ASH Abstract - Adcetris single agent frontline in elderly patients - "compelling" results
A Phase 2 Study Of Single-Agent Brentuximab Vedotin For Front-Line Therapy Of Hodgkin Lymphoma In Patients Age 60 Years and Above: Interim Results
Of the 11 patients with a response assessment (see table), the ORR was 82% (n=9) and the complete remission (CR) rate was 64% (n=7). For the 10 patients who had interim PET scans after 2 cycles of therapy, the mean decrease in maximum standardized uptake value (SUVmax) between baseline and Cycle 2 was 83%. Cycle 2 PET scans were negative (Deauville Score 1-3) in 36% of patients, and the range of duration of response was 0.1+ to 20.6+ weeks thus far.
Treatment-related adverse events (AEs) occurring in ≥15% of patients included neutrophil count decreased, peripheral sensory neuropathy, pruritus, and rash (n=2 each); most events were Grade 1 or 2. Grade 3 treatment-related AEs included neutrophil count decreased, rash, and orthostatic hypotension (n=1 each). No Grade 4 or 5 events have been observed to date.
In this interim analysis of patients aged ≥60 years with newly diagnosed HL, compelling antitumor activity with single-agent brentuximab vedotin has been demonstrated. To date, a response rate of 82% has been shown in this historically challenging population of patients who either declined or were not eligible for standard chemotherapy. Preliminary safety data demonstrate tolerability in this patient population and the data are consistent with the current safety profile of brentuximab vedotin.
The frontline AVD+ Adcetris trial prelim results of 95% CR rate exced current standard treatment with NO PULMONARY TOXICITY assures frontline approval in my mind. The plus 60 group has no comparable current group. These are high risk patients whose options were nil. My comments should not be taken as negative in any way.
Frontline is a given imo. Frontline plus retreatment will generate 1bl+ revenue. Bcell and other cd30s could easily double that. Although my current target is just $31, I am a longterm bull with a $100 2015 target. I am a buyer on pull backs.
I agree completely. Frontline is a virtual lock. Additional revenue will come from other ADCs in the SGEN pipeline and from partnerships. As for the current pps fade, we've seen it before. This, too, shall pass.
While there is no comparable current group, this gives us the first window into how Adcetris might do in a frontline single-agent setting. Like in pretransplant, Adcetris does extremely well but not quite as good as current standard. I think it has assured approval in both settings. HL responses redially to treatment. What Adcetris has going for it is the lack of toxicity.
I'm not getting the inferiority statement. CR for Current standard therapy for newly diagnosed HL for all age groups is 77% and is higher for the younger cohorts than for the over 60 group. Adcetris is doing 64% but it is based on a too small sample to be accurate in addition to the fact that several over 60's would not be able to tolerate the side effects of current therapy and would have to skip it. As for the lung toxicity of Bleomicyn vs none for Adcetris that is huge.