Median duration of response
was not reached at the time of the analysis, with probability of no progression or death above 80% at the 20-month mark, according to Dr.
These indications are approved under accelerated approval based on tumor response rate and duration of response
. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
The ALTA trial showed that brigatinib (ALUNBRIG) was highly effective post-crizotinib with the majority of patients who received 180 mg once daily with a seven-day lead in at 90 mg once daily achieving an overall response and a median duration of response
greater than one year.
Out of 394 patients in the trial, 188 were responders to medication and 154 we re-evaluated after one, two and three years (following initial treatment) for the duration of response
to medication and the possible occurrence of relapse.
The duration of response
for 2 of the patients was 9 and 12 months; 3 patients are continuing to respond at an earlier stage.
Among these long-term responders, the median duration of response
was 28.1 months.
Longer follow-up is needed to assess the duration of response
. As part of an accelerated approval program, Novartis is required to conduct further studies to determine whether the treatment results in improved survival and other clinical benefits.
Others experience a reduction in relief from spasm and a shorter duration of response
This is a remarkable magnitude and duration of response
for a heavily pretreated population.
Primary efficacy endpoints consist of complete response rate and duration of response
for patients in Cohort 1.
The primary efficacy endpoint will be progression-free survival, and secondary efficacy endpoints will include overall survival, disease control rate, overall response rate and duration of response
. The confirmatory study will involve a safety run-in that is likely to start in the second half of 2019.
Secondary endpoints include safety, duration of response
, and progression-free survival.