Trial Outcomes & Findings for Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China (NCT NCT03575065)

Last Updated: 2024-10-26

Results Overview

ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

Results posted on

2024-10-26

Participant Flow

A total of 88 participants were recruited in China.

Participant milestones

Participant milestones
Measure	Triple-negative Breast Cancer (TNBC) Participants received 60 milligrams (mg) pamiparib twice daily (BID) orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	Hormone Receptor-positive(HR+) Human Epidermal Growth Factor receptor2 Negative(HER2-) Breast Cancer Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Overall Study STARTED	62	26
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	62	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Triple-negative Breast Cancer (TNBC) Participants received 60 milligrams (mg) pamiparib twice daily (BID) orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	Hormone Receptor-positive(HR+) Human Epidermal Growth Factor receptor2 Negative(HER2-) Breast Cancer Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Overall Study Death	31	12
Overall Study Sponsor's Decision	28	13
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TNBC n=62 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+)/HER2(-) Breast Cancer n=26 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	Total n=88 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 8.56 • n=5 Participants	46.4 years STANDARD_DEVIATION 10.75 • n=7 Participants	45.8 years STANDARD_DEVIATION 9.20 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	26 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Chinese	62 Participants n=5 Participants	26 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

Population: Efficacy Evaluable Analysis Set: includes all participants in the safety population who have measurable disease at baseline per RECIST v1.1 by IRC and have at least one evaluable post baseline tumor assessment by IRC unless discontinued treatment due to clinical progression or death prior to tumor assessment. Participants with available data were included in the analysis.

Outcome measures

Outcome measures
Measure	TNBC n=55 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=21 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)	38.2 Percentage of participants Interval 25.4 to 52.3	61.9 Percentage of participants Interval 38.4 to 81.9

SECONDARY outcome

Timeframe: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

Population: Efficacy Evaluable Analysis Set; Participants with available data were included in the analysis

ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Outcome measures

Outcome measures
Measure	TNBC n=55 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=21 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
ORR as Assessed by Investigator	36.4 Percentage of participants Interval 23.8 to 50.4	57.1 Percentage of participants Interval 34.0 to 78.2

SECONDARY outcome

Timeframe: From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months)

Population: Safety Analysis Set

PFS is defined as the time from first dose of pamiparib to the first documented disease progression or death due to any cause, assessed by IRC or the investigator

Outcome measures

Outcome measures
Measure	TNBC n=62 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=26 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Progression-free Survival (PFS) as Assessed by IRC and Investigator IRC	5.49 Months Interval 3.65 to 7.33	9.20 Months Interval 7.39 to 11.93
Progression-free Survival (PFS) as Assessed by IRC and Investigator Investigator	3.78 Months Interval 3.68 to 6.41	9.69 Months Interval 5.55 to 12.85

SECONDARY outcome

Timeframe: From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

Population: Efficacy Evaluable Analysis Set; Only the participants with confirmed objective responses by IRC were included in DOR analysis;

DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by IRC

Outcome measures

Outcome measures
Measure	TNBC n=21 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=13 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Duration of Response (DOR) as Assessed by IRC	6.97 Months Interval 3.94 to NA = NE Not estimable due to insufficient number of events	7.49 Months Interval 5.55 to 14.75

SECONDARY outcome

Timeframe: From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

Population: Efficacy Evaluable Analysis Set; Only the participants with confirmed objective responses by Investigator were included in DOR analysis.

DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by the investigator

Outcome measures

Outcome measures
Measure	TNBC n=20 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=12 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Duration of Response (DOR) as Assessed by the Investigator	6.28 Months Interval 4.63 to 11.76	11.57 Months Interval 5.95 to 13.9

SECONDARY outcome

Timeframe: Approximately 2 years and 10 months

Population: Efficacy Evaluable Analysis Set; Participants with available data were included in the analysis

BOR is defined as the percentage of participants with best overall response recorded from the start of the treatment until disease progression or recurrence, assessed by IRC or the investigator. BOR included complete response \[CR\], partial response \[PR\], stable disease \[SD\], disease progression and not evaluable \[NE\].

