On June 4, 2021 Lvgen Biopharma, a biotech company focused on developing innovative immuno-oncology therapeutics, reported that it will present a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), to be held in a virtual format from June 4 to 8, 2021 (Press release, Lyvgen Biopharma, JUN 4, 2021, View Source [SID1234583587]).

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The Trials in Progress poster presentation summarizes the safety profile, antitumor activity observed in a phase I clinical trial (NCT04130542) in collaboration with Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside of the U.S. and Canada. The trial is evaluating LVGN6051, a second generation 4-1BB (CD137) agonist antibody based on Lyvgen proprietary xLinkAb platform, as monotherapy or in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy, in adult patients with advanced malignancies. No MTD was reached at 7 mg/kg monotherapy and 4 mg/kg q3w monotherapy was determined as RP2D. Preliminary antitumor activity in late stage cancer patients was observed. Combination with pembrolizumab induced rapid antitumor responses in advanced cancer patients with immune-cold tumor or relapsed from prior immunotherapies.

Presentation Details:

Abstract title: Early safety and efficacy from a phase I open-label clinical trial of CD137 (4-1BB) agonistic antibody LVGN6051 as monotherapy and in combination with pembrolizumab.
Abstract number: 2521
Poster Session: Developmental Therapeutics—Immunotherapy
The 2021 ASCO (Free ASCO Whitepaper) Annual Meeting will take place virtually on June 4 – 8, 2021 via the ASCO (Free ASCO Whitepaper) website, View Source

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

About LVGN6051

LVGN6051 is xLinkAb anti-4-1BB (CD137) agonist mAb that has been designed to activate 4-1BB optimally in tumor microenvironment by targeting both 4-1BB and FcγRIIB. LVGN6051 strikes a balance between antitumor efficacy and safety by agonizing 4-1BB only in the presence of FcγRIIB, which is expressed on immune cells enriched in the tumor microenvironment, including B cells, dendritic cells and granulocytes.

On June 14, 2021 POINT Biopharma Inc. (POINT), a global radiopharmaceutical company dedicated to successfully delivering precision radioligand therapy to cancer patients, reported that it has successfully dosed multiple patients in its Phase 3 SPLASH study evaluating the efficacy of PNT2002, the Company’s investigational 177Lu-PSMA targeted radioligand therapy for patients with PSMA expressing metastatic castration resistant prostate cancer (mCRPC) who are not eligible for chemotherapy (Press release, Point Biopharma, JUN 4, 2021, View Source [SID1234583586]).

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The Phase 3 SPLASH study is a multi-center, randomized, open label assessment of PNT2002 in patients with mCRPC who have progressed on ARAT therapy and refuse or not eligible for chemotherapy. The study will commence with a single-arm dosimetry lead-in and expects to enroll a total of approximately 450 patients across North America, Europe and the UK. Patients will be randomized 2:1 with patients in arm A receiving PNT2002 and patients in arm B receiving either Abiraterone or Enzalutamide. The primary endpoint of the study is radiographic progression-free survival (rPFS). Key secondary endpoints include overall response rate (ORR), overall survival (OS), and pharmacokinetics (PK).

"We are pleased to announce dosing of patients in our Phase 3 SPLASH study, which represents a significant milestone for POINT. I am very proud of the work our clinical and CMC teams have done to bring us to this stage and believe that this study holds the potential to demonstrate an improvement against the current standard of care for patients with little to no current therapeutic options," said Joe McCann, Chief Executive Officer of POINT Biopharma. "It is exciting to be working on PSMA targeted radiopharmaceuticals, a technology which will likely continue to gain interest as results from studies like the VISION trial are published. We appreciate the collaboration and engagement from our trial investigators as well as the guidance from global key opinion leaders in the field."

The first patients in the trial were dosed last month by Dr. Luke Nordquist, Urologic Medical Oncologist, Urology Cancer Center & GU Research Network, Omaha, Nebraska, and Dr. Ebrahim Delpassand, Nuclear Medicine Physician, Excel Diagnostics and Nuclear Oncology Center, Houston, Texas. "There is a significant unmet need for therapeutic alternatives with a novel mechanism of action for patients with PSMA expressing mCRPC, particularly in advance of chemotherapy. The current standard of care is not sufficient for patients with this aggressive form of cancer," said Dr. Nordquist. "As a nuclear medicine physician with special interest in nuclear Oncology, I have seen an increasing demand and appreciation for this therapeutic modality and believe it holds much promise as the future of precision medicine," added Dr. Delpassand.

