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DeciBio Liquid Biopsy Weekly Digest
February 19th, 2020
A major milestone in cancer early detection this week - GRAIL has initiated its PATHFINDER study (NCT04241796), a prospective, interventional, multicenter study that will involving returning results pf GRAIL's multi-cancer liquid biopsy early detection assay to physicians. So far, previous clinical trials (STRIVE, CCGA, SUMMIT), which involved sequencing tens to hundreds of thousands of patients have all been observational. In the PATHFINDER study, GRAIL's assay will be used to help guide appropriate diagnostic workup for more than 50 cancer types, enrolling approximately 6,200 participants with 12 month follow up from time of enrollment, according to GRAIL's website.
Pharma partnerships seem to be the theme of other news this week, as Foundation Medicine and Natera both saw developments on that front:
Novartis' new drug application for its investigational MET inhibitor capmatinib (for NSCLC) was accepted by the US FDA and granted priority review. Foundation Medicine has partnered with Novartis to develop both tissue- and liquid biopsy-based companion diagnostics for capmatinib, with the new indication planned for inclusion on FoundationOne CDx and their new liquid biopsy assay
Foundation Medicine and Chugai Pharmaceutical (both are owned by / subsidiaries of Roche) partnered with the National Cancer Center Japan to use FoundationOne Liquid as part of SCRUM-Japan, a genomic screening consortium
Elicio Therapeutics and Natera announced a collaboration for a prospective, 108-patient multicenter Phase 1/2 study of ELI-002, an immuno-oncology therapeutic targeting KRAS mutations in the adjuvant setting for patients with pancreatic ductal adenocarcinoma (PDAC). Natera's Signatera assay will be used to select patients with KRAS mutations and are at high risk for relapse based on their MRD status
We expect to see increasing activity involving liquid biopsy-pharma partnerships in efforts to demonstrate clinical utility and gain companion diagnostics status - a clear point of differentiation and an adoption driver.
Finally, the the ASCO 2020 Genitourinary Cancer Symposium took place over the past week. We took a brief scan through the abstracts search results and found that ctDNA and CTCs dominated the results - 29 results for "cfDNA", 21 for "CTC", 4 for "exosome"/"exosomes" and 1 for "extracellular vesicles". The abstracts and posters can be accessed here.
