On May 24, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported the presentation of new analyses for BRUKINSA (zanubrutinib) at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 31 – June 4, 2024 (Press release, BeiGene, MAY 24, 2024, View Source [SID1234643669]). The presentations highlight analyses of the efficacy and safety of BRUKINSA compared to other Bruton’s tyrosine kinase inhibitors (BTKis) used to treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

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"At this year’s ASCO (Free ASCO Whitepaper), multiple presentations continue to add to our extensive body of evidence demonstrating BRUKINSA’s uniquely differentiated clinical profile," Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "These new analyses, which highlight improved PFS and response rates and a low usage of antihypertensive medicines, provide valuable insights for oncologists to consider when making treatment decisions for their patients with CLL and SLL."

BRUKINSA Survival and Response Rates for CLL vs. Acalabrutinib and other BTKis in a Network Meta-Analysis

A network meta-analysis evaluated the relative efficacy of available treatments for patients with high-risk relapsed/refractory (R/R) CLL using data from three randomized controlled clinical trials: ALPINE, ELEVATE-RR and ASCEND. The analysis found a statistically significant improvement in PFS for BRUKINSA over acalabrutinib in high-risk patients and a trend toward improvement in overall survival (OS), overall response (ORR) and complete response (CR). BRUKINSA led to statistically significant improvements in PFS, as well as a trend toward improvement in OS, vs. ibrutinib and bendamustine + rituximab/idelalisib + rituximab (BR/IR).

"Given the lack of head-to-head trials comparing BTK inhibitors in high-risk R/R CLL patients, we undertook a network meta-analysis to estimate the relative efficacy of available treatments," said Mazyar Shadman, M.D. M.P.H, Associate Professor and Innovators Network Endowed Chair, Assistant Medical Director, Cellular Immunotherapy, Fred Hutch Cancer Center and University of Washington. "We found zanubrutinib to be the most efficacious BTKi for patients with high-risk R/R CLL, offering significantly delayed disease progression and favorable response compared with the other BTKi treatments in the analysis, including acalabrutinib."

Network meta-analyses are intended to be hypothesis-generating, and do not establish superior efficacy or safety of one drug over another. Results should be viewed in the context of analysis limitations and available randomized clinical trial data.

This poster will be presented Monday, June 3, from 9 a.m. – noon CT (Abstract #7048).
BRUKINSA Effective and Generally Well-Tolerated for Patients with CLL/SLL Regardless of Prior Ibrutinib Use

A retrospective analysis assessed treatment patterns, treatment-emergent adverse events (TEAEs), treatment-limiting adverse events (TLAEs) and treatment-related mortality among patients with CLL/SLL treated at Kaiser Permanente Northern California. Among 281 patients who received BRUKINSA, 190 switched from ibrutinib and 91 received only BRUKINSA, with a median follow up of 24.4 and 8.2 months, respectively. Similar TEAE rates were seen with both BTKi therapies, with lower TLAE rates with BRUKINSA. Cardiac TLAE and non-TLAE rates overall were higher with ibrutinib than BRUKINSA, and the rates decreased after switching to BRUKINSA. There were no reports of treatment-related deaths.

This poster will be presented Monday, June 3, from 9 a.m. – noon CT (Abstract #11158).
ALPINE Post Hoc Analysis Shows Less Frequent Initiation of Anti-hypertensive Medications in Patients Treated with BRUKINSA vs. Ibrutinib

A post-hoc analysis of the ALPINE clinical trial data evaluated the risk of developing hypertension based on initiation of anti-hypertensive medications among patients with CLL/SLL treated with BRUKINSA vs. ibrutinib. The analysis found that initiation of new anti-hypertensives or a new class of anti-hypertensives occurred less frequently in the BRUKINSA arm vs. the ibrutinib arm. In addition, initiation of anti-hypertensives occurred sooner for patients treated with ibrutinib vs. BRUKINSA. Data from this analysis provide important insights when evaluating the overall safety profile of individual BTKi treatments.

This abstract is available online (Abstract #e19016).
During the meeting, BeiGene will also sponsor a virtual panel discussion featuring perspectives from leading hematology/oncology experts as they discuss the BTKi treatment evolution, and the considerations healthcare providers and patients should weigh when choosing treatment for CLL. The panel, titled "Exploring the landscape of next-generation BTK inhibitors in blood cancers" will take place during the Endpoints at #ASCO24 event on June 4 at 12:35 – 1:05 p.m. ET (register here).

For additional information about BeiGene’s presence at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit our meeting hub in our newsroom.

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib)

INDICATIONS
BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Waldenström’s macroglobulinemia (WM).
Mantle cell lymphoma (MCL) who have received at least one prior therapy.
Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information including U.S. Patient Information.

