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Clinical Trial
. 2023 May:184:1-9.
doi: 10.1016/j.ejca.2023.01.001. Epub 2023 Jan 9.

Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041)

Peter A Fasching  1 , Alexander Hein  2 , Hans-Christian Kolberg  3 , Lothar Häberle  4 , Sabrina Uhrig  2 , Matthias Rübner  2 , Erik Belleville  5 , Carolin C Hack  2 , Tanja N Fehm  6 , Wolfang Janni  7 , Arndt Hartmann  8 , Ramona Erber  8 , Anna-Katharin Theuser  9 , Sara Y Brucker  10 , Andreas D Hartkopf  7 , Michael Untch  11
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Free article
Clinical Trial

Pembrolizumab in combination with nab-paclitaxel for the treatment of patients with early-stage triple-negative breast cancer - A single-arm phase II trial (NeoImmunoboost, AGO-B-041)

Peter A Fasching et al. Eur J Cancer. 2023 May.
Free article

Abstract

Background: Pembrolizumab is approved for the neoadjuvant/adjuvant treatment of early triple-negative breast cancer (TNBC) patients in combination with chemotherapy. The Keynote-522 trial used platinum chemotherapy. As neoadjuvant nab-paclitaxel (nP) is also highly effective in triple-negative breast cancer patients, this study investigates the response to nP-containing neoadjuvant chemotherapy in combination with pembrolizumab.

Patients and methods: NeoImmunoboost (AGO-B-041/NCT03289819) is a multicenter, prospective single-arm phase II trial. Patients were treated with 12 weekly cycles of nP followed by four three-weekly cycles of epirubicin/cyclophosphamide. Pembrolizumab was given three-weekly in combination with these chemotherapies. The study was planned for 50 patients. After 25 patients, the study was amended to include a pre-chemotherapy single application of pembrolizumab. The primary aim was pathological complete response (pCR), and the secondary aims were safety and quality of life.

Results: Of 50 included patients, 33 (66.0%; 95%confidence interval: 51.2%-78.8%) had a (ypT0/is ypN0) pCR. The pCR rate in the per-protocol population (n = 39) was 71.8% (95%confidence interval: 55.1%-85.0%). The most common adverse events of any grade were fatigue (58.5%), peripheral sensory neuropathy (54.7%) and neutropenia (52.8%). The pCR rate in the cohort of 27 patients with a pre-chemotherapy pembrolizumab dose was 59.3%, and 73.9% in the 23 patients without pre-chemotherapy dose.

Conclusions: pCR rates after NACT with nP and anthracycline combined with pembrolizumab are encouraging. With acceptable side-effect profiles, this treatment might be a reasonable alternative to platinum-containing chemotherapy in cases of contraindications. However, without data from randomised trials and long-term follow up, platinum/anthracycline/taxane-based chemotherapy remains the standard combination chemotherapy for pembrolizumab.

Keywords: Neoadjuvant chemotherapy; PD-L1; Pembrolizumab; Triple-negative.

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