Additional information on the Phase 3 SPLASH study can be found at View Source

POINT Biopharma has entered into a definitive merger agreement with Research Alliance Corp. I (Nasdaq: RACA). Upon closing, the combined company is expected to be listed on Nasdaq under the ticker symbol "PNT". A full description of the terms of the business combination can be found in registration statement on Form S-4 filed with the SEC by RACA.

On June 4, 2021 Physicians from Dallas-based Texas Oncology and researchers from Seattle-based Navigating Cancer will present two posters highlighting the benefits of electronic patient management at the virtual 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which takes place June 4-8, 2021 (Press release, Navigating Cancer, JUN 4, 2021, View Source [SID1234583585]). The two poster presentations examine the impact that Navigating Cancer’s digital monitoring program, Health Tracker, has on symptom management for cancer patients at a large, multi-site community oncology practice.

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The first poster session titled, "Implementation of Electronic Patient-Reported Outcomes (ePROs) for Symptom Monitoring in a Large Multi-Site Community Oncology Practice," is part one of the Texas Two-Step study, a two-part (hybrid) implementation-effectiveness evaluation of ePROs. In part one of the Texas Two-Step study, researchers found that utilization of the ePRO tool can help provide just-in-time symptom management and, despite the challenges of the global COVID-19 pandemic on cancer practices, implementation of ePROs for digital symptom monitoring across a large multi-site statewide cancer practice is feasible, and compliance is high. Step two of the Texas Two-Step study will evaluate the impact ePROs have on healthcare resource utilization, time on therapy, and symptom control.

"The data shows that digital healthcare systems like Health Tracker can help clinicians manage their patients’ symptoms quickly and efficiently, potentially leading to improved clinical outcomes, fewer visits to emergency departments, higher patient satisfaction, and compliance with therapy," said lead author Debra Patt, M.D., Ph.D., MBA, medical oncologist and executive vice president, public policy, and strategic initiatives at Texas Oncology. "For cancer patients especially, response time is critical, and this technology allows care teams to monitor a patient’s symptoms in real-time and swiftly respond to patients who are in need and require symptom control. It also gives us better insight on compliance with oral therapies."

The second poster session titled, "Improvement in Incident Resolution Time with the Implementation of an Electronic Patient Management Solution at a Community Oncology Practice," evaluates the impact of the digital monitoring program on time to symptom resolution – prolonged times to system resolution can lead to unnecessary emergency department visits. The researchers found that the program, with Plan Do Study Act (PDSA) cycles of quality improvement, can markedly improve incident resolution times, especially for symptom-related calls.

"Staying connected with cancer patients and monitoring their symptoms outside of the clinic can be challenging for busy clinicians," said Bill Bunker, CEO of Navigating Cancer. "This research demonstrates that when technology is effectively integrated into existing practice workflows, it can fill this care gap and drive improved outcomes and better experiences for patients."

Texas Oncology focuses on delivering quality cancer care and mitigating healthcare disparities for Texans fighting cancer through its locations in communities of all sizes throughout the state, including smaller cities and towns. In addition, telemedicine connects patients with care teams both locally and with access to specialized physician expertise in other cities. Online support groups, including nutrition support groups, serve patients no matter where they live so they can receive the critical support they need.

The full abstracts and both posters are available at NavigatingCancer.com/publications. Additional insights into the Texas Two-Step study are available in the JCO Clinical Cancer Informatics.

Abstract Summaries:

Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multi-Site Community Oncology Practice, Abstract 12103

Lead author: Debra Patt M.D., Ph.D., MBA, medical oncologist and executive vice president, public policy, and strategic initiatives at Texas Oncology

Patients initiating a new systemic therapy at one of 210 Texas Oncology practice sites were invited to use the Navigating Cancer ePRO platform from July-December 2020. Participating patients received a weekly prompt by SMS text message or email (patient choice) to self-report common symptoms and well-being via computer or smartphone. Severe self-reported symptoms triggered a real-time notification alert to a triage nurse to address the symptom.

Highlights:

More than 4,000 cancer patients initiating systemic therapy enrolled in the program throughout the study period with 25% of patients living more than 20 miles from their clinic.
Of the patients who were enrolled in the platform, 73% completed at least one ePRO assessment, and among these individuals, 65% of all available weekly ePRO assessments were completed.
SMS (89%) was strongly preferred over email (6%) or clinic collect (5%). SMS was also associated with the highest participation rate (77%) vs. email (54%) or clinic collect (45%).
Improvement in Incident Resolution Time with the Implementation of an Electronic Patient Management Solution at a Community Oncology Practice, Abstract 1578

Lead author: Lalan Wilfong, M.D., medical oncologist and executive vice president for value-based care and quality programs at Texas Oncology

Incident volumes and resolution times were monitored at all Texas Oncology locations along with the implementation of PDSA cycles, which had a goal of less than 90-minute resolution of symptom-related incidents. Utilizing Navigating Cancer’s electronic dashboard allowed Texas Oncology to continue this initiative during the pandemic as some staff could work remotely. Nurses could document if a potential emergency department visit was avoided, and these data points allowed the practice to establish comprehensive and strategic actions plans for quality improvement.

