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Expert Interview

Slingshot members are talking to an expert! The topic is:

A Second Opinion on VYXEOS. After positive Phase 3 results in secondary AML can VYXEOS become backbone therapy for all of AML?

Ticker(s): CPXX, JAZZ

Who's the expert?

Name: Dr Michael Andreeff - MD/ PhD

Institution: MD Anderson Cancer Center

Bio:

  • Chair of Genetics and Professor of Medicine
  • Serves as PI of the P01 grant entitled “The Therapy of AML” , participates as PI in MDACC Leukemia , Lymphoma, Ovarian and Breast Cancer SPORE grants , the CML P01 and additional R21 and R01 grants
  • Has published over 450 peer-reviewed papers, 5 books and 75 book chapters 

Interview Questions
Q1.

What is your experience treating high-risk AML and do you have any experience with VYXEOS or cytarabine and daunorubicin?

Added By: joe_mccann
Q2.

What are you impressions of the Phase 3 data released by Celator? Are there any red flags to you from what we know?

Added By: joe_mccann
Q3.

Do you think the VYXEOS can move into AML more broadly? Are there reasons or concerns in your mind that the drug might not beat 7+3 in other situations?

Added By: joe_mccann
Q4.

Do you believe the use of Vyxeos therapy could be done as outpatient procedure or potentially reduce the amount of hospitalization required vs. traditional 7+3

Added By: user801f8285
Q5.

ASCO abstracts are due to be released May 18, 2016.  What additional impressions do you have from Celator's Vyxeos abstracts, or others in the AML space?

Added By: philk
Q6.

How much of a buzz is Vyxeos creating among your peers? Is it the "big thing" every AML physician is talking about, or, after 40 years of failure trying to improve on 7+3 have they stopped even trying to keep up with "what's new"?   

Added By: philk
Q7.

What is the cost of induction 7+3? Regarding the drug alone, a 2012 U.S. article states $12.08 for 2 g of cytarabine, and $58.62 for 20 mg/4 mL of daunorubicin.  What type of premium could Vyxeos command over 7+3 for the relative benefit before payers and doctors are reluctant to cover it?

Added By: william gerber
Q8.

Can you give a quick overview of the difference in biology between secondary AML and de novo? When announcing the data, I believe the company stated that there is no biological reason that the drug should work differently in sAML versus primary.  Do you agree? 

Added By: william gerber
Q9.

It's hard to tell for sure, but the Phase 2 study that included primary AML allowed crossover upon progression from the 7+3 group to Vyxeos treatment, and counted those patients in the 7+3 group.  I assume the results may have been impacted by this to some extent though can't tell how much.  For Vyxeos to be gain traction in use for de novo AML, do you think physicians will prescribe it off label or will Celator have to run a full phase 3 trial? 

Added By: william gerber
Q10.

7+3 is given by 7 day continuous infusion versus Vyxeos by 90 minute infusions days 1-3-5.  How important do you see this regarding impact on patient quality of life (QoL) and would QoL be a material driver in payers coverage and physicians prescribing? 

Added By: william gerber
Q11.

In a 2013 study reviewing Medicare claims for 2,657 patients with AML (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4212516/pdf/nihms634218.pdf ), the largest cost driver was hospital reimbursement (84% of costs) followed by physician payments (7% of costs), outpatient hospital/clinic payments (4% of costs), and home health care payments (2% of costs).  As a followup on the question above about potential for less days in hospital with Vyxeos vs 7+3, what are the typical costs/risks of AML treatment in the hospital beside the fixed cost of the bed? E.g. 1. continuous infusion requires prolonged nursing attention/monitoring; 2. high risk of infection (including fungal) in hospital. 3. any others?

Added By: william gerber
Q12.

Are cytogenetic tests usually done for AML patients and, if so, will decision to use Vyxeos or other treatments be based on cytogenetics (as opposed to "de novo" versus "secondary"


Added By: william gerber
Q13.

As a follow up to the use of Vyxeos in secondary vs de novo AML, is there any reason that use in secondary AML would be limited to ages 60 and above?  Do you know why Celator's trial included only 60 to 75 year olds and not younger patients?  I assume one reason could be fear of imbalanced trial arms since the majority of sAML patients are older.  Will Celator have to run a separate trial for younger sAML patients or will the label likely not include an age band?

Added By: william gerber
Q14.

What is your opinion of the small data set showing Vyxeos's markedly higher CR + CRi rates than 7+3 in FLT3 mutated AML?  Other drugs targeting FLT3 mutated AML include quizartinib, crenolanib, ASP2215 (gilteritinib), midostaurin, etc.- will the development of these drug be impacted if the Vyxeos results hold up?

Added By: william gerber
Q15.

Are there other treatments currently being tested such as high dose daunorubicin that might be used in the AML population? Will cost drive these decision in your opinion?

Added By: joe_mccann
Q16.

Considering Vyxeos consists of the same active drugs as 7+3, but is apparently easier to administer, then assuming FDA approval, what barriers to adoption might there be?  

Added By: philk

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