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iwfal

04/20/12 2:53 PM

#140552 RE: oc631 #140547

At a meta level suggest that you actually research before dis(miss)ing

Why did BMY withdraw the late-stage, head-to-head study between Peg-lambda and Peg-Alfa?



A- They were unable to enroll patients. Nobody wants to use that shit.


Last lambda trial enrolled WAY faster than expected

Lambda arguably has lower SAE than some DAAs


B- The cost of running the late-stage study couldn't be justified since BMY realises the market is going oral.

It might - but then why are they funding clinicaltrials.gov/ct2/show/NCT01309932


C- BMY was worried Lambda would show inferior efficacy and/or safety in the head-to-head late-stage trial.

Not likely - the ph iia interim was pretty unequivocal as showing meaningfully better efficacy and meaningfully lesser SAE than ifn-a.

Again, the point isn't that Lambda is a lock. Only that there is expected value owed to having a potentially sizable niche all to itself - vs the dog-eat-dog world of DAAs and the potential surprises of a DAA-only regimen.




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iwfal

08/01/12 9:32 PM

#146431 RE: oc631 #140547

Why did BMY withdraw the late-stage, head-to-head study between Peg-lambda and Peg-Alfa?



A- They were unable to enroll patients. Nobody wants to use that shit.

B- The cost of running the late-stage study couldn't be justified since BMY realises the market is going oral.

C- BMY was worried Lambda would show inferior efficacy and/or safety in the head-to-head late-stage trial.

D- All the above.



To add to my earlier reply - because they wanted to add two different ph iii trials going in a little bit different direction:

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3


Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir