Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-015 Trial Evaluating LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy in Patients with Certain Types of Gastroesophageal Adenocarcinoma

On January 24, 2025 Eisai (Headquarters: Tokyo, CEO: Haruo Naito) and Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada) reported results from the Phase 3 LEAP-015 trial evaluating LENVIMA (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, plus KEYTRUDA (pembrolizumab), the anti-PD-1 therapy from Merck & Co., Inc., Rahway, NJ, USA, in combination with chemotherapy (LENVIMA plus KEYTRUDA-based regimen), for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma (Press release, Eisai, JAN 24, 2025, View Source [SID1234649865]).

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At an interim analysis, the LENVIMA plus KEYTRUDA-based regimen demonstrated a statistically significant improvement in progression-free survival (PFS), one of the study’s dual primary endpoints, and objective response rate (ORR), a key secondary endpoint, compared to standard of care chemotherapy. The study continued, and at the final analysis, it did not meet its other primary endpoint of overall survival (OS). The safety profile of the LENVIMA plus KEYTRUDA-based regimen was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing, and Eisai and Merck & Co., Inc., Rahway, NJ, USA will present these results at an upcoming medical meeting.

"Locally advanced unresectable or metastatic gastroesophageal adenocarcinoma remains a challenging disease to treat and a leading cause of cancer death worldwide," said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, MSD Research Laboratories. "These study results add to our understanding of this combination and will inform our future research as we strive to improve outcomes for more patients with cancer."

"Gastric and gastroesophageal cancers continue to present challenges due to their heterogeneity and generally poor prognoses," said Dr. Corina Dutcus, Senior Vice President, Oncology Global Clinical Development Lead at Eisai Inc. "While the LEAP-015 trial did not show a statistically significant increase in overall survival, we were pleased to observe an improvement in progression-free survival and objective response rate for patients treated with LENVIMA plus KEYTRUDA in combination with chemotherapy. These results contribute to the scientific community’s collective understanding of these complex diseases and add to the body of knowledge in oncology research. We are deeply grateful to the patients, caregivers and investigators who participated in this study."

LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Lenvatinib is marketed as KISPLYX for advanced RCC in the EU. Eisai and Merck & Co., Inc., Rahway, NJ, USA are studying the LENVIMA plus KEYTRUDA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in hepatocellular carcinoma and esophageal cancer across multiple clinical trials.

Results from the LEAP-015 trial do not affect the current approved indications for KEYTRUDA plus LENVIMA or other ongoing trials from the LEAP clinical program.

About Leap-015

LEAP-015 is a randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT04662710) evaluating LENVIMA plus KEYTRUDA in combination with chemotherapy versus chemotherapy alone for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastroesophageal adenocarcinoma. There are two parts of the study: a safety run-in (Part 1) and the main study (Part 2). In Part 2, the primary endpoints are OS and PFS as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) and in all patients. Secondary endpoints are ORR and duration of response (DOR) as assessed by BICR per RECIST v1.1 in both patients whose tumors express PD-L1 (CPS ≥1) as well as in all patients, and safety. In Part 2, up to 880 patients were randomized 1:1 to receive:

• LENVIMA plus KEYTRUDA plus chemotherapy:
o Induction Phase: approximately 12 weeks
 Oral LENVIMA 8 mg every day (QD) plus KEYTRUDA 400 mg intravenously (IV) every six weeks (Q6W) x 2 cycles plus chemotherapy (CAPOX or mFOLFOX6)
• CAPOX: oral capecitabine 1000 mg/m2 twice daily (BID) for 14 days plus oxaliplatin 130 mg/m2 IV, every 3 weeks (Q3W) x 4 cycles or
• mFOLFOX6: bolus IV 5-fluorouracil (5-FU) 400 mg/m2, plus 5-FU 2400 mg/m2 continuous IV plus leucovorin 400 mg/m2 IV or levoleucovorin 200 mg/m2 IV plus oxaliplatin 85 mg/m2 IV, every 2 weeks (Q2W) x 6 cycles
o Consolidation Phase:  Oral LENVIMA 20 mg QD, plus KEYTRUDA 400 mg IV Q6W, for less than or equal to 16 doses ; or
• Chemotherapy (either CAPOX regimen or mFOLFOX6 regimen, dosed as above; maximum cycles per local standards).

