TriangleNCT03974022 · OUTCOME
Part A: DoR and PFS by Investigator.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- month
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.
What was measured
To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. DoR was presented for patients with confirmed objective response (CR or PR). DoR was the time from date of first documentation of CR or PR, which was subsequently confirmed, to date of first documentation of objective progression or death. Patients who had no documentation of objective progression or death was censored. PFS was the time from first dose date of sunvozertinib to date of first documentation of progression or death due to any cause, whichever occurred first. Patient who had no PFS event was censored.
Analysis population: Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
Groups in this outcome
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 200 mg once daily continuously.
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 300 mg once daily continuously.
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 400 mg once daily continuously.
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
| Group | Source count |
|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 3 |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 6 |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | 3 |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 7 |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 5 |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 10 |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 13 |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 14 |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 5 |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 29 |
| Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg | 0 |
| Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted | 5 |
| Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal | 7 |
Reported measurements
Median duration of response(month)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | NA | Not reported | NA | NA | DoR cannot be calculated due to none achieved PR or CR. |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 4.0 | Not reported | NA | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | NA | Not reported | NA | NA | DoR cannot be calculated due to none achieved PR or CR. |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 5.5 | Not reported | 2.8 | 5.5 | Not reported |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | NA | Not reported | NA | NA | DoR cannot be calculated due to none achieved PR or CR. |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | NA | Not reported | 3.2 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 4.2 | Not reported | 3.2 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 6.3 | Not reported | 2.8 | 23.4 | Not reported |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 4.3 | Not reported | 3.0 | 5.6 | Not reported |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 9.8 | Not reported | 5.6 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted | 19.3 | Not reported | NA | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal | 5.6 | Not reported | NA | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
Median progression free survival(month)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg | 3.1 | Not reported | 3.1 | 9.6 | Not reported |
| Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg | 1.9 | Not reported | 0.9 | 22.5 | Not reported |
| Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg | 12.5 | Not reported | 1.7 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg | 3.3 | Not reported | 1.2 | 7.4 | Not reported |
| Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg | 4.6 | Not reported | 1.0 | 6.0 | Not reported |
| Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State | 4.9 | Not reported | 1.2 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State | 5.5 | Not reported | 4.0 | 12.7 | Not reported |
| Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal | 4.2 | Not reported | 2.4 | 9.0 | Not reported |
| Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal | 4.2 | Not reported | 1.4 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
| Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal | 10.8 | Not reported | 5.5 | 12.5 | Not reported |
| Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted | 3.3 | Not reported | 1.4 | 21.3 | Not reported |
| Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal | 5.3 | Not reported | 3.2 | NA | NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%). |
Complete source fields
- classes
- categories
- measurements
- comment
- DoR cannot be calculated due to none achieved PR or CR.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.0
- comment
- DoR cannot be calculated due to none achieved PR or CR.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG003
- lower Limit
- 2.8
- upper Limit
- 5.5
- value
- 5.5
- comment
- DoR cannot be calculated due to none achieved PR or CR.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG005
- lower Limit
- 3.2
- upper Limit
- NA
- value
- NA
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG006
- lower Limit
- 3.2
- upper Limit
- NA
- value
- 4.2
- group Id
- OG007
- lower Limit
- 2.8
- upper Limit
- 23.4
- value
- 6.3
- group Id
- OG008
- lower Limit
- 3.0
- upper Limit
- 5.6
- value
- 4.3
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG009
- lower Limit
- 5.6
- upper Limit
- NA
- value
- 9.8
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG011
- lower Limit
- NA
- upper Limit
- NA
- value
- 19.3
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG012
- lower Limit
- NA
- upper Limit
- NA
- value
- 5.6
- title
- Median duration of response(month)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.1
- upper Limit
- 9.6
- value
- 3.1
- group Id
- OG001
- lower Limit
- 0.9
- upper Limit
- 22.5
- value
- 1.9
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG002
- lower Limit
- 1.7
- upper Limit
- NA
- value
- 12.5
- group Id
- OG003
- lower Limit
- 1.2
- upper Limit
- 7.4
- value
- 3.3
- group Id
- OG004
- lower Limit
- 1.0
- upper Limit
- 6.0
- value
- 4.6
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG005
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 4.9
- group Id
- OG006
- lower Limit
- 4.0
- upper Limit
- 12.7
- value
- 5.5
- group Id
- OG007
- lower Limit
- 2.4
- upper Limit
- 9.0
- value
- 4.2
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG008
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 4.2
- group Id
- OG009
- lower Limit
- 5.5
- upper Limit
- 12.5
- value
- 10.8
- group Id
- OG011
- lower Limit
- 1.4
- upper Limit
- 21.3
- value
- 3.3
- comment
- NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
- group Id
- OG012
- lower Limit
- 3.2
- upper Limit
- NA
- value
- 5.3
- title
- Median progression free survival(month)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 10
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 14
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 29
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 5
- units
- Participants
- description
- To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. DoR was presented for patients with confirmed objective response (CR or PR). DoR was the time from date of first documentation of CR or PR, which was subsequently confirmed, to date of first documentation of objective progression or death. Patients who had no documentation of objective progression or death was censored. PFS was the time from first dose date of sunvozertinib to date of first documentation of progression or death due to any cause, whichever occurred first. Patient who had no PFS event was censored.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
- id
- OG000
- title
- Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 100 mg once daily continuously.
- id
- OG001
- title
- Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 200 mg once daily continuously.
- id
- OG002
- title
- Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 300 mg once daily continuously.
- id
- OG003
- title
- Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
- description
- Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy. Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 400 mg once daily continuously.
- id
- OG004
- title
- Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
- description
- Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
- id
- OG005
- title
- Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
- description
- Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
- id
- OG006
- title
- Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
- id
- OG007
- title
- Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
- id
- OG008
- title
- Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
- id
- OG009
- title
- Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
- description
- Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment. No patient was enrolled into this cohort.
- id
- OG010
- title
- Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
- description
- Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy. Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
- id
- OG011
- title
- Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
- param Type
- MEDIAN
- population Description
- Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
- reporting Status
- POSTED
- time Frame
- The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.
- title
- Part A: DoR and PFS by Investigator.
- type
- SECONDARY
- unit Of Measure
- month
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