TY - JOUR
T1 - Pertuzumab Plus Trastuzumab in Patients With Lung Cancer With ERBB2 Mutation or Amplification: Results From the Targeted Agent and Profiling Utilization Registry Study
T2 - Results from the Targeted Agent and Profiling Utilization Registry Study
AU - Ganti, Apar K.
AU - Rothe, Michael
AU - Mangat, Pam K.
AU - Garrett-Mayer, Elizabeth
AU - Dib, Elie G.
AU - Duvivier, Herbert L.
AU - Ahn, Eugene R.
AU - Behl, Deepti
AU - Borghaei, Hossein
AU - Balmanoukian, Ani S.
AU - Gaba, Anu
AU - Li, Rui
AU - Osei-Boateng, Kwabena
AU - Thota, Ramya
AU - Grantham, Gina N.
AU - Gregory, Abigail
AU - Halabi, Susan
AU - Schilsky, Richard L.
N1 - Publisher Copyright:
© 2023 American Society of Clinical Oncology.
PY - 2023/6/14
Y1 - 2023/6/14
N2 - PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with lung cancer and
ERBB2 mutation or amplification treated with pertuzumab plus trastuzumab (P + T) are reported.
METHODS: Eligible patients had advanced lung cancer of any histology, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with
ERBB2 mutation or amplification. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) per RECIST v. 1.1 or stable disease (SD) of at least 16 weeks duration (SD16+). Secondary end points included safety, duration of response, duration of SD, progression-free survival, and overall survival.
RESULTS: Twenty-eight patients with lung cancer (27 non-small-cell, 1 small-cell) and
ERBB2 mutation (n = 15),
ERBB2 amplification (n = 12), or both (n = 1) were enrolled from November 2016 to July 2020. All patients were evaluable for efficacy and toxicity. Three patients with partial response (two
ERBB2 mutation; one both mutation and amplification) and seven patients with SD16+ (five
ERBB2 mutation; two amplification) were observed for a DC rate of 37% (95% CI, 21 to 50;
P = .005) and OR rate of 11% (95% CI, 2 to 28). Five patients had one or more grade 3 or 4 adverse or serious adverse events at least possibly related to P + T.
CONCLUSION: Combination P + T showed evidence of antitumor activity in heavily pretreated patients with non-small-cell lung cancer and
ERBB2 mutation or amplification, particularly those with
ERBB2 exon 20 insertion mutations.
AB - PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with lung cancer and
ERBB2 mutation or amplification treated with pertuzumab plus trastuzumab (P + T) are reported.
METHODS: Eligible patients had advanced lung cancer of any histology, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with
ERBB2 mutation or amplification. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) per RECIST v. 1.1 or stable disease (SD) of at least 16 weeks duration (SD16+). Secondary end points included safety, duration of response, duration of SD, progression-free survival, and overall survival.
RESULTS: Twenty-eight patients with lung cancer (27 non-small-cell, 1 small-cell) and
ERBB2 mutation (n = 15),
ERBB2 amplification (n = 12), or both (n = 1) were enrolled from November 2016 to July 2020. All patients were evaluable for efficacy and toxicity. Three patients with partial response (two
ERBB2 mutation; one both mutation and amplification) and seven patients with SD16+ (five
ERBB2 mutation; two amplification) were observed for a DC rate of 37% (95% CI, 21 to 50;
P = .005) and OR rate of 11% (95% CI, 2 to 28). Five patients had one or more grade 3 or 4 adverse or serious adverse events at least possibly related to P + T.
CONCLUSION: Combination P + T showed evidence of antitumor activity in heavily pretreated patients with non-small-cell lung cancer and
ERBB2 mutation or amplification, particularly those with
ERBB2 exon 20 insertion mutations.
KW - Antineoplastic Agents
KW - Carcinoma, Non-Small-Cell Lung/drug therapy
KW - Humans
KW - Lung Neoplasms/drug therapy
KW - Mutation
KW - Receptor, ErbB-2/genetics
KW - Trastuzumab/therapeutic use
UR - https://doi.org/10.1200/PO.23.00041
UR - http://www.scopus.com/inward/record.url?scp=85174078655&partnerID=8YFLogxK
U2 - 10.1200/PO.23.00041
DO - 10.1200/PO.23.00041
M3 - Article
C2 - 37315265
SN - 2473-4284
VL - 7
SP - e2300041
JO - JCO Precision Oncology
JF - JCO Precision Oncology
M1 - e2300041
ER -