About Gastric Cancer

Gastric (stomach) cancer tends to develop slowly over many years and rarely causes early symptoms, resulting in most cases going undetected until an advanced stage.1,2 More than 70% of patients with gastric cancer develop advanced-stage disease.3 Most gastric cancers are adenocarcinomas (about 90% to 95%), which develop from cells in the innermost lining of the stomach (known as the mucosa).1 Gastric cancer is the fifth most diagnosed cancer and the fifth leading cause of cancer death worldwide, with approximately 969,000 patients diagnosed and 660,000 deaths from the disease globally in 2022.4 In Japan, it is estimated there were approximately 126,000 patients diagnosed with gastric cancer and almost 44,000 deaths from the disease in 2022. 5 In the U.S., it is estimated there will be approximately 27,000 patients diagnosed with gastric cancer and almost 11,000 deaths from the disease in 2024.6 The five-year relative survival rate for patients diagnosed with gastric cancer at a distant stage is 7% in the U.S.

About esophageal cancer

Esophageal cancer is the 11th most commonly diagnosed cancer and the seventh leading cause of death from cancer worldwide.4 It is estimated there were 511,000 new cases of esophageal cancer diagnosed and about 445,000 deaths resulting from the disease worldwide in 2022.4 In Japan, it is estimated there were approximately 20,000 patients diagnosed with esophageal cancer and almost 12,000 deaths from the disease in 2022.5 In the U.S., it is estimated there will be approximately 22,000 patients diagnosed with esophageal cancer and almost 16,000 deaths from the disease in 2024.8 The five-year relative survival rate for patients diagnosed with advanced esophageal cancer is 6% in the US.9 Cancers that start in gland cells (cells that make mucus) are called adenocarcinomas and are often found in the lower third of the esophagus (lower thoracic esophagus).10 Adenocarcinoma is the most common form of esophageal cancer in the U.S. and its incidence is rapidly increasing in other parts of the world.

About LENVIMA (lenvatinib) Capsules

LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1-4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below.

Thyroid cancer

 Indication as monotherapy (Approved mainly in Japan, the United States, Europe, China and Asia) Japan: Unresectable thyroid cancer The United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC) Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)

Hepatocellular carcinoma

 Indication as monotherapy (Approved mainly in Japan, the United States, Europe, China and Asia) Japan: Unresectable hepatocellular carcinoma The United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy

Thymic carcinoma

 Indication as monotherapy (Approved in Japan)
Japan: Unresectable thymic carcinoma

Renal cell carcinoma (In Europe, the agent was launched under the brand name Kisplyx)

 Indication in combination with everolimus (Approved mainly in the United States, Europe and Asia) The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy Europe: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy

 Indication in combination with KEYTRUDA (generic name: pembrolizumab) (Approved mainly in Japan, the United States, Europe and Asia) Japan: Radically unresectable or metastatic renal cell carcinoma The United States: The first-line treatment of adult patients with advanced renal cell carcinoma Europe: The first-line treatment of adult patients with advanced renal cell carcinoma Endometrial carcinoma

 Indication in combination with KEYTRUDA (Approved mainly in Japan, the United States, Europe and Asia) Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy The United States: The treatment of patients with advanced endometrial carcinoma (EC) that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation Europe: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery.

About KEYTRUDA (pembrolizumab) Injection, 100mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer

On January 24, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy (Press release, Clarity Pharmaceuticals, JAN 24, 2025, View Source [SID1234649847]).

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This milestone builds on Clarity’s earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy1. These 2 FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product.

The FDA’s FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For 64Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a faster review process once Clarity submits its product approval applications. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner.

The FTD submission highlighted several advantages of 64Cu-SAR-bisPSMA over currently approved PSMA PET agents due to the bivalent structure of bisPSMA and the longer half-life of 64Cu (12.7 hours vs. <2 hours for 18F and 68Ga). These advantages include improved diagnostic performance, flexible imaging schedule and broader availability. The data for this FTD submission was primarily focused on the results of the Phase I/II COBRA study, which assessed the safety and diagnostic performance of 64Cu-SAR-bisPSMA in detecting prostate cancer in patients with BCR of their disease who had a negative or equivocal standard of care (SOC) scan at study entry. Advantages have been shown with same-day and next-day imaging, however, the standout was next-day 64Cu-SAR-bisPSMA PET imaging, showing localised disease in up to 80% of participants and detecting lesions as small as 2 mm. This compares favourably against the current SOC PSMA PET agents, with which the detection of lesions smaller than 5 mm is challenging. The number of lesions detected by 64Cu-SAR-bisPSMA on next-day imaging almost doubled compared to same-day imaging, and 64Cu-SAR-bisPSMA was also able to identify more lesions at much earlier timepoints (Figure 1) compared to approved PSMA PET agents.The COBRA trial paved the way for Clarity’s second diagnostic registrational trial, AMPLIFY, and an investigator-initiated trial (IIT) Co-PSMA, led by Prof Louise Emmett at St Vincent’s Hospital Sydney. The AMPLIFY trial will be a non-randomised, single-arm, open-label, multi-centre, Phase III diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in approximately 220 participants with rising or detectable PSA after initial definitive treatment. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer in patients with BCR. The Co-PSMA IIT will aim to build on the evidence generated so far, evaluating the diagnostic performance of 64Cu-SAR-bisPSMA in comparison to SOC 68Ga-PSMA-11 for the detection of recurrent prostate cancer lesions with curative intent.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Receiving the second FTD for 64Cu-SAR-bisPSMA and well within the 60-day period following our application submission, reserved by the U.S. FDA for review, is yet another significant milestone in our bisPSMA program. This highlights the high unmet need for novel diagnostics in prostate cancer and the high quality of data we presented to the FDA.

