On June 4, 2021 Daiichi Sankyo Company, Limited reported that New data from patritumab deruxtecan (HER3-DXd), a HER3 directed antibody drug conjugate (ADC), demonstrated preliminary evidence of clinically meaningful and durable tumor response in patients with locally advanced or metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer (NSCLC) (Press release, Daiichi Sankyo, JUN 4, 2021, View Source [SID1234583581]).

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These extended follow-up data from the dose escalation portion and one expansion cohort of a phase 1 study of patritumab deruxtecan were presented today during an oral presentation (Abstract #9007) at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO21) Virtual Scientific Program.

While the efficacy of targeted therapy with EGFR TKIs is well-established in the treatment of patients with advanced EGFR-mutated NSCLC, the development of a broad range of resistance mechanisms commonly leads to disease progression.1,2 Subsequent salvage therapies after EGFR TKI and platinum-based chemotherapy have limited efficacy with progression-free survival (PFS) of approximately 2.8 to 3.2 months.2 New treatment approaches are needed to overcome resistance and improve survival in these patients.

An objective response rate (ORR), as assessed by blinded central review, was 39% (CI 95%; 26-52%) in 57 evaluable patients treated with patritumab deruxtecan (5.6 mg/kg). One confirmed complete response and 21 partial responses were observed. The disease control rate was 72% (CI 95%; 59-83%). After a median follow-up of 10.2 months (range, 5.2-19.9 months), the estimated median duration of response was 6.9 months (CI 95%; range, 3.1-NE months) and the estimated median PFS was 8.2 months (CI 95%; range, 4.4-8.3 months). Confirmed responses were observed in patients across a spectrum of baseline tumor HER3 membrane expression levels, EGFR activating mutations and EGFR TKI resistance mechanisms, including EGFR activating mutations (Ex19del, L858R, G719Y), other EGFR mutations (T790M, C797S, Ex20ins), amplifications (EGFR, CCNE1, MET) and non-EGFR mutations and fusions (MET, KRAS). A subgroup of patients treated with osimertinib and platinum-based chemotherapy (n=44) prior to enrollment in the study demonstrated similar efficacy. An ORR of 39% (CI 95%; 24-55%) and PFS of 8.2 months (CI 95%; 4.0-NE) was observed in this subgroup. Additionally, the confirmed ORR and median PFS were similar in patients with or without a history of brain metastases.

"EGFR TKIs are the standard of care for patients with advanced EGFR-mutated NSCLC. However, the activity of these agents is limited by the development of acquired resistance mechanisms," said Pasi A. Jänne, MD, PhD, Director, Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. "In this study, where patients were heavily pre-treated, efficacy was observed in patients with and without known EGFR TKI resistance mechanisms in a population that is often difficult to treat. Targeting HER3 with patritumab deruxtecan may be a novel and promising strategy, and we look forward to further evaluating clinical activity and safety in the pivotal HERTHENA-Lung01 trial."

The safety profile of patritumab deruxtecan in patients treated with the 5.6 mg/kg dose (n=57) is consistent with that seen across all patients (n=81) in both the dose escalation and dose expansion cohort 1 of the study (doses range from 3.2 to 6.4 mg/kg). Grade 3 or higher treatment emergent events (TEAEs) occurred in 64% of all patients (n=81). TEAEs grade 3 or higher severity occurring in ≥ 5% of all patients were platelet count decreased, neutrophil count decreased, fatigue, anemia, dyspnea, febrile neutropenia, hypoxia, white blood cell count decreased, hypokalemia and lymphocyte count decreased. There were four cases of treatment-related interstitial lung disease (ILD) reported, as determined by an independent adjudication committee, including two of grade 1 severity, one grade 2, and one grade 3. The median time to adjudicated onset of treatment-related ILD was 53 days (range, 13-130 days). There were five TEAEs associated with death including two cases of disease progression, two cases of respiratory failure and one case of shock. All TEAEs associated with death were considered not related to the study drug.

