On June 3, 2022 During the scientific program of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, principal investigators from US Oncology Research, The US Oncology Network (The Network) and Ontada reported that it will present detailed results from more than 80 studies (Press release, US Oncology, JUN 3, 2022, View Source [SID1234615521]). Presentations include 10 oral sessions on topics including lung and ovarian cancers, as well as research involving value-based care and the use of health technologies. The ASCO (Free ASCO Whitepaper) Annual Meeting, a leading conference delivering the latest in cancer science to the global community, will be held June 3-7, 2022 in Chicago.

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"The oncology community is constantly transforming, and past discoveries provide rationale for the community structures we have today, but new challenges, like changes in the healthcare landscape, will always present themselves," said Robert L. Coleman, MD, chief scientific officer, US Oncology Research. "The strengths of community-based research and dedication to improving patients’ outcomes and cancer care experience provide the tenacity needed to turn these challenges into opportunities. Our team of community-based researchers are committed to advancing research, offering ways for patients to receive care from virtual locations, and making access to leading treatments possible for a myriad of patients more than ever before."

MYLUNG Consortium Data to be Highlighted in Two Presentations

Included in the research presentations during this year’s meeting will be findings from Protocol 2 of the Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG Consortium) clinical trial platform in non-small cell lung cancer (Abstract #1503), which will be presented during an oral session by Elizabeth Koselke, PharmD, BCOP, senior clinical pharmacist with The Network. Protocol 2 of the study platform included an examination of an oncology clinical pharmacist on the research team and the impact on clinical trial enrollment. The abstract "Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The US Oncology Network’s MYLUNG Consortium," will be featured in the "Care Delivery and Regulatory Policy" session on Monday, June 6 at 4 p.m.

"This is one of the first studies that looked at the effectiveness of pharmacists in this role," said Koselke. "Pharmacists are uniquely positioned to make an impact on all aspects of care, including potentially identifying a patient who may qualify for a clinical study. Enrolling clinical studies has become more challenging, and community research teams need to be more efficient when identifying potential candidates in order to generate meaningful advances at a faster rate. Our hope is that the impact seen within the MYLUNG Consortium will advance how we think and assemble clinical research teams."

In addition to the oral presentation, Nicholas Robert, MD, chief medical officer of Ontada, will lead a poster presentation (Abstract #9004) from a retrospective study of MYLUNG Consortium Protocol 1. The abstract, "Predictors of biomarker testing among patients (pts) with metastatic non-small cell lung cancer (mNSCLC)," analyzes the impact of clinical and/or social factors (such as race, histology and clinical practice size) on undertested populations. These data will be presented during the "Lung Cancer—Non-Small Cell Metastatic" session, which will be held Monday, June 6 at 8 a.m.

Additional Featured Research Selected for Presentation

An oral presentation (Abstract #LBA5500) on a phase 3 study evaluating rucaparib monotherapy titled, "ATHENA–MONO (GOG-3020/ENGOT-ov45): A randomized, double-blind, phase 3 trial evaluating rucaparib monotherapy versus placebo as maintenance treatment following response to first-line platinum-based chemotherapy in ovarian cancer," was co-authored by Dr. Coleman. These data will be presented during the "Gynecologic Cancer" session on Monday, June 6 at 8 a.m.

"Survivorship of women with advanced ovarian cancer has improved, primarily the result of two key agents, bevacizumab and the Poly (ADP-ribose) polymerase (PARP) inhibitors. In the ATHENA trial, we demonstrate the substantial efficacy and safety of a third agent (rucaparib) for primary maintenance treatment," said Dr. Coleman. "Our team looks forward to presenting our findings involving PARP inhibitors and immune checkpoint inhibitors and their potential as therapeutic options for patients in this population."

