How many patients have been profiled by Caris to date?
Over 100,000, which is more than any other company and demonstrates experience and credibility.
100
What Antibody does Foundation Medicine use to measure PD L1?
SP142. Caris uses 22C3 for NSCLC, which is the companion diagnostic for Keytruda.
100
What is the difference between a somatic and a germline mutation?
Somatic mutations are acquired/ Germline mutations are inherited.
Caris measures somatic mutations.
100
Define "matched" vs. "ummatched" with regards to Caris registry data?
Matched means a patient received only agents listed in the benefit column.
Unmathced means the patient may have received agents in the benefit column, but they also received at least one agent from the lack of benefit column.
100
What is the new PARP inhibitor for ovarian cancer and what does it target?
Rubraca (Rucaparib)
BRCA germline and somatic mutations
200
How many drug associations does Caris make?
Over 60, including targeted, chemo and immunotherapy options providing the oncologist with the most treatment options.
200
What is the actual sensitivity of blood based profiling? (Circulating DNA)
Around 50%. CMI uses tissue, as it is "gold standard", and should always be tested first for the highest sensitivity.
200
What does on compendium mean?
On Compendium refers to an FDA approved treatment in lineage. Caris provides both on and off compendium drug associations to give the oncologist more treatment options.
200
Define TTF
TTF- Time to treatment failure.
The amount of time before progression of disease from the time the last treatment was completed.
Caris data shows an increase in TTF.
200
What anti PD L1 drug can now be used first line in NSCLC, and what are the requirements?
Keytruda (Pembrolizumab)
TPS of 50% or above
300
Almost 90% of drug associations are made from which 2 technologies?
IHC and ISH. These technologies look at proteins and translocations to provide additional treatment options whereas DNA analysis alone can only provide targeted therapies.
300
What are the list prices for both FM and CMI?
$5800 for FM
$6500 for Caris
Cost should never be an issue. Caris offers compassionate care pricing and our patient navigators will assist with payment options.
300
Define Meta- Analysis
A method for combining data from several selected studies to develop a single conclusion that has greater statistical power. Caris uses this type of data to make drug associations.
300
What is the significance of a Kaplan-Meier curve with regards to CMI?
Kaplan- Meier curves are statistical and are used to estimate overall survival of patients after treatment.
Caris resources show increased survival curves when patients are treated using MP.
300
What does Caris define as high TML and what is the clinical significance?
TML refers to the number of non synonomous mutations found.
Caris considers greater than 17 to be high.
Patients with high mutational loads seem to respond better to immune checkpoint inhibitors.
400
Define clinical utility / clinically actionable?
Clinical utility is defined as any use of a diagnostic test to inform clinical decision making to improve outcomes. Caris provides the most clinically actionable report.
400
What is the total number of genes measured by Foundation medicine?
315. Caris tests for 592 genes. More genes equals more opportunities for discovery and clinical trials.
400
What is the advantage of RNA seq?
RNA sequencing can better frame the significance of the translocation/fusion as compared to DNA sequencing. For example, we may detect clinically relevant translocations/fusions in the DNA but the tumor may not express the fused RNA, therefore the translocation/fusion is not likely relevant to the cancer or treatment.
400
Define negative predictive value and its importance with CMI.
The negative predictive value relates to the ability to predict the likelihood of treatment failure, or our lack of benefit column.
This helps oncologists avoid resistant drugs.
400
Describe the TAPUR study.
Sponsored by ASCO, TAPUR is a non-randomized prospective clinical trial collecting clinical outcomes data for additional uses of these targeted therapies.
Caris is an approved lab for the study.
500
Name 3 types of patients who are good candidates for CMI?
Refractory patients
Recurrent patients
Rare/uncommon tumors where there is defined standard of care.
Caris provides the most clinically actionable report for these therapeutic dilemmas.
500
Foundation Medicine makes mechanistic drug associations. Define this term.
Mechanistic drug associations are based on assumption and logic, outside of empirical evidence. CMI only makes associations based on evidence.
500
Define Level l, and Level ll data.
Level l- Randomized, controlled studies, Meta-analysis
Level ll- Well designed, prospective, non-randomized studies
Over 90% of CMI associations are made from Level l and Level ll data.
500
What is the name (or author) of the landmark study for CMI? What was the average response rate for patients in this study and why is it important?
The Bisgrove (Von Hoff) study which showed a 27% response rate for heavily pre-treated patients when treated using molecular profiling. This study serves as Proof of Concept for molecular profiling.
500
Name 2 key takeaways from our newest resource found in The International Journal of Surgery & Surgical procedures (Ussia)?
1) Multi platform tumor profiling provides the highest clinical utility
2) In 10 physician studies 75% of patients were treated using CMI report
3) 40% of patients showed a clinical benefit