GRAIL to Present New Data From NHS-Galleri and PATHFINDER 2 at 2026 ASCO Annual Meeting

On April 21, 2026 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported it will present additional data from both the NHS-Galleri trial and the PATHFINDER 2 study further evaluating the Galleri multi-cancer early detection (MCED) test at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 29-June 2, 2026.

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The NHS-Galleri trial presentation will expand on topline results announced in February 2026. The NHS-Galleri trial, the first and only randomized controlled study of an MCED test, was designed to demonstrate population-level impact through the reduction of late-stage cancer diagnosis and increased cancer detection rate within England’s National Health Service (NHS). The trial evaluated annual screening with the Galleri test in addition to standard of care screening over three years in more than 142,000 demographically representative participants aged 50 to 77, compared to standard of care screening alone.

Building on initial results presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2025, the complete PATHFINDER 2 dataset of more than 32,000 evaluable participants will be presented. Conducted under an FDA-approved investigational device exemption, PATHFINDER 2 is the largest MCED interventional study in North America in an intended-use population with no clinical suspicion of cancer.

"The goal of cancer screening is to detect cancer before it becomes advanced or spreads, when treatment options may be broader, care and cost may be less intensive, and the opportunity for cure is often greater. Yet the status quo still leaves too many cancers unscreened. In the U.S., more than 70 percent of cancer deaths are from cancers without recommended screening tests," said Josh Ofman, MD, MSHS, President of GRAIL. "These results from NHS-Galleri and PATHFINDER 2, two large, rigorous studies, underscore Galleri’s strong performance, ability to shift detection of cancers earlier before metastatic disease, and strong safety profile. We look forward to sharing these findings, which strengthen the body of evidence supporting the clinical utility, performance, and safety of Galleri in intended-use populations and reflect GRAIL’s extensive experience building a robust evidence base for multi-cancer early detection."

ASCO Presentations

Title: NHS-Galleri: Primary results from a randomised controlled trial to assess the clinical utility of a multi-cancer early detection (MCED) test in population screening

Abstract Number: LBA100
Session Title: Clinical Science Symposium – ctDNA in Clinical Practice: From Detection to Clinical Decision-Making
Presentation type: Oral Presentation
Date/Time: Saturday, May 30, 2026 – 8:12-8:24 am CDT

Title: Safety and performance results from PATHFINDER 2 (PF2), a registrational study of a multi-cancer early detection (MCED) test in an intended-use population

Abstract Number: LBA10509
Session Title: Rapid Oral Abstract Session – Prevention, Risk Reduction, and Genetics
Presentation type: Oral Presentation
Date/Time: May 31, 2026 – 9:45-9:52 am CDT

Title: Implementation of a multi-cancer early detection (MCED) test in a private practice: adoption, performance, and repeat-testing patterns

Abstract Number: 10532
Presentation Type: Poster #493
Date/Time: June 1, 2026 – 1:30-4:30 pm CDT

(Press release, Grail, APR 21, 2026, View Source [SID1234664634])

Personalis Highlights Clinical Impact of Ultrasensitive ctDNA Monitoring and New Therapy Resistance Tracking at AACR 2026

On April 21, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the successful presentation of clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data, spanning one oral podium presentation and three posters, underscore the use of the NeXT Personal ultrasensitive ctDNA assay in monitoring treatment response, identifying early recurrence, and tracking the emergence of therapy resistance.

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Neoadjuvant Monitoring in Colorectal Cancer. A highlight was the oral podium presentation of the NEOPRISM-CRC trial, delivered by Dr. Jiang from the University College London, which utilized NeXT Personal to monitor patients with high-risk stage II-III dMMR/MSI-H colorectal cancer (CRC) receiving neoadjuvant pembrolizumab. In addition to 100% sensitivity for disease at baseline, the study identified three distinct groups of patient response to neoadjuvant treatment: super molecular responders, dynamic molecular responders, and poor molecular responders. Notably, 100% of "super molecular responders"—those who cleared ctDNA by the second cycle of treatment—also achieved pathological complete response (pCR). Conversely, of "poor molecular responders"—patients with relatively stable ctDNA levels during neoadjuvant treatment—100% did not achieve pCR. These findings could provide clinicians with a critical window to adjust treatment strategies prior to surgery. Post-surgery, the test achieved a 100% negative predictive value (NPV) and 100% specificity for disease relapse.