Outcome measures

Outcome measures
Measure	TNBC n=55 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=21 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator IRC - CR	5.5 Percentage of participants	4.8 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator IRC - PR	32.7 Percentage of participants	57.1 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator IRC - SD	34.5 Percentage of participants	28.6 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator IRC - PD	27.3 Percentage of participants	9.5 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator IRC - NE	0 Percentage of participants	0 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator Investigator - CR	3.6 Percentage of participants	0 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator Investigator - PR	32.7 Percentage of participants	57.1 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator Investigator - SD	36.4 Percentage of participants	23.8 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator Investigator - PD	27.3 Percentage of participants	19.0 Percentage of participants
Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator Investigator - NE	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months).

Population: Efficacy Evaluable Set; Participants with available data were included in the analysis

DCR is defined as the percentage of participants who achieved a confirmed BOR of CR, PR, or stable disease (SD), assessed by IRC or the investigator

Outcome measures

Outcome measures
Measure	TNBC n=55 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=21 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Disease Control Rate (DCR) as Assessed by IRC and Investigator IRC	72.7 Percentage of participants Interval 59.0 to 83.9	90.5 Percentage of participants Interval 69.6 to 98.8
Disease Control Rate (DCR) as Assessed by IRC and Investigator Investigator	72.7 Percentage of participants Interval 59.0 to 83.9	81.0 Percentage of participants Interval 58.1 to 94.6

SECONDARY outcome

Timeframe: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

Population: Efficacy Evaluable Set; Participants with available data were analyzed.

CBR is defined as percentage of participants with confirmed CR or confirmed PR or a durable SD (SD lasting ≥ 24 weeks), assessed by IRC or the investigator

Outcome measures

Outcome measures
Measure	TNBC n=55 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=21 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator IRC	43.6 Percentage of participants Interval 30.3 to 57.7	71.4 Percentage of participants Interval 47.8 to 88.7
Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator Investigator	41.8 Percentage of participants Interval 28.7 to 55.9	66.7 Percentage of participants Interval 43.0 to 85.4

SECONDARY outcome

Timeframe: From the first dose of pamiparib until death (approximately 2 years and 10 months)

Population: Safety Analysis Set

OS is defined as time from the first dose of pamiparib to the date of death due to any cause

Outcome measures

Outcome measures
Measure	TNBC n=62 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=26 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Overall Survival (OS)	17.08 Months Interval 15.57 to NA = NE Not estimable due to insufficient number of events	27.89 Months Interval 18.1 to NA = NE Not estimable due to insufficient number of events

SECONDARY outcome

Timeframe: Up to approximately 2 years and 10 months

Population: Safety Analysis Set

A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation. SAE is defined as any AE that leads to death or is life-threatening.

Outcome measures

Outcome measures
Measure	TNBC n=62 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+) /HER2(-) Breast Cancer n=26 Participants Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) With At Least 1 TEAE	61 participants	26 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) Grade 3 or higher	37 participants	18 participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) SAEs	12 participants	7 participants

Adverse Events

TNBC

Serious events: 12 serious events

Other events: 61 other events

Deaths: 31 deaths

HR(+)/HER2(-)

Serious events: 7 serious events

Other events: 26 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

BeiGene

Phone: +1 - 877-828-5568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	TNBC n=62 participants at risk Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor	HR(+)/HER2(-) n=26 participants at risk Participants received 60 mg pamiparib BID orally in 28-day cycles until disease progression, unacceptable toxicity, death, withdrawal of consent or study termination by sponsor
Blood and lymphatic system disorders Anaemia	11.3% 7/62 • Number of events 7 • Up to approximately 2 years and 10 months	11.5% 3/26 • Number of events 3 • Up to approximately 2 years and 10 months
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/62 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Blood and lymphatic system disorders Leukopenia	3.2% 2/62 • Number of events 2 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Blood and lymphatic system disorders Neutropenia	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Blood and lymphatic system disorders Thrombocytopenia	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Eye disorders Cataract	0.00% 0/62 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Gastrointestinal disorders Diarrhoea	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
General disorders Death	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Infections and infestations Upper respiratory tract infection	0.00% 0/62 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Investigations Alanine aminotransferase increased	0.00% 0/62 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Investigations Aspartate aminotransferase increased	0.00% 0/62 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Investigations Platelet count decreased	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.00% 0/62 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months
Nervous system disorders Altered state of consciousness	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Nervous system disorders Cerebral haemorrhage	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Renal and urinary disorders Acute kidney injury	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	0.00% 0/26 • Up to approximately 2 years and 10 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/62 • Number of events 1 • Up to approximately 2 years and 10 months	3.8% 1/26 • Number of events 1 • Up to approximately 2 years and 10 months