Chemoimmunotherapy Boosts Pathological Complete Responses in MIBC

"Given the superior efficacy of [chemoimmunotherapy], it holds promise as a first-line neoadjuvant therapy for MIBC, providing greater benefits to patients," according to the study authors.

Neoadjuvant chemotherapy in combination with immune checkpoint blockade conferred improvements in pathological complete response (pCR) rates and pathological downstaging vs chemotherapy alone among patients with muscle-invasive bladder cancer (MIBC), according to findings from a real-world study published in Scientific Reports.¹

The pCR rate was 25.4% (95% CI, 16.7%-36.6%) with chemotherapy alone (n = 71) vs 48.3% (95% CI, 31.4%-65.6%) with chemotherapy plus immunotherapy (n = 29; P = .034). In each respective treatment group, data showed partial responses in 22.5% (95% CI, 14.4%-33.5%) vs 27.6% (95% CI, 14.7%-45.7%), stable disease in 29.6% (95% CI, 20.2%-41.0%) vs 20.7% (95% CI, 9.8%-38.4%), and progressive disease in 22.5% (95% CI, 14.4%-33.5%) vs 3.4% (95% CI, 0.6%-17.2%).

Investigators achieved pathological downstaging for 47.9% (95% CI, 36.7%-59.3%) of patients who received chemotherapy alone and 75.9% (95% CI, 57.9%-87.8%) of those who received chemoimmunotherapy (P = .014; adjusted P = .034). Additionally, the disease control rate (DCR) was 77.5% (95% CI, 66.5%-85.6%) and 96.6% (95% CI, 82.8%-99.4%) in each treatment group (P = .020; adjusted P = .034).

“Achieving pCR after neoadjuvant therapy was positively associated with significant improvements in survival outcomes.² In our study, the pCR rate in the [chemoimmunotherapy] cohort reached 48.3%, significantly higher than the 25.4% pCR rate observed in the [chemotherapy alone] cohort,” lead study author Xinjia Ding, from the Department of Medical Oncology at Peking University First Hospital in Beijing, China, wrote with coauthors.¹ “This study demonstrates that combining [neoadjuvant chemotherapy] with immunotherapy significantly enhances the pCR rate and pathological downstaging in patients with MIBC compared to [neoadjuvant chemotherapy] alone. Given the superior efficacy of [chemoimmunotherapy], it holds promise as a first-line neoadjuvant therapy for MIBC, providing greater benefits to patients.”

Investigators retrospectively gathered data from patients who underwent treatment at Peking University First Hospital from January 2022 to June 2024. Patients who were treated with neoadjuvant chemotherapy alone received gemcitabine at 1000 mg/m² on days 1 and 8 plus cisplatin at 70 mg/m² on day 1 every 3 weeks. In the chemoimmunotherapy cohort, 21 patients also received tislelizumab (Tevimbra) at 200 mg on day 1, 7 received pembrolizumab (Keytruda) at 200 mg on day 1, and 1 received camrelizumab at 200 mg on day 1 of each cycle.

The study included a data collection process of patient information related to factors such as age, gender, smoking status, tumor grade, surgical approach, and pretreatment laboratory values. The primary research outcome was the pCR rate, and the second research outcome was the pathological downstaging rate.

Patients with a confirmed diagnosis of MIBC, completion of 2 or more cycles of neoadjuvant treatment, and undergoing radical cystectomy with confirmed pathological staging after neoadjuvant treatment were included in the analysis. Those with pathological diagnoses of cancers apart from urothelial carcinoma or incomplete perioperative pathological data were excluded from the analysis.

Most patients in the chemotherapy alone and chemoimmunotherapy groups, respectively, were male (78.9% vs 75.9%) and had no smoking history (57.7% vs 55.2%). Additionally, most of each cohort had stage T2 disease (64.8% vs 48.3%), stage N0 disease (81.7% vs 58.6%), and high-grade disease (97.2% vs 96.6%).

In the chemoimmunotherapy cohort, patients with a pCR had significantly lower platelet levels vs those without a pCR (P = .026). Investigators noted that higher pretreatment hemoglobin levels may correlate with a higher likelihood of pCR (P = .018).

References

1. Ding X, Liu C, Li X, et al. Real-world comparison of neoadjuvant chemoimmunotherapy and chemotherapy in muscle-invasive bladder cancer. Sci Rep. 2025;15:17588. doi:10.1038/s41598-025-99889-7
2. Ravi P, Pond GR, Diamantopoulos LN, et al. Optimal pathological response after neoadjuvant chemotherapy for muscle-invasive bladder cancer: results from a global, multicentre collaboration. BJU Int. 2021;128(5):607-614. doi:10.1111/bju.15434.