Agree with this, if there are no serious adverse effects, it does no harm to allow its use for the subset of patients. RFA, TDox and 45 minutes.
could you update us the failed Phase III data ~ 1 years ago. Namely: Hazard Ratio, P-value and OS if they had published.
thanks for the info. Wish FDA can be wise enough to allow NDA based on the subgroup data, give patients one more treatment option. Otherwise, they need wait for another 5 years for the OPTIMA trial data.
Statistically Significant is the common lingo in these releases. It's like saying M&M's are made with Milk Chocolate. Positive news. I'll take it for now. But a loooooong way to go before I (and many more here longer than me) see gains or have confidence.
Not an expert,, but a little history..
The last phase of the HEAT TRIAL used an SPA -- special protocol assessment -- which would allow for an
approval using a progression formula,, which was not met.. The SPA was negotiated with the FDA after the agency suggested CLSN skip phase 2 and go to a phase 3 SPA.. To the best of my knowledge OS has always been the primary end point.. Even if the SPA had been a success,, OS end point still had to be met..
For a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in OS, a Hazard Ratio of 0.639 (95% CI 0.419 – 0.974), and a p-value of 0.037. --- "Median overall survival for this subgroup has not yet been reached..
When Median overall survival is reached, possibility exists for an NDA for this subgroup.. JMO..
Should be an interesting upcoming CC in 2 weeks...
Found the answer in OPTIMA trial info. The new OPTIMA trial actually specified OS as the primary and PFS as secondary (The HEAT study did the opposite).
can any expert share some insight? I remember OS was secondary end point in the original HEAT trial? The sub-group OS number looks very impressive now.