LAVA Therapeutics Discontinues LAVA-1207 Development for mCRPC
LAVA Therapeutics has announced the discontinuation of LAVA-1207 development, a potential treatment for patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC). This decision follows the phase 1/2a trial (NCT05369000) results, which did not meet the company's internal benchmarks. Importantly, the discontinuation was not due to safety concerns, allowing LAVA-1207 to remain available for patients currently under treatment at their physician's discretion.
Trial Insights and Findings
The phase 1 portion of the study revealed that several patients experienced reductions in prostate-specific antigen (PSA) levels. Additionally, a higher baseline circulating Vd2 T-cell level was linked to a longer duration on the study. The safety and tolerability data aligned with the intended mechanism of action of LAVA-1207.
Stephen Hurly, President and CEO of LAVA Therapeutics, expressed disappointment but highlighted the company's commitment to advancing other promising treatments. "We are reprioritizing our pipeline to focus on LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome and will continue to support our partnered programs," Hurly stated. He also noted the company's strong financial position, with approximately $79 million in cash, expected to fund operations into 2027.
Study Design and Objectives
The phase 1/2a trial included a 3+3 dose-escalation portion in phase 1, with expansion cohorts in phase 2a. It enrolled patients with mCRPC who had progressed after prior treatment with at least one androgen receptor pathway inhibitor and taxane-based chemotherapy. The study's primary endpoints were to assess the safety of LAVA-1207 alone or in combination with pembrolizumab or low-dose IL-2 and to determine the recommended phase 2 dose. Secondary endpoints included pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity.
Moving Forward
Despite the discontinuation of LAVA-1207, the findings from the trial have provided valuable insights. Charlie Morris, MD, Chief Medical Officer of LAVA Therapeutics, thanked all participants and emphasized the importance of the data collected. "The longer time to progression, with several patients on trial beyond 6 months and duration of treatment observed for patients with higher circulating gamma delta2 T cells, are consistent with the mechanism of action and support continued clinical investigation of the platform," Morris stated.
LAVA Therapeutics remains committed to developing innovative immuno-oncology medicines, with a renewed focus on its other pipeline projects and partnered programs.