Highlights:

Resolution time for all incidents started at 3.2 hours pre-implementation and improved to 2.2 hours in December 2020.
Sixty-two percent of symptom-related incidents were resolved in less than one hour.
Eight percent of symptom-related incidents resulted in definite or probable emergency department avoidances by nursing assessment.
Shortness of breath, vomiting, chills, and weakness were the top symptom types addressed for emergency department avoidances.

On June 4, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that new data from the first-of-its kind, national FLEX registry was debuted today at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Agendia, JUN 4, 2021, View Source [SID1234583584]).

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The FLEX study is led by clinicians across the United States and utilizes a shared study infrastructure to develop and investigate hypotheses for targeted patient subsets based on full transcriptome data, and annotated with over 800 clinical data elements. FLEX allows for diverse groups of patients and their physicians to participate in a clinical trial even if they are not living near a major research center.

"FLEX has continued to show its value in the enormous breadth of growing data we as oncologists and researchers can access," said Cynthia X. Ma, MD, PhD, oncologist and FLEX national PI at Washington University School of Medicine in St. Louis. "The collaborative nature of the registry gives physicians the chance to investigate the hypotheses formed in our real-world practices on a national level, to answer questions of both clinical importance and scientific interest. The depth and clinical significance of our findings are felt throughout the breast cancer community."

At the virtual ASCO (Free ASCO Whitepaper) 2021 conference, Agendia and its research collaborators provided a general update on the currently enrolling FLEX trial in a poster titled "The FLEX real-world data platform explores new gene expression profiles and investigator-initiated protocols in early stage breast cancer."

The power of FLEX to address relevant and pressing clinical questions was illustrated by data presented in a poster entitled "Whole transcriptome analysis comparing HR+ HER2- breast cancer tumors from patients <50 years and >50 years." The study showed that whole transcriptome analysis identified no substantial differences in gene expression between HR+/HER2- tumors in women with breast cancer, regardless of their age (over or under 50 years old). The data support the likely explanation that the apparent age-dependent benefit of chemotherapy in women younger than 50 with genomically Low Risk cancer, observed in recent trials, is not due to intrinsic biological differences in breast cancer, but rather to differences in the indirect effects of chemotherapy on the patient. These findings reinforce the essential need for shared decision making between a patient and her physician using the patient’s genomic expression profile as part of an informed treatment plan.

"We are excited to present an age-based analysis of the genomics in early stage breast cancer which has garnered so much attention in the last couple of years," said Cathy Graham, MD, FACS, Director of Breast Surgery, Glenn Family Breast Center of Winship Cancer Institute at Emory Saint Joseph’s Hospital, and first author of a FLEX poster focused on age-based analysis. "The trend that has emerged, which suggests that chemotherapy benefit seen in younger women may be a side effect of ovarian suppression – not necessarily the cytotoxic effects of the chemo on a tumor – is seen again in these results and must be considered when potentially less-aggressive alternatives are available."

Additional data of clinical significance for high risk ER+ breast cancer were presented by FLEX investigators including Joyce O’Shaughnessy, MD, Co-Chair of Breast Cancer Research and Chair of Breast Cancer Prevention Research at Baylor-Sammons Cancer Center and for The US Oncology Network, and a member of the Scientific Advisory Board for US Oncology Research Network, in the poster titled "Molecular profiles of genomically High Risk ER+ HER2- breast cancer tumors classified as functionally Basal or Luminal B by the 80-gene signature." This study outlined the identification by BluePrint of a subgroup of high risk ER+ tumors that are genomically Basal, and showed that analysis of whole transcriptome expression profiles reveals these cancers to be biologically closer to ER- Basal (and triple negative breast cancer) than ER+ Luminal cancers. ER+ Basal tumors may therefore require more aggressive treatment than ER+ Luminal tumors, confirming that BluePrint provides clinically actionable information beyond pathological subtyping and may guide neoadjuvant treatment decisions.