"The data presented at AACR (Free AACR Whitepaper) confirm ultrasensitive ctDNA detection with NeXT Personal as a promising therapy monitoring tool in neoadjuvant colorectal cancer treatment," said Dr. Richard Chen, President and Chief Medical Officer at Personalis. "By measuring molecular response with high resolution, we are providing the tools needed to explore ctDNA-guided management of colorectal cancer patients receiving neoadjuvant therapy."

Ultrasensitivity in Real-World Data. In a large-scale analysis of nearly 25,000 plasma samples from 10,000 real-world patients, NeXT Personal demonstrated consistent ultrasensitive performance with a median limit of detection of 1.92 PPM. The study also revealed that 39% of all positive MRD detections occurred in the ultrasensitive range below 100 PPM, with 14.6% below 10 PPM—detections that could be missed with less sensitive assays. This study also highlights the robust ultrasensitive performance of the NeXT Personal assay in real-world testing conditions across more than 14 cancer types, stage I-IV disease, and a variety of challenging sample types.

Innovation in Therapy Resistance Tracking. Personalis also debuted analytical validation and real-world data for a new opt-in feature of its NeXT Personal MRD test: Real-Time Variant Tracker. This feature allows for the simultaneous monitoring of MRD and the longitudinal tracking of specific resistance-associated mutations, such as ESR1. With a specificity of >99.9%, resistance and other clinical mutations were identified in 38% of MRD-positive patients across the real-world cohort, offering a new tool for tracking treatment resistance as it emerges.

Monitoring Immunotherapy Response in NSCLC. The DARWIN 2 study results in metastatic non-small cell lung cancer (NSCLC) demonstrated NeXT Personal’s ability to stratify risk in patients receiving immunotherapy. Patients who achieved a durable molecular complete response (dmCR) remained 100% progression-free at three years, whereas patients who failed to achieve molecular clearance were five times more likely to experience disease progression.

Together, these studies illustrate Personalis’ commitment to improving cancer management through ultrasensitive MRD testing throughout the patient journey.

(Press release, Personalis, APR 21, 2026, View Source [SID1234664650])

Disc Medicine Announces Oral Presentation of Data from RALLY-MF Phase 2 Trial of DISC-0974 in Patients with Myelofibrosis and Anemia at the American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported that it will present data from the RALLY-MF Phase 2 trial of DISC-0974 in anemia of myelofibrosis (MF) in an oral abstract session at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held in Chicago, IL on May 29-June 2, 2026.

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"Initial data from the RALLY-MF trial showed anemia response rates that are unprecedented in the hard-to-treat myelofibrosis population," said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc Medicine. "We look forward to bringing a more complete dataset, with additional data from patients receiving transfusions, to the ASCO (Free ASCO Whitepaper) stage."

The abstract will be published online on the ASCO (Free ASCO Whitepaper) conference website on May 21, 2026. Pursuant to Disc Medicine practice, the abstract published will contain previously presented data, and new data and analyses are reserved for presentation at the conference.

DISC-0974 is an investigational agent and is not approved for use as a therapy in any jurisdiction worldwide.

Details of Oral Presentation:

Abstract Number: 6501
Abstract Title: RALLY-MF: Initial efficacy of a phase 2 study of DISC-0974, an anti-hemojuvelin antibody, to treat anemia in myelofibrosis.
Session Type/Title: Oral Abstract Session – Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Session Date and Time: June 2, 2026, 9:45 AM-12:45 PM CDT
Presenting Author: Naseema Gangat, M.B.B.S.

(Press release, Disc Medicine, APR 21, 2026, View Source [SID1234664666])

Cogent Biosciences Announces Oral Presentation of Positive Phase 3 PEAK Trial in Gastrointestinal Stromal Tumors (GIST) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 21, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the results from the Phase 3 PEAK trial have been selected for oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago, IL, May 29-June 2, 2026. The presentation will feature data from the positive trial of bezuclastinib in combination with sunitinib in patients with Gastrointestinal Stromal Tumors (GIST) who have received prior treatment with imatinib. Top line results were reported in November 2025, and the New Drug Application was submitted under the Real-Time Oncology Review (RTOR) program in March 2026.

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Oral Presentation Details

Abstract Title: Primary Results of the Phase 3 Peak Study of bezuclastinib + sunitinib vs sunitinib Monotherapy in Advanced Gastrointestinal Stromal Tumors (GIST)
Abstract Number for Publication: 11500
Presenter: Andrew J. Wagner, M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School
Session Date and Time: May 30, 2026, 3:00 PM-6:00 PM CT (4:00 PM-7:00 PM ET)
Session Title: Oral Abstract Session – Sarcoma
Location: South Building, Floor 1, Grand Ballroom, S100bc – McCormick Place Convention Center, Chicago, IL

Cogent is on track this quarter to initiate a Phase 2 trial investigating the benefit of the bezuclastinib plus sunitinib combination for first-line GIST patients with exon 9 mutations who are naive to, or recently initiated treatment with, imatinib.

