On May 30, 2022 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported that its phase IIb study in prostate cancer, BRaVac, in spite of the previous positive results related to the compound, failed to demonstrate RV001 (onilcamotide) superiority over placebo in preventing progression in patients with biochemical recurrence (a rise in PSA) after curative intent therapy (Press release, RhoVac, MAY 30, 2022, View Source;bravac-failed-to-meet-its-primary-endpoint-301557156.html [SID1234615221]). Progression was defined as either a doubling of PSA, clinical recurrence, or death. RhoVac will undertake a more thorough analysis of the results, and a clear plan on how to proceed will be communicated end June. The primary outcome analysis, however, regrettably offers little hope of a license or acquisition deal based on the results of this study alone.
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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001 (onilcamotide) late 2019, in prostate cancer patients with biochemical recurrence (a rise in PSA) after curative intent therapy. Positive phase I/II data offered significant hope, and in November of 2020, RhoVac was awarded Fast Track Designation by the FDA for its drug candidate in this cancer indication. The objective of the BRaVac study was to show that onilcamotide could significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. Interim safety reviews have been conducted, and no unexpected adverse events have been identified, and the end trial results also confirm the anticipated safety of the drug candidate.
On efficacy however, BRaVac, the first placebo controlled study of the drug candidate, failed to deliver on its primary endpoint, which was to demonstrate drug candidate superiority over placebo in reducing the risk of progression, and the primary results did not indicate any significant finding on improved outcomes for the studied patients. RhoVac will now undertake a more thorough analysis of the study results, but the primary outcome analysis obviously offers little hope of a license or acquisition deal based on the results of this study alone. RhoVac will now execute on a cost minimisation contingency plan, while conducting further analyses of the results, aiming to come up with clear recommendations on the future of the project and next steps end June.
RhoVac CEO, Anders Månsson, comments: "Even though we know that benchmarks state that the probability of success for a phase II project in oncology is less than 50% and that clinical development is always a calculated risk, we are surprised and deeply saddened to find that BRaVac failed to meet its primary endpoint. We will immediately minimise expenditure, while further assessing the study data, with the aim of coming up with firm recommendations on how to proceed, and to communicate this end June."
This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 29-05-2022 19:53 CET.