On 26, 2022 Incyte (Nasdaq:INCY) reported that multiple abstracts featuring data from its oncology portfolio will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 (EHA2022) Congress (June 9-17; virtual and in Vienna) (Press release, Incyte, MAY 26, 2022, View Source [SID1234615111]).

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"We are committed to advancing science that can lead to solutions for patients with serious unmet medical needs, including those with cancer"

"We are committed to advancing science that can lead to solutions for patients with serious unmet medical needs, including those with cancer," said Steven Stein, M.D., Chief Medical Officer, Incyte. "For that reason, we look forward to convening with the oncology community and presenting data from across our portfolio, including both Incyte-led and partnered programs."

Key abstracts accepted by EHA (Free EHA Whitepaper) include:

Oral Presentation

Long-term Efficacy and Safety Results from an Ongoing Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #S286. Session: Transfusion and Autoimmune Hemolytic Anemia. Session Time: Friday, June 10, 11:30 a.m. – 12:45 p.m.)

Poster Presentations

A Real-World Evaluation of the Association Between Elevated Blood Counts and Thrombotic Events in Polycythemia Vera: An Analysis of Data from the Reveal Study (Abstract #P1062. Session: Myeloproliferative neoplasms – Clinical)

Does Early Intervention in Myelofibrosis Impact Outcomes? A Pooled Analysis of the COMFORT 1 and 2 Studies (Abstract #P1037. Session: Myeloproliferative neoplasms – Clinical)

Ruxolitinib Demonstrates a Greater Corticosteroid-Sparing Effect than Best Available Therapy in Patients with Corticosteroid-Refractory/Dependent Chronic Graft-Vs-Host Disease1 (Abstract #P1389. Session: Stem cell transplantation – Clinical)

Real-World Safety of Ruxolitinib in Patients with Intermediate or High Risk of Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis in China1 (Abstract #P1047. Session: Myeloproliferative neoplasms – Clinical)

Efficacy and Safety of Parsaclisib-Ruxolitinib Combination Therapy in Myelofibrosis Patients with Low vs Higher Baseline Platelet Count: A Subgroup Analysis of Data from a Phase 2 Study (Abstract #P1063. Session: Myeloproliferative neoplasms – Clinical)

A Phase 1 Study Evaluating Safety and Efficacy of Parsaclisib in Combination with Bendamustine + Obinutuzumab in Patients with Relapsed or Refractory Follicular Lymphoma (CITADEL-102) (Abstract #P1104. Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical)

A Phase 1 Study of Parsaclisib in Combination with Investigator Choice of Rituximab, Bendamustine + Rituximab, or Ibrutinib in Patients with Previously Treated B-Cell Lymphoma (CITADEL-112): Preliminary Safety Results (Abstract #P1102. Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical)

inMIND: A Phase 3 Study of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo Plus Lenalidomide and Rituximab for Relapsed/Refractory Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) (Abstract #P1103. Session: Indolent and mantle-cell non-Hodgkin lymphoma – Clinical)

Real-Life Effectiveness and Safety Outcomes of Ponatinib Treatment in Patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (PH+ALL): 5-Year-Data from a Belgian Registry (Abstract #P699. Session: Chronic myeloid leukemia – Clinical)

Dose Modification Dynamics of Ponatinib in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) from the PACE and OPTIC Trials2 (Abstract #P707. Session: Chronic myeloid leukemia – Clinical)

All (e)Poster presentations will be made available as of Friday, June 10, 2022, at 3:00 a.m. EST and will be accessible for on-demand viewing until Monday, August 15, 2022, on the Congress platform. For full session details and data presentation listings, please see the EHA (Free EHA Whitepaper)2022 online program (View Source).

About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF, for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older and for the treatment of chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi (ruxolitinib) outside the U.S. Jakafi is a registered trademark of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the U.S.

About Tafasitamab (Monjuvi / Minjuvi)
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S. and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

About Ponatinib (Iclusig) Tablets
Ponatinib (Iclusig) targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Click here to view the Iclusig EU Summary of Medicinal Product Characteristics.

