Gilead Sciences and Strata Oncology have signed an agreement in which Gilead has agreed to collaborate on the Strata Precision Indications for Approved THerapies (Strata PATH; NCT05097599) study by providing sacituzumab govitecan-hziy (Trodelvy®) for eligible patients with cancer.

Sacituzumab govitecan is a Trop-2-directed antibody conjugated to a topoisomerase I inhibitor (SN-38).  The antibody-drug conjugate or ADC, developed by Immunomedics  (now part of Gilead Sciences) was designed to treat adults patients with metastaitic triple-negative breast cancer (mTNBC; a cancer that is negative for estrogen and progesterone hormone receptors and HER2) that has metastasized or cannot be removed by surgery.  the drug is generally prescribed to patients who have received two or more prior treatments, including at least one treatment for metastatic disease. [1] Under accelerated approval based on tumor response rate and duration of response, the drug is also approved for the treatment of locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. [2]

Prospective study
Strata PATH is a 700-patients prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations.

Several types of biomarkers are being evaluated, including quantitative RNA and multivariate algorithms that may optimize the use of different anti-cancer therapies. These biomarkers can be analyzed in parallel with the genomic mutations assessed by comprehensive genomic profiling (CGP), thus maximizing the information available from often limited tumor tissue samples.

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The Strata PATH study will enroll patients with advanced cancer, as well as patients with early-stage cancer who have evidence of micrometastatic disease after initial treatment. The study will evaluate a range of therapeutic classes including targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors.

Enrollment for multiple arms in Strata PATH is based on Strata Oncology’s quantitative RNA and multivariate algorithms.

“As the first diagnostics company to run its own prospective interventional trial to show the utility of its tests, Strata is honored to have the support and collaboration of forward-thinking biopharma companies like Gilead Sciences for the Strata PATH trial,” explained Dan Rhodes, Ph.D., Chief Executive Officer and co-founder, Strata Oncology.

“Quantitative RNA and multivariate biomarkers have the potential to optimize the use of expression-based therapies and improve the outcomes and the quality of life for cancer patients,” Rhodes added.

Other evaluations
In 2022 Pfizer agreed to provide encorafenib (Braftovi®), binimetinib (Mektovi®), and lorlatinib (Lorbrena®) for up to six new cohorts of patients with early-stage lung, melanoma, colorectal, and other cancers who have evidence of micrometastatic disease after initial treatment.  The company already participated in the study with talazoparib, (Talzenna®), and axitinib (Inlyta®) for evaluation in four late-stage cohorts of the Strata PATH trial.

Clinical trials
Strata PATH™ (Precision Indications for Approved Therapies) (Strata PATH) – NCT05097599

Highlights of prescribing information
Sacituzumab govitecan-hziy (Trodelvy®; Gilead Sciences)[Prescribing Information]

[1] Syed YY. Sacituzumab Govitecan: First Approval. Drugs. 2020 Jul;80(10):1019-1025. doi: 10.1007/s40265-020-01337-5. PMID: 32529410; PMCID: PMC7288263.
[2] Fontes MS, Vargas Pivato de Almeida D, Cavalin C, Tagawa ST. Targeted Therapy for Locally Advanced or Metastatic Urothelial Cancer (mUC): Therapeutic Potential of Sacituzumab Govitecan. Onco Targets Ther. 2022 Dec 21;15:1531-1542. doi: 10.2147/OTT.S339348. PMID: 36575731; PMCID: PMC9790156.

Featured image: Gilead Exhibition booth during ASCO 2019. Photo courtesy: © 2019 – 2023 Evan Wendt/Sunvalley Communication. Used with Permission

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