Abstract 170P
Background
Triple-negative breast cancer (TNBC) is considered to be more aggressive and to have poorer prognosis. Immune checkpoint inhibitors have shown promising antitumor activity in neoadjuvant and metastatic settings. This study aimed to evaluate the efficacy and safety of camrelizumab (anti-PD-1 antibody) plus chemotherapy as neoadjuvant therapy in patients with early TNBC.
Methods
In this prospective, single-arm, phase II study, eligible patients were 18-70 years and had previously untreated stage II-III TNBC. Patients received neoadjuvant therapy with four 4-week cycles of camrelizumab (200 mg, d1, 15, q2w) plus nab-paclitaxel (125 mg/m2, d1, 8, 15, qw 3/4), and four 2-week cycles of camrelizumab (200 mg, d1, q2w) plus epirubicin (90 mg/m2, d1, q2w) + cyclophosphamide (600 mg/m2, d1, q2w). The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0) rate. Secondary endpoints included breast pathological complete response (bpCR, ypT0/is) rate, objective response rate (ORR), event-free survival (EFS), and safety.
Results
From Jun 2020 to Aug 2021, 23 patients were enrolled. Among 20 patients with evaluable efficacy, 16 (80%) were node-positive. The tpCR rate was 65% (13/20), and bpCR rate was 70% (14/20). The ORR was 95% (19/20) at the end of neoadjuvant treatment. Among 23 patients, grade ≥3 treatment-related adverse events were observed in 14 (60.9%) patients, with the most common being neutropenia (13 [56.5%]), leucopenia (11 [47.8%]), alanine aminotransferase increased (3 [13.0%]), aspartate aminotransferase increased (3 [13.0%]), lymphocyte count decreased (3 [13.0%]), and anaemia (2 [8.7%]). Adverse events that led to discontinuation of any agent occurred in 2 (8.7%) patients. Four (17.4%) patients had treatment-related serious adverse events.
Conclusions
In patients with early TNBC, neoadjuvant therapy with camrelizumab plus nab-paclitaxel and anthracycline-based chemotherapy showed high pCR rate with an acceptable safety profile. Further study is warranted to validate our findings.
Clinical trial identification
NCT04676997.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.