Biotech Values

[DewDiligence]

Re: Tecentriq in bladder cancer

Why 2nd to chemo?

Not sure exactly what you're asking. The trial that supported today's FDA accelerated approval was a single-arm phase-2 in first-line bladder cancer (https://www.clinicaltrials.gov/ct2/show/NCT02951767 ), while the trial that supported Tecentriq's FDA accelerated approval in May 2016 (#msg-122739924) was a single-arm phase-2 in second/third-line bladder-cancer patients who had progressed on chemo (https://www.clinicaltrials.gov/ct2/show/NCT02108652 ). In both of these trials, the primary endpoint was response rate (as you would expect for a single-arm cancer trial). In the second/third-line trial, the accelerated approval will have to be confirmed by a randomized phase-3 comparing Tecentriq monotherapy to chemo (employing a different chemo combination than the one(s) previously used) with an OS primary endpoint; this trial is expected to report in late 2017 (https://www.clinicaltrials.gov/ct2/show/NCT02302807 ).

Perhaps your question is why Tecentriq is not yet approved for bladder cancer in combination with chemo. A large 3-arm trial is in progress testing Tecentriq + chemo vs Tecentriq monotherapy vs chemo only in first-line bladder cancer with a PFS primary endpoint; this trial is expected to report in late 2018 (https://www.clinicaltrials.gov/ct2/show/NCT02807636 ).

For regimens containing Tecentriq + chemo, safety/tolerability is a major concern. Other trials are underway testing various doses and dosing schedules to minimize toxicity (https://www.clinicaltrials.gov/ct2/show/NCT02989584, https://www.clinicaltrials.gov/ct2/show/NCT03093922 ).