TriangleNCT03797326 · OUTCOME
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 66 months
What was measured
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.
Analysis population: All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
Groups in this outcome
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
| Group | Source count |
|---|---|
| Cohort C: Gastric Cancer (Lenva + Pembro) | 15 |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 15 |
| Cohort D2: Colorectal Cancer (Lenva) | 2 |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 22 |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 18 |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort C: Gastric Cancer (Lenva + Pembro) | 8.3 | Not reported | 4.2 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Cohort D1: Colorectal Cancer (Lenva + Pembro) | 8.3 | Not reported | 4.2 | 18.5 | Not reported |
| Cohort D2: Colorectal Cancer (Lenva) | NA | Not reported | NA | NA | NA = Median, Lower and Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
| Cohort E: Glioblastoma Multiforma (Lenva + Pembro) | 4.6 | Not reported | 3.2 | 15.6 | Not reported |
| Cohort F: Biliary Tract Cancer (Lenva + Pembro) | 6.2 | Not reported | 4.2 | 7.1 | Not reported |
| Cohort G: Pancreatic Cancer (Lenva + Pembro) | 5.8 | Not reported | 2.7 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- NA
- value
- 8.3
- group Id
- OG001
- lower Limit
- 4.2
- upper Limit
- 18.5
- value
- 8.3
- comment
- NA = Median, Lower and Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 3.2
- upper Limit
- 15.6
- value
- 4.6
- group Id
- OG004
- lower Limit
- 4.2
- upper Limit
- 7.1
- value
- 6.2
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG005
- lower Limit
- 2.7
- upper Limit
- NA
- value
- 5.8
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 8
- units
- Participants
- description
- For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG000
- title
- Cohort C: Gastric Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG001
- title
- Cohort D1: Colorectal Cancer (Lenva + Pembro)
- description
- Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG002
- title
- Cohort D2: Colorectal Cancer (Lenva)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG003
- title
- Cohort E: Glioblastoma Multiforma (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG004
- title
- Cohort F: Biliary Tract Cancer (Lenva + Pembro)
- description
- Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
- id
- OG005
- title
- Cohort G: Pancreatic Cancer (Lenva + Pembro)
- param Type
- MEDIAN
- population Description
- All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
- reporting Status
- POSTED
- time Frame
- Up to approximately 66 months
- title
- Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice