TriangleNCT02924376 · OUTCOME
ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 424 days
What was measured
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
Analysis population: Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
Groups in this outcome
Cohort A: FGFR2 Rearrangements or Fusions
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Cohort C: Negative for FGF/FGFR Alterations
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
Other
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort A: FGFR2 Rearrangements or Fusions | 0 |
| Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 20 |
| Cohort C: Negative for FGF/FGFR Alterations | 0 |
| Other | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions | 0.0 | Not reported | 0.0 | 16.84 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 16.84
- value
- 0.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. ORR was based on central genomics laboratory results. Response was based on review of scans by an independent centralized radiological review committee.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG000
- title
- Cohort A: FGFR2 Rearrangements or Fusions
- description
- Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG001
- title
- Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
- description
- Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG002
- title
- Cohort C: Negative for FGF/FGFR Alterations
- description
- Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
- id
- OG003
- title
- Other
- param Type
- NUMBER
- population Description
- Efficacy Evaluable Population. Two participants were assigned to a group labeled "Other" and were excluded from the EEP because the local laboratory FGF/FGFR results could not be confirmed centrally. Confidence intervals were calculated based on the exact method for binomial distribution.
- reporting Status
- POSTED
- time Frame
- up to 424 days
- title
- ORR in Participants FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice