Phase 3 Clinical Trial
PFS, ORR, and Safety
What are the secondary endpoints
4.2 months
What is the mOS for the 5-FU/LV arm
80,000
What is the approximate number of Irinotecan molecules found in each liposome
59%
What is the % of Diarrhea for all grades (1-4)
70 mg/m2 IV over 90 minutes
What is the approved starting dose for Onivyde
NCCN category 1 chemotherapy recommendation in Post-Gem mPC patients
What is Liposomal Irinotecan (Onivyde) + 5-FU/LV
The process that confirms patients’ coverage, restrictions and copay/coinsurance amounts
What is Benefit Verification
over 400
What is the number of Health Plans Onivyde is covered on
Treatment continued until disease progression or this
What is unacceptable toxicity
With regards to OS, it’s what the HR 0.68 indicates
What is a 32% reduction in mortality
It’s the active metabolite of irinotecan conversion
What is SN-38
This was the discontinuation rate due to adverse reactions
What is 11%
The recommended dosing for 5-FU and Leucovorin when given in combination with Onivyde
What is Leucovorin 400 mg/m2 IV over 30 min, followed by Fluorouracil 2,400 mg/m2 over 46 hours
The evidence to ___ ___ with Onivyde
What is FIGHT ON
8:00am-8:00pm ET, Monday-Friday
What is time eligible patients can call to enroll
Name the 3 C’s to watch for mPC progression
Clinical signs & symptoms, CA 19-9 Biomarker, and CT/PET Scans
Onivyde 100mg/m2
What is the dosage of Onivyde in the monotherapy arm
It’s the mPFS for the Onivyde+5-FU/LV arm
What is 3.1 months
It’s the half-life (t1/2) of total irinotecan following administration of ONIVYDE 70mg/m2
What is 25.8 hours
The amount of grade 3-4 Neutropenia
What is 20%
Onivyde 50mg/m2
What is the starting dose for patients homozygous for the UGT1A1*28 allele
Onivyde + 5-FU/LV is proven to extend this
What is Overall Survival
Program to assist patients to stay on therapy
What is Adherence Program
About half of mPC patients who completed 1L treatment may be eligible for this
What is Active 2L treatment
34%
What is the % of patients with prior lines of metastatic therapy ³ 2
7.7% and 0.8%
What are the confirmed Objective Response Rates (ORR) for Onv+5-FU/LV and 5-FU/LV
95%
What is the amount of irinotecan that remains liposome-encapsulated in circulation
Monitoring of complete blood cell counts (CBC) is recommended on these days
What are Days 1 and 8
Onivyde patients who develop interstitial lung disease or anaphylactic reaction should do this
What is discontinue Onivyde
NCCN rating defined as “Based upon lower level evidence, there is a uniform consensus that the intervention is appropriate"
What is 2A
It’s what “CARES” stands for in IPSENCares
What is Coverage, Access, Reimbursement & Educational Support
60 evenings, 9 weekends, a holiday season
What is 2 possible extra months of time for mPC patients (mOS 6.1 months vs 4.2 months)
KPS, Albumin level, and Ethnicity
What are the randomization patient stratification factors
This version of RECIST was used for investigator assessment
What is version 1.1
This was achieved in mice bearing human tumor xenografts
What is similar intratumoral exposure at a 5-fold lower dose
This % of patients received atropine for early diarrhea of any severity
What is 26%
When the dose of Onivyde is reduced for adverse reactions, how is the 5-FU dose adjusted?
What is reduced by 25%
Safety profile studied in a large ____
What is Phase 3 trial
Part of IPSENCares that dispenses free product to eligible patients
What is the Patient Assistance Program (PAP)
Between Nov 2015-Oct 2018, Flatiron Health database analyzed mOS data for 2L and 3L patients treated with Onivyde. Name those results.
What is 2L – 6.3 months and 3L – 4.1 months