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Signatera™ MRD Data at ASCO GU Highlights Potential Utility Across GU Cancers, Including for Bladder Preservation

On February 27, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported it will present new data in genitourinary malignancies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026.

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Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA).

Bladder Preservation: INDIBLADE and RETAIN

The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved.

INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively.

RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes.

Perioperative Care: NIAGARA

This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease.

"As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it," said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. "The data presented at ASCO (Free ASCO Whitepaper) GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions."

"Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life."

The full list of presentations at ASCO (Free ASCO Whitepaper) GU includes:

February 27, 8:10 AM PT | Abstract #633 (Oral Presentation)
Presenter: Joaquim Bellmunt, M.D.
Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial

February 27, 8:10 AM PT | Abstract #632 (Oral Presentation)
Presenter: Pooja Ghatalia, M.D.
Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials

February 27, 11:30 AM PT | Abstract #797
Presenter: Can Aydogdu, M.D.
Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer

February 27, 11:30 AM PT | Abstract #831
Presenter: Can Aydogdu, M.D.
Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC

February 27, 2:30 PM PT | Abstract #637 (Oral Presentation)
Presenter: Jan-Jaap J. Mellema, M.D.
Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial

February 27, 4:00 PM PT | Abstract #636 (Oral Presentation)
Presenter: Michiel van der Heijden, M.D., Ph.D.
Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

February 28, 7:00 AM PT | Abstract #532
Presenter: Shuchi Gulati, M.D., M.Sc.
Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC)

February 28, 7:00 AM PT | Abstract #620
Presenter: Dalia Kaakour, M.D., MPH
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer

February 27, 11:30 AM PT | Abstract #860
Presenter: Lingbin Meng, M.D., Ph.D.
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer

February 27, 11:30 AM PT | Abstract #800
Presenter: Tanya Jindal, BS, BA
Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP).

February 28, 7:00 AM PT | Abstract #541
Presenter: David F. McDermott, M.D.
Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study.

(Press release, Natera, FEB 27, 2026, View Source [SID1234663139])

Bayer Reports Results for the Investigational Targeted Radionuclide Therapy 225Ac-PSMA-Trillium in Advanced Metastatic Prostate Cancer

On February 27, 2026 Bayer reported results from the ongoing global Phase I first-in-human, dose-escalation PAnTHa study (NCT06217822) evaluating the safety, tolerability and preliminary efficacy of 225Ac-PSMA-Trillium (BAY 3563254), a next-generation targeted alpha therapy (TAT) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). The dose for expansion was successfully identified, with ≥80% of patients achieving a PSA50 response at the expansion dose.

New data were presented during the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, taking place in San Francisco, CA, United States, from February 26-28, 2026. These clinical data represent the first disclosure for 225Ac-PSMA-Trillium and were selected as part of the rapid oral session focused on advanced prostate cancer research. They support advancing 225Ac-PSMA-Trillium to the next phase of clinical development. TAT is a strategic pillar of precision oncology at Bayer, with the potential to accelerate novel treatment options for patients with mCRPC.

"We are excited to see the results from the Phase I PAnTHa study demonstrating the potential of our next-generation targeted alpha therapy to provide new treatment options for patients with advanced metastatic castration-resistant prostate cancer (mCRPC), a type of cancer with limited treatment options and poor prognosis," said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development for Oncology at Bayer’s Pharmaceuticals Division. "The development of 225Ac-PSMA-Trillium confirms our ongoing focus on prostate cancer treatment and continued drive to develop precise and personalized healthcare solutions."

"Despite progress, patients with metastatic castration-resistant prostate cancer continue to face high mortality, highlighting the urgent need for new precision therapies," said Fred Saad, MD, FRCS, Professor and Chairman of Surgery at the University of Montreal and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), Canada. "The promising data support the further investigation of this molecule to provide a potentially meaningful clinical benefit for patients with mCRPC."

