By Scott Tomlins, MD, PhD, Co-Founder & Chief Medical Officer, Strata Oncology
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At Strata Oncology, we are on a mission to accelerate the impact of precision medicine for patients with cancer, with the ultimate goal of getting every patient their best possible therapy.
Our approach to fulfilling this mission has been to develop an advanced molecular profiling platform paired with a suite of innovative clinical research programs.
Recently, we’ve launched two prospective clinical trials that together have the potential to enable smarter and earlier cancer treatment: Strata PATH™ and Strata Sentinel™.
The next wave in precision-matched cancer treatment
Due to the rapid clinical development of immunotherapy and other agents against expression-based targets (which cannot be assessed by testing DNA), comprehensive genomic profiling alone is insufficient to identify an individual patient’s best treatment. Our goal is to make cancer treatment smarter by developing quantitative RNA algorithms that can guide the use of expression-based therapies—including immunotherapies, antibody-drug conjugates, bispecific antibodies, CAR-based therapies, and radiopharmaceuticals—across multiple tumor types.
To advance this next wave of innovative care and drive better patient outcomes, we are sponsoring Strata PATH (Precision Indications for Approved Therapies), a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations.
Eligibility for several arms of Strata PATH is based on proprietary quantitative RNA algorithms we developed using our clinical molecular database that ties together real-world outcomes with genomic and quantitative transcriptomic data from tens of thousands of patients.
Strata PATH will enroll patients with advanced cancer, as well as patients with early-stage cancer who have evidence of micrometastatic disease (too small to be detected by conventional imaging technology) after initial treatment, many of whom we expect to be identified in our other trial, Strata Sentinel.
Bringing precision oncology advances to early-stage patients
While the hope for every patient with early-stage cancer is that their disease will be cured with their initial treatment, we know many will have a recurrence. We see an incredible opportunity to bring the precision oncology advances we’ve seen in late-stage cancer to these patients.
Strata Sentinel is a 100,000-patient, prospective, observational, pan-solid tumor study we are conducting at sites across the United States that will 1) evaluate the clinical utility of our highly sensitive, tumor-informed circulating tumor DNA (ctDNA)-based MRD test across all tumor types and 2) determine the clinical benefit of providing therapy to patients who are ctDNA-positive after surgery or other therapy with curative intent.
Until now, the main use for MRD testing has been to simply identify patients with micrometastatic disease prior to radiographic recurrence. We believe, however, that the full value of MRD testing encompasses adjuvant therapy clinical decision support—namely MRD testing can help physicians determine which patients should and should not receive adjuvant therapy. This is further complemented by integrating MRD testing with advanced molecular profiling to provide comprehensive treatment planning that spans multiple therapeutic modalities.
In Strata Sentinel, a single tumor sample for each patient will be used to develop both the recurrence-monitoring assay and a therapy selection profile. If recurrence is detected, the treating physician can use this profile to make treatment decisions.
And here’s where smarter and earlier treatment come together: Because the therapy selection profile created for every patient assessed with our MRD test includes our quantitative RNA algorithms, patients in Strata Sentinel with recurrence who match to a Strata PATH study arm (and who are otherwise eligible) will have the opportunity to enroll in that study too.
The combined results of these trials have the potential to radically shift the paradigm in cancer care. Doctors will be empowered to give each patient their optimal biomarker-matched therapy as early as possible, achieving the ultimate precision medicine goal of getting the right treatment to the right patient at the right time.
Scott Tomlins, MD, PhD is the Co-Founder and Chief Medical Officer of Strata Oncology, a precision oncology company committed to accelerating the impact of precision medicines for patients with cancer.
For additional information: www.strataoncology.com