(Press release, Cogent Biosciences, APR 21, 2026, View Source [SID1234664603])

Revolution Medicines to Present Pivotal Phase 3 RASolute 302 Clinical Trial Results for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer During a Plenary Session at the 2026 ASCO Annual Meeting

On April 21, 2026 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported that detailed results from the global, randomized Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) will be presented in a Plenary Session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29 – June 2, 2026 in Chicago.

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Revolution Medicines recently reported an unprecedented overall survival (OS) benefit with daraxonrasib from the RASolute 302 clinical trial. These topline results showed that daraxonrasib taken once daily orally met all primary and key secondary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and OS compared with standard of care intravenous cytotoxic chemotherapy. The presentation will describe these findings, as well as additional analyses of efficacy and safety.

Presentation Details

Presenting Author: Brian M. Wolpin, M.D., M.P.H., Dana-Farber Cancer Institute
Title: Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Primary and final analysis from the phase 3 RASolute 302 study
Abstract: LBA5
Session Name: Plenary Session
Session Date: May 31, 2026
Presentation Time: 3:21-3:33 PM CDT
Location: McCormick Place, Hall B1

Additional Accepted Abstracts

The following additional Revolution Medicines–sponsored abstracts have been accepted for online publication:

Systemic anticancer therapy in patients with de novo metastatic pancreatic adenocarcinoma: a real-world analysis (Abstract #e16383)
Patient characteristics, treatment patterns, and survival in a metastatic pancreatic adenocarcinoma U.S. patient population (Abstract #e16379)
Safety and efficacy of daraxonrasib monotherapy as later-line (3L+) treatment for patients (pts) with metastatic pancreatic adenocarcinoma (PDAC) (Abstract #e15104)

About the RASolute 302 Clinical Trial

RASolute 302 (NCT06625320) is a global, randomized Phase 3 registrational clinical trial designed to evaluate the efficacy and safety of daraxonrasib as a monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). In the trial, patients were randomized to receive either an oral dose of 300 mg daraxonrasib once daily or investigator’s choice of standard of care cytotoxic chemotherapy. The trial enrolled patients with metastatic PDAC harboring a wide range of RAS variants, including those with RAS G12 mutations (such as G12D, G12V, and G12R), as well as patients without an identified tumor RAS mutation (wild type).

The primary endpoints of RASolute 302 are progression-free survival (PFS), as assessed by a Blinded Independent Central Review, and overall survival (OS) in patients with tumors harboring RAS G12 mutations. Secondary endpoints include PFS and OS in all enrolled patients (the intent-to-treat population) encompassing patients with and without identified tumor RAS mutations, as well as objective response rate, duration of response, and patient-reported quality of life.

About Daraxonrasib

Daraxonrasib is an investigational, oral RAS(ON) multi-selective, non-covalent inhibitor that is not approved by any regulatory authority, including in the United States or Europe. The U.S. Food and Drug Administration (FDA) granted daraxonrasib Breakthrough Therapy Designation and Orphan Drug Designation for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) harboring G12 mutations. In addition, daraxonrasib was selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.

Daraxonrasib is designed to target cancers driven by a broad range of common RAS mutations, including PDAC, non-small cell lung cancer (NSCLC), and colorectal cancer. In addition to the RASolute 302 trial, daraxonrasib is being evaluated in three other global Phase 3 registrational trials, including in patients with PDAC and metastatic RAS mutant NSCLC.

Daraxonrasib works by suppressing RAS signaling through inhibition of the interaction between both wild-type and mutant RAS(ON) proteins and their downstream effectors.

About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma

Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that annually approximately 60,000 people will be diagnosed with pancreatic cancer, and about 50,000 people will die from this aggressive disease.1

Due to the lack of early symptoms and detection methods, approximately 80% of patients are diagnosed with PDAC at an advanced or metastatic stage. It is the most commonly RAS-addicted of all major cancers, and more than 90% of patients have tumors that harbor RAS mutations.2 Metastatic PDAC remains one of the most common causes of cancer-related deaths in the U.S., with a five-year survival rate of approximately 3%.

(Press release, Revolution Medicines, APR 21, 2026, View Source [SID1234664619])