Alexander I. Spira, MD, PhD, FACP, director of the thoracic and Phase I program for Virginia Cancer Specialists, a practice in The Network, will have an oral presentation (Abstract #9002) on the effect of adagrasib (MRTX849) in patients with NSCLC titled, "KRYSTAL-1: Activity and safety of adagrasib (MRTX849) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation." These data will be presented during the "Lung Cancer—Non-Small Cell Metastatic" session on Friday, June 3 at 1:24 p.m.

Additional key NSCLC data presentations involving Dr. Spira’s research include a late breaking abstract (#LBA9009) titled "Activity of adagrasib (MRTX849) in patients with KRASG12C-mutated NSCLC and active, untreated CNS metastases in the KRYSTAL-1 trial," which is being held during the "Including the Excluded: Advancing Care for All Patients With Lung Cancer" clinical symposium on Monday, June 6 at 4:30 p.m. Dr. Spira was also involved in the research featured in (Abstract #9008), "Amivantamab in patients with NSCLC with MET exon 14 skipping mutation: Updated results from the CHRYSALIS study," selected for oral presentation during the "Lung Cancer—Non-Small Cell Metastatic" session, which will be held on Friday, June 3 at 3:24 p.m.

"Immunotherapy research will ultimately lead to greater knowledge and more precise treatments for patients," said Dr. Spira. "There is still so much to learn in the area of precision oncology and targeted therapies in NSCLC, and we are constantly working towards ways to develop new and effective therapies that can create better outcomes for patients. The vital research showcased in this clinical symposium and oral presentations on the effect of adagrasib (MRTX849) and amivantamab in patients with NSCLC will help inform the clinical development of these targeted therapies and explain their potential clinical utility and promise."

Featured Health Technology-Related Research

An oral presentation (Abstract #1507) evaluating health technologies and their impact on quality of care and health disparities was co-authored by Debra Patt, MD, PhD, MBA, executive vice president of public policy, payer relations and strategic initiatives at Texas Oncology, a practice in The Network. The presentation titled, "Evaluating mass implementation of digital health solutions to improve quality and reduce disparities in a large multisite community oncology practice," will be presented during the "Care Delivery and Regulatory Policy" session on Monday, June 6 at 5:12 p.m.

"Digital health solutions engage patients with our clinical teams and improve patient care," said Dr. Patt. "These solutions reduce response time for symptomatic patients and improve transparency and health literacy improving the partnership between our clinical teams and the patients we serve. Digital health solutions are of great value for all patients, especially those classified as ‘at risk’. I am grateful to be part of a practice leading some of these important efforts."

An abstract (#1521) evaluating the usage of a machine learning (ML) model titled "The initial outcome of deploying a mortality prediction tool at community oncology practices," will be presented during the "Care Delivery and Regulatory Policy" poster session. The ML model predicted 90-day mortality risk for patients with metastatic cancer and was designed to facilitate earlier end-of-life discussions, including hospice care, with the patients. These results, researched by members of The US Oncology Network, will be delivered on Saturday, June 4 at 1:15 p.m.

"Aligning care at the end of life with patients’ goals and values helps reduce the likelihood of undesirable hospitalization, ICU stays and side effects of therapy," said Ping Ye, PhD, a senior data scientist for The Network. "We deployed a predictive mortality tool to The Network practices to help physicians proactively initiate care discussions earlier with identified patients, allowing them access to care aligned with their wishes as they near life’s final stages."

On June 3, 2022 Scandion Oncology (Scandion), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported that it will on June 10, 2022, at 11:00 CET host a webcast and conference call (Press release, Scandion Oncology, JUN 3, 2022, View Source;2022,c3580063 [SID1234615520]). Here, the company’s Executive Management will present the Rights Issue announced on June 1, 2022.

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REPLAY access:

Webcast replay will be available at View Source in the Investors section and at View Source

The information was provided by the contact person above for publication on June 3, 2022 at 14.30 CET.

