Dosing/ Trial Design
What is the dosing for Kisqali in the EBC patient as studied in the NATALEE Trial?
400mg QD.
3 weeks on and 1 week off
What are the 3 most common adverse reactions leading to Verzenio discontinuation in combination with tamoxifen or an AI in the MonarchE trial?
Diarrhea : 5%
Fatigue: 2%
Neutropenia: .9%
Note: Monarch 3: 2% of patients discontinued due to diarrhea.
What is the Verzenio patient profile?
1. Node + and high risk
2. Longest duration of efficacy with the shortest treament of only 2 years.
3. Efficacy at any dose.
True or False: At the 4 year analysis of IDFS, all patients had completed Verzenio?
True
How many employees does Eli Lilly have worldwide?
Just over 42,000
How would you handle a situation where a customer asks about efficacy of Verzenio at doses less than 150 BID for the EBC patients?
Consider:
1.Verzenio EBC/MBC IVA- slide - Verzenio can be taken everyday. ( showing Verzenio efficacy was not compromised following dose reductions )
2. Medical Letter
In the NATALEE trial, what was the rate of Grade 3 or 4 Neutropenia?
NATALEE
PI Table 11; Section 6.1 (Grade 3 or 4)
Lymphocytes decreased 19%
Leukocytes decreased 27%
Neutrophils decreased 45%
Added Context…
MonarchE
PI Table 9; Section 6.1 (Grade 3 or 4)
White blood cell decrease 19%
Neutrophils decreased 18.7%
Lymphocytes decreased 13.2%
How would you best describe some of the differences between the MonarchE vs NATALEE Trial?
Broader range of patients in the NATALEE. Monarch E trial really only targets about 10% of the EBC population. Given that about 35% of EBC patients have stage 2 disease and still experience recurrence at some point, there is an unmet need for broader population with both stage 2 and 3.
At year 5, what percentage of the Verzenio+ ET patients has a reduction in risk of recurrance?
33%
Eli Lilly has made 95 medications over the course of the company’s history.
False. The company has made over 100 medicines.
What is the dose reduction schedule for Verzenio and Kisqali in EBC patients?
Verzenio dosed 150mg BID; dose reduce by 50 mg until you get to 50 mg BID allowing for two dose reductions.
Kisqali dosed 400 mg QD; dose reduce to 200 mg once daily allowing for one dose reduction.
What is the discontinuation rate due to AE’s in both NATALEE and MonarchE?
NATALLE: 20%
MonarchE: 18.5%
What percent of patients are at risk of recurrence within 5 years while on ET?
33%. Some data suggests it can be up-to over 50% of recurrence.
In MonarchE, what is the 5-year absolute difference between treatment arms in DRFS?
7.1%
Who is the person on the Team with the longest tenure in Oncology?
Michelle Hudson
What percentage of patients in the NATALEE trial had Stage 2 disease?
40%
Stage 2A: Cancer is 2cm or less and 1-3 nodes or Cancer is 2-5cm and no nodes
Stage 2B: Cancer is larger than 2cm not larger than 5cm and a few nodes or cancer is larger than 5cm and no nodes
MonarchE: 40% of patients had 1-3 nodes, 39% of patients had 4-9 nodes and 22% of patients had 10+ nodes. Bottom line: 65% of patients had 4 plus nodes.
In NATALEE Trial, dose interruptions due to an AE occurred in ___ percentage of patients on Kisqali and an AI? Why is this important?
73%
PI Section 6.1
The rate of dosage interruptions for Verzenio in MonarchE was 62%. In spite of the fact that the recommended dosage for Kisqali in EBC is reduced at 400 mg QD, the rate of dose interruption was still higher.
What is the wording NCCN uses to describe category 1?
High level of evidence with uniform consensus.
2A: lower level of evidence with uniform consensus
2B: lower level of evidence without a uniform consensus
True or False
Both Verzenio and Kisqali are NCCN Category 1 for EBC.
True
Name all the Oncology medications that Lilly has ever promoted?
Alimita
Cyramza
Erbitux
Retevmo
Jaypirca
Verzenio
*** DOUBLE JEOPARDY ***
In the NATALEE Trial, what percentage of patients had node negative status at diagnosis? Node negative at surgery?
Node negative status at diagnosis- 27.2% (694 patients)
Node negative status at surgery- 14.8% (378 patients)
In the NATALEE trial, what was the most common adverse event leading to permanent discontinuation at 8%? Why is this important?
PI- Section: 6.1
Adverse reactions which resulted in permanent discontinuation of Kisqali in greater than 2% of patients were AST’s & ALT’s at 8%.
In MonarchE, the most common adverse event leading to discontinuation with Verzenio was diarrhea at 5%.
In which CDK4/6 trial were patients restricted from taking Tamoxifen as an AI? Why?
Kisqali
PI Section 5.4
Concomitant use of Tamoxifen with Kisqali causes increase in QTC prolongation.
***DOUBLE JEOPARDY ***
What was the 3-year IDFS difference for patients on Kisqali and an AI in the NATALEE Trial?
What was the 4-year IDFS difference?
PI Table 18
IDFS at 36 mos. (3 years) 90.7% Kisqali & AI and 87.6% AI & Placebo. Absolute difference of 3.1%.
Absolute difference in IDFS at 4 years is 4.9%
This is important because the 3-year and 4-year IDFS benefit for Verzenio is 5% and 6.9% respectively.
When Shauna shared her 3 areas of focus in 2024 at our recent area meeting, she mentioned her focus on the 3 P’s. Can you name them?
People/ Performance/ Patients