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Epizyme Announces Data from TAZVERIK® (Tazemetostat) Clinical Programs to be Presented During Poster Sessions at 2021 ESMO Virtual Congress

On September 14, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that clinical data will be presented at the upcoming 2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress, taking place on September 16-21, 2021 (Press release, Epizyme, SEP 14, 2021, View Source [SID1234587681]).

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At the conference there will be two posters on two of the trials examining tazemetostat use in solid tumors. One details updated data from the ongoing safety run-in portion of the EZH-1101 prostate cancer study evaluating tazemetostat in combination with either abiraterone/prednisone or enzalutamide. The second poster describes the ongoing study investigating tazemetostat’s use in combination with other agents to treat solid tumors.

"Consistent with the preliminary data we shared during our Next Episode vision call earlier this year, the data presented at ESMO (Free ESMO Whitepaper) from our EZH-1101 study suggest tazemetostat combinations in prostate cancer led to a subset of patients having durable ≥50% decline in prostate-specific antigen levels (PSA50) with one patient having a radiographic tumor response," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "We are encouraged to see the progression free survival data with a follow-up of almost two years in the safety run-in, and this data, while still maturing, will be shown in the poster session. Additionally, the adverse events data with the combination treatment were consistent with the known safety profile of the individual agents with no new safety signals. The randomized portion of the EZH-1101 study is ongoing with more than one-third of patients enrolled to date. This study is one part of our overall program exploring tazemetostat as both monotherapy and in combinations across multiple hematologic and solid tumor cancers."

Details of the presentations are listed below:

ESMO Poster Presentations

Title: Safety of Tazemetostat in Combination With Abiraterone/Prednisone or Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
Presenters: Wassim Abida, MD, PhD; Daniel Saltzstein, MD
Abstract Code: 586P
Title: Trial in Progress: Tazemetostat in Combination With a PARP Inhibitor or Durvalumab in Patients With Solid Tumors
Presenter: Charles M. Rudin, MD, PhD; Robert L. Coleman, MD
Abstract Code: 1870TiP
The ESMO (Free ESMO Whitepaper) abstracts are available at View Source All oral and poster presentations will be available on the ESMO (Free ESMO Whitepaper) website on Thursday, September 16, 2021 8:30 a.m. CEST / 2:30 a.m. ET.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com

Seneca Therapeutics, Inc. Announces Novel SVV-001 Patient Screening Test For Patient Selection With SVV-001 Therapy

On September 14, 2021 Seneca Therapeutics, Inc. ("STI"), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics for cancer based on Seneca Valley Virus (SVV-001), reported the successful development of a novel SVV-001 Patient Screening Test (Press release, Seneca Therapeutics, SEP 14, 2021, View Source [SID1234587680]). The test uses a unique set of genes to predict sensitivity to SVV-001 in tumor cells obtained from patient samples. The SVV-001 Patient Screening Test can be used on Formalin-Fixed-Paraffin-Embedded (FFPE) tumor blocks allowing for patient screening using previous biopsies. The SVV-001 Patient Screening Test will identify which cancer patients will benefit from SVV-001 treatment either as monotherapy or in combination with other immune therapies like checkpoint inhibitors. The SVV-001 Patient Screening Test can also be used to identify types of cancer patients that will benefit from SVV-001. The test can be used to screen patients for products in the SVV-001 based Armed Construct Cancer Gene Therapy Portfolio currently in development. The selection of patients using the SVV-001 Patient Screening Test will be applicable whether the patient is treated with either the Intra-tumoral or Intravenous route of administration. The SVV-001 Patient Screening Test will be available through CLIA laboratories.

"Using the SVV-001 Patient Screening Test to select patients, it will be possible to identify and select cancer patients that will benefit from SVV-001 therapy either as monotherapy, combination therapy with check point inhibitors or therapy using SVV-001 Armed Constructs," said Dr. Paul Hallenbeck, CSO, President and Founder of Seneca Therapeutics. "We are excited that this pre-screening test offers the ability to selectively identify which patients will likely benefit from SVV-001."

Seneca Therapeutics is also using the SVV-001 Patient Screening Test to identify relevant cancer patient populations that could benefit from SVV-001 therapy. The company recently screened nearly 300 sarcoma samples and determined that more than 94% were sensitive to SVV-001 therapy. The work to screen other cancers for SVV-001 sensitivity is ongoing.

Novocure Announces Clinical Trial Collaboration with Roche to Evaluate Tumor Treating Fields as Part of a Novel Combination for the First-line Treatment of Metastatic Pancreatic Cancer

On September 14, 2021 Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with Roche (SIX: RO. ROG; OTCQX: RHHBY), to develop Tumor Treating Fields (TTFields) together with Roche’s anti-PD-L1 therapy, atezolizumab, in metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, NovoCure, SEP 14, 2021, View Source [SID1234587679]).

