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Msg  53051 of 53272  at  12/3/2021 5:52:13 PM  by

Bibliobiftek

The following message was updated on 12/3/2021 5:57:40 PM.

 In response to msg 53049 by  WilCravenMckrye
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Re: Where Mirv could grow

Mirv's results from SORAYA provides a solid foothold for them in both EOC and oncology in general to launch all of these label expansions. The question will be how many long, late stage randomized controlled PIII trials they run with Mirv. rather than wait for IMGN151 which may cannibalize any EOC related indications they expand into with Mirv. rendering those costs less than efficient uses of their capital.
 
Despite the possibility of compendia listing based on their existing PII's, I think it may make sense to run a RCT PIII trial with Bev. in the biggest possible 2L EOC indication now to ensure its standing with FDA, practitioners and insurers to secure some revenue as a an operational bridge to potential IMGN151 indications (and possibly a bigger buyout) and rely on compendia listing for the other combo possibilities. I think it may make sense to focus on FR-a high patients to maximize effect size which would allow them to do a smaller PIII with less statistical powering, and leave some label expansion room should 151 do much better as well as fund other potential indications for 151, 936, 632 and possibly reboot R&D. Waiting the rest of next year on IMGN151 results without initiating a meaningful PIII for a Mirv. combo seems too risky as they may be caught flat footed by competitors or lackluster 151 outcomes.
 
As for 1L EOC, it's not clear that they demonstrated vastly superior ORR results from their Mirv + Bev + Pt. triplet vs. the standard of care nor any sensitivity of outcomes based on FR-a expression; however I could believe that the tolerability of the drug could result in both better PFS and OS. The 1L EOC space seems more tenuous though and I think they may pass on doing a PIII for now.


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Msg # Subject Author Recs Date Posted
53052 Re: Where Mirv could grow wolingfeng 4 12/3/2021 8:01:44 PM


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