On June 3, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported the publication of data reinforcing the clinical utility of the Decipher Prostate genomic classifier for helping to guide the timing and intensity of therapy in men experiencing prostate cancer recurrence following radical prostatectomy (RP) (Press release, Veracyte, JUN 3, 2022, View Source [SID1234615519]). The findings, from an ancillary study of the prospective open-label, multicenter, randomized phase 3 SAKK 09/10 trial conducted at 28 centers in Belgium, Germany, and Switzerland, appear in Annals of Oncology.

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It is estimated that more than 40 percent of men with intermediate- or high-risk prostate cancer may experience a biochemical disease recurrence after RP, which is characterized by rising levels of serum prostate-specific antigen (PSA). For men who experience a rising PSA, determining the optimal timing to initiate salvage radiotherapy (SRT) and whether to add androgen deprivation therapy (ADT) to SRT is challenging. This decision is important in part because the side effects of ADT when given concurrently with SRT are often difficult for patients to manage and are associated with long-term cardiovascular impact of hormone therapy.

"Each year in the United States, tens of thousands of men are diagnosed with biochemically recurrent prostate cancer, yet conventional clinical measures such as PSA and Gleason score are often insufficient to predict which of them will do well with SRT alone and who will need more intensive therapy to improve their oncologic outcomes," said Elai Davicioni, Ph.D., Veracyte’s medical director for urology. "The data from this study suggest that the Decipher Prostate genomic classifier can help fill this gap by providing objective information to guide customized treatment planning in the postoperative setting."

Researchers in the Swiss Group for Clinical Cancer Research (SAKK) and collaborating cancer centers assessed the clinical outcomes and Decipher Prostate genomic risk for 226 prostate cancer patients from the SAKK 09/10 trial, which randomized patients to standard vs. dose-escalated SRT. This study involved men experiencing a rise in PSA following RP, all of whom received SRT without the addition of ADT. Patients in the Decipher Prostate analysis were followed for a median of 6.3 years.

Findings suggest that Decipher Prostate can identify the patients who are at highest risk of cancer progression following RP and would benefit from earlier, more intensive treatment. Patients with a high Decipher score were more than twice as likely than those with a lower Decipher score to experience biochemical and clinical progression, and to receive long-term salvage hormone therapy. Additionally, patients with high Decipher scores had markedly improved outcomes when treated with SRT when the PSA burden was still low as compared to late SRT, when PSA levels have already risen.

"These findings add meaningfully to the existing literature supporting the use of the Decipher Prostate RP test in postoperative decision-making. Decipher Prostate RP is the only genomic test backed by evidence from randomized Phase 3 trials and we look forward to our continued collaboration with the SAKK team, with studies aimed at further elucidating the subset of men that benefit most from dose-escalation," said Dr. Davicioni.

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. Decipher Prostate is available as part of Veracyte’s CLIA-validated laboratory developed test (LDT) service. This test has not been cleared or approved by the FDA.

On June 3, 2022 OncXerna Therapeutics, Inc. ("OncXerna"), a precision medicine company using an innovative RNA-expression based biomarker platform to predict patient responses to its targeted oncology therapeutic candidates, reported new clinical data from an investigator-sponsored Phase 2 trial evaluating bavituximab combined with chemoradiation and adjuvant temozolomide in newly diagnosed glioblastoma (GBM) patients (Press release, OncXerna Therapeutics, JUN 3, 2022, View Source [SID1234615518]). The data, which show that the trial met its primary endpoint, will be featured in a poster at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place both virtually and in-person at the McCormick Place Convention Center in Chicago, Illinois.

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Bavituximab is a potentially first-in-class phosphatidylserine (PS) inhibitor designed to reverse immune suppression. The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP)-funded Phase 2 investigator-sponsored trial that will be featured in the ASCO (Free ASCO Whitepaper) poster was an open-label, single-arm study in newly diagnosed IDH wild-type GBM patients that was designed to evaluate the safety and efficacy of bavituximab combined with chemoradiation and adjuvant temozolomide. Per the trial protocol, success on the primary endpoint was defined as a twelve-month overall survival rate (OS-12) of greater than or equal to 72% in evaluable patients.

