Cancer Trial Hopes to Find New Patient Populations That Will Respond to Already-Approved Drugs

A phase 2 clinical trial recently launched evaluating outcomes of patients undergoing Food and Drug Administration (FDA)-approved therapies for solid tumors that were guided by a new biomarker-guided testing developed by the pharmaceutical company, Strata Oncology.

The Strata PATH (Precision Indications for Approved Therapies) will analyze safety and efficacy of the following therapies in new, biomarker-driven patients:

• Lorbrena (lorlatinib) in ALK and ROS1 gene fusion-positive solid tumors, excluding non-small cell lung cancer
• Braftovi (encorafenib) plus Mektovi (binimetinib) in BRAF p.600x-mutated solid tumors, excluding melanoma and colorectal cancer
• Talzenna (talazoparib) in patients with advanced solid tumors harboring deep deletions or deleterious mutations with LOH in BRCA and PALB2, excluding HER2-negative breast cancer
• Enhertu (fam-trastuzumab deruxtecan-nxki) for advanced solid tumors with HER2 over-expression, excluding breast and gastric cancers
• Padcev (enfortumab-vedotin) in patients with advanced solid tumors that have Nectin-4 overexpression, excluding urothelial cancer

The main goals of the study are overall response rate (percentage of patients whose disease shrinks or disappears as a result of treatment), and ctDNA response (percentage of patients with less than 50% ratio of variant allele frequency, which determines germline mutations).

Secondary goals of Strata PATH are: duration of response; time until treatment discontinuation; time to next treatment; ctDNA response rate; overall survival; and incidence of serious side effects.

“There is no time to spare when it comes to getting patients their best possible therapies, so we have taken the initiative to sponsor this trial to prospectively test novel biomarker-guided treatment hypotheses that we believe may result in new, highly-responsive pan-tumor molecular indications for FDA-approved therapies,” Dan Rhodes, co-founder and CEO of Strata Oncology, said in a press release.

An estimated 700 adults will be enrolled in the trial, including those with advanced cancer and those with early-stage cancer who have evidence of micro-metastatic disease after their first treatment. Strata PATH is an open-label trial, meaning that both patients and providers will be aware of the intervention, and patient data will be gathered until November 2026, with a final study completion date estimated for November 2029.

"Due to the rapid clinical development of multiple therapies against expression-based targets, comprehensive genomic profiling alone is often insufficient to identify a patient's best treatment," Rhodes said. "Strata Oncology is making cancer treatment smarter by developing quantitative RNA and multivariate algorithms that can guide the use of a range of therapeutic classes, including antibody-drug conjugates, immunotherapies and angiogenesis inhibitors."

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