Editor’s Note: The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting was held in Chicago from May 30 to June 3. At the conference, Professor Ting Li of Fudan University Shanghai Cancer Center delivered a Rapid Oral Abstract presentation on behalf of her team, showcasing a phase II clinical study (Abstract #1018) titled "A phase II clinical study of adebrelimab and bevacizumab combined with cisplatin/carboplatin in triple-negative breast cancer patients with brain metastases." Following her presentation, Oncology Frontier conducted an exclusive interview with Professor Li, where she shared insights into the rationale behind the study design, the benefits of the triplet therapy, and the specific patient groups most likely to benefit.Study Overview
Abstract #1018 – A Phase II Clinical Study of Adebrelimab and Bevacizumab Combined with Cisplatin/Carboplatin in Triple-Negative Breast Cancer Patients with Brain Metastases
Background Brain metastases (BMs) of triple-negative breast cancer (TNBC) is a lethal disease often associated with a limited life span of approximately 6 months and local therapy is usually the first treatment choice due to lack of effective anti-tumor agents. Here reported a triplet, anti-PD-L1 (Adebrelimab, SHR-1316), bevacizumab plus cisplatin/ carboplatin in BMs of triple negative breast cancer.
Methods This is a single center, single-arm, phase II clinical trial involving triple-negative breast cancer patients with active brain metastases. A total of 35 participants were administered a triplet treatment consisting of Adebrelimab, bevacizumab and cisplatin/carboplatin. Prior use of bevacizumab or anti-PD-1/PD-L1 was not allowed. Prior use of platinum was allowed only in cases with platinum-sensitive disease. The primary endpoint was the objective response rate in the central nervous system (CNS-ORR), and the secondary endpoints included the clinical benefit rate in CNS (CNS-CBR), progression-free survival (PFS), overall survival (OS), the first progression site and safety.
Study Results
As of the data cutoff on April 10, 2025, a total of 35 eligible patients were enrolled between August 2020 and October 2024. At baseline, 42.9% (15 out of 35) presented with neurological symptoms, and 80% (28 out of 35) had not received any prior local therapy for brain metastases. The median number of prior lines of therapy for metastatic disease was 2 (range: 0–4), and 40% (14 patients) had previously received platinum-based chemotherapy.
In the intention-to-treat (ITT) population—defined as patients who received at least one cycle of study treatment—the central nervous system objective response rate (CNS-ORR) was 77.1% (27 of 35 patients), including 5 complete responses (CR) and 22 partial responses (PR). The confirmed CNS-ORR was 71.4% (25 of 35). Among the 23 patients who experienced disease progression, 69.6% (16 of 23) had brain as the first site of progression.
At the time of data analysis, the median follow-up duration was 17.5 months (95% CI: 8.5–26.5). The median progression-free survival (PFS) was 8.3 months (95% CI: 5.8–11.5), while the median CNS progression-free survival (CNS-PFS) was 11.5 months (95% CI: 6.2–not reached). Median overall survival (OS) data were not yet mature.
All patients (100%) reported at least one treatment-related adverse event (TRAE). Grade ≥3 TRAEs occurred in 57.1% (20 of 35), with the most common being neutropenia (8.6%), thrombocytopenia (11.4%), and peripheral sensory neuropathy (8.6%).
Treatment discontinuation or interruption due to adebrelimab occurred in 11.4% of patients (4 of 35). Bevacizumab-related discontinuation occurred in 8.6% (3 of 35), and platinum-based chemotherapy (cisplatin or carboplatin) required dose reduction, interruption, or discontinuation in 60% (21 of 35) of patients.
Study Conclusion
The triplet treatment of anti-PD-L1 Adebrelimab, bevacizumab and cisplatin/carboplatin, was the first regimen demonstrating a high intracranial anti-tumor activity, a prolonged CNS-PFS and OS with a good safety profile. Warranting further investigation in this highly aggressive disease.
Expert Interview
Oncology Frontier: What was the rationale behind designing this phase II clinical trial combining adebrelimab, bevacizumab, and platinum-based chemotherapy for patients with triple-negative breast cancer (TNBC) brain metastases?
Professor Ting Li: In clinical practice, we’ve consistently observed that TNBC is one of the most challenging subtypes to treat. Among these patients, those with brain metastases present the most difficult therapeutic dilemma. Prior studies have shown that this population has extremely poor outcomes, particularly those who present with neurological symptoms at diagnosis or experience progression in the brain even after radiotherapy. In many cases, these patients deteriorate rapidly and may succumb to the disease within a short time.
Given the limitations of local treatment like radiotherapy, there is an urgent need for a more effective systemic therapy to prolong survival. Against this backdrop, we initiated this study to evaluate whether the combination of adebrelimab, bevacizumab, and cisplatin or carboplatin could offer a better treatment strategy for these patients. That was the core motivation behind the design of this trial.
Oncology Frontier: Among the many immunotherapy agents available, why did you choose adebrelimab, a PD-L1 inhibitor, for this study in TNBC brain metastases? What advantages does this triple combination have over other similar regimens?
Professor Ting Li: In the treatment of TNBC, numerous clinical trials involving immunotherapy have already been conducted, and in China, immunotherapy is now part of the recommended treatment for these patients. We selected adebrelimab based on a thorough review of the literature at the time of the study design. Multiple preclinical studies suggested that adebrelimab effectively restores suppressed T-cell function, enhancing their cytotoxic activity against tumor cells. Moreover, T cells have the ability to cross the blood-brain barrier, which gave us a scientific rationale to explore immunotherapy for brain metastases.
We also chose bevacizumab and platinum agents as part of the combination. Bevacizumab is well known for its ability to reduce cerebral edema, which is a common complication in patients with brain metastases. Large phase III trials have shown that combining bevacizumab with chemotherapy can significantly prolong progression-free survival. In China, platinum-based chemotherapy is widely used in TNBC, and it has demonstrated strong efficacy.
Importantly, all three agents in this regimen—adebrelimab, bevacizumab, and platinum—have shown potential to cross the blood-brain barrier and exert antitumor effects within the CNS. Therefore, their combined use in this study was a scientifically sound and strategically targeted approach to address the unmet need in TNBC brain metastases.
Oncology Frontier: In future clinical applications of this triple combination therapy, which patient populations do you think are most likely to benefit? Are there specific biomarkers or clinical characteristics that might help identify ideal candidates?
Professor Ting Li: In our clinical study, we enrolled only 35 patients. Among these, we conducted a preliminary analysis based on their CPS (Combined Positive Score) and immune subtype classification. Early observations suggested that patients with CPS ≥1 and those classified as having an immune-modulatory subtype appeared to show slightly better response rates numerically.
However, due to the limited sample size and the absence of statistically significant differences between subgroups, we cannot yet draw firm conclusions about predictive biomarkers. Identifying such markers remains one of our key objectives for future research.
In upcoming studies focusing on TNBC brain metastases, we plan to carry out more comprehensive biomarker analyses. This may include combined biomarker profiling using cerebrospinal fluid, blood, and tissue samples. We hope that future clinical data will provide clearer answers on which patients are most likely to benefit from this treatment and how to better tailor therapy to individual profiles.
