Trial Outcomes & Findings for Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery (NCT NCT02658812)

Last Updated: 2023-01-25

Results Overview

Overall Response Rate defined as the rate of patients who achieved a partial response or complete response as the best response for the measurable and nonmeasurable disease. Evaluated using RECIST ver.1.1. Complete Response (CR): Disappearance of all target and non-target lesions at a minimum of 4 weeks. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of the target lesions at a minimum of 4 weeks, taking as a reference the baseline sum of the longest diameter with target.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

at the end of cycle 4 , cycle 8, and cycle 10, up to 5 months

Results posted on

2023-01-25

Participant Flow

11 participants registered, 1 participant registered twice and 1 participant withdrew consent before initiating treatment to pursue alternate treatment.

Participant milestones

Participant milestones
Measure	Treatment (Talimogene Laherparepvec) Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Overall Study STARTED	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Talimogene Laherparepvec) Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Overall Study Disease Progression	7
Overall Study Unrelated to study treatment	1
Overall Study Adverse Event	1

Baseline Characteristics

Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Talimogene Laherparepvec) n=9 Participants Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Age, Continuous	49 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	9 participants n=93 Participants
Herpes Simplex Virus Type 1- HSV-1 Serology Positive	6 Participants n=93 Participants
Herpes Simplex Virus Type 1- HSV-1 Serology Negative	3 Participants n=93 Participants
Type of breast cancer Inflammatory Breast Cancer	0 Participants n=93 Participants
Type of breast cancer Non-Inflammatory Breast Cancer	9 Participants n=93 Participants
Estrogen Receptor Status Positive	2 Participants n=93 Participants
Estrogen Receptor Status Negative	7 Participants n=93 Participants
Progesterone Receptor Status Positive	2 Participants n=93 Participants
Progesterone Receptor Status Negative	7 Participants n=93 Participants
HER2 Status Positive	1 Participants n=93 Participants
HER2 Status Negative	8 Participants n=93 Participants
Distant Metastases No	6 Participants n=93 Participants
Distant Metastases Yes	3 Participants n=93 Participants

PRIMARY outcome

Timeframe: at the end of cycle 4 , cycle 8, and cycle 10, up to 5 months

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=9 Participants Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Number of Participants With Overall Response Rate (ORR) Complete Response	0 Participants
Number of Participants With Overall Response Rate (ORR) Partial Response	0 Participants

SECONDARY outcome

Timeframe: Time from treatment initiation until disease progression, uncontrolled disease progression or death. Maximum PFS follow-up for this study cohort was 3.9 months.

Progressive disease is measured based on Response Evaluation Criteria (RECIST v1.1) beyond 10 cycles. Uncontrolled disease progression is defined as rapid growth of multiple measurable or non-measurable new lesions or sum of the longest diameter of existing targeted lesions is \>40% from the baseline.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=9 Participants Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Median Progression-Free Survival	77 days Interval 63.0 to the upper bound of the Kaplan-Meier curve has not reached 50% yet therefore the upper bound of the median survival time cannot be estimated.

SECONDARY outcome

Timeframe: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first

Overall survival is defined as the time from treatment initiation until death. Estimated using the Kaplan-Meier method with 95% confidence intervals (CIs).

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=9 Participants Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Median Overall Survival	361 days Interval 240.0 to the upper bound of the Kaplan-Meier curve has not reached 50%yet therefore the upper bound of the median survival time cannot be estimated.

SECONDARY outcome

Timeframe: before each cycle and 30 days after the last dose of trial treatment or before the initiation of a new anti-cancer treatment, whichever comes first

The number of Grade 2 or higher adverse events possibly, probably, or definitely related to T-VEC. Evaluated according to Common Terminology Criteria for Adverse Events version 4.0.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=9 Participants Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
Number of Adverse Events Grade 3	4 adverse events
Number of Adverse Events Grade 2	29 adverse events

Adverse Events

Treatment (Talimogene Laherparepvec)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Talimogene Laherparepvec) n=9 participants at risk Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
General disorders Injection Site Infections	22.2% 2/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
General disorders Fever	11.1% 1/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.

Other adverse events

Other adverse events
Measure	Treatment (Talimogene Laherparepvec) n=9 participants at risk Patients receive talimogene laherparepvec IT on day 1. Cycles repeat every 3 weeks in cycle 1 and every 2 weeks a total of at least 10 cycles, thereafter in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Talimogene Laherparepvec: Given IT
General disorders Fatigue	44.4% 4/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
General disorders Fever	22.2% 2/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
General disorders Injection site reaction	77.8% 7/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
General disorders Tumor/injection site pain	55.6% 5/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Gastrointestinal disorders Constipation	11.1% 1/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Gastrointestinal disorders Nausea	22.2% 2/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Gastrointestinal disorders Vomiting	22.2% 2/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Gastrointestinal disorders Tumor/injection site infection	33.3% 3/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Gastrointestinal disorders Myalgia	11.1% 1/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Skin and subcutaneous tissue disorders Pruritus	11.1% 1/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Vascular disorders Lymphedema	33.3% 3/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Investigations Neutrophil count decreased	11.1% 1/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	11.1% 1/9 • From the date of treatment initiation until 30 days after the last dose of drug; All-Cause Mortality: From the date of treatment initiation until 1 year after removal from the study or until death, whichever occurs first. Grade 2 or higher non-hematologic AEs and grade 3 or higher hematologic AEs will be recorded upon observation by the investigator or reported by the patient (regardless of whether they are attributed to investigational product), documented in the patient's medical record, and recorded in CORe. Grade 2 or higher abnormal lab values will be recorded as AEs; and grade 1 abnormal laboratory values will not be recorded as AEs.

Additional Information

Dr. Naoto T. Ueno, MD-Professor Breast Medical Oncology

UT MD Anderson Cancer Center

Phone: 713-792-8754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place