"Novel approaches are needed to treat GBM, as the current standard-of-care of chemoradiation and temozolomide has historically provided an OS-12 of only 60%," said Elizabeth Gerstner, M.D., Mass General Cancer Center, the study’s lead investigator. "The Phase 2 results being presented at ASCO (Free ASCO Whitepaper) suggest bavituximab modulates the immunosuppressive GBM microenvironment, demonstrating its on-target effects. The OS-12 of evaluable patients exceeded both the study’s pre-specified criteria and the historical benchmark. Improved survival also correlated with positive changes in tumor immune cell gene expression and reductions in cerebral blood flow, which indicates that bavituximab was a contributor to treatment response and supports continued clinical evaluation in GBM."

Key data and conclusions from the ASCO (Free ASCO Whitepaper) poster include:

Efficacy data in evaluable patients (N = 33, median age of 59)

OS-12: 73% (95% confidence interval: 59% – 90%)
Median progression-free survival (PFS): 6.9 months (95% confidence interval: 6.2 – 9.7 months)
Median overall survival (OS): 15.4 months (95% confidence interval: 13.3 – 23.6 months)
Disease control rate: 91% (30/33)
Overall response rate: 12% (4/33)
Safety findings:

The studied combination was generally well tolerated. There were eight grade 3 or 4 adverse events (AEs) and no grade 5 AEs observed.
Immune profile and MRI assessments:

A statistically significant reduction of pro-tumor, immunosuppressive, myeloid-derived suppressor cells (MDSCs) was observed post-treatment
Tumor samples from patients with longer PFS and OS showed a significantly positive shift in myeloid-related gene expression
The studied combination was shown to have anti-angiogenic effects as evidenced by a post-treatment decrease in relative cerebral blood flow
Laura Benjamin, Ph.D., Chief Executive Officer of OncXerna Therapeutics, commented, "Confirming the on-target effect of bavituximab in modulating the GBM immune microenvironment is a significant finding that suggests combining bavituximab with an immune checkpoint inhibitor is a reasonable potential next step in its development. Incorporating our Xerna TME panel prospectively in a future study may further enable us to understand which patients would most likely benefit from this treatment approach as well as bavituximab’s potential to significantly improve outcomes in a setting where new treatment options are desperately needed. We look forward to discussing these latest Phase 2 data with key thought leaders as we assess next steps for bavituximab in GBM."

The Xerna TME Panel is OncXerna’s novel RNA gene expression-based diagnostic panel. It uses a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). By utilizing the Xerna TME Panel, OncXerna aims to match a specific patient’s tumor with the drugs best suited to treat that tumor.

The ASCO (Free ASCO Whitepaper) poster (# 368), entitled, Phase 2 Trial of Bavituximab with Chemoradiation and Adjuvant Temozolomide in Newly Diagnosed Glioblastoma, will be presented during the ASCO (Free ASCO Whitepaper) Annual Meeting’s "Central Nervous System Tumors" poster session, which is taking place on June 5, 2022, beginning at 8:00 a.m. CT (9:00 a.m. ET). Following its presentation at the conference, a copy of the poster will be available on the OncXerna website here.

About the Phase 2 Trial

This study is one of three investigator-sponsored studies funded through a collaboration between the NCCN ORP and OncXerna Therapeutics. The investigator-sponsored study was led by Elizabeth Gerstner, M.D., Mass General Cancer Center. The Phase 2 trial was an open-label, single-arm study designed to evaluate the safety and efficacy of bavituximab with chemoradiation and adjuvant temozolomide in adult patients with newly diagnosed glioblastoma. The trial included 33 evaluable patients who were treated with bavituximab weekly, temozolomide daily, and chemoradiotherapy in accordance with hospital guidance. The primary endpoint of the trial was OS-12, with the trial’s pre-specified statistical analysis plan indicating an OS-12 greater than or equal to 72% would result in the null hypothesis being rejected. Secondary endpoints included progression-free survival, overall survival, radiographic response, and toxicity assessments. Exploratory assessments evaluated the immune profile in tumor tissue and peripheral blood mononuclear cells with treatment and the impact of treatment on relative cerebral flood flow. For more information, see ClinicalTrials.gov Identifier: NCT03139916.

