Veru Announces ESMO Congress 2020 Oral Presentation of Positive Clinical Results from its VERU-111 Phase 1b Study in Metastatic Prostate Cancer
—Advancing VERU-111 to a Pivotal Phase 3 Clinical Program—
MIAMI, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer, today announced that positive clinical results from its Phase 1b study of VERU-111 were orally presented at the European Society for Medical Oncology (ESMO) Congress 2020.
The results of the Phase 1b study evaluating VERU-111, a novel oral microtubule targeting agent that selectively inhibits alpha and beta tubulin, in 39 men with metastatic castration resistant prostate cancer that have also failed at least one androgen receptor targeting agent (enzalutamide or abiraterone) and a large and growing unmet medical need in advanced prostate cancer, have been presented as an oral presentation by Mark Markowski, MD, Assistant Professor of Oncology from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. The oral presentation is entitled “Phase 1b/2 study of VERU-111, novel, oral tubulin inhibitor, in men with metastatic castration resistant prostate cancer (mCRPC) who failed an androgen blocking agent.″
The highlights of the study were as follows:
- Phase 1b portion of the study enrolled 39 men in 7 clinical sites in the United States and used a two-part dosing schedule with a standard 3+3 dose escalation strategy followed by an expanded dose and dose schedule of VERU-111 daily continuous dosing until disease progression or toxicity.
- Patient demographics: 44% failed both abiraterone and enzalutamide; 55% had bone only metastatic disease.
- The Maximum Tolerated Dose (MTD) of VERU-111 was 72mg (3 /11 men had Grade 3 diarrhea). No Grade 3 diarrhea was observed at doses <72 mg per day. At doses < 72mg/d, the most common adverse events (AEs) were mild to moderate nausea, vomiting, diarrhea, and fatigue, with no observed neurotoxicity or neutropenia.
- Antitumor activity was assessed by PSA as well as bone and CT scans in 10 men that were treated for ≥ 4 continuous 21-day cycles which represents 33% of all men enrolled in the Phase 1b
who were chemotherapy naive.
- 6/10 had PSA declines: 4/10 had ≥ 30% and 2/10 ≥ 50% declines compared to their 21-day cycle baseline.
- Based on PCWG3/RECIST 1.1 criteria, objective tumor responses were seen in 2/10 (soft tissue and bone) and 7/10 (70%) had stable disease.
- Median duration of treatment without radiographic progression was greater than 11+ months (range 6-17+ months) as 5/10 men are still on study.
- Median duration of treatment without progression in all men who received any 63mg oral dosing was 9.8+ (range 2-15.4+ months).
- For point of reference from the scientific literature, in similar men with mCRPC who have failed at least one androgen receptor targeted agent, the median radiographic progression free survival was 3.6 months on an alternative androgen receptor targeting agent and for men with mCRPC who failed both abiraterone or enzalutamide the radiographic progression free survival was 2.6 months.
- Phase 2 clinical study has almost completed enrollment of 40 men with mCRPC who have failed at least one androgen blocking agent.
- In conclusion, the recommended Phase 2 dose is 63mg oral daily continuous dosing for 21-day cycles and daily chronic drug administration is feasible and safe in the Phase 1b study. At the recommended Phase 2 dose, there were no reports of neutropenia, neurotoxicity, or Grade 3 diarrhea.
Based on these promising clinical data, VERU met with FDA on the Phase 3 clinical trial design in July 2020. The plan is to submit a final Phase 3 clinical protocol to evaluate VERU-111 in men with mCRPC and who have also failed one androgen receptor targeting agent in the 4th calendar Quarter 2020 and initiate a Phase 3 study in the 1st calendar Quarter 2021.