Pancreatic ductal adenocarcinoma (PDAC) is the most common type of pancreatic cancer and accounts for 85%–95% of all solid pancreatic tumors. As a highly lethal malignancy, it is the seventh leading cause of cancer death worldwide and is responsible for more than 300,000 deaths per year. PDAC is highly resistant to current therapies, affording patients a 5-year overall survival rate of only 7.2%.

"We are pleased to collaborate with Roche, a global leader in oncology, to explore the efficacy of TTFields together with atezolizumab immunotherapy in pancreatic cancer," said William Doyle, Novocure’s Executive Chairman. "The immune-shielded environment of the pancreas has proved challenging for immunotherapies alone to provide benefit. Our phase 2 pilot trial with Roche will study the ability of TTFields together with atezolizumab to improve clinical outcomes for patients with this deadly disease."

The phase 2 study was designed to test the safety and efficacy of TTFields together with atezolizumab, gemcitabine and nab-paclitaxel as a first-line treatment for mPDAC. The study is designed to enroll approximately 75 patients in the EU and United States. The primary endpoint of the study is disease control rate by RECIST 1.1. The secondary endpoints include overall survival, progression free survival, one year survival, objective response rate, PFS at six months, duration of response, and toxicity profile. Novocure is the study sponsor and Roche is providing atezolizumab for the trial.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs. Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference. All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane. As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected.

Whether cells are healthy or cancerous, cell division, or mitosis, is the same. When mitosis starts, charged proteins within the cell, or microtubules, form the mitotic spindle. The spindle is built on electric interaction between its building blocks. During division, the mitotic spindle segregates the chromosomes, pulling them in opposite directions. As the daughter cells begin to form, electrically polarized molecules migrate towards the midline to make up the mitotic cleavage furrow. The furrow contracts and the two daughter cells separate. TTFields can interfere with these conditions. When TTFields are present in a dividing cancer cell, they cause the electrically charged proteins to align with the directional forces applied by the field, thus preventing the mitotic spindle from forming. Electrical forces also interrupt the migration of key proteins to the cell midline, disrupting the formation of the mitotic cleavage furrow. Interfering with these key processes disrupts mitosis and can lead to cell death.

TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields has demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

Veracyte Announces that New NCCN Guidelines Uniquely Recommend Use of Decipher Prostate Genomic Test Score to Guide Specific Treatment for Men Following Radical Prostatectomy

On September 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that its Decipher Prostate RP genomic classifier is uniquely recommended in the 2022 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Oncology to guide treatment decisions for men with prostate cancer (Press release, Veracyte, SEP 14, 2021, View Source [SID1234587678]). The new guidelines specifically recommend Decipher Prostate RP after radical prostatectomy and that men with high-risk scores (>0.6) should be strongly considered for salvage radiotherapy with the addition of concurrent hormone therapy, when early radiation therapy is missed.

"We are thrilled that Decipher Prostate RP is now recommended by the NCCN to guide specific treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, scientific and clinical operations, urologic cancers. "The NCCN’s designation is unique to Decipher Prostate RP and underscores the extensive clinical validation and clinical utility data behind the test. We believe this recommendation will ultimately enable more men to receive the treatment they need, while reducing unnecessary therapy."

The new NCCN recommendations are based on results of the NRG Oncology Phase 3 randomized controlled trial, RTOG 96-01. This study, which followed patients for a median of 12 years, demonstrated that Decipher risk results were associated with hormone therapy benefit, with Decipher high-risk men receiving greater absolute benefit from hormone therapy compared to Decipher low-risk men. In the subset of patients who received hormone therapy in addition to early salvage radiotherapy, Decipher high-risk men experienced improvements in distant metastasis, prostate cancer-specific mortality and overall survival, while Decipher low-risk men had good oncologic outcomes without hormone therapy.

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. 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.

SELLAS Life Sciences to Present at the 2021 Cantor Virtual Global Healthcare Conference on September 28th

On September 14, 2021 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel cancer immunotherapies for a broad range of indications, reported that Angelos Stergiou, MD, ScD. h.c., President and Chief Executive Officer of SELLAS, will present at the 2021 Cantor Global Healthcare Conference to be held virtually on Tuesday, September 28, 2021, at 4:00 p.m. ET (Press release, Sellas Life Sciences, SEP 14, 2021, View Source [SID1234587676]).

For more information about the conference, or to schedule a one-on-one meeting with SELLAS management, please contact your Cantor representative directly, or send an email to Cantor at [email protected] or KCSA Strategic Communications at [email protected].