Dr. Markowski on the Safety and Efficacy of VERU-111 in mCRPC

Mark Christopher Markowski, MD, PhD, an assistant professor of oncology, and a medical oncologist at the Kimmel Cancer Center, Sibley Memorial Hospital, discusses the safety and efficacy of VERU-111 in patients with metastatic castration-resistant prostate cancer (mCRPC).

One of the most important aspects of the phase 1b/2 clinical trial examining the VERU-111 was its safety profile, according to Markowski. As the agent is a microtubular polymerization inhibitor, it was important to understand its safety profile vs taxane chemotherapy, he added. VERU-111 is an oral, targeted compound that is not quite a cytotoxic chemotherapy agent.

The drug was found to be safe and well tolerated, with most adverse effects being gastrointestinal, including nausea and diarrhea, the majority of which were low grade and manageable with oral medications, or by stopping treatment, Markowski explained.

Moreover, the phase 2 portion of the study yielded promising clinical responses, including objective responses in 44.4% of patients, as well as durable disease stability. The results were surprising, because while patients did not experience a notable decrease in tumor volume, they also did not develop disease progression, and have been on the study for a long time, Markowski said.

Two patients from the phase 1 portion of the study have been on treatment for more than 2 years. In addition to seeing prostate-specific antigen decreases and objective responses, investigators also observed disease stability, Markowski concludes.