On August 18, 2025 Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection, reported the publication of a landmark pooled analysis in the Journal of Clinical Oncology demonstrating that MRD analysis using Foresight CLARITY at end of therapy provided greater prognostic accuracy than PET/CT in large B-cell lymphoma (LBCL) (Press release, Foresight Diagnostics, AUG 18, 2025, View Source [SID1234655362]). The findings highlight the potential of ultrasensitive MRD testing as a robust and reliable tool for remission assessment following frontline treatment.

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The study integrated data from five prospective clinical studies and included 137 patients treated with curative-intent chemotherapy. MRD was measured using the Foresight CLARITY assay, which leverages PhasED-Seq, a next-generation circulating-tumor DNA detection technology capable of identifying fewer than one mutant molecule per million.1

Key findings from the study include:

ctDNA-MRD assessment was prognostic as early as after two cycles of frontline chemotherapy. Patients with undetectable MRD after 2 cycles achieved a 2-year progression-free survival (PFS) of 96% compared to 67% for patients with detectable MRD (hazard ratio 6.9; p=0.0025).

ctDNA-MRD assessment was most prognostic at end of therapy: 78% of patients were MRD-negative and had a 2-year PFS of 97%, compared to just 29% among MRD-positive patients (hazard ratio 28.7; p<0.0001). By comparison, PET/CT status at end of therapy was less predictive, with a hazard ratio of 3.6.

MRD status further stratified risk within both PET-negative and PET-positive groups at end of therapy. Patients with detectable MRD faced a higher risk of relapse even if their imaging was negative. Conversely, PET-positive patients with undetectable MRD had significantly better outcomes than patients with both positive imaging and MRD results.

Overall, Foresight CLARITY demonstrated 86% clinical sensitivity for relapse detection and 91% clinical specificity for remission at end of therapy, based on a median follow-up of 37 months.2
"These findings highlight the clinical value of achieving ctDNA-MRD negativity at the end of treatment and underscore the limitations of relying solely on PET/CT for remission assessment," said Dr. David Kurtz, Chief Medical Officer at Foresight Diagnostics and co-author on the analysis. "With the ultra-high sensitivity of Foresight CLARITY, we can detect disease that imaging misses, offering clinicians a more accurate and actionable tool for post-treatment risk stratification."

"Our study illustrates the potential of ctDNA-MRD detection to more precisely define remission in B-cell lymphoma," said Dr. Mark Roschewski, Senior Clinician and Deputy Branch Chief of the Lymphoid Malignancies Branch at the Center for Cancer Research and lead author of the publication. "The results support the incorporation of novel surrogate endpoints such as molecular response into prospective studies evaluating how they could aid clinical decisions following frontline therapy."

Ongoing trials are already evaluating ctDNA-guided treatment decisions in B-cell lymphoma. These include the ALPHA3 trial (NCT06500273), which is enrolling patients who achieve remission following frontline treatment but retain detectable ctDNA-MRD, and the SHORTEN-ctDNA study (NCT06693830), which is evaluating early ctDNA-MRD clearance as a potential marker to support frontline chemotherapy de-escalation.

Additionally, the results from this pooled analysis were included in Foresight’s clinical recommendations to the National Comprehensive Cancer Network (NCCN) and supported the December 2024 update to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-Cell Lymphomas, which incorporated ctDNA-MRD testing as a tool to adjudicate PET-positive end-of-therapy scans.3

The full manuscript, titled "Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma," is available online in the Journal of Clinical Oncology. These findings were previously presented at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and the 2023 International Conference on Malignant Lymphoma (ICML).

On August 18, 2025 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported agenda topics for its in-person R&D Day in conjunction with the company’s 10-Year Anniversary on September 8, 2025 in New York from 8:00-10:30am EST (Press release, Ideaya Biosciences, AUG 18, 2025, View Source [SID1234655361]).

