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Avastin Studies
iDetail Only
Alimta PI
Tarceva PI
Avastin PI
100
Where are the safety results for study E4599?
Study E4599
Safety profile
100
Where is the histology pie chart for study E4599?
Study E4599
Histologies pie chartWhere is the histology pie chart for study E4599?
100
In the Alimta Maintenance Following Non-Alimta containing Platinum-Based induction Therapy Study plus Cisplatin, What was the median OS in the Adenocarcinoma subgroup receiving Alimta vs placebo group?
16.8 mos (Alimta) vs. 11.5 mos (placebo) [HR 0.73]
Alimta PI-Table 15 Efficacy by Histologic Subrgoups
100
What was the median OS in the treatment and placebo arms of the TARCEVA SATURN trial?
12 Mos in Tarceva arm 11 Moa in placebo arm
100
What study # is E4599 in the interactive Avastin PI and where would you find it?
Study 5
OR
Clinical Studies Section 14.3
200
Where is the statement "15 mg/kg Q3W is the only dose of Avastin demonstrated to significantly increase OS in first-line metastatic non-squamous NSCLC?"
Hist Persp & Key Trials
15 mg/kg q3w increase OS
OR
Study E4599
15 mg/kg q3w increase OS
OR
Duration
15 mg/kg q3w increase OS
OR
Dose
15 mg/kg q3w increase OS
200
Where is the NCCN recommendation for continuation/maintenance?
NCCN and PI Guidelines
OR
Treatment Algorithm
NCCN Category 1 Recommendation
200
Where would you go in the app to address ”I use Avastin in combination with Alimta/carbo followed by maintenance Alimta or Tarceva”?
Tx Algorithm
Tx Algorithm
AND/OR NNCN and PI Guidelines
200
Tarceva is indicated for the maintenance Treatment of patients with locally advanced or metastatic cancer whose disease ….
“has not progressed after 4 cycles of platinum-based first line chemotherapy”
Indications and Usage
Clinical Studies (section 14.1)
200
Where is the Clinical Trial safety information on in Avastin NSCLC?
Section 6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
Unresectable Non- Squamous Non-Small Cell Lung Cancer (NSCLC)
300
Where is the median OS for study E1594?
Hist Persp & Key Trials
Chemo standard (E1594)
300
Where is Avastin stated to be a standard of care?
Hist Persp & Key Trials
Avastin + PC a Standard of Care
300
Alimta is indicated for use maintenance treatment of patients with locally advanced or metastatic NSCLC who's disease...
"....has not progressed after four cycles of platinum-based first-line therapy."
300
Tarceva in 1L therapy is not recommended for use …..
In combination with platinum-based chemotherapy Section 1 (1.1) Indications and Usage/Limitations of Use:
OR
14 Clinical Studies (14.3)
300
Where is information on the MOA of Avastin located in the Interactive PI?
Section 12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
400
Where are the OS results of the Johnson AVF0757 (Phase II) trial?
Hist Persp & Key Trials
Johnson Phase II OR
Dose
Johnson Phase II
400
Where is the information about the randomization in E4599?
Study E4599
ITT Population
400
In the study of Continuation of Alimta as Maintenance Following Alimta plus Platinum Therapy, what was the median number of maintenance cycles administered to patients receiving one or more doses of maintenance therapy in the Alimta and placebo arms?
The median number of maintenance cycles was 4 for both the Alimta and placebo arms.
400
What was the median PFS and HR for Tarceva 150 mg vs Placebo in the NSCLC Maintenance Trial in patients whose disease did not progress during first-line platinum based chemotherapy?
2.8 mos (Tarceva) vs 2.6 (placebo); HR 0.71
Section 14.2, Table 7
400
Where is information on the risk of ovarian failure in women taking Avastin?
Section 8 8.6 Females of Reproductive Potential
OR
Section 5 Warnings and Precautions
5.10 Ovarian Failure
OR
Section 6 Adverse Reactions 6.1 Clinical Trial Experience
500
Where is the INTERACTIVE KM curve for E4599 1 and 2 year OS?
What is Study E4599 Efficacy/Safety,br /> OS
500
Where is the Dr. Mark Kris quote regarding the "trifecta of benefits" in the E4599 study?
E4599 Efficacy/Safety
PFS/RR
500
In the trial Phase III Alimta Scagliotti Trial, What was the benefit seen in the adenocarcinoma population?
1.7 months (12.6 mo VS 10. 9 mo)
1L study Alimta PI
500
What was the OS for Tarceva in the ITT population for patients receiving second/third line therapy?
6.7mo (Tarceva) vs 4.7 (Placebo) br /> Section 14.3, Table 8
500
Of the 89% of patients with newly diagnosed disease in the pivotal Phase 111 trial of Avastin in NSCLC, what percentage had Stage IIIB disease with malignant pleural effusion?
12% of the that subset had Stage IIIB with pleural effusion. PI Section 14.3