Incyte has an exclusive license from Takeda Pharmaceuticals International AG to commercialize ponatinib in the European Union and 29 other countries, including Switzerland, UK, Norway, Turkey, Israel and Russia. Iclusig is marketed in the U.S. by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

About Parsaclisib
Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in non-Hodgkin lymphomas and autoimmune hemolytic anemia, and in combination with ruxolitinib and tafasitamab for myelofibrosis and non-Hodgkin lymphomas, respectively.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

On May 26, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported new clinical data for the HER2-targeted bispecific antibody zanidatamab in both HER2-positive breast cancer and gastric/gastroesophageal junction adenocarcinoma (Press release, Zymeworks, MAY 26, 2022, View Source [SID1234615109]). The data are being presented in two separate poster sessions at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting June 3-7, 2022 in Chicago, IL.

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"These encouraging new data sets presented at ASCO (Free ASCO Whitepaper) provide further validation of zanidatamab’s potential in the treatment of advanced HER2-positive cancers and follow the release of other promising data in gastroesophageal and breast cancer in 2021," said Neil Josephson, M.D., Chief Medical Officer at Zymeworks. "These new data continue to demonstrate the potential for zanidatamab to be an important advancement in the treatment of a wide range of HER2-expressing cancers, including in first-line treatment regimens."

The presentations detailed below are available to conference registrants on the ASCO (Free ASCO Whitepaper) conference website as well as to the general public at www.zymeworks.com/publications.

Poster Session: Zanidatamab in Combination with Chemotherapy and Tislelizumab in HER2-Positive Gastric/Gastroesophageal Junction Cancer – Clinical Results – Saturday, June 4, 08:00-11:00 am CDT

Zanidatamab, a HER2-targeted bispecific antibody, in combination with chemotherapy and tislelizumab as first-line therapy for patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GJEC): Preliminary results from a Phase 1b/2 study

Presenter: Keun Wook Lee, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea

Over one million patients are diagnosed with gastric cancer every year worldwide, and it is the fourth most common cause of cancer-related deaths1. Human epidermal growth factor receptor 2 (HER2)-positive disease accounts for 15–25% of gastric cancers2. For these patients, trastuzumab in combination with chemotherapy is the global standard of care treatment but with an expected overall survival of less than 18 months, there remains a significant unmet need.

1
Globocan 2020. Available at: View Source Accessed April 2022

2
Nakamura Y, et al. Nat Rev Clin Oncol 2021;18:473–87

In 33 response-evaluable patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma treated with zanidatamab and tislelizumab in combination with the CAPOX chemotherapy regimen the cORR was 75.8% (25/33). The DCR was 100% (33/33) and duration of response (DOR) ranged from 2.1+ to 18.2+ months. Twenty patients (61%) remain on study at the time of data cut-off.

In addition, the data demonstrate that zanidatamab and tislelizumab in combination with the CAPOX chemotherapy is generally well tolerated, with the majority of treatment-related adverse events (TRAEs) considered mild to moderate in severity (Grade 1 or 2). The most common grade ≥ 3 TRAE was diarrhea, which was manageable in the outpatient setting; introduction of prophylactic loperamide reduced the incidence from 33% to 21%. Immune mediated adverse events occurred in 27% of patients, including ≥ Grade 3 events in 21% of patients and resulted in discontinuation of tislelizumab in 3 patients (9%). This manageable safety profile compares favorably to the current standard of care as well as to emerging treatments and is consistent with previous reports.3

This new data set further supports the launch of Zymeworks’ global Phase 3 study (HERIZON-GEA-01; NCT05152147), which is investigating zanidatamab in combination with chemotherapy with or without tislelizumab for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive gastroesophageal adenocarcinoma. Zymeworks, along with its Asia-Pacific partner BeiGene, plan to enroll 714 patients at approximately 300 sites across 38 countries. Enrollment is expected to be completed by the end of 2023. The study design will be presented in a Trials in Progress poster (Poster ID: P-26) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain from June 29-July 2, 2022. The presentation will be available to conference registrants on the conference website as well as to the general public at www.zymeworks.com/publications at the time of presentation at the conference.

