Positive Results With 42.9% Objective Response Rate, and 90.5% Disease Control Rate in Heavily Pre-treated Patients With Ultra-personalised Pan-cancer Treatment Protocol

In Clinical Trials by Barbara Jacoby

Source: Datar Cancer Genetics

From: PR Newswire

– RESILIENT Protocol captures Encyclopedic information from tumors and uses Artificial Intelligence (AI) to optimize treatments;

– Objective Response and Disease Control Comparable to or better than most Immunotherapy options;

– Unique Ultra-personalised combination of drugs already approved for cancer;

– RESILIENT Protocol commercially launched

Datar Cancer Genetics, a cancer research company, today announced positive data from the phase II/III RESILIENT trial intended to validate clinical benefit for cancer patients who have run out of treatment options under the present standard of care guidelines. The study achieved its primary and secondary end points of Objective Response Rate, Progression Free Survival and Disease Control Rate respectively.

Drug resistant cancers present a serious clinical challenge since there are virtually no treatments available and the prognosis is invariably poor. As a large proportion of all patients with advanced cancers ultimately progress towards this phase, life extending treatment options for these patients are urgently required.

The RESILIENT Protocol is designed to analyse all functional layers of a cancer cell i.e., DNA, RNA, proteins and germline genetics as also the chemoresistance/sensitivity of live tumour cells. This data is integrated through an Artificial Intelligence algorithm to derive treatment regimens which are most efficacious and yet show the least risk of toxicity.

RESILIENT is the world’s first and only prospective Precision Oncology trial where drug combinations were selected on multi-analyte integration. Most prior trials based on a single molecular alteration for drug selection had dismal outcomes. 143 patients started treatment and 126 patients were evaluable as per study criteria. All patients underwent PET-CT and Brain MRI scans prior to start of treatment to establish extent of disease. Treatment response was determined by follow-up PET-CT and MRI scans.

In the majority (90.5%) of patients, further spread of cancer was effectively halted. In 42.9% of patients, treatments also led to a significant decrease in the extent of cancer. Remarkably, among the 12 patients where disease progressed, no new metastases were reported in 9 patients. There were no serious treatment related adverse events or deaths. Most patients reported stable to improved quality of life.

The data of the RESILIENT Trial is published in the peer revived oncology journal ‘Oncotarget’ (https://doi.org/10.18632/oncotarget.27188)

“The RESILIENT trial marks a watershed moment for molecular oncology as it unequivocally proves that patients who have failed even 2 to 3 lines of treatment can benefit from already approved drugs if comprehensive tumour analysis is used to guide treatments. Patients in the United Kingdom and all over the world have much to gain from the outcome of this trial,” said Dr. Tim Crook, Medical Oncologist at the St. Luke’s Cancer Centre, Royal Surrey County Hospital, Guildford, UK, who is one of the authors of the publication.

Datar is a leading cancer research corporation specialising in tumour analysis for better diagnosis, treatment decisions, and management of cancer. Datar’s research initiatives are poised to bring about meaningful, patient-friendly and practice changing advancements in cancer treatment. Datar is also pursuing Adoptive Cell Immunotherapy for Multiple Solid Organ Cancers.