Gallbladder Neoplasms

BOSTON--( BUSINESS WIRE )-- Foundation Medicine, Inc. today announced a collaboration to develop Foundation Medicine’s RNA platform as a companion diagnostic for Merus N.V.’s (Nasdaq: MRUS) bispecific antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion (NRG1+) cancer. Zeno is a Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival. In May the U.S. Food and Drug Administration (FDA) accepted under priority review a Biologics License Application for Zeno in patients with NRG1+ non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. The FDA has also granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy. NRG1 gene fusions are rare and have been identified in patients with different types of solid tumors, including NSCLC, pancreatic cancer, gallbladder cancer, renal cell carcinoma, bladder cancer, ovarian cancer, breast cancer, neuroendocrine tumor, sarcoma, and colorectal cancer. 1 NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions). 2 While DNA sequencing with optimized targeting can detect fusions, Foundation Medicine’s RNA platform can provide another layer of sophisticated fusion detection in 318 genes through RNA sequencing. It also has expanded capabilities for research use to offer gene expression reporting of over 1,500 genes to support biomarker discovery. Foundation Medicine is the only company with FDA-approved CDx indications for fusion biomarkers using CGP tests, including approved claims using tissue or liquid biopsy for ALK, ROS1, RET, NTRK1/2/3, and FGFR2. 3 “We are excited to partner with Merus on this RNA companion diagnostic opportunity to provide fusion detection through next-generation sequencing,” says Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “We anticipate this innovative molecular information will help detect more NRG1 fusions and provide healthcare providers with important information to inform their care decisions for patients.” About Foundation Medicine: Your Essential Partner in Cancer Care Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X . 1 Jonna S, Feldman RA, Swensen J, et al. Detection of NRG1 gene fusions in solid tumors. Clin Cancer Res . 2019;25(16):4966-4972. doi: 10.1158/1078-0432.CCR-19-0160 . 2 Suda K, Mitsudomi T. Emerging oncogenic fusions other than ALK , ROS1 , RET , and NTRK in NSCLC and the role of fusions as resistance mechanisms to targeted therapy. Transl Lung Cancer Res . 2020;9(6):2618-2628. doi:10.21037/tlcr-20-186 3 Data on file, Foundation Medicine, Inc. as of 2024.

Novo Nordisk’s semaglutide has been associated with a lower risk of cognitive problems, according to new research conducted by a team from the University of Oxford. The observational study suggests that people with diabetes receiving the glucagon-likepeptide-1 (GLP-1) receptor agonist, which is marketed under brand names including Ozempic and Wegovy, experienced cognitive benefits as well as lower nicotine dependence. The analysis, published in The Lancet’s eClinicalMedicine journal, used records from more than 100 million patients in the US, including over 20,000 who were taking semaglutide. The team found that the drug was not associated with an increased risk of neurological and psychiatric conditions, such as dementia, depression or anxiety, compared to other common anti-diabetic medications, challenging recent safety concerns surrounding the treatment. Dr Riccardo De Giorgi, clinical lecturer at the University of Oxford and lead author of the study, said: “The findings of our study… not only help reassure the millions of patients relying on semaglutide for diabetes management, but, if confirmed, might also have significant implications for public health in terms of reducing cognitive deficit… among patients with diabetes.” The researchers outlined that, while the study’s “robust methodology and extensive data provide strong evidence”, further investigation is needed and that it remains unclear how semaglutide may be having these effects. “Our study is observational and these results should therefore be replicated in a randomised controlled trial to confirm and extend our findings,” said Dr Max Taquet, clinical lecturer at the University of Oxford and senior author of the study. The findings come just days after researchers from Case Western Reserve University School of Medicine in the US found that type 2 diabetes patients being treated with GLP-1 receptor agonists, such as semaglutide, were less likely to develop ten types of 13 obesity-related cancers. The team found that, compared to insulin, GLP-1 treatment reduced the risk of gallbladder cancer by 65%, meningioma by 63%, pancreatic cancer by 59%, hepatocellular carcinoma by 53% and ovarian cancer by 48%, with benefits seen across multiple other cancers. Beyond cancer outcomes, semaglutide has been shown to significantly reduce the risk of major kidney outcomes, cardiovascular events and death in patients with type 2 diabetes and chronic kidney disease.

Phesi has published the results of its mid-year analysis of 66,935 clinical trials conducted globally in the first half of 2024 from its Trial Acceleratory platform, containing data from over 120 million patients in more than 400,000 cohorts. The analysis revealed that COVID-19 was no longer in the top five most studied indications. Instead, the top five most studied diseases were breast cancer, solid tumours, stroke, prostate cancer and type 2 diabetes (T2D), and it revealed that three of the top five most studied diseases being studied were in oncology. In May, Merck & Co – known as MSD outside the US and Canada – shared positive phase 3 results from the KEYNOTE-522 study for its Keytruda (pembrolizumab) in combination with chemotherapy (CRT) in patients with high-risk, early-stage triple-negative breast cancer, which showed that Keytruda demonstrated a statistically significant and clinically meaningful overall survival compared to pre-operative CRT. Similarly, a phase 2 trial led by researchers from the Royal Marsden NHS Foundation Trust and the Institute of Cancer Research revealed that stereotactic body radiotherapy in combination with androgen receptor-targeted agents – a type of hormone therapy – could delay the need for chemotherapy in patients with oligoprogressive prostate cancer. In addition to this, Phesi acknowledged the “growing interest” in studies of glucagon-like peptide-1s (GLP-1s), as seen in a recent US study conducted by researchers at Case Western Reserve University School of Medicine, Ohio. Results showed that T2D patients treated with the GLP-1 receptor antagonist semaglutide had a decreased risk of developing ten of the 13 obesity-linked cancers, including gallbladder and kidney cancer. In addition to this, the analysis revealed that 32% of trials were terminated during phase 2, highlighting a 56% increase in pre-pandemic levels while increasing clinical development costs and affecting the rates of new therapies reaching patients. Dr Gen Li, president and founder, Phesi, commented: “Trial design requires huge volumes of data to ensure participant selection matches the level of precision in the medicines being tested. “By leveraging predictive analytics, sponsors can design protocols better aligned with the target patient population and identify the best-performing investigator sites with a higher level of precision.”