A further study from the FLEX database analyzed the correlation between a traditional poor prognosis pathology feature, lymphovascular invasion (LVI), and gene expression patterns. The study, titled "Gene expression associated with lymphovascular invasion and genomic risk in early-stage breast cancer," was presented by Nina D’Abreo, MD, medical director, breast program, Winthrop University Hospital, Perlmutter Cancer Center, and her colleagues, and showed that the potential prognostic information gained from the presence or absence of lymphovascular invasion (LVI) gene expression is likely already captured by MammaPrint and BluePrint. Importantly, presence or absence of LVI in MammaPrint Low Risk cancers was not associated with any discernible differences in whole transcriptome gene expression. LVI is currently excluded from most breast cancer clinical risk assessments, and while further studies will assess clinical outcomes, these data suggest that MammaPrint and BluePrint may be able to address a current gap in stratification of early stage breast cancers.

Agendia’s large-scale, prospective FLEX study continues to provide a rich source of data from real-world evidence in one of the most dynamic and inclusive study designs in breast cancer research to date, underscoring the company’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients.

On June 4, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting revealed new data from the national FLEX registry that identify differences in tumor biology between ethnic groups that can lead to meaningful treatment decisions, reinforcing the need for appropriate representation of diverse patient populations in breast cancer studies (Press release, Agendia, JUN 4, 2021, View Source [SID1234583583]).

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A major theme of this year’s ASCO (Free ASCO Whitepaper) meeting centers around disparities in care and outcomes, which Agendia’s FLEX study aims to combat by prospectively enrolling 30,000 patients from various ethnicities, ages and demographic groups representative of the total breast cancer population. The data presentation from this study, "Disparities within Luminal breast cancer: clinical and molecular features of African American and non-Hispanic White patients," delivered by first author of the study Kent Hoskins, MD, Co-Leader of the Breast Cancer Research Group and Director of Cancer Genetics at the University of Illinois Cancer Center, details significant biological differences in luminal breast tumors from African American and non-Hispanic White women, suggesting that shared adverse socioeconomic exposures and/or genetic ancestry may be driving disproportionately aggressive tumor biology in African American women. This finding further underscores the need for inclusion of diverse patient groups in clinical trials to ensure equity in drug development.

"The data presented at ASCO (Free ASCO Whitepaper) 2021 show significant transcriptomic differences between Luminal tumors from African American and non-Hispanic White patients, seen even more starkly as our study controlled for age, obesity, and genomic classification," said Dr. Hoskins. "The data show ER+ breast cancers in African American women more often had upregulation of the mTOR pathway and cell cycle genes, which require different treatment approaches than other ER+ breast cancers. These data tell us that we desperately need proper representation of diverse populations in clinical trials, and future studies focused on the efficacy of these agents specifically in African American women with breast cancer, so that all patients can benefit from precision medicine, tailored to them, and accounting for their ancestry and genomic profiles."

Additional data from Agendia regarding breast cancer in African American women was shared in an abstract titled "Genomic risk classification by the 70-gene signature and 21-gene assay in African American, early-stage breast cancer patients." This study was triggered by recent research showing less accurate prognostic performance of OncotypeDX in African American women with early stage breast cancer. The abstract compared MammaPrint and OncotypeDX results in a cohort of African American women with ER+ breast cancer, and observed an overall discordance of 51% between the two tests in African American patients; notably, of tumors with a TAILORx intermediate risk score (11-25), 61% were classified as MammaPrint High Risk. Combined with previously published data in African American patients, 57% of OncotypeDX low risk score tumors are re-classified as MammaPrint High Risk, suggesting that OncotypeDX results could be less accurate in African American patients.

In addition, recent data indicate that African American patients who receive a low or intermediate OncotypeDX risk score have higher recurrence rates and lower survival than Caucasian patients with early stage breast cancer with the same risk score, a difference that can have meaningful clinical implications and requires further investigation.1

"It is essential that genomic tests either work consistently across diverse groups of patients, or have the ability to be calibrated to do so," said Patricia Robinson, MD, Associate Professor of Hematology and Oncology at Loyola University Medical Center, and Assistant Dean of Diversity, Equity and Inclusion at the Strich School of Medicine, "We cannot be using genomic tests that work for some people and not others, or accepting that the tests, which offer such crucial information, work better for some than for others. While the clinical evaluation of the discrepancy between OncotypeDX and MammaPrint may be ongoing, this data still captures the diversity of pathways driving tumor metastasis, and reinforces the importance of proper representation in trials and in test development and optimization."

Agendia’s large-scale, prospective FLEX registry continues to highlight data from real-world practices in one of the most flexible and inclusive studies in breast cancer research to date, playing an important part in the company’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.