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Strata Oncology Enrolling Patients in Basket Trial Exploring Biomarker-Defined Indications

NEW YORK – Strata Oncology on Wednesday enrolled the first patient in the Strata PATH trial, which is exploring the activity of marketed targeted therapies in a pan-tumor fashion.

The prospective trial will enroll 700 patients with advanced solid tumors and those with early-stage cancer who have evidence of micro-metastatic disease. Based on patients' tumor biomarkers, they will receive treatments in the study that the US Food and Drug Administration has approved in other settings. The researchers will collect blood samples from patients for circulating tumor DNA (ctDNA) analysis.

The drugs included in the Strata PATH trial are Pfizer's Lorbrena (lorlatinib), Pfizer's Braftovi (encorafenib) and Mektovi (binimetinib), Pfizer's Talzenna (talazoparib), Daiichi Sankyo/AstraZeneca's Enhertu (fam-trastuzumab deruxtecan-nxki), and Astellas/Seagen's Padcev (enfortumab-vedotin).

"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," Strata CEO Dan Rhodes said in a statement.

Pfizer partnered with Strata on the study last year to explore four of its drugs in new indications. The Lorbrena arm will enroll patients with ALK and ROS1 fusion-positive solid tumors, excluding non-small cell lung cancer patients, for whom the drug's already approved. The Braftovi and Mektovi arm will enroll patients with BRAF p.v600X-mutated solid tumors, but exclude melanoma and colorectal cancer. The Talzenna arm will enroll patients with advanced solid tumors harboring deep deletions or deleterious mutations with loss of heterzygosity in BRCA1/2 and PALB2.

The study will evaluate Enhertu in advanced solid tumors harboring HER2 over-expression, excluding breast and gastric cancer, and explore Padcev in patients with advanced solid tumors harboring Nectin-4 over-expression, except for urothelial cancer.

Strata developed the trial arms based on data from its clinical molecular database, which includes DNA mutation profiles and quantitative RNA expression data, alongside treatment history and outcomes data from thousands of patients. The company also expects to identify some patients with early-stage micro-metastatic disease for the PATH study through a separate trial, the Strata Sentinel, which is evaluating its ctDNA-based minimal residual disease (MRD) test in up to 100,000-patients with solid tumors.