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Expert Interview

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

A Look at the efficacy of Mavacamten as a treatment of hypertrophic cardiomyopathy

Ticker(s): BMY, LIAN

Who's the expert?

Institution: Yale School of Medicine

  • Assistant Professor of Medicine specializing in Cardiovascular Medicine, specifically in the field of infiltrative cardiomyopathies, at the Yale Cardiomyopathy Program.
  • Treats 50 patients with diabetic cardiomyopathy
  • Her clinical and research endeavors revolve around cardiac amyloidosis, sarcoidosis, and the intersection of advanced cardiac imaging techniques in diagnosing and managing these conditions.

Interview Questions
Q1.

Details about your practice

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Q2.

How many patients with symptomatic obstructive hypertrophic cardiomyopathy do you treat? 
Out of your HCM patients in general, what is the breakdown in terms of % that are symptomatic obstructive.  

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Q3.

How did you manage patients with HCM pre-Mavacamten/Camzyos? 
How is that changing now?  
Have you prescribed Camzyos, and if so, to how many?

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Q4.

Do you use combination treatment of beta blocker AND calcium channel blocker or only one or the other for these patients?
How will that factor into how you use Camzyos given the clinical trial run in patients on only 1 or the other?

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Q5.

Mechanistically does a cardiac myosin inhibitor like Camzyos add an additional element for this condition that can't be achieved by a beta blocker or calcium channel blocker?  How does myosin activity contribute to the condition

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Q6.

Please comment on the Phase 3 trial (EXPLORER-HCM) data

Endpoints:  
Primary (Either ≥1·5 mL/kg per min increase in pVO2 with ≥1 NYHA classimprovement or ≥3·0 mL/kg per min increase in pVO2 with no worsening of NYHA class)
37% vs. 17% placebo
Secondaries:
post-exercise LVOT gradient
-47 mmHg vs. -10 mmHg placebo
KCCQ-CSS
-13.6 vs. -4.2
All stat sig.

How would you characterize these results?
Did anything stand out?  Pros/cons?
How will this guide your prescribing if at all?

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Q7.

Safety - How do you characterize the safety profile? 
How concerning is the LVEF decline observed in some patients? 
FDA established a REMS program based on this. Could you talk about the monitoring required and how that has gone so far with patients you've treated? 
Will it limit your use of Camzyos?  

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Q8.

Recently the Longterm extension study data was presented, as well as the VALOR-HCM trial data, at ACC. Any important takeaways?

On VALOR-HCM, for severe patients eligible for septal reduction therapy18% vs. 77% at week 16 on placebo, so 82% no longer eligible for SRT with Camzyos.  Do you think this can be a longterm benefit and avoid surgeries indefinitely in patients who otherwise needed them? 

How might this data inform your use of Camzyos?

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Q9.

In terms of specific patients you will put on Camzyos, what were the types of patients you prescribed it for so far? 

In the trial they had a LVOT gradient 50mm Hg or greater inclusion criteria with NYHA class 2 or 3.  
The approval is for NYHA class 2 or 3 without any LVOT cutoff that I saw in the label.  
Is there a cutoff you will be using or do you see this as appropriate for any class 2 or 3 patient? 

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Q10.

What percentage of your symptomatic obstructive HCM patients do you anticipate prescribing Camzyos in the next 6 months to 1 year.   And years from now? 

What factors will influence that longterm prescribing trend?

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Q11.

Are there specific patients you think are inappropriate for Camzyos, where you won't be using it?

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Q12.

On a scale of 1-10 what is your level of excitement about Camzyos for HCM? 

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Q13.

In terms of additional indications how do you see its potential for nonobstructive HCM or for heart failure with preserved ejection fraction, which are both currently in phase 2 clinical development?

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Q14.

Looking at the broader Bristol Myers cardiovascular franchise, could you talk about your use of Eliquis, if you anticipate that changing at all going forward, and how you view the competing products in development such as Factor XIa inhibitors?
Can these potentially prove to be safer and compete with Eliquis in the future?  

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