"The market for first-generation diagnostic PSMA PET today is approximately US$2 billion (AU$3.2 billion) in the U.S. alone, with little differentiation between products. It is expected to further grow to US$3 billion (AU$4.75 billion) by 2029. The development pipeline of new products coming to market, outside of 64Cu-SAR-bisPSMA, also offers no differentiation from the existing offering, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already.

"Being able to now fast-track the development of 64Cu-SAR-bisPSMA for patients with BCR as well as for patients prior to initial definitive therapy is incredibly exciting. The news is especially timely as we are actively preparing to commence recruitment for our second registrational trial, AMPLIFY, in the coming months. The designation will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostic.

"The dual targeting structure of bisPSMA enables increased uptake and retention of the product in the lesions, while the longer half-life of copper-64 provides greater flexibility with imaging scheduling, including next-day imaging (something that gallium-68 and fluorine-18 based products cannot support). When combined, these features make 64Cu-SAR-bisPSMA stand out from its competitors who are known to have issues with sensitivity. We have seen 2-3 times higher uptake in prostate cancer lesions and the identification of more lesions using 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 in pre-prostatectomy patients in our PROPELLER study. The COBRA trial results showed great diagnostic performance in the BCR setting, with lesions identified by 64Cu-SAR-bisPSMA in the 2-mm range and visualised many months before SOC PSMA PET agents are able detect them.

"Not only are we developing a product that may have improved diagnostic performance compared to SOC PSMA PET agents, but the longer half-life of copper-64 also enables a longer shelf-life of 64Cu-SAR-bisPSMA than currently used diagnostic radiopharmaceuticals, allowing for centralised manufacture and wider distribution. These attributes have the potential to reduce disparities in prostate cancer care and ensure that most patients, regardless of geographic location, can benefit from the latest advances in diagnostic technology.

"This designation highlights the unique opportunity for 64Cu-SAR-bisPSMA in this very large market by addressing the limitations of the current-generation diagnostic radiopharmaceuticals and providing patients with prostate cancer with a more accurate diagnosis leading to more optimal treatment options. As such, we are fully committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide4. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the U.S. and around 35,770 deaths from the disease.

Ascentage Pharma Announces Pricing of U.S. Initial Public Offering

On January 23, 2025 Ascentage Pharma (Nasdaq: AAPG) (HKEX: 6855) reported the pricing of its U.S. initial public offering of 7,325,000 American depositary shares ("ADSs"), at a public offering price of $17.25 per ADS, before underwriting discounts and commissions (Press release, Ascentage Pharma, JAN 23, 2025, View Source [SID1234650021]). Each ADS represents four ordinary shares of Ascentage Pharma. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Ascentage Pharma, are expected to be approximately $126.4 million. In addition, Ascentage Pharma has granted the underwriters a 30-day option to purchase up to an additional 1,098,750 ADSs at the initial public offering price, less underwriting discounts and commissions. The ADSs are expected to begin trading on the Nasdaq Global Market on January 24, 2025, under the ticker "AAPGV" on a "when-issued" basis, and on January 27, 2025, under the ticker symbol "AAPG" for "regular-way" trading. The offering is expected to close on January 28, 2025, subject to customary closing conditions.

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J.P. Morgan and Citigroup are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on January 23, 2025. The offering will be made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected], and Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Parabilis Medicines to Present Trial-in-Progress Poster on Phase 1/2 Study of FOG-001, a β-cateninTCF4 Inhibitor, at ASCO Gastrointestinal Cancers Symposium

On January 23, 2025 Parabilis Medicines (formerly Fog Pharmaceuticals), a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for people living with cancer, reported the presentation of a trial-in-progress poster on the Company’s first-in-human clinical trial evaluating FOG-001, the first and only direct inhibitor of β-cateninTCF4, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium taking place in San Francisco from January 23-25, 2025 (Press release, Parabilis Medicines, JAN 23, 2025, View Source [SID1234649861]).

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FOG-001 is being evaluated in a Phase 1/2 clinical trial (NCT05919264). The multicenter, open-label, non-randomized trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of FOG-001 in patients with microsatellite stable colorectal cancer (MSS CRC) and other solid tumors with Wnt pathway activating mutations (WPAM+). The trial plans to enroll patients in multiple third-line MSS CRC cohorts as both a monotherapy and in combination with FOLFOX+bevacizumab, anti-PD-1/PD-L1, or trifluridine/tipiracil+bevacizumab.