225Ac-PSMA-Trillium (BAY 3563254) is a next-generation investigational TAT labeled with actinium-225 and comprising a novel PSMA (prostate-specific membrane antigen)-targeting small molecule with a customized albumin-binding moiety. The compound is designed specifically to increase uptake within the tumor, with the goal to provide a differentiated safety and efficacy profile.

Prostate cancer is the second most commonly diagnosed cancer in men with less than three years median survival among metastatic patients, who have developed castration-resistance. There is an increasing unmet need to improve the outcomes of men with mCRPC.6

About the PAnTHa study (NCT06217822)
PSMA-targeted Actinium-225-Trillium FiH study in Advanced mCRPC (PAnTHa), is a Phase I, open-label, first-in-human, multicenter study to evaluate safety, tolerability, pharmacokinetics, and antitumor activity of 225Ac-PSMA-Trillium (BAY 3563254) in participants with advanced metastatic castration resistant prostate cancer (mCRPC) that have at least 1 PSMA-positive lesion on PSMA-PET. In the trial, patients received 225Ac-PSMA-Trillium intravenously every 6 weeks for up to 4 doses. At data cut-off, 50 patients were enrolled across four dose levels in the escalation cohort and 80% completed all four cycles of 225Ac-PSMA-Trillium (range: 75 to 150 kBq/kg; 12-13 patients/cohort).

Detailed Results from PAnTHa
To date, 225Ac-PSMA-Trillium has had no dose-limiting toxicities (DLTs) or treatment-related deaths. Most common treatment-emergent adverse events (TEAEs) were dry mouth, fatigue and nausea. Overall, 38% of patients had Gr ≥3 TEAEs, most commonly lymphopenia, 16% of patients had serious TEAEs and 4% of patients discontinued treatment due to TEAEs. The overall response rate per PCWG3 criteria across all doses in patients with measurable disease at baseline (n=24) was 46%, with disease control rate of 83%. Respective PSA50 and PSA90 response rates were 58% and 36% overall, and 83% and 58% at the Recommended Dose for Expansion (RDE). This was further supported by the decline in circulating tumor DNA (ctDNA) fraction at the RDE. Further, PSA50 responses were observed across all baseline mean Standardized Uptake Value (SUVmean) groups.

About 225Ac-PSMA-Trillium (BAY 3563254)
225Ac-PSMA-Trillium (BAY 3563254) is a next-generation TAT that comprises a highly specific PSMA-targeting motif, an albumin-binding domain to optimize tumor uptake and retention, and a MacropaTM chelator complexed with the alpha-emitter actinium-225. The distinctive structural components are designed to provide a differentiated safety and efficacy profile. Both in vitro and in vivo characterization of 225Ac-PSMA-Trillium demonstrates high tumor uptake and retention. Potent antitumor efficacy has been observed in several preclinical models of prostate cancer. PSMA-Trillium resulted from the acquisition of PSMA Therapeutics and Noria Therapeutics in 2021 and are now under clinical investigation.

About Targeted Alpha Therapy
Targeted alpha therapy (TAT) is an emerging class of radionuclide therapy that can be used against a variety of tumors. It delivers alpha particle radiation directly to the tumor inside the body, either via its bone-seeking property (radium-223) or by combining alpha radionuclides, such as actinium-225, with specific targeting moieties.

Actinium-225 is an alpha particle–emitting radionuclide with a 9.9-day half-life. Alpha particles deposit highly ionizing radiation over a short range. This localized delivery of the radioactive payload induces irreparable DNA double-strand breaks, often resulting in cell death.

About prostate cancer
Prostate cancer is the second most commonly diagnosed cancer in men. Despite significant advances in the last decade, the prognosis for men with mCRPC remains poor with a median survival of about 31 months.2 With increasing incidence, more than 300 thousand prostate cancer cases were reported in the US in 2025; 5-year relative survival with distant disease is only 34%.3 Advances in imaging technologies (i.e. PSMA-PET) and their utilization across all stages of prostate cancer will likely result in an increased number of patients diagnosed with metastatic disease earlier. Consequently, more men will be diagnosed with de novo PSMA-positive metastatic disease.

