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Decipher Prostate RP Identifies Patients Likely to Benefit from Hormonal Therapy in Men with Recurrent Prostate Cancer

Data presented as part of a practice-changing, phase III clinical trial

San Diego – February 18, 2020

Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, today announced that Decipher Prostate RP, studied in patients from the phase III, randomized controlled trial, RTOG 96-01, demonstrated the ability to accurately identify which prostate cancer patients with recurrent disease benefit most from anti-androgen hormonal therapy.

Hormone therapy is often administered in combination with radiotherapy as treatment for men with localized prostate cancer who experience disease recurrence following surgical removal of their prostate. To determine the efficacy of hormonal therapy in this setting, the RTOG 96-01 trial investigated treatment of patients with radiotherapy alone versus combined radiation and hormonal therapy, with 12-year follow-up.

Upon completion of RTOG 96-01, Decipher Prostate RP genomic risk assessment of trial participants demonstrated that Decipher high-risk patients received greater benefit from hormonal therapy than Decipher low-risk patients. The study also validated Decipher Prostate RP as the most accurate predictor of metastasis, prostate cancer-specific survival, and overall survival in the context of a prospective, randomized controlled trial.

“Identifying which patients with recurrent disease are most likely to benefit from hormonal therapy will improve our ability to extend patient survival, while minimizing unnecessary toxicity for a large group of men with prostate cancer,” said Felix Feng, MD, vice chair of radiation oncology at University of California, San Francisco. “Decipher Prostate RP improves upon clinical and pathological risk stratification methods and informs the use of hormonal therapy, making it a reasonable and recommended component of the prostate cancer standard of care.”

Results were presented February 13, 2020, at the Genitourinary Cancer Symposium Oral Abstract A session:

Feng FY, et al. Transcriptome profiling of NRG Oncology/RTOG 9601: Validation of a prognostic genomic classifier in salvage radiotherapy prostate cancer patients from a prospective randomized trial. Abstract #276

Findings from nine other studies of Decipher tests were presented at the Genitourinary Cancer Symposium:

Ganguly S, et al. Tumor cell intrinsic androgen biosynthesis by 3β-hydroxy steroid dehydrogenase (HSD3B1) to modulate radiosensitivity in prostate cancer cells. Abstract #349

Grist E, et al. Multiregion expression profiling of prostate cancer from men randomized in the STAMPEDE trial: Stage I results of a multistage biomarker analysis. Abstract #349

Gupta S et al. Results from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in muscle invasive bladder cancer (MIBC) undergoing cystectomy. Abstract #439

Hamid A, et al. Luminal B subtype as a predictive biomarker of docetaxel benefit for newly diagnosed metastatic hormone sensitive prostate cancer (mHSPC): A correlative study of E3805 CHAARTED. Abstract #162

King M, et al. INTREPId (INTermediate Risk Erection Preservation Trial): A randomized trial of radiation therapy and darolutamide for prostate cancer. Abstract #TPS384

Muralidhar V, et al. Clinical-genomic sub-classification of high-risk prostate cancer: Implications for tailoring therapy and clinical trial design. Abstract #337

Necchi A, et al. Association of an immune-gene signature with pathologic response and outcome after neoadjuvant pembrolizumab (pembro), compared to neoadjuvant chemotherapy (NAC), in muscle-invasive bladder cancer (MIBC). Abstract #533

Necchi A, et al. Development of a composite biomarker-based calculator to predict the probability of pathologic complete response (pT0) after neoadjuvant pembrolizumab (pembro) in muscle invasive bladder cancer (MIBC). Abstract #539

Shahait M, et al. Head-to-head comparison between decipher and prolaris tests: Two commercially available post-prostatectomy genomic tests. Abstract #348

About Decipher Prostate RP and Decipher GRID

Our Decipher Prostate RP genomic tests are currently marketed and sold to physicians treating prostate cancer through the adjuvant therapy decision for patients who have received a radical prostatectomy and are being considered for additional therapy. The test reports the Decipher score which prognosticates a patient’s risk of metastasis within five years. The Decipher score is intended to improve clinical decision making by helping physicians identify patients who have high risk of metastasis and require more intensive therapy or who have low risk of metastasis and can reduce treatment intensity. We have obtained Medicare coverage for patients, including for those who have been diagnosed with adverse pathology following a radical prostatectomy and are being considered for additional therapy. Decipher Prostate RP can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

Decipher GRID is our Real-World Evidence genomic database containing over 75,000 urologic cancer transcriptomes matched to patient demographics and including clinical trial outcome data, which is one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID’s patient data is derived from decades of clinical trials and is continuously being expanded through a growing community of pharmaceutical and academic partners. The diversity of clinical sample inputs, ranging from global clinical trials to standard-of-care practices in urban, suburban and rural centers, help provide a comprehensive view of the future and current states of the practice of urologic cancer care. We leverage Decipher GRID outputs to partner with investigators and pharmaceutical companies to help identify patient populations that might benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. Decipher GRID is our proprietary engine that drives product development for us, and informs the product development efforts for our pharmaceutical partners.

About Decipher Biosciences

Decipher Biosciences is a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers. Our novel prostate cancer genomic testing products, Decipher Prostate Biopsy and Decipher Prostate RP, provide valuable information about the underlying biology of a patient's tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient's entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Decipher Biosciences is headquartered in San Diego, California.

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