1. The overall response rate (ORR) was 25.6%, with 8.0% of the patients achieved complete response.
2. Common treatment-related adverse events included hypothyroidism, diarrhea, fatigue, and nausea.
Evidence Rating Level: 2 (Good)
Study Rundown: Cervical cancer is the fourth common cancer in women and is one of the more successfully treatable cancers if detected early. However, for patients with recurrent/metastatic cancer, there are currently limited options for those who did not respond to first-line chemotherapy doublet plus bevacizumab treatment. There has been interest to explore the dual immunotherapy of bastilimab (antiprogrammed dealth-1) plus zalifrelimab (anticytotoxic T-lymphocyte-associated antigen-4) Therefore, this study aimed to evaluate the efficacy and safety of a combination therapy of bastilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy. The median time to follow-up was 21 months (minimum: 11.8 months, maximum: 32.1+ months). In addition, the overall response rate (ORR) was 25.6% with median duration of response not reached in the 6, 9 and 12 months. The overall disease control rate was 52% and the median time to response was 2.7 months. Most of the treatment-related adverse events were either grade 1 or 2 in severity. Common adverse events included hypothyroidism (16.8%), diarrhea (14.2%), fatigue (11.6%), and nausea (9.0%). Limitations to the study include lack of ethnically diverse patients and a short duration of follow-up to capture long-term effects of the treatment. Overall, this study demonstrated that bastilimab plus zalifrelimab could be an effective treatment for patients with recurrent and/or metastatic cervical cancer. However, further investigation is required to confirm the findings and establish a more comprehensive efficacy and safety profile.
In-Depth [randomized controlled trial]: This was a global, open-label, single-arm, phase II study of 155 patients at 45 sites in the United States, Europe, South America, and Australia. Patients received bastilimab once every 2 weeks and zalifrelimab once every 6 weeks over a 6-week cycle. The median age of the patients were 50 years old (range: 24-76 years) and 95.5% of the patients were White. The most common tumour histology was squamous cell carcinoma (70.3%) and 55.5% of the patients had PD-L1-positive tumours. The efficacy of the combination therapy was calculated based on the 125 patients who had measurable disease at baseline and have received prior platinum therapy. The overall response rate (ORR) was 25.6% (95% confidence interval [CI]: 18.8-33.9) with median duration of response not reached in the 6 (86.5%), 9 (75.5%) and 12 (64.2%) months. 8.0% of the patients achieved complete response and 17.6% achieved partial response. The overall disease control rate was 52% (95% CI: 43.3 – 60.6%) and the median time to response was 2.7 months (range: 1.3 – 15.8 months). 20% of the patients experienced grade 3 and above treatment-related adverse events. These include increased alanine transaminase (ALT) (2.6%) and diarrhea (1.9%). 12.3% of the patients experienced dose interruptions, mainly due to elevations in aspartate transaminase (AST) or ALT. 7.7% of the patients experienced discontinuation of treatment, mainly due to diarrhea.
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