On May 24, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL and online (Press release, Hutchison China MediTech, MAY 24, 2024, View Source [SID1234643602]).

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Results will be presented from the registration Phase II study of fruquintinib combined with sintilimab in 98 second-line or above patients with endometrial cancer ("EMC") with pMMR status by central laboratory analysis, which supported the New Drug Application (NDA) filed in China. The primary endpoint was objective response rate ("ORR") per RECIST v1.1, assessed by an independent review committee. The combination showed meaningful efficacy improvements in advanced EMC patients with pMMR status, regardless of prior bevacizumab treatment, with a manageable safety profile. The median follow-up time was 15.7 months. The ORR in 87 efficacy evaluable patients was 35.6% including two complete responses. Disease control rate ("DCR") was 88.5%, and duration of response was not reached, with 80.7% remaining in response after nine months. Amongst the 98 patients, median progression-free survival (PFS) was 9.5 months, and median overall survival (OS) was 21.3 months. Further details are available in the abstract link below.

Following the initial data of the FRUTIGA Phase III study of fruquintinib in second-line gastric cancer published during the February 2024 ASCO (Free ASCO Whitepaper) Plenary Series session, further updated efficacy data in key subgroups, and quality of life data will be presented at this year’s ASCO (Free ASCO Whitepaper) annual meeting. In addition, further data from the FRESCO and FRESCO-2 Phase III colorectal cancer studies, the study of surufatinib combinations in small cell lung cancer, and initial clinical data for the ERK1/2 inhibitor HMPL-295 will be presented.

Details of the presentations, including links to available abstracts, are as follows:

Abstract title Presenter / Lead author Presentation details

SPONSORED STUDIES
Fruquintinib plus Sintilimab in Treated Advanced Endometrial Cancer (EMC) Patients (Pts) with pMMR Status: Results From a Multicenter, Single‑Arm Phase 2 Study Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China #5619
Poster Session – Gynecologic Cancer
Efficacy and safety of fruquintinib in patients with metastatic colorectal cancer according to prior treatment sequence in the refractory setting: Results from FRESCO and FRESCO-2 Tanios S. Bekaii-Saab,
Mayo Clinic, U.S. #3579
Poster Session – Gastrointestinal Cancer — Colorectal and Anal
Fruquintinib in Refractory Metastatic Colorectal Cancer
Cathy Eng,
Vanderbilt-Ingram Cancer Center, U.S. Link
Education Session: New Drugs in Oncology: Incorporation Into Practice
Updates on Abstract 438730: Fruquintinib Plus Paclitaxel Versus Paclitaxel as Second-Line Therapy for Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (FRUTIGA): A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study Feng Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China Link
Education Session: ASCO (Free ASCO Whitepaper) Plenary Series: Rapid Abstract Updates
Surufatinib plus PD-1/L1 inhibitors as maintenance therapy following first line (1L) platinum-based chemotherapy combined with PD-1/L1 inhibitors in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) Yi Hu, Chinese PLA General Hospital, Beijing, China #e15109
Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology
First-in-human study of HMPL-295, an ERK1/2 inhibitor, in patients with advanced solid tumors: dose-escalation results of monotherapy Xianjun Yu, Fudan University Shanghai Cancer Center, Shanghai, China #e15112
Publication Only: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

