Results for Jaypirca from 2 clinical trials in CLL/SLL
Not an actual patient.
Understanding how Jaypirca was studied in CLL
Jaypirca was studied in 2 different clinical trials in people with CLL/SLL. In the more recent trial, Jaypirca was compared with 2 other possible treatments. The primary measure of this trial was how long people lived without their disease getting worse (progression-free survival). In the earlier trial, Jaypirca was studied alone. The primary measure of that trial was the percentage of people who responded to treatment with Jaypirca. (A response means their cancer shrank and stopped spreading.) This study also measured how long those responses lasted.
Clinical trial of Jaypirca against 2 other treatments
In the primary analysis, Jaypirca delayed CLL progression longer
The trial measured progression-free survival (how long patients lived without their CLL getting worse) in 119 people who were assigned to take Jaypirca and 119 people who were assigned to take another treatment.
People in this group were assigned to take 1 of 2 treatment combinations. One was idelalisib plus rituximab, and the other was bendamustine plus rituximab. Either combination may be used to treat CLL.
Image showing that people who were assigned to take Jaypirca lived for a median of 11.2 months without their CLL getting worse compared with a median of 8.7 months for people who were assigned to take another treatment. (People in this group were assigned to take 1 of 2 treatment combinations. One was idelalisib plus rituximab, and the other was bendamustine plus rituximab. Either combination may be used to treat CLL.) Median is the middle number in a range of numbers.
People in this group were assigned to take 1 of 2 treatment combinations. One was idelalisib plus rituximab, and the other was bendamustine plus rituximab. Either combination may be used to treat CLL.
The data collected in the updated analysis of progression-free survival are from an unplanned look at the data that used less rigorous testing. This means the findings are less certain and may be due to chance.
Image showing that people who were assigned to take Jaypirca lived for a median of 14 months without their CLL getting worse compared with a median of 8.7 months for people who were assigned to take another treatment. (People in this group were assigned to take 1 of 2 treatment combinations. One was idelalisib plus rituximab, and the other was bendamustine plus rituximab. Either combination may be used to treat CLL.) Median is the middle number in a range of numbers. The data collected in the updated analysis of progression-free survival are from an unplanned look at the data that used less rigorous testing. This means the findings are less certain and may be due to chance.
aMedian is the middle number in a range of numbers.
Jaypirca was studied in 238 adults with relapsed or refractory* CLL
- All people in the study had already received a Bruton’s tyrosine kinase (BTK) inhibitor
- The trial measured how long people lived without their CLL getting worse (progression-free survival)
- The people in the trial were randomly assigned to receive either Jaypirca (119 people) or 1 of 2 other CLL treatment combinations (119 people)†
- People who were assigned to receive Jaypirca took it until their CLL got worse or they were no longer able to tolerate treatment
*Refractory is when your cancer doesn't respond to treatment.
†These combinations were idelalisib plus rituximab or bendamustine plus rituximab.
SELECT SAFETY INFORMATION
Warnings - Jaypirca may cause serious side effects, including:
Bleeding problems (hemorrhage). Bleeding problems can happen during treatment with Jaypirca. They can be serious and may lead to death. Your risk of severe bleeding may increase if you are also taking a blood thinner medicine. Tell your doctor if you have any signs or symptoms of bleeding, including:
- blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or you cannot control
- vomit blood or vomit blood that looks like coffee grinds
- cough up blood or blood clots
- increased bruising
- dizziness
- weakness
- confusion
- changes in your speech
- headache that lasts a long time
Clinical trial of Jaypirca studied alone
In a clinical trial that measured the number of people who responded to treatment and how long the response lasted:
72%
of adults with CLL (78 out of 108) saw their cancer shrink and stop spreading while taking Jaypirca
For those who saw their CLL shrink and stop spreading, their response lasted a median‡ of 12.2 months.
‡Median is the middle number in a range of numbers.
Jaypirca was studied in a clinical trial that included adults with CLL who had received at least two treatments, including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor.
Jaypirca was studied in 108 adults with previously treated CLL
All people in the study were treated with a prior BTK inhibitor and a BCL-2 inhibitor
Trial evaluated response to treatment and how long the response lasted (a response means their cancer shrank and stopped spreading)
Trial participants took Jaypirca once daily until their disease got worse or they were no longer able to tolerate treatment
Taking Jaypirca and possible side effects