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In Brief This Week: Nuvalent, Flatiron Health, Elicio Therapeutics, Guardant Health, Neurophth

NEW YORK – Nuvalent this week began the Phase II portion of the Phase I/II ARROS-1 clinical trial of NVL-520 for patients with ROS1-positive non-small cell lung cancer and other solid tumors. The firm selected 100 mg of NVL-520 daily as the recommended Phase II dose based on data from the first part of the trial, which was also supported by the US Food and Drug Administration. The Phase II portion will include multiple cohorts of ROS1-positibe NSCLC patients grouped by whether they had prior treatment with tyrosine kinase inhibitors, along with an exploratory cohort in previously treated ROS1-positive solid tumor patients. 


Flatiron Health this week said it has renewed its collaboration with the US Food and Drug Administration's Oncology Center of Excellence focused on exploring how real-world data can be used in regulatory review of medical interventions. Flatiron, a Roche subsidiary, operates a clinico-genomics repository of de-identified clinical data from electronic health records and comprehensive genomic profiling data. In 2016, Flatiron began exploring with the FDA how clinical and genomics data collected on cancer patients outside of the clinical trial setting can provide real-world insights into the safety and efficacy of treatments they're receiving. 

In renewing their collaboration, Flatiron and the FDA will implement study designs and analytical methods using real-world data and investigate new questions about the activity of cancer treatments and patients' outcomes. "Together we will explore the potential strengths and limitations of using real-world evidence through investigations of a broad set of research questions regarding the care and clinical outcomes of patients diagnosed with solid tumors and hematological malignancies," Flatiron Chief Medical Officer Javier Jimenez said in a statement. 


Elicio Therapeutics said this week that it received a $2.6 million grant from the GI Research Foundation in Chicago to support research for two of its therapeutic cancer vaccines, ELI-007, a mutant BRAF-peptide vaccine, and ELI-008, a p53 hotspot mutation-peptide vaccine. The funding will be used to complete all manufacturing of the vaccines and support regulatory and clinical preparation move ELI-007 and ELI-008 to the clinic. This grant will enable Elicio to pursue initial patient clinical assessment. The GI Research Foundation previously awarded a $2.8 million grant to the company to fund research of ELI-007 and ELI-008 in 2022. 


Guardant Health said this week that Geisinger Health Plan now covers its Guardant Reveal minimal residual disease test. The assay, which detects circulating tumor DNA in blood samples, is intended to help oncologists identify cancer patients with residual or recurring disease — after initial surgery or other treatment — who may benefit most from adjuvant therapy or surveillance. It is the first blood-only liquid biopsy test commercially available for MRD testing. Specifically, Geisinger will cover testing for individuals with stage II or III colorectal cancer after curative-intent treatment. The frequency of testing covered is aligned with monitoring guidelines established by the National Comprehensive Cancer Network for colorectal cancer, which includes an initial ctDNA test four to six weeks after surgery or two to four weeks after completion of systemic therapy, and follow-up tests every three to six months for the first two years and every six to 12 months for the following three years.  


Chinese gene therapy developer Neurophth this week said its autosomal dominant optic atrophy (ADOA) candidate NFS-05 has been approved for clinical trials in Australia. ADOA is an inherited optic neuropathy, about 80 percent of cases of which are caused by mutations in the OPA1 gene that lead to a reduction in function for the proteins it produces. The gene therapy is designed to deliver a functional copy of the OPA1 gene with an adeno-associated virus vector. 


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.