"Treatment options that provide meaningful therapeutic benefit for patients with EGFR-mutated non-small cell lung cancer with disease progression following standard treatment with EGFR TKIs and platinum-based chemotherapy are limited," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "HER3 represents a novel target for therapeutic development as it is broadly expressed in non-small cell lung cancer. These results are encouraging since the safety profile was consistent with previous findings and response to patritumab deruxtecan was seen irrespective of the level of HER3 expression or mechanism of resistance to prior therapies."

Patients receiving 5.6 mg/kg (n=57) of patritumab deruxtecan were pre-treated with a median of four prior lines of therapy (range, 1-9), including EGFR TKIs (100%), platinum-based chemotherapy (91%) and immunotherapy (40%). A majority (86%) were previously treated with osimertinib. Of the 57 patients, 27 patients had brain metastases at baseline. As of data cut-off on September 24, 2020, 32% of patients remain on treatment with patritumab deruxtecan.

Summary of Results

Efficacy Measure

HER3-DXd Dose Escalation 5.6 mg/kg
Plus Dose Expansion 5.6 mg/kg (n=57) iv

Prior TKI±PBC
(n=57)

Prior OSI and PBC
(n=44)

ORR (%) (95% CI) i, ii

39% (26-52)

39% (24-55)

CR (%)

2%

2%

PR (%)

37%

36%

SD (%)

33%

30%

PD (%)

16%

18%

NE (%)

12%

14%

DCR (%) (95% CI)iii

72% (59-83)

68% (52-81)

Time to response (months)

2.6 months (1.2-5.4)

2.7 months (1.2-5.4)

Median DOR (months) (95% CI)

6.9 months (3.1-NE)

7.0 months (3.1-NE)

Median PFS (months) (95% CI)

8.2 months (4.4-8.3)

8.2 months (4.0-NE)

CI, confidence interval; CR, complete response; DCR, disease control rate; DOR, duration of response; OSI, osimertinib; NE, not estimable; PBC, platinum-based chemotherapy; PD, progressive disease; PR, partial response; PFS, progression-free survival; SD, stable disease; TKI; tyrosine kinase inhibitor
i As assessed by independent central review
ii ORR is (CR + PR)
iii DCR is (CR + PR + SD)
iv Median follow up: 10.2 (range, 5.2-19.9) months

About the Phase 1 Non-Small Cell Lung Cancer Study

The global, multicenter, open label, two-part phase 1 study is evaluating patritumab deruxtecan in previously treated patients with metastatic or unresectable NSCLC.

The dose escalation part of the study evaluated patients with EGFR-mutated disease either with progression on osimertinib or T790M-negative after progression on erlotinib, gefitinib or afatinib. The primary objective of this part of the study was to assess the safety and tolerability of patritumab deruxtecan and determine the recommended dose for expansion (RDE).

The dose expansion part of the study is evaluating patritumab deruxtecan at the RDE (5.6 mg/kg every three weeks) in three cohorts. Cohort 1 includes patients with locally advanced or metastatic EGFR-mutated NSCLC who experienced disease progression after taking one or more EGFR TKIs and one or more platinum based chemotherapy regimens. Cohort 2 includes patients with squamous or non-squamous NSCLC without EGFR-activating mutations following platinum-based chemotherapy and following an anti-PD-1 or anti-PD-L1 antibody regimen. Cohort 3 includes patients with NSCLC with EGFR-activating mutations including any histology other than combined small cell and non-small cell lung cancer; patients in Cohort 3 are randomized 1:1 to receive the 5.6 mg/kg RDE regimen (Cohort 3a) or an escalating up-titration regimen of patritumab deruxtecan (Cohort 3b).

Preliminary data from the dose escalation part of the study were presented previously at the 2019 World Conference on Lung Cancer, and early data from the dose escalation part (5.6 mg/kg dose) and Cohort 1 of the dose expansion were presented at the 2020 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress. Exploratory biomarker analyses assessing genomic alterations of patient tumors were presented at the 2020 World Conference on Lung Cancer.

