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Demonstrated Utility - Improved Clinical Outcomes

Demonstrated Utility – Improved Clinical Outcomes

Clinical research studies continue to demonstrate the clinical utility of tumor profiling with Caris Molecular Intelligence® (CMI) in physician treatment selection and its positive effect on the overall survival (OS) outcomes of cancer patients. Two studies, one conducted on a large group of cancer patients in 2015 and the other on a cohort of ovarian cancer patients in 2014, showed that patients treated according to CMI results experienced one year longer survival and received one fewer cancer drugs (avoiding potential toxicities and extra cost of therapy), vs patients not treated according to CMI recommendations.

Solid Tumors Cancers Study – Treatment Decisions Informed with Tumor Profiling Improve Outcomes

Caris Life Sciences presented data in 2015 demonstrating that multi-platform molecular profiling (MMP) has a significant ability to detect a better prognostic group for OS for across a variety of tumors. MMP was also demonstrated to have clinical impact on physician treatment selection in a majority of cases.

The study included all 1180 enrolled patients where treatment, follow-up, and MMP data was available, spanning more than 40 lineages. Patients who received one or more drugs predicted to be of benefit, and no drugs predicted to be of lack of benefit, were placed into the “Matched” (M) arm. Patients who received at least one drug predicted to be of lack of benefit were placed into the “Unmatched” (U) group. Classification of patients into each arm was made for drugs administered after (n=1027) as well as before MMP (n=1180; 153 patients received no therapies after profiling).

Select highlights from this clinical study include:

  • Patients who received only those treatments associated with potential benefit according to the CMI report (n=534) had a significantly longer post-profiling survival compared to those in the Unmatched cohort (n=493). The median increase in survival was 422 days (1068 vs. 646 days, Hazard Ratio = 0.68, p=0.001).
  • Patients in the Matched cohort were treated with less treatments overall after profiling compared to those in the Unmatched cohort (median 3.2 vs. 4.2 therapies).
  • Median overall survival from diagnosis including treatments given prior to comprehensive tumor profiling also demonstrated a survival benefit in the Matched cohort (data not shown) (median OS 978 vs 580 days; Hazard Ratio =0.714; p=0.0003).
  • When patients receive effective drugs, they are exposed to fewer overall agents, reducing the toxicity, potentially decreasing costs, and improving survival. A 32% reduction in the risk of death was observed in patients who received only treatments associated with benefit after profiling. This further supports the utility of MMP in the Matched group.clinical utility tumor profiling

Spetzler D, et al. Multi-platform molecular profiling of 1,180 patients increases median overall survival and influences treatment decision in 53% of cases. European Journal of Cancer, September 2015, Volume 51, S44. View data.

Ovarian Cancer Study

Caris Life Sciences® presented data in 2014 demonstrating that CMI significantly improved survivorship of ovarian cancer patients. The results of a study conducted on 450 patients, showed that treatments consistent with the predictions of CMI tumor profiling significantly improved the OS in patients with ovarian, primary peritoneal and fallopian tube carcinomas. Patients were stratified based on the chemotherapeutic agents administered during the course of their disease. Of 450 patients, a total of 278 were divided between two cohorts: the Benefit cohort included patients whose treatments were predicted to be of benefit (170) while the Lack of Benefit cohort included patients who received at least one treatment predicted to be of lack of benefit (178). There were no significant differences in the baseline characteristics of these two cohorts.

Select highlights from this clinical study include:

  • Patients in the Benefit cohort experienced significantly longer post-profiling survival, as evidenced by a 46% reduction in the risk of death, compared to the Lack of Benefit cohort (Hazard Ratio = 0.54, 95% CI 0.37-0.80; p=0.0018).
  • Median OS observed for patients included in the Benefit cohort (158.0 months) was significantly longer compared to patients included in the Lack of Benefit cohort (63.4 months) – see image belowclinical utility tumor profiling
  • Patients in the Benefit cohort also trended toward significantly longer OS, as evidenced by a 31% reduction in the risk of death, compared to the Lack of Benefit cohort (Hazard Ratio = 0.69, 95% CI 0.47-1.02; p=0.065).

TJ Herzog, et al. Impact of molecular profiling on overall survival of patients with advanced ovarian cancer. Oncotarget [Online], Volume 5 (1 March 2016). View paper.

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