Yaewon Yang (Cheongju, Korea, Republic of)

Chungbuk National University Hospital

Author Of 1 Presentation

 Conference Calendar
Poster Display session (ID 9)

176P - Poziotinib for HER2-positive metastatic breast cancer (MBC): Final clinical efficacy and safety results for long-term follow-up of the phase II NOV120101-203 trial (ID 184)

Presentation Number
176P
Lecture Time
12:15 - 12:15
Speakers
Authors
Session Name
Poster Display session (ID 9)
Room
Exhibition area
Date
Wed, 04.05.2022
Time
12:15 - 13:00

Abstract

Background

The phase II trial of the pan-HER inhibitor poziotinib (NCT02418689) demonstrated the clinical effectiveness of poziotinib 12 mg p.o. once daily (QD) in patients with HER2-positive metastatic breast cancer (mBC) in a heavily pretreated setting with median progression free survival (PFS) of 4 months from the primary analysis. Diarrhea and stomatitis were the major toxicities. We now report the results from the final planned analysis of overall survival (OS).

Methods

Eligible patients have received anticancer chemotherapy including taxane and ≥2 prior HER2-directed regimens including trastuzumab. PFS was the primary endpoint. Secondary endpoints included OS and objective response rate (ORR), and safety was evaluated. The database was locked on October 1, 2021 including data from the last patient who received poziotinib for 104 cycles (72.7 months) and transferred to the early access program. The final OS analysis was planned when ≥ 54 deaths occurred. The final OS analysis occurred after 68 deaths.

Results

From April 2015 to February 2016, 106 patients were enrolled at seven sites in Korea. At data cut off on 1 October 2021, the full analysis set included 102 patients. Median age was 51.0 (range 30–76) years. Median number of treatment regimens before poziotinib was 4 (2-16). At the data cut-off, median PFS (95% CI) was 4.0 (3.0–4.4) months. Median OS (95% CI) was 17.7 (95% CI 12.4–20.8) months (68/102 events; 66.7%). OS rate (95% CI) at 36 and 60 months was 18 (10-28)% and 14 (7-24)%, respectively. Most frequent all-grade adverse events (AEs) considered to be treatment related were: diarrhea (96.2%), stomatitis (92.5%), pruritus (63.2%), rash (63.2%), dry skin (38.7%), dermatitis acneiform (32.1%), and decreased appetite (26.4%). Grade ≥3 AEs and serious AEs occurred in 45.3% and 8.5% of patients, respectively.

Conclusions

Poziotinib showed clinically meaningful OS benefit for patients with HER2-positive mBC and the safety profile was as expected for tyrosine kinase inhibitors(TKIs). This encouraging result provide an important update on the clinical effectiveness and safety of poziotinib in HER2-positive mBC patients who were previously heavily treated.

Clinical trial identification

NCT02418689.

Legal entity responsible for the study

The authors.

Funding

Hanmi.

Disclosure

Y.H. Park: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Other, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Institutional, Other, Research Grant: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Other, Research Grant: Roche; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Institutional, Other, Research Grant: MSD; Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Non-Financial Interests, Principal Investigator: AstraZeneca; Non-Financial Interests, Principal Investigator: Pfizer; Non-Financial Interests, Principal Investigator: Novartis; Non-Financial Interests, Principal Investigator: MSD; Non-Financial Interests, Principal Investigator: Lilly; Non-Financial Interests, Principal Investigator: Roche; Non-Financial Interests, Principal Investigator: Daiichi Sankyo. J. Sohn: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Lilly; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Sanofi; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim. K.S. Lee: Financial Interests, Institutional, Research Grant: Ono. J.H. Kim: Financial Interests, Institutional, Research Grant: Ono. E. Baek: Financial Interests, Personal and Institutional, Other, Employee: Hanmi. H. Han: Financial Interests, Personal and Institutional, Other, Employee: Hanmi. S. Im: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Institutional, Principal Investigator: MSD; Financial Interests, Institutional, Principal Investigator: Novartis; Financial Interests, Institutional, Principal Investigator: Prizer; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Institutional, Research Grant: Hanmi; Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Institutional, Principal Investigator: Lilly; Financial Interests, Institutional, Principal Investigator: Novartis. All other authors have declared no conflicts of interest.

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