The primary objective of the dose expansion part of the study is to assess efficacy of patritumab deruxtecan as measured by confirmed objective response rate assessed by blinded independent central review. Secondary study endpoints include investigator-assessed objective response rate; safety, tolerability and preliminary efficacy; and characterization of the pharmacokinetics of patritumab deruxtecan. The study enrolled patients at multiple sites in the U.S., Europe, Japan and other countries in Asia. For more information, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide. There were an estimated 2.2 million new cases of lung cancer and 1.8 million deaths in 2020.3 Most lung cancers are diagnosed at an advanced or metastatic stage.4 Non-small cell lung cancer (NSCLC) accounts for 80 to 85% of all lung cancers.5

The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC; however, the prognosis is particularly poor among patients who have progressed after treatment with standard therapies. For patients who are not eligible for current treatments, or whose cancer continues to progress, new therapeutic approaches are needed.6

The mutationally-activated EGFR tyrosine kinase is a well-established oncogenic driver and molecular target for management of advanced stage NSCLC.7 For patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and progression-free survival compared to chemotherapy.7 However, most patients eventually develop resistance to these therapies, and standard treatment options are limited.8 Treatment options used in this setting historically have demonstrated limited efficacy with progression free survival of up to 6.4 months for platinum-based chemotherapy and 3.2 months for other salvage therapies.3,9 New treatment approaches are needed to overcome resistance and improve survival in these patients.

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.10 Approximately 25 to 30% of lung cancers worldwide have an EGFR-activating mutation, and it is estimated that about 83% of all NSCLC tumors express the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard of care treatment.11,12,13 Currently, no HER3 directed medicines are approved for the treatment of cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Patritumab deruxtecan is currently being evaluated in a comprehensive development program across multiple cancers as both a monotherapy and in combination with other anticancer treatments. The development program includes HERTHENA-Lung01, a pivotal phase 2 study in patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with a TKI and platinum-based chemotherapy; a phase 2 study in patients with advanced/metastatic colorectal cancer with disease progression following at least two prior lines of systemic therapy; a phase 1/2 study in HER3 expressing metastatic breast cancer; a phase 1 study in combination with osimertinib in locally advanced/metastatic EGFR-mutated NSCLC; and, a phase 1 study in previously treated patients with metastatic or unresectable NSCLC.

Patritumab deruxtecan is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

On June 4, 2021 Agilent Technologies Inc. (NYSE: A) reported a presentation by Memorial Sloan Kettering Cancer Center (MSK) at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) to discuss the Resolution ctDx Lung, a laboratory-developed test (LDT) developed by Resolution Bioscience (Press release, Agilent, JUN 4, 2021, View Source [SID1234583580]).

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"Significantly, the study highlighted important differences between liquid biopsies and tissue testing, including faster turnaround to reporting, while providing the benefits of guided targeted therapy."

The presentation titled Overall survival with circulating tumor DNA-guided therapy in advanced non-small cell lung cancer will present evidence for the clinical utility of Resolution ctDx Lung in detecting actionable mutations in non-small cell lung cancer (NSCLC) patients.

Previous findings have supported the clinical utility of the Resolution ctDx Lung for accurately selecting patients for targeted therapies.1 The latest study, involving the largest prospective liquid biopsy cohort (>1,000 patients) with 3–4 years of survival data, demonstrates that cell-free DNA guided targeted therapies help result in better overall survival.

"This is the first and largest prospective study of ctDNA guided therapy to show an overall survival benefit in patients with lung cancers, providing evidence for the utility of liquid biopsy in clinical practice," said Bob Li, MD, PhD, MPH, Co-Director of the Thoracic Liquid Biopsy Program at MSK.

"This large cohort highlights the utility of the Resolution ctDx Lung in helping guide therapy selection to improve patient outcomes," said Mark Li, CEO of Resolution Bioscience, now a part of Agilent. "Significantly, the study highlighted important differences between liquid biopsies and tissue testing, including faster turnaround to reporting, while providing the benefits of guided targeted therapy."

The success of Resolution ctDx Lung further strengthens Agilent’s ability to deliver precision oncology testing assays for patients worldwide and demonstrates the company’s commitment as a partner in the development of powerful new clinical diagnostics solutions to expand the fight against cancer.