Poster Session: Zanidatamab in Combination with Docetaxel in HER2-Positive Breast Cancer – Clinical Results – Monday, June 6, 08:00-11:00 am CDT

Zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study

Presenter: Keun Seok Lee, National Cancer Center, Center for Breast Cancer, Goyang, Republic of Korea

Worldwide, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer deaths in women, with over 650,000 deaths in 20201,4. HER2-positive breast cancer accounts for approximately 20% of all breast cancers5,6,7. Though HER2-targeted agents have improved outcomes in HER2-positive breast cancer, most patients treated for advanced disease eventually relapse and develop resistant disease8,9.

In 21 response-evaluable patients with advanced HER2-positive breast cancer treated with zanidatamab and docetaxel the cORR was 90.5%, with 15 patients (78.9%) having an ongoing response at the time of the data cut. The median follow-up was 7.0 months (range 1.1-17.4 months) and the six-month progression-free survival rate was 95.2%.

3
Ku G, et al. Ann Oncol 2021;32:S1044

4
Bray F, et al. CA Cancer J Clin 2018; 68:394–424

5
Harris L, et al. J Clin Oncol 2007; 25(33)

6
Wolff AC, et al. Arch Pathol Lab Med 2007; 131(1):18–43

7
Giordano SH, et al. J Clin Oncol 2014;32(19):2078–99

8
Ayoub NM, et al. Breast Cancer 2019:11;53–69

9
Rier HN, et al. Oncologist 2017;22:901–9

The combination of zanidatamab and docetaxel had a manageable safety profile with the incidence of TRAEs consistent with standard of care therapy. The most common TRAEs were neutrophil count decreased (13 patients; 54.2%), diarrhea (13 patients; 54.2%), and anemia (nine patients; 37.5%), and the most common ≥ Grade 3 TRAEs were neutrophil count decreased (12 patients; 50.0%), diarrhea (3 patients; 12.5%), and white blood cell count decreased (2 patients; 8.3%).

"We will continue to support ongoing R&D efforts to generate and report robust data highlighting and reinforcing the potential applications of our therapeutics and technology platforms in the treatment of a wide range of diseases," said Kenneth Galbraith, Chair and CEO of Zymeworks. "We remain focused on exploring potential research and collaboration opportunities that can lead to a broader portfolio of innovative therapies for patients in need around the world with difficult-to-treat cancers."

Conference Call and Webcast

Zymeworks will host a conference call and webcast on Monday, June 6th at 4:30 pm ET to discuss the clinical data presented at ASCO (Free ASCO Whitepaper) and provide an overview on the clinical development strategy for zanidatamab. The event will be led by Kenneth Galbraith, Zymeworks’ Chair and CEO, and Neil Josephson, M.D., Zymeworks’ Chief Medical Officer. Members of Zymeworks’ executive team will be available to answer questions at the conclusion of the call.

Interested parties can access the live webcast via the Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

On May 26, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Shakeel Modak, MD from Memorial Sloan Kettering ("MSK") will present results from the naxitamab-based chemoimmunotherapy trial in patients with chemoresistant high-risk neuroblastoma ("HR-NB"), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held June 3-7, 2022 (Press release, Y-mAbs Therapeutics, MAY 26, 2022, View Source [SID1234615108]).

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This clinical trial studied the combination of Humanized anti-GD2 antibody naxitamab, Irinotecan, Temozolomide and Sargramostim (GM-CSF), ("HITS") protocol, and included cohort of patients that were treated at MSK in a phase 2 protocol, and at Hospital Sant Joan de Déu ("HJSD") per protocol on compassionate use basis. Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities.

Eligibility criteria included evaluable or measurable chemoresistant disease. Prior anti-GD2 or irinotecan/temozolomide therapy was permitted. Each cycle, administered 3-5 weeks apart, comprised irinotecan, temozolomide, naxitamab and GM-CSF. The primary endpoint of the phase 2 trial at MSK was complete response ("CR") and partial response ("PR") after 4 cycles.

