Steba Biotech, a privately-owned biotechnology company focused on the development of innovative and minimally invasive photodynamic therapies and systems to treat cancers, today announced that the Journal of Urology has published 4-year follow up data of the landmark PCM301 trial of TOOKAD® (padeliporfin di-potassium), a novel treatment for localized, low-risk prostate cancer. The publication of this study provides the longest reported Level 1 evidence of safety and efficacy of partial gland ablation (PGA) for early-stage prostate cancer to date.
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Analysis of 4-year follow up of PCM301 – the first multicenter, phase 3, prospective, randomized trial evaluating PGA for the treatment of localized prostate cancer – demonstrated that vascular targeted photodynamic therapy (VTP) mediated by TOOKAD® significantly reduced the subsequent finding of higher-grade cancer on biopsy, and, consequently, significantly fewer patients converted to radical therapy (RT), typically surgery or radiotherapy. The rate of conversion to RT after TOOKAD® VTP compared with Active Surveillance (AS) at 2 years (7% vs 32%) was maintained at 3 (15% vs 44%) and 4 years (24% vs 53%) (HR=0.31, 95% CI=0.21-0.46; p<0.001). The reduction in conversion to RT is a clinically-meaningful outcome, as it lowers treatment-related morbidity.
“Men need a much wider range of options for prostate cancer, a disease that we can now characterise with much more certainty than in the past,” said Professor Mark Emberton, University College London and Principal Investigator of PCM301. “Precision therapies such as TOOKAD® create a much needed and welcome opportunity for men that want treatment but are unwilling to risk the harms associated with traditional radical therapies.”
TOOKAD was approved for commercialization in Mexico, Israel, as well as in 31 countries of the European Union (EU) and in the European Economic Area (EEA) in November 2017.
“Given prostate cancer is the most common cancer in men, it is critical that we provide patients with effective treatment options to help tackle their cancer early on, ” said Fabrice Harari, Chairman and CEO of Steba Biotech. “Currently, early-stage prostate cancer patients face the dilemma of choosing between a) treating their cancer with radical therapy, which is associated with frequent long-term sexual, urinary or bowel toxicities or b) being put under ‘active surveillance’ where the disease is monitored and only treated when it becomes more severe. This new long-term data shows that TOOKAD® provides an effective alternative for men wishing to treat their early-stage cancer while still avoiding the debilitating sexual, urinary and bowel consequences of radical therapy. With European approval of TOOKAD® in November 2017, we look forward to making this important treatment option available to patients in Europe soon.”
Dr. Peter Scardino, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, and senior corresponding author of the publication, commented,
“These intermediate-to-long-term data provide further evidence that TOOKAD® VTP is an effective treatment option for men with early-stage localised prostate cancer, offering a treatment that can kill cancer without removing or destroying the prostate. This is excellent news for men and for the treatment of prostate cancer – we now have a tissue-preserving treatment that will reduce the use of radical therapy and its significant long-term erectile and incontinence problems. An important milestone indeed”
About TOOKAD® (padeliporfin di-potassium)
TOOKAD® is a first-in-class, minimally invasive treatment that relies on photoactivation with low-energy, non-thermal laser to trigger selective tumor necrosis without damaging healthy tissue. The treatment is administered through a short (~1h30), 3-step outpatient procedure. TOOKAD®‘s mechanism of action relies on fast vascular occlusion to eradicate tumors within a 5mm millimeter range of optic fibers.
The technology was licensed from the Weizmann Institute in Israel. The lead program in early stage prostate cancer has successfully completed Phase III studies and is approved for commercialization in Israel as well as in 31 countries of the European Union (EU) and in European Economic Area (EEA) since Nov-2017. TOOKAD® is also approved in Mexico, where its labeling includes intermediate risk prostate cancer (Gleason Score 3+4). The application to the US FDA for marketing authorization is ongoing. Beyond early stage prostate cancer, TOOKAD® is also being developed in multiple other oncology indications.
About PCM301 extended follow-up and analyses of effectiveness study design
The PCM301 study is a European, prospective, multicenter, open label, randomized, controlled study that compared TOOKAD® versus active surveillance. The study enrolled 413 low-risk prostate cancer patients (clinical stage up to cT2a, PSA<10 ng/ml, absence of Gleason pattern 4 or 5, at least one positive cancer core with 3 to 5mm cancer involvement or 2-3 positive cancer cores with no more than 5mm cancer involvement) in 47 centers across 10 European countries. 206 patients were included in the TOOKAD® arm (4mg/kg infusion and 200J/cm light activation) and 207 in the active surveillance arm. Two-year outcomes were reported previously. This study reports four-year rates of conversion to radical therapy and further assesses efficacy based on biopsy results. Prostate biopsies were mandated at 12 and 24 months. Thereafter, patients were monitored for radical therapy, with periodic biopsies performed according to standard of care in each institution.
About low-risk prostate cancer
Low-risk prostate cancer (typically defined by clinical stage T1c-T2a, PSA<10 ng/ml, Gleason score ≤6) is one of the most common stages among newly diagnosed prostate cancer patients. It is currently managed through active surveillance, radical prostatectomy or radiotherapy. A key challenge in the management of the disease is to avoid progression to higher grade, which is associated with higher risk of metastasis and mortality, while preserving the patients’ quality of life (in particular urinary and erectile functions).
About Steba Biotech
Steba Biotech is a privately-owned, biotechnology company headquartered in Luxembourg with offices in France, Israel, Switzerland, and the US. Steba Biotech is focused on the development of TOOKAD® (padeliporfin di-potassium), an innovative and minimally invasive photodynamic therapy evaluated in late-stage clinical trials to demonstrate its ability to safely and effectively treat low-risk prostate cancer. Steba Biotech is also pursuing early stage studies of TOOKAD® in esophageal cancer, urothelial carcinoma, advanced prostate cancer, and triple negative breast cancer in collaboration with the Weizmann Institute and Memorial Sloan Kettering Cancer Center.
- Gill IS et al. J Urol. 2018 Jun 1. pii: S0022-5347(18)43299-5. doi: 10.1016/j.juro.2018.05.121. [Epub ahead of print]
- Azzouzi AR et al. Lancet Oncol. 2017 Feb;18(2):181-191. doi: 10.1016/S1470-2045(16)30661-1.
- Tookad SPC. https://ec.europa.eu/health/documents/community-register/2017/20171110139127/anx_139127_en.pdf. Accessed June 2018.
Sarah Giles, Rude Health Consulting
Emmanuel Coeytaux, Steba Biotech
SOURCE Steba Biotech