Resolution Bioscience is dedicated to developing a highly sensitive, non-invasive liquid biopsy platform that improves cancer diagnostics and monitoring for patients around the world. The company has developed core technology for circulating cell-free DNA NGS analysis. Resolution Bioscience’s Liquid Biopsy assays are powered by the company’s cell-free DNA (cfDNA) analysis platform, which includes targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. The Resolution Bioscience homologous recombination deficiency (HRD) assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration.

References:

Sabari JK, Offin M, Stephens D, Ni A, Lee A, et al. (2019). A Prospective Study of Circulating Tumor DNA to Guide Matched Targeted Therapy in Lung Cancers. Journal Of The National Cancer Institute 111: 575-583. View Source PMID: 30496436

On June 4, 2021 Candel Therapeutics, Inc., a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported initial results from an ongoing Phase 1 clinical trial of its oncolytic virus, CAN-3110, in patients with high-grade glioma (HGG) that has recurred after initial treatment (Press release, Candel Therapeutics, JUN 4, 2021, View Source [SID1234583579]). The data are presented today in an Oral Abstract Session of the Clinical Science Symposium at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"This is the first clinical trial of a novel oncolytic HSV engineered to selectively express ICP34.5 in tumor cells, leading to tumor-specific cell death. This novel oncolytic viral immunotherapy has been shown to be well tolerated with primarily low grade, and manageable side effects"

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Highlights from the Oral Abstract Session of the Clinical Science Symposium at ASCO (Free ASCO Whitepaper) 2021

An ongoing Phase 1 study is evaluating the safety and activity of CAN-3110, an engineered replication-competent herpes simplex virus (HSV) oncolytic viral immunotherapy, in patients with HGG who have experienced disease progression following prior treatment with standard of care therapies. As of the data cutoff date of April 21, 2021:

30 patients were evaluable for safety.
Nine dose levels ranging from 1×106 to 1×1010 plaque forming units (PFU) were administered.
No dose-limiting toxicity was observed. The maximum administered dose was 1×1010 PFU.
CAN-3110 was well-tolerated and all but one adverse events (AEs) were Grade 1 or 2.
A preliminary Kaplan-Meier estimate of median overall survival was 11.7 months.
All patients have been treated for more than 12 months.
One patient who responded for over a year, a 56-year-old male with multifocal glioblastoma, demonstrated a significant reduction in both an injected and an uninjected lesion, suggesting an abscopal effect of CAN-3110.
An additional 12 patients have been enrolled into a dose expansion arm of the trial.
"CAN-3110 has demonstrated a significant number of durable responses in patients with high-grade glioma who experienced disease progression following prior standard of care therapy," said Antonio Chiocca, MD, PhD, FAANS, Neurosurgeon-in-Chief and Chairman, Department of Neurosurgery at Brigham and Women’s Hospital. "The results of this first-in-human study are encouraging as they demonstrate a median overall survival that was substantially longer than the six to nine months typically observed for these patients as well as a favorable safety profile."

"This is the first clinical trial of a novel oncolytic HSV engineered to selectively express ICP34.5 in tumor cells, leading to tumor-specific cell death. This novel oncolytic viral immunotherapy has been shown to be well tolerated with primarily low grade, and manageable side effects," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel Therapeutics. "There are few treatment options for patients with high-grade glioma whose tumors progress following initial surgery and chemoradiation. We are encouraged by the duration of the responses observed to date in this patient population given the extremely limited treatment options. Based on these data, we are excited to advance this innovative agent into further clinical trials."

Details of the presentation are as follows:

Abstract Title: First-in-human CAN-3110 (ICP34.5 expressing HSV-1 oncolytic virus) in patients with recurrent high-grade glioma

Presenter: Dr. E. Antonio Chiocca

Session Date and Time: The presentation is available to ASCO (Free ASCO Whitepaper) attendees beginning June 4, 2021 at 9 AM EDT/ 6 AM PDT and has been reposted to the Candel Therapeutics website at www.candeltx.com/news

Abstract Link: View Source

Session Title: CNS Targeting: From Delivery to Biomarker Assessment

Abstract Number: 2009

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of malignant cells while sparing healthy normal neighboring cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in glioma cells and other tumor tissue but is absent in the healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 for recurrent glioblastoma. For more information on this clinical study, please visit View Source