INVESTIGATOR-INITIATED STUDIES
Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE) Chen Yajie, Zhang Zhen, Fudan University Shanghai Cancer Center, Shanghai, China #e15570
Publication Only: Gastrointestinal Cancer—Colorectal and Anal
A propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world data Lina He, Shuiping Tu,
Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China #e15564
Publication Only: Gastrointestinal Cancer—Colorectal and Anal
Phase Ib/II trial of hepatic arterial infusion chemotherapy (HAIC) in combination with fruquintinib as third-line therapy for refractory unresectable colorectal cancer liver metastases Zhu Xu,
Peking University Cancer Hospital and Institute, Beijing, China #3561
Poster Session – Gastrointestinal Cancer—Colorectal and Anal
Efficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter study Jianjun Peng,
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China #3536
Poster Session – Gastrointestinal Cancer — Colorectal and Anal
A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survival Lu Wang, Zhang Ti,
Fudan University Shanghai Cancer Center, Shanghai, China #3543
Poster Session – Gastrointestinal Cancer — Colorectal and Anal
Fruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trial Suxia Luo, Fei Ma,
Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China #e16021
Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary
Short-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II study Tao Zhang, Zhenyu Lin,
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China TPS3643
Poster Session: Gastrointestinal Cancer — Colorectal and Anal
Fruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II study Junjie Peng, Wenhua Li,
Fudan University Shanghai Cancer Center, Shanghai, China #3567
Poster Session: Gastrointestinal Cancer — Colorectal and Anal
Efficacy and safety of fruquintinib plus investigator’s choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trial Yongshun Chen, Wensi Zhao,
Renmin Hospital of Wuhan University, Wuhan, China #3571
Poster Session: Gastrointestinal Cancer — Colorectal and Anal
Comparative analysis of first-line therapy with fruquintinib plus chemotherapy versus standard therapy in advanced metastatic colorectal cancer (mCRC): A prospective cohort study compared with propensity score matching (PSM) cohort Fuxiang Zhou, Wenbo Wang,
Zhongnan Hospital of Wuhan University, Wuhan, China #3591
Poster Session: Gastrointestinal Cancer —Colorectal and Anal
Efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective study Lu Xie, Binghao Li,
Peking University People’s Hospital, Beijing, China; The Second Affiliated Hospital Zhejiang University, Hangzhou, China #11528
Poster Session: Sarcoma
Disitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm study Hui Xu,
Zhongnan Hospital of Wuhan University. Wuhan, China #e15003
Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology
Surufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II Study Dongsheng Zhang,
Sun Yat-sen University Cancer Center, Guangzhou, China #e16297
Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary
Surufatinib monotherapy or combined with vinorelbine as a late-line therapy in patients with refractory advanced non–small cell lung cancer (NSCLC) Yanfang Zheng,
Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China #e20543
Publication Only: Lung Cancer — Non-Small Cell Metastatic
Updated efficacy and safety results from the phase Ib/II study of surufatinib combined with camrelizumab and chemotherapy in patients with advanced colorectal cancer Liangjun Zhu, Sheng Li,
Jiangsu Cancer Hospital, Nanjing, China #e15547
Publication Only: Gastrointestinal Cancer — Colorectal and Anal
Phase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysis Xing Zhang,
Sun Yat-sen University Cancer Center, Guangzhou, China #11539
Poster Session: Sarcoma
Efficacy and safety of Surufatinib combined with EP regimen and Serplulimab in first-line treatment of NEC Tao Zhang, Zhenyu Lin,
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China #e15123
Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology
Performance of surufatinib in treating advanced neuroendocrine neoplasms: Insights from a real-world study Qing Zhai, Linhui Zhu,
Fudan University Shanghai Cancer Center; Shanghai Medical College, Fudan University, Shanghai, China #e15124
Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology
Epidemiological investigation of neuroendocrine differentiation in carcinomas: Focus on pancreatic and cholangiocarcinoma cohorts Susheng Shi, Yaru Wen,
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China #e16375
Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary
Efficacy and safety of surufatinib, toripalimab, nab-paclitaxel in combination with radiotherapy or surgery in the first-line treatment of esophageal squamous cell cancer: A single-centered prospective clinical trial Fang Liu, Xiang Huang,
Chinese PLA General Hospital, Beijing, China #e16047
Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary
Efficacy and safety of second-line treatment with surufatinib for anlotinib-resistant radioiodine-refractory differentiated thyroid cancer: An exploratory multicenter study Libo Chen, Yang Wang,
Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China #e15127
Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology

On May 23, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4, 2024 in Chicago, IL (Press release, Bio-Path Holdings, MAY 23, 2024, View Source [SID1234643776]).

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Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, will present interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). The data show prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

"We are honored that our abstract was selected by the ASCO (Free ASCO Whitepaper) Scientific Program Committee and Leadership for a prestigious oral presentation as part of a Rapid Oral Abstract Session. ASCO (Free ASCO Whitepaper) is the ideal setting to present these encouraging data, as it is the world’s largest clinical cancer research meeting with more than 30,000 oncology professionals in attendance," said Peter Nielsen, Chief Executive Officer of Bio-Path. "It is important to showcase these important data and expand awareness of prexigebersen within the field as it may encourage greater participation in this and our other prexigebersen studies."

Details for the oral presentation are as follows:

Title: Interim Safety and Efficacy of BP1001 in a Phase II Acute Myeloid Leukemia
Study Date and Time: Saturday, June 1, 2024 at 8:00 AM CT
Location: McCormick Place
Abstract Number: 6511

On May 23, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration (FDA)’s Medical Devices Advisory Committee has strongly recommended FDA approval of the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease (Press release, Guardant Health, MAY 23, 2024, View Source [SID1234643674]).

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The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year.

"The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk," said AmirAli Talasaz, co-CEO of Guardant Health. "Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths."

The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.2 yet has a 91% five-year survival rate when caught at stage I (localized).3 Despite this, one out of three eligible Americans – 50 million people – are not being screened for CRC.4 Current primary non-invasive screening options include stool-based tests which have proven efficacy in detecting CRC; however, studies have consistently found that barriers such as handling stool and challenges performing the test impact adherence.5,6,7,8 Shield offers patients a choice that can be completed with a simple blood draw during a routine office visit.

"Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,"9 said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. "Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion."

The panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in the March 2024 issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.10

For more information about Shield for CRC screening, visit BloodBasedScreening.com.

About the Shield test

The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, age 45 years or older. Patients with an "Abnormal Signal Detected" may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. The test is performed at Guardant Health, Inc.

On May 23, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that the company, along with its collaborators, will present new data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024 (Press release, Natera, MAY 23, 2024, View Source [SID1234643668]).

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The presentations feature data across a variety of indications, including breast cancer, colorectal cancer (CRC), lung cancer, melanoma, esophageal cancer, and urothelial cancer, with one oral presentation and 12 poster presentations on Signatera, Natera’s personalized and tumor-informed molecular residual disease test, as well as one poster with data on Empower, Natera’s test for hereditary cancer.

Minetta Liu, MD, chief medical officer of oncology at Natera, said, "We look forward to sharing new data across cancer types, reflecting Natera’s deep clinical pipeline in MRD with results from randomized trials as well as real-world studies. This includes promising new findings from the CIRCULATE-Japan GALAXY study demonstrating the prognostic and predictive utility of Signatera and actionable biomarkers in colorectal cancer."

GALAXY is part of the CIRCULATE-Japan trial platform, which also includes ALTAIR, a first-of-its-kind, "treat on molecular recurrence" study evaluating the utility of Signatera in CRC. Natera expects to announce topline results for this phase III randomized trial in August 2024.

Below is the full list of presentations featuring Signatera and Empower at ASCO (Free ASCO Whitepaper):

Poster Presentation | Abstract # 3609 | Presenter: Yoshiaki Nakamura, MD, PhD | CRC
Prognostic and predictive value of ctDNA-based MRD and actionable biomarkers in patients with resectable CRC: CIRCULATE-Japan GALAXY
Oral Presentation | Abstract # LBA507 | Presenter: Sherene Loi, MD, PhD | Breast Cancer
Prognostic utility of ctDNA dynamics in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC)
Poster Presentation | Abstract # 3586 | Presenter: Eric Lander, MD | CRC
Genomic alterations in early-onset versus average-onset stage IV CRC
Poster Presentation | Abstract # 5034 | Presenter: Rebecca Hassoun, MD | Testicular Cancer
Longitudinal Evaluation of ctDNA as a Prognostic Biomarker to Detect Minimal Residual Disease (MRD) in Testicular Cancer
Poster Presentation | Abstract # 4587 | Presenter: Adanma Ayanambakkam, MD | Urothelial Cancer
Longitudinal analysis of ctDNA in localised and metastatic urothelial cancer
Poster Presentation | Abstract # 4028 | Presenter: Aziz Zaanan, MD | Esophageal Cancer
Longitudinal ctDNA analysis during treatment (Tx) of locally advanced resectable (LAR) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ADENOCA): the PLAGAST prospective biomarker study
Poster Presentation | Abstract # 9564 | Presenter: Michael LaPelusa, MD | Melanoma
Association between ctDNA and Recurrence-Free Survival (RFS) in Patients (pts) with Resected Stage III Melanoma – an Exploratory Analysis of SWOG S1404
Poster Presentation | Abstract # 6056 | Presenter: Glenn Hanna, MD | Head and Neck Squamous Cell Carcinoma
Personalized ctDNA for monitoring disease status in HPV-negative head and neck squamous cell carcinoma
Poster Presentation | Abstract # TPS8659 | Presenter: Yasushi Goto, MD, PhD | Lung Cancer
Randomized phase III study comparing suspension or continuation of PD- 1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study: JCOG1701)
Poster Presentation | Abstract # 569 | Presenter: Mridula George, MD | Breast Cancer
Predicting response to neoadjuvant therapy (NAT) in patients (pts) with early-stage breast cancer (BC) using ctDNA testing
Poster Presentation | Abstract # 549 | Presenter: Marla Lipsyc-Sharf, MD | Breast Cancer
Impact of ctDNA surveillance on clinical care for patients with stage I-III breast cancer: Findings from a multi-institutional study.
Poster Presentation | Abstract # 518 | Presenter: Yoichi Naito, MD | Breast Cancer
ctDNA monitoring for breast cancer at high risk of recurrence: Interim analysis of JCOG1204A1
Poster Presentation | Abstract # 10596 | Presenter: Sarah Lee, MD | Pan-Cancer (Empower)
A targeted panel of actionable high risk hereditary cancer predisposition genes can identify patients with pathogenic/likely pathogenic variants (PVs) irrespective of meeting established NCCN testing criteria
About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 60 peer-reviewed papers.