(Press release, Bayer, FEB 27, 2026, View Source [SID1234663138])

Novocure to Participate in 2026 Leerink Global Healthcare Conference

On February 27, 2026 Novocure (NASDAQ: NVCR) reported that management will participate in the Leerink Global Healthcare Conference on Tuesday, March 10, 2026. Frank Leonard, Chief Executive Officer, and Christoph Brackmann, Chief Financial Officer, will take part in a fireside chat at 11:20 a.m. EST, as well as one-on-one meetings with investors throughout the event.

A live audio webcast of this presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

(Press release, NovoCure, FEB 27, 2026, View Source [SID1234663137])

Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE034

On February 27, 2026 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, reported that its partner IDEAYA Biosciences, Inc. ("IDEAYA"; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investiagational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million milestone payment to Biocytogen.

According to IDEAYA, the Phase 1 study is designed to characterize IDE034’s safety profile, tolerability, and PK as a monotherapy, and IDEAYA also intends to evaluate combination regimens with DNA damage response (DDR) -targeting agents such as its oral PARG inhibitor IDE161 as the program advances.

IDE034 is a potential first-in-class bispecific B7H3/PTK7 TOP1 ADC, independently developed by Biocytogen and licensed to IDEAYA in July 2024. IDEAYA has stated that IDE034 is designed to preferentially internalize in tumor cells co-expressing B7H3 and PTK7, supporting selectivity and tolerability, and estimates 30–40% co-expression across several major solid tumors with limited dual expression in normal tissues.

"Reaching first dosing in the IDE034 Phase 1 trial marks an important step in translating this bispecific TOP1 ADC concept into clinical evaluation," said Dr. Yuelei Shen, President and CEO of Biocytogen. "We appreciate IDEAYA’s strong execution in advancing IDE034 into the clinic and look forward to the readout of initial safety and PK data from the ongoing Phase 1 study."

(Press release, Biocytogen, FEB 27, 2026, View Source [SID1234663136])

WuXi XDC Enters Strategic Collaboration with Earendil Labs on WuXiTecan-2 Payload-Linker Technology Platform

On February 27, 2026 WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, reported a strategic collaboration with Earendil Labs on WuXi XDC’s proprietary WuXiTecan-2 payload-linker technology platform. Earendil Labs is an AI-powered biotech company focused on researching and developing next-generation innovative biologics for the treatment of autoimmune diseases, cancer, and other conditions with unmet medical needs. This collaboration marks the establishment of a robust strategic partnership aimed at accelerating the development of next-generation ADCs by synergistically combining WuXi XDC’s globally leading ADC technology platform with Earendil Labs’ cutting-edge AI-driven antibody discovery and development capabilities to address significant unmet medical needs.

Under the agreement, WuXi XDC will grant Earendil Labs an exclusive global license to its proprietary WuXiTecan-2 payload-linker technology for use against multiple specific targets. Earendil Labs will utilize this technology to conjugate antibodies and bispecific antibodies discovered through its AI platform and to advance the development of the ADC candidates against these specific targets. The total potential deal value could reach up to approximately $885 million, comprising an upfront payment, and certain development, regulatory, and sales milestone payments. Additionally, WuXi XDC will be eligible to receive tiered royalties on net sales upon commercialization of any resulting ADC products.

Leveraging its world-leading integrated CRDMO platform, WuXi XDC will also fully support the Chemical, Manufacturing, and Controls (CMC) development and manufacturing of the ADC components within the collaboration. Earendil Labs will focus on subsequent product development, global regulatory submissions, and commercialization. This complementary partnership ensures maximized resource utilization and efficient project progression.

Jimmy Li, PhD, CEO of WuXi XDC, stated, "We are very pleased to establish this strategic partnership with Earendil Labs. This collaboration not only fully demonstrates the value of our WuXiTecan-2 payload-linker technology platform but also marks another significant milestone for WuXi XDC in empowering cutting-edge innovation alongside our partners. Earendil Labs has generated bispecific antibodies with differentiated advantages using its unique AI platform. Combining these with our WuXiTecan-2 technology helps