On June 4, 2021 Foundation Medicine, Inc. and its collaborators reported the presentation of new data analyzing the genomic landscape, comprehensive genomic profiling (CGP) utilization and treatment patterns among more than 11,000 men with advanced prostate cancer, including 12% with a predicted African genomic ancestry (Press release, Foundation Medicine, JUN 4, 2021, View Source [SID1234583578]). In what is believed to be the largest known cohort of its kind, researchers found that despite similar rates of actionable gene alterations between men of European and African ancestry, men of African ancestry were less likely to receive CGP early in their treatment course and less likely to be enrolled in clinical trials. These findings highlight the importance of additional factors, beyond inherent differences in disease biology, in potentially driving disparities in outcomes. They also underscore the need to expand access to precision medicine and clinical trial enrollment. Data will be presented during an oral presentation on June 8 at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO21).

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Prostate cancer incidence and clinical outcomes vary widely across race and ethnicity, and the underlying drivers of these outcomes are multifactorial, including systemic barriers that lead to differences in access to genomic and precision medicine. Men of African ancestry are particularly underrepresented in prostate cancer research. With this study, Foundation Medicine and collaborators at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, the University of Michigan and Harvard Medical School explored the interplay between ancestry and patient care.

"Men of African ancestry experience the greatest burden of disease in prostate cancer, and this research indicates that differences in cancer care are not solely based on biological factors, but rather points to socioeconomic factors such as access to comprehensive genomic profiling and clinical trial enrollment," said study investigator Brandon Mahal, M.D., Assistant Professor, Radiation Oncology and Assistant Director of Community Outreach and Engagement, Sylvester Comprehensive Cancer Center. "To ensure equitable opportunities for precision medicine, we need to expand access to and awareness of advances that impact patient care and outcomes, including timely use of genomic testing to help make informed treatment decisions."

The study analyzed 11,741 men with advanced prostate cancer who received CGP as part of routine clinical care, along with a subset of 897 patients with real-world clinical data from Foundation Medicine and Flatiron Health’s joint clinico-genomic database (CGDB). Results showed that the rates of genomic alterations were largely similar across ancestry, including alterations in BRCA1/2, androgen receptor, DNA damage response pathway genes and actionable genes with therapy implications. Within the CGDB cohort, the proportion of patients receiving immunotherapy and PARP inhibitors was also similar across ancestry. However, men of African ancestry were less likely to receive a clinical study drug than men of European ancestry (11% vs. 30%). Further, men of African ancestry received a median of two lines of therapy prior to CGP, compared to one line of therapy for men of European ancestry, highlighting the extended time from diagnosis to implementation of precision medicine. These factors may potentially impact the genomic landscape, outcomes, and ultimately disparities.

"At Foundation Medicine, we strive to better understand barriers at different stages of a patient’s journey and identify opportunities to mitigate disparities in cancer care. Our study highlights the need for the cancer community to understand and systematically define barriers to care across different populations, especially those traditionally underrepresented in clinical research," said study co-lead Smruthy Sivakumar, PhD, scientist at Foundation Medicine. "The results contribute to our knowledge of comprehensive genomic profiling and real-world data to better understand the barriers patients face in accessing quality cancer care – a critical step toward addressing persistent disparities," added Jessica Lee, study co-lead and scientist at Foundation Medicine.

A full list of research being presented by Foundation Medicine and its collaborators at ASCO (Free ASCO Whitepaper)21 can be found at www.foundationmedicine.com/event/asco2021.

On June 4, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early,reported the first results from the interventional PATHFINDER study evaluating Galleri, a multi-cancer early detection (MCED) blood test (Press release, Grail Bio, JUN 4, 2021, View Source [SID1234583577]). The results, presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, support Galleri’s performance in clinical settings. The company also announced today that Galleri is now available in the U.S. by prescription only.

