Publication
Journal of Clinical Oncology Article
Botensilimab (Fc-enhanced anti–cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti–PD-1 antibody) in Patients With Relapsed/Refractory M
What is it about?
This study tested a new immunotherapy combination called BOT+BAL (botensilimab and balstilimab) for people with advanced sarcomas whose cancer had continued to grow despite prior treatments.
Sarcomas are rare cancers of bone and soft tissue. When they spread (metastasize), outcomes are often poor, and most types do not respond well to currently approved immunotherapies. New treatment options are urgently needed.
In this early-phase (phase I) clinical trial (ClinicalTrials.gov identifier: ClinicalTrials.gov NCT03860272), 64 patients with advanced sarcomas received two immune-based drugs: botensilimab and balstilimab. These medicines are designed to help the immune system recognize and attack cancer cells. Many patients had already received several previous treatments, and some had tried other immunotherapies.
Why is it important?
The main goal of the study was to evaluate safety. The most common side effect was diarrhea or inflammation of the colon (colitis), occurring in about one-third of patients. Most cases were manageable with steroids or other medications. Importantly, no life-threatening treatment-related side effects were reported.
Researchers also looked at how well the treatment worked. Among 52 patients who could be evaluated for tumor response, about 19% had significant tumor shrinkage. An additional group had stable disease, meaning their cancer stopped growing for a period of time. Some responses lasted a long time, the median duration of response was nearly 22 months. Results were especially encouraging in patients with angiosarcoma, a subtype of sarcoma, where about 28% experienced tumor shrinkage.
Overall, this combination showed promising activity in several sarcoma subtypes that usually do not respond to immunotherapy. Although this was a small, early-stage study, the findings suggest this approach could become a new option for patients with advanced sarcoma. Larger studies are needed to confirm these results and better understand who is most likely to benefit.
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