Biotech Values

[DewDiligence]

Addendum re the Boceprevir RESPOND-2 study in the second-line setting: In the prologue of #msg-52949888, I said:

…the Boceprevir RESPOND-2 study may have had an easier-to-treat patient pool than the Telaprevir PROVE-3 study in terms of the proportion of patients who were relapsers vs non-responders during prior treatment; VRTX disclosed the relapser-vs-non-responder breakdown from PROVE-3 in #msg-48759554, but MRK is refusing to disclose the breakdown from RESPOND-2 until the full dataset is presented at AASLD.

I was being too gentle on MRK by using the word may in the above passage. Based on the eligibility requirements for RESPOND-2, it’s clear that RESPOND-2 did in fact have an easier-to-treat patient pool than VRTX’s PROVE-3 study. From the clinicaltrials.gov entry for RESPOND-2:

http://clinicaltrials.gov/ct2/show/NCT00708500

Inclusion Criteria:

• Qualifying regimen defined as peginterferon alfa-2a plus ribavirin or peginterferon alfa-2b plus ribavirin for a minimum of 12 weeks.

• During qualifying regimen, subjects must have either a documented undetectable HCV-RNA within 30 days of end of treatment (EOT) and a subsequent detectable HCV-RNA during follow-up or a documented decline in HCV-RNA by >=2 log10 by Treatment Week 12

In other words, so-called null responders during first-line therapy were ineligible for enrollment in RESPOND-2.

MRK’s assertion that 25% of the patients in RESPOND-2 are considered null responders based on their lack of a 1-log viral-load decline during the 4-week SoC lead-in period in RESPOND-2 is therefore nothing but spin, IMO.