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In Brief This Week: ImmunoGen, Elevation Oncology, Strata Oncology

NEW YORK – ImmunoGen said this week that it has filed a biologics license application with the US Food and Drug Administration for its antibody-drug conjugate mirvetuximab soravtansine for previously treated ovarian cancer patients whose tumors show high expression of folate receptor-alpha. The firm has submitted data from its Phase III SORAYA trial evaluating mirvetuximab soravtansine monotherapy among patients with platinum-resistant, folate receptor alpha-high ovarian cancer. The FDA has granted the therapy priority review and is expected to decide on approval by Nov. 28, 2022. 

The US Food and Drug Administration this week granted fast track designation to Elevation Oncology's seribantumab for solid tumors harboring NRG1 gene fusions. Elevation Oncology is currently evaluating seribantumab in its ongoing Phase II CRESTONE study and plans to present initial data during an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) annual meeting. The primary aim of the Phase II study is to evaluate the drug's anti-tumor activity and safety. Elevation has inked several partnerships aimed at identifying NRG1 fusion-positive patients and supporting enrollment. Collaborators include Strata Oncology, Caris Life Sciences, Ashion Analytics, US Oncology Research, and Genomic Testing Cooperative, among others. 

Strata Oncology said this week that the University of Wisconsin's Carbone Cancer Center and the University of Alabama's O'Neal Comprehensive Cancer Center will join the Strata PATH trial. Earlier this month, the company began enrollment in the trial, in which advanced and early-stage cancer patients with evidence of micro-metastatic disease will have their tumors profiled and receive off-label treatments based on the identified biomarkers. Strata aims to enroll 700 patients with solid tumors into the prospective trial and researchers will collect blood samples from patients for circulating tumor DNA analysis. Kettering Health Cancer Center is also participating in the study.

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 Oncology News.