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Members of IDEAYA’s senior leadership team will provide an overview of the company’s progress to date, including presentation of new clinical data on darovasertib in neoadjuvant uveal melanoma (UM), IDE849 (DLL3 TOP1 ADC) and IDE397 (MAT2A), and outline key areas of focus as part of their future growth strategy. Details of the R&D Day agenda are below.

Agenda topics

IDEAYA 10-Year Anniversary and R&D Day Introduction
Darovasertib (PKC)
Phase 2 Neoadjuvant UM Data in Plaque Brachytherapy-eligible Patients
IDE849 (DLL3 TOP1 ADC)
Phase 1 SCLC Data from the 2025 World Conference on Lung Cancer (WCLC)
Mechanistic Data from 2025 WCLC to Support Combination of TOP1-ADCs with IDE161/PARG
IDE397 (MAT2A)
Combination Rationale with Trodelvy (TROP2 TOP1 ADC) in MTAP-deletion solid tumors
Initial Phase 1 Clinical Data from IDE397/Trodelvy Combination in MTAP-deletion urothelial cancer
IDE892 (PRMT5)
Potentially Best-in-Class PRMT5 Profile and Combination Opportunity with IDE397 (MAT2A) in MTAP-deletion solid tumors
Application of AI/ML in Our Discovery Capabilities
Closing Remarks and Q&A
Joining IDEAYA’s leadership team at the R&D Day will be Dr. Arun D. Singh, Director of the Department of Ophthalmic Oncology at the Cole Eye Institute, Cleveland Clinic. Dr. Singh will present data from IDEAYA’s Phase 2 trial of darovasertib in the neoadjuvant setting of UM and discuss the design and objectives of IDEAYA’s recently initiated Phase 3 OptimUM-10 trial to support a potential approval in this indication.

A live question and answer session will follow the presentation. Registration for this event can be accessed here or through the IDEAYA website View Source

On August 18, 2025 Merck & Co. reported that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy (Press release, Merck & Co, AUG 18, 2025, View Source [SID1234655360]).

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Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines.

The FDA granted the BTD based on data from the IDeate-Lung01 Phase 2 trial, with support from the IDeate-PanTumor01 Phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). This is the first BTD for ifinatamab deruxtecan and represents the first BTD since the start of the Daiichi Sankyo and Merck collaboration.

"This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer," said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. "We are committed to advancing this medicine with the goal of bringing the first B7-H3 directed antibody drug conjugate to patients in order to transform the outcomes of those facing this aggressive disease."

"Patients living with extensive-stage small cell lung cancer often have limited therapeutic options following disease progression after standard of care treatments," said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "This Breakthrough Therapy Designation reinforces our confidence in the promise of ifinatamab deruxtecan to play an important role in the treatment of extensive-stage small cell lung cancer, and we are looking forward to sharing data at the upcoming IASLC 2025 World Conference on Lung Cancer that show the potential of this novel option."

About IDeate-Lung01

IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part Phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible.

In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan 8 or 12 mg/kg intravenously Q3W. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan 12 mg/kg intravenously Q3W.

The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis.

IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About IDeate-PanTumor01

IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label Phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists.

The Phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The Phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistance prostate cancer or esophageal squamous cell carcinoma.

The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating overall response rate, duration of response, disease control rate, progression-free survival, overall survival and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints will also be assessed.

IDeate-PanTumor01 enrolled approximately 250 patients in Asia and North America. For more information about the trial, visit ClinicalTrials.gov.

About small cell lung cancer

More than 2.48 million lung cancer cases were diagnosed globally in 2022. Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for approximately 15% of cases. SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate. While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches.

About B7-H3

B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. There are currently no B7-H3 directed medicines approved for the treatment of any cancer.

About ifinatamab deruxtecan

Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC.

About the ifinatamab deruxtecan clinical development program

A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other anticancer medicines across multiple cancers.