About Bavituximab

Bavituximab is an antibody designed to reverse immune suppression by inhibiting phosphatidylserine (PS) signaling. The mechanism of action of bavituximab is to block tumor immune suppression signaling from PS to multiple immune cell receptor families (e.g., TIMs and TAMs). This biology is relevant across multiple types of solid tumors. A Phase 2 clinical trial is evaluating the combination of bavituximab with KEYTRUDA to test the hypothesis that relieving immunosuppression can enhance responses to checkpoint inhibitors. Bavituximab is an investigational agent that has not been approved, and it has not been demonstrated to be safe or effective for any use, including for the treatment of advanced gastric cancer.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About the Xerna TME Panel

The Xerna TME Panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients based on the interplay between angiogenic and immunogenic dominant biologies of the tumor microenvironment (TME). The Xerna TME Panel is an investigational assay that has not been approved and has not been demonstrated to be safe or effective for any use.

On June 3, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported data from a Phase 1 study demonstrating efficacy proof-of-concept of the Company’s lead program, ST101, in patients with refractory solid tumors (Press release, Sapience Therapeutics, JUN 3, 2022, View Source [SID1234615517]). The data will be presented in a poster discussion session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 5, 2022.

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ST101, a first-in-class peptide antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). The primary objectives of the Phase 1 clinical study were to evaluate the safety and tolerability of ST101 and to determine the recommended Phase 2 dose. Secondary and exploratory objectives included pharmacokinetics (PK), preliminary efficacy (RECIST 1.1), and pharmacodynamic (PD) evaluation. The study used a 3+3 dose-escalation design, with once-weekly IV infusion dosing of ST101 at 0.5, 1, 2, 4, 6, 9 mg/kg or a flat dose of 500 mg.

Phase 1 Study Results:

As of May 5, 2022, 25 patients with multi-metastatic disease that were refractory to standard therapy received a median of 8 weeks of treatment
Three patients show ongoing clinical benefit:
One confirmed PR lasting more than 51 weeks in a patient with cutaneous melanoma
Eight patients with varying histologies had stable disease lasting 9-81+ weeks (2 ongoing)
No DLTs, dose modifications, or serious adverse events (SAEs) related to ST101
Pharmacokinetics and pharmacodynamics support the selection of a 500 mg flat dose as the recommended Phase 2 dose
Dr. Alice Bexon, Sapience’s Chief Medical Officer, commented, "We remain extremely pleased with the safety and efficacy ST101 has demonstrated in Phase 1, with evidence of clinical benefit across the whole dose range explored, particularly at higher doses and in patients with melanoma. The Phase 2 expansion portion of the study is going very well, with all cohorts enrolling, and a confirmed partial response in a patient with recurrent glioblastoma, which is very exciting. We believe that ST101’s unique mechanism of action targeting C/EBPß represents a potentially transformative approach to treating cancer."

+indicates ongoing treatment

SD=stable disease
PR=partial response

Details of the poster presentation at ASCO (Free ASCO Whitepaper) 2022 are as follows:

Abstract Number: 3014
Title: Efficacy proof-of-concept from a phase 1 study of a novel therapeutic peptide, ST101, targeting the oncogenic transcription factor C/EBPβ in patients with refractory solid tumors
Session Title/Track: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Session Type: Poster Discussion Session
Date/Time: June 5, 2022, 2:30 PM CDT

Abstracts and full session details can be accessed through the ASCO (Free ASCO Whitepaper) meeting planner: Abstracts | ASCO (Free ASCO Whitepaper) Annual Meeting

About ST101 and the Phase 1-2 Study
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.