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Mark C. Markowski, MD, PhD, discusses the safety and efficacy of sabizabulin in a phase 1b/2 trial in metastatic castration-resistant prostate cancer.
Mark C. Markowski, MD, PhD, assistant professor, Oncology, Johns Hopkins Medicine, discusses the safety and efficacy of sabizabulin (VERU-111) in a phase 1b/2 trial (NCT03752099) in metastatic castration-resistant prostate cancer (mCRPC).
The study was conducted to establish the maximum tolerated dose and evaluate the preliminary efficacy in men with mCRPC resistant to androgen receptor targeting agents.
Efficacy data showed sabizabulin achieved objective response rates between 20% and 30%, Markowski says. However, the most impressive finding was a median progression-free survival of more than 9 months, and some patients have demonstrated disease control after being on the trial for multiple years, Markowski explains. Along with observing preliminary tumor shrinkage, the durable disease control responses are benefiting patients, Markowski adds.
In terms of adverse effects, some grade 1 and 2 toxicities were seen, including fatigue and diarrhea, Markowski continues. While most toxicities were low grade, a couple instances of grade 3 toxicities, including diarrhea, were reported, though those were solved with dose interruption or dose reduction, Markowski adds. Notably, instances of cytopenia or neutropenia, which are common with taxane chemotherapy, were not observed with sabizabulin, Markowski concludes.