At the 2025 J.P. Morgan Healthcare Conference, Parabilis provided an update on the trial’s progress. The Company disclosed that more than 60 patients with locally advanced or metastatic solid tumors have been dosed with FOG-001 to date, and that early clinical data demonstrate monotherapy antitumor activity and in-tumor target engagement. Preliminary Phase 1/2 data are expected to be shared publicly in 2025.

Full details of the poster are as follows:

Title: "A Phase 1/2 study of FOG-001, a first-in-class direct β-catenin:TCF inhibitor, in patients with colorectal cancer, hepatocellular carcinoma, and other locally advanced or metastatic solid tumors"
Abstract Number: TPS322
Presentation Date and Time: January 25, 2025, 7:00-7:55 a.m. PST
Session Information: Trials in Progress Poster Session C
Location: Level 1, West Hall, Moscone West

About FOG-001
FOG-001 is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors, and is currently in clinical development. By directly targeting the β-cateninTCF4 protein-protein interaction, FOG-001 is intended to block the Wnt signaling pathway irrespective of the various APC and beta-catenin mutations that typically drive disease.

FOG-001 combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and FOG-001 blocks the Wnt pathway at the most downstream node, disrupting the interaction between β-catenin and the transcription factor TCF, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis. FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors.

Guardant Health to Present Data at ASCO GI Demonstrating the Value of Its Precision Oncology Tools for Cancer Detection, Treatment Decisions and Therapy Development

On January 23, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data showcasing the benefits of Guardant’s precision oncology tools across cancer screening, recurrence monitoring, treatment selection and therapy development at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, January 23-25, 2025 (Press release, Guardant Health, JAN 23, 2025, View Source [SID1234649860]).

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Key focus areas in Guardant’s co-authored abstracts and collaborator presentations utilizing Guardant products include the impact of mutations on treatment response in colorectal cancer and biliary tract cancers, and additional support for the benefits of blood-based screening in colorectal, gastric and esophageal cancers. A rapid oral presentation will feature data from the phase II NEO trial highlighting Guardant Reveal as a decision tool to support organ preservation in patients with node-negative rectal cancer undergoing neoadjuvant chemotherapy, excision and observation.

"Data increasingly supports the value of precision oncology tools, and specifically liquid biopsy, in detecting GI cancers, informing treatment selection, and monitoring for recurrence and therapy response," said Craig Eagle, MD, Guardant Health chief medical officer. "Findings presented at ASCO (Free ASCO Whitepaper) GI demonstrate the advancements being made by Guardant Health and our partners in these areas and show the potential for these tools to provide even more personalized cancer care, leading to better patient outcomes."

Guardant Health ASCO (Free ASCO Whitepaper) GI 2025 Co-Authored Posters and Presentations

Time and Location

Title

Abstract and

Presentation Type

Guardant Reveal

January 25, 2025

9:15 – 10:00 am PST

Level 2, Ballroom

Tumour-free ctDNA detection as a decision tool to support organ preservation in node-negative rectal cancer undergoing neoadjuvant chemotherapy, excision, and observation in the phase II NEO trial (CCTG CO.28)

Rapid Oral Abstract

Session C

Abstract #20

Guardant360

January 25, 2025

7:00 – 7:55 am PST

Level 1, West Hall

Retrospective study evaluating the genomic landscape of anal squamous cell carcinoma using liquid biopsy

Poster Session C

Abstract #8

Landscape of metastatic colorectal cancer (CRC) using comprehensive circulating tumor DNA (ctDNA) next-generation sequencing (NGS) in India: Expanding beyond RAS and RAF

Poster Session C

Abstract #49

GuardantINFORM

January 24, 2025

11:30 am – 1:00 pm PST

Level 1, West Hall

Real-world survival differences in advanced biliary tract cancer patients with ctDNA detected IDH1 mutations and FGFR2 fusions receiving first-line gemcitabine-cisplatin with and without immunotherapy

Poster Session B

Abstract #548

ShieldTM

January 25, 2025

7:00 – 7:55 am PST

Level 1, West Hall

Cost-effectiveness of blood-based colorectal cancer screening: A simulation model incorporating real-world longitudinal adherence

Poster Session C

Abstract #93

A method for classifying colorectal cancer and gastric/esophageal cancer using blood-based testing

Poster Session C

Abstract #52

The full abstracts for Guardant Health and a list of all abstracts being presented at ASCO (Free ASCO Whitepaper) GI 2025 can be found on the ASCO (Free ASCO Whitepaper) website.