Decipher Identifies a Molecular Subtype Most Likely to Benefit from Neoadjuvant KEYTRUDA Immunotherapy in Bladder Cancer Patients

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Decipher Identifies a Molecular Subtype Most Likely to Benefit from Neoadjuvant KEYTRUDA Immunotherapy in Bladder Cancer Patients

San Diego – April 28, 2020


Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, announced today that patients with the molecular subtype Basal Claudin Low, identified by the Decipher Bladder test and studied in the PURE-01 clinical trial, received the most benefit in progression-free survival from neoadjuvant KEYTRUDA (pembrolizumab) immunotherapy in patients with muscle-invasive bladder cancer (MIBC).

Identification of patients who benefit from immune checkpoint inhibitors, such as KEYTRUDA (a PD-1 inhibitor), is an unmet need in numerous disease settings for clinicians and pharmaceutical development teams. Currently, the use of KEYTRUDA is approved for patients with locally advanced or metastatic bladder cancer who are either platinum-ineligible or who have disease progression on platinum-based chemotherapy, and also for patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high risk, non-muscle-invasive bladder cancer. The PURE-01 clinical trial examined the use of KEYTRUDA prior to surgical removal of the bladder in platinum-eligible patients with non-metastatic MIBC.

“Identification of a predictive biomarker to a PD-1 inhibitor is essential for us to move the use of immunotherapy earlier in bladder cancer,” said Andrea Necchi, MD, medical oncologist at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. “The results of this study support the further examination of subtyping classifiers and their inclusion in ongoing and future immunotherapy clinical trials.”

Standard of care for patients with MIBC is cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgical removal of the bladder, however, many patients suffer from comorbidities prohibiting the use of NAC, resulting in low utilization. Immunotherapy is a promising alternative, as demonstrated in the PURE-01 clinical trial, with rates of response and progression-free survival with neoadjuvant KEYTRUDA similar to rates reported for NAC.

In the PURE-01 clinical trial, the Basal Claudin Low molecular subtype represented 13% of patients with a unique tumor profile and RNA expression enriched for immune activity. These patients demonstrated exceptional improvement in two-year progression-free survival. Other Basal Claudin Low patients treated with the standard of care NAC had significantly worse outcomes with ~ 50% rate of disease progression.

The study, led by Dr. Necchi and titled “Impact of Molecular Subtyping and Immune Filtration on Pathological Response and Outcome Following Neoadjuvant Pembrolizumab in Muscle-Invasive Bladder Cancer,” was published in the peer-reviewed journal European Urology on March 9, 2020. Additionally, the website UroToday published a “Beyond the Abstract” commentary by Dr. Necchi highlighting the findings from the study.

About Decipher Bladder

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder cancer specimens. It was developed in bladder cancer patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy. The assay results are reported as one of five molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), each of which has distinct biological composition, clinical behavior and predicted benefit from NAC.

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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