Adding camrelizumab to chemotherapy improves outcomes in triple-negative breast cancer
Key takeaways:
- The addition of camrelizumab to platinum-containing intensive chemotherapy improved response for certain patients with triple-negative breast cancer.
- EFS, DFS and distant DFS data remained immature, but trends favored the camrelizumab regimen.
SAN ANTONIO — The addition of camrelizumab to platinum-containing intensive neoadjuvant chemotherapy improved pathologic complete response for certain patients with triple-negative breast cancer.
Camrelizumab (SHR-1210, Jiangsu Hengrui Medicine Co.) also exhibited a manageable safety profile, according to investigators.
“This phrase 3 trial demonstrates the added benefit of camrelizumab when combined with an intensive chemotherapy regimen,” Zhi-Ming Shao, MD, of Fudan University Cancer Institute in China, said during a presentation at San Antonio Breast Cancer Symposium. “Pathologic complete response benefits were generally consistent across subgroups, including higher-risk categories.
Background and methods
Approximately 15% of patients with breast cancer have triple-negative breast disease, a highly aggressive subtype associated high risk for recurrence and poor survival outcomes.
The long-standing preferred neoadjuvant treatment for this population includes a four-drug chemotherapy regimen consisting of anthracyclines, cyclophosphamide, taxanes and platinum.
Camrelizumab is an anti-PD-1 antibody that previously demonstrated antitumor activity among patients with advanced or metastatic triple-negative breast cancer.
Researchers conducted the randomized phase 3 CamRelief study to evaluate the addition of camrelizumab or placebo to neoadjuvant chemotherapy for patients with early or locally advanced triple-negative breast cancer.
The study included 441 patients with previously untreated, invasive stage II or III disease. A majority (70.5%) had lymph node involvement.
All patients received 100 mg/m2 nab-paclitaxel and area under curve 1.5 carboplatin on days 1, 8 and 15 every 4 weeks for 16 weeks, followed by four cycles of dose-dense 90 mg/m2 epirubicin and 500 mg/m2 cyclophosphamide every 2 weeks for 8 weeks.
Patients assigned 222 patients (median age, 49 years) to receive 200 mg camrelizumab once every 2 weeks. The other 219 patients (median age, 48 years) received placebo.
After surgery, patients assigned camrelizumab cohort continued to receive the agent for up to 1 year from date of the first dose.
Pathologic complete response (pCR) served as the primary endpoint.
Secondary endpoints included EFS, DFS, distant DFS and pre-surgery objective response rate.
Results
After median follow-up of 14.4 months, a higher percentage of patients assigned camrelizumab achieved pCR (56.8% vs. 44.7%; difference = 12.2%; 95% CI, 3.3-21.2).
The benefit persisted regardless of PD-L1 expression, nodal status or disease stage at baseline.
Researchers also observed the pCR benefit with camrelizumab among patients with poor prognostic factors, including those with node-positive disease (57.8% vs. 42.7%; difference = 15.1%; 95% CI, 4.1-26.1) or stage III disease (49.4% vs. 38%; difference = 11.4%; 95% CI, 4 to 26.8).
A higher percentage of patients assigned camrelizumab achieved response prior to surgery (87.4% vs. 82.6%).
Data for other outcomes remained immature; however, researchers reported trends toward improvement with camrelizumab for EFS (HR = 0.8; 95% CI, 0.46-1.42), DFS (HR = 0.58; 95% CI, 0.27 to 1.24) and distant DFS (HR = 0.62; 95% CI, 0.29-1.33).
More patients assigned camrelizumab experienced grade 3 or higher treatment-related adverse events (89.2% vs. 83.1%) and serious adverse events (34.7% vs. 22.8%). Two patients (0.9%) assigned camrelizumab experienced fatal adverse events.
“Our data support camrelizumab plus chemotherapy as a potential new neoadjuvant therapeutic option for treating early or locally advanced triple-negative breast cancer,” Shao said.
References:
- Chen L, et al. JAMA. 2024;doi:10.1001/jama.2024.23560.
- Shao ZM, et al. Abstract GS3-06. Presented at: San Antonio Breast Cancer Symposium; Dec. 10-13, 2024; San Antonio.
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Shao ZM, et al. Abstract GS3-06. Presented at: San Antonio Breast Cancer Symposium; Dec. 10-13, 2024; San Antonio.