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"The interim results of PATHFINDER demonstrate that a routine blood test is capable of detecting many different cancers even before symptoms arise, an approach that has significant potential advantages," said Dr. Tomasz M. Beer, deputy director at the OHSU Knight Cancer Institute and presenting author. "Most importantly, it can detect cancers that have no recommended screening tests today, and more than two-thirds of cancers go unscreened for this reason. These results are a pivotal step toward extending early detection to many more types of cancer."

Clinical Data from PATHFINDER

PATHFINDER was designed to assess the implementation and performance of Galleri in a clinical care setting, evaluate the clinical care pathways following a "signal detected" Galleri test result, and measure the time required to achieve diagnostic resolution.

The study analyzed 6,629 individuals aged 50 years or older, an age group at elevated risk for cancer, but with no suspicion of active cancer. Compared to the general population, participants had equal or higher compliance with recommended breast and colon cancer screening tests.

In the interim analysis, an earlier version of Galleri accurately detected 29 cancers across 13 types: breast, colon or rectum, head and neck, liver and bile duct, lung, lymphoid leukemia, lymphoma, ovary, pancreas, plasma cell neoplasm, prostate, small intestine, and Waldenstrom macroglobulinemia. Of the new cancers detected, nearly 40% (9/23) were localized (stage I-II), and more than half (13/23) were detected before distant metastases (stage I-III). PATHFINDER participants will continue to be followed for 12 months, with final results expected in the first half of 2022.

"Finding cancer early, when treatment is more likely to be successful, is one of the most significant opportunities we have to reduce the burden of cancer," said Dr. Joshua Ofman, chief medical officer and head of external affairs at GRAIL. "These data suggest that, if used at scale alongside existing screening tests, the Galleri test could have a profound impact on how cancer is detected and, ultimately, on public health."

The interim PATHFINDER positive predictive value (PPV), or the likelihood that a person has cancer when a positive test result is returned, was 44.6% (95% CI: 33.2-56.7%), which is consistent with findings from GRAIL’s case-controlled Circulating Cell-free Genome Atlas (CCGA) Study.

When cancer was confirmed, Galleri’s first or second cancer signal origin prediction was 96.3% accurate (95% CI: 81.7-99.8%), with a median observed time to cancer diagnosis of 50 days. The interim analysis identified only four study-related adverse events (two related to mild anxiety before the test, one related to mild anxiety about the blood draw, and one related to mild bruising).

"Early cancer detection is critical to reducing the burden of cancer-related morbidity and mortality. These results reflect the potential real-world ability of Galleri to find deadly cancers earlier, and represent a leap forward in the effort to treat cancer more effectively," Dr. Beer said.

Data is presented by Dr. Beer, and the presentation will be available at View Source

Introducing Galleri

Galleri is now available in the U.S. by prescription only. The Galleri test is intended for use in those with an elevated risk of cancer, such as adults aged 50 or older, and as a complement to existing single cancer screening tests.

In an observational study, Galleri has demonstrated the ability to detect more than 50 types of cancer1, over 45 of which lack recommended screening tests today in the U.S., with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy. New CCGA data published today in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), also demonstrate the ability of GRAIL’s technology to preferentially detect cancers that are more aggressive than expected based on age, and the cancer stage and type.

The blood test is supported by what is believed to be the largest clinical study program in genomic medicine, with over 140 clinical study sites, including the Mayo Clinic, Dana-Farber Cancer Institute, Cleveland Clinic, Sutter Health, OHSU, Intermountain Healthcare, and U.S. Oncology Research.

Cancer is expected to become the leading cause of death in the United States this year, in large part because the majority of cancers are found too late when outcomes are poor. Recommended screening tests save lives, but only cover five cancer types in the U.S. In fact, 71% of cancer deaths in the U.S. have no recommended early detection screening.

For more information about Galleri, visit www.galleri.com.

REFLECTION Registry

GRAIL also announced it will establish a real-world evidence study, REFLECTION, to understand the experience and clinical outcomes of 35,000 individuals in the U.S. who are prescribed the Galleri test from a healthcare provider. This follows an announcement last fall that Galleri will be offered to eligible patients in the United Kingdom (UK) later this year as part of a partnership with the UK National Health Service to support its Long Term Plan for earlier cancer diagnoses.