, while normal-appearing samples had low levels of aneuploidy. The team suggests ...
Ovarian high-grade serous carcinoma (HGSC) is the predominant form of ovarian cancer affecting women. Serous tubal intraepithelial carcinomas (STICs), which are precancerous lesions on the fallopian tubes, are considered the main precursors of HGSC. Women undergoing salpingectomy, the surgical removal of fallopian tubes, often do so without a detailed examination of these precancerous lesions. The challenge lies in the molecular diversity of STICs and the difficulty in detecting aggressive forms early, owing to their small size. In response to this urgent diagnostic need, researchers have developed an algorithm to identify STICs before they can progress to cancer. This pioneering algorithm, named “REAL-FAST” (RealSeqS-based algorithm for fallopian tube aneuploidy pattern in STIC), was developed by a team at Johns Hopkins Medicine (Baltimore, MD, USA). In a pilot study, REAL-FAST distinguished five unique types of precancerous lesions in fallopian tubes, with two identified as particularly aggressive and often linked to recurrent HGSC. ...
Davy James Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus cisplatin and gemcitabine in the frontline treatment of adults with unresectable or metastatic urothelial carcinoma (UC).1 The regulatory action adds to an array of approved indications for Opdivo, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic UC; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.2 “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients ...
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