On August 18, 2025 PharmaCyte Biotech, Inc. (Nasdaq:PMCB) ("PharmaCyte" or the "Company") reported that it has entered into a securities purchase agreement for a $7.0 million financing with existing investors involving the sale of 7,000 shares of its newly designated Series C convertible preferred stock ("preferred stock"), with a stated value of $1,000 per share, convertible into an aggregate of 7,000,000 shares of its common stock and unregistered common stock purchase warrants to purchase up to an aggregate of 7,000,000 shares of its common stock in a private placement (Press release, PharmaCyte Biotech, AUG 18, 2025, View Source [SID1234655359]). The private placement is expected to close on or about August 19, 2025, subject to the satisfaction of customary closing conditions.

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GP Nurmenkari Inc. is acting as the sole placement agent for the private placement.

"This financing, priced at a premium to our current market price and led by our existing investors, reflects strong confidence in PharmaCyte’s future," said Josh Silverman, Interim Chief Executive Officer of PharmaCyte. "It meaningfully strengthens our balance sheet, positions us to enhance shareholder value, and enables us to continue pursuing strategic alternatives that we believe can maximize long-term returns for our stockholders."

The shares of preferred stock have a conversion price of $1.00 per share of common stock and accrue a 7.0% quarterly dividend payable in cash. The warrants have an exercise price of $1.00 per common share, are exercisable immediately and are exercisable for a term of five years from the date of issuance. The securities in the private placement were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. Accordingly, the shares of common stock issuable upon conversion or exercise of the preferred stock and warrants offered and sold in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in connection with the private placement.

This press release is not 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 an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 18, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported positive data from a retrospective analysis of the CNSide Cerebrospinal Fluid (CSF) Assay Platform at the 2025 Society for Neuro-Oncology (SNO)/American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) CNS Metastases Conference in Baltimore, Maryland (Press release, Plus Therapeutics, AUG 18, 2025, View Source;_hsenc=p2ANqtz-9sWh547QDdk85Psi7xBTXd3_kx0otYbSOU1FT06Mjww3bsfxpz8hZNcZGnbq0j6JxbNij01hpgF2VOxEuUzPjgi6ef7g&_hsmi=376442183&utm_content=376442183&utm_source=hs_email [SID1234655358]).

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The presentation, titled "The Oncogenic Flip in Patients with Leptomeningeal Metastatic Disease (LMD): Longitudinal Detection in Cerebrospinal Fluid Tumor Cells (CSF-TCs) Reveals Implications for Differential Treatment of the LMD Tumor," was a retrospective, multi-center analysis of 613 CNSide assays ordered by 19 physicians from 5 institutions at 2 health systems for 218 individual patients. 74% of the patients were female and the cancers most analyzed were breast (n=105) and lung (n=65). The research was presented by Priya U. Kumthekar, M.D., Professor of Neurology and Medicine at Northwestern University.

Data Demonstrated:

CSF tumor cells detected in 67% (412/613) patients using CNSide;
66 patients underwent 2 or more CSF draws; 24 patients underwent 5 or more;
20% (13/66) of patients were found to have a flip in immunocytochemistry (ICC) detection; and
88% (58/66) of patients were found to have a flip in FISH probe detection.
"The CNSide CSF Assay Platform can be used to detect gene amplification on CSF tumor cells of patients with LM and, therefore, may provide therapeutic insights to specifically target the LM tumor," said Priya U. Kumthekar, M.D., "Further, longitudinal CSF tumor cell analysis using CNSide may provide insights to modify treatment of the LM tumor over time."

The data builds upon previously announced results, "CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker Assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease," from the prospective FORESEE study, which was also presented by Dr. Kumthekar, principal investigator. The study met key primary and secondary endpoints and showed that the CNSide CSF Assay platform influenced clinical management decisions in over 90% of LM cases. Further the CNSide CSF Assay demonstrated 2.8 times the diagnostic sensitivity versus standard CSF cytology.