Of 90 previously heavily treated patients, (38 at MSK in the phase 2 trial, and 52 at HJSD), eight had HR-NB refractory to induction chemotherapy and 82 had up to six prior relapses.

The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate ("ORR") according to the International Neuroblastoma Response Criteria ("INRC") of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease ("PD"). In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue (48%) and skeletal MIBG uptake (66%). CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42% (five out of 12 patients).

Toxicities included myelosuppression and diarrhea as expected with irinotecan/temozolomide, pain and hypertension as expected with naxitamab, plus febrile neutropenia. No other >grade 2 unexpected toxicities occurred, and the treatment was outpatient. In this trial, human anti-human antibody did not develop in any of the 50 patients providing samples for testing.

"We are very pleased to present data for the HITS protocol," stated Thomas Gad, Founder, President and Interim CEO. "Responses in patients with relapsed or progressive high-risk neuroblastoma are challenging, as chemo-resistant disease is considered an obstacle, so we are excited to see this study met its primary endpoint. This further demonstrates the potential role for DANYELZA in HR-NB. No other GD2 antibody has been studied in such a heavily pre-treated patient population."

Researchers at Memorial Sloan Kettering Cancer Center MSK developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in two upcoming investor conferences (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615107]). Veracyte will present at the William Blair 42nd Annual Growth Stock Conference on Wednesday, June 8, and will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Monday, June 13 .

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Event: William Blair 42nd Annual Growth Stock Conference
Date: Wednesday, June 8, 2022
Time: 10:40 a.m. PT / 1:40 p.m. ET

Event: Goldman Sachs 43rd Annual Global Healthcare Conference
Date: Monday, June 13, 2022
Time: 2:40 p.m. PT / 5:40 p.m. ET

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from a large, population-based study reinforce the clinical utility of the Decipher Prostate genomic classifier (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615106]). The findings, which will be shared for the first time at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, suggest that the Decipher Prostate tests are helping to guide prostate cancer treatment decisions and improve patient care.

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"This is the first study linking patient data from SEER, the most commonly used cancer database in the United States, and the Decipher Prostate genomic classifier, to explore the association between Decipher Prostate test results and prostate cancer treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s medical director for urology and an author on the study. "The resulting data are exciting, because they demonstrate that population-based prostate cancer treatment patterns are independently associated with Decipher classifier scores."

Researchers identified 10,528 patients with a primary prostate cancer diagnosis from 2010 to 2018 in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database who had undergone testing with either Decipher Prostate Biopsy (n=5,015) or Decipher Prostate RP (n=5,513) between 2014 and 2020. They then evaluated the association between these patients’ Decipher scores (range 0-1) and risk groups (low, intermediate and high), and the use of active surveillance and watchful waiting (AS/WW) as well as adverse pathology at the time of radical prostatectomy (RP).

Results show that use of AS/WW was highest among those men with low risk Decipher Prostate Biopsy results (41%), as compared to men who had intermediate (32%) or high risk (17%) Decipher scores. Conversely, RP usage increased based on individuals’ Decipher test risk group (19% of low, 25% of intermediate, and 34% of high risk). Researchers observed a similar association and trend by Decipher risk group in the use of radiation therapy (13% of low, 19% of intermediate, and 29% of high Decipher risk).

"These findings provide a powerful demonstration that the Decipher Prostate genomic classifiers are giving physicians and patients valuable information to help them make important and often challenging treatment decisions. In other words, the test is positively impacting patient care, as intended," said Dr. Davicioni. "We are thrilled to be collaborating with the National Cancer Institute’s SEER program and academic researchers from leading comprehensive cancer centers and believe that these data will substantially enrich SEER’s prostate cancer registry and provide a valuable resource for oncology researchers."

About Decipher Prostate

Decipher Prostate is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis (Decipher Prostate Biopsy) and after surgical removal of the prostate (Decipher Prostate RP). The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.