Dive Brief:
- Natera said on Friday that it has received Food and Drug Administration approval of its blood-based molecular residual disease test as a companion diagnostic.
- The FDA approval covers the use of the test, Signatera CDx, to inform the treatment of muscle-invasive bladder cancer patients with Genentech’s immunotherapy Tecentriq.
- Physicians will use Signatera CDx to monitor patients after bladder-removal surgery to identify people who may benefit from Tecentriq.
Dive Insight:
Researchers have linked the presence of circulating tumor DNA, or ctDNA, to cancer recurrence risk, leading Roche’s Genentech to use Signatera to monitor patients in a clinical trial. Patients underwent serial ctDNA testing for up to one year and received Tecentriq or placebo if they tested positive. Almost half of patients were ctDNA-negative across the monitoring period.
Disease-free survival in ctDNA-negative patients was 95% after one year and 88% after two years. Among patients who tested positive, median disease-free survival was 9.9 months with Tecentriq, as compared with 4.8 months with placebo. The trial generated evidence that Signatera can reliably identify patients who are likely or unlikely to benefit from Tecentriq after surgery.
The trial and FDA approval mark a shift to using MRD to guide “when to treat, whom to treat and how to treat more precisely,” Thomas Powles, chair of Barts Cancer Centre at St. Bartholomew’s Hospital, said in a statement. The advances allow for more timely detection of disease recurrence than imaging, which finds tumors when millions of cancer cells are already in the body, Powles said.
Solomon Moshkevich, president of clinical diagnostics at Natera, outlined the economic implications on the company’s first-quarter earnings call this month. An immunotherapy course can cost about $196,000 a year, and managing adverse events incurs further costs, Moshkevich said, making the ability to avoid the treatment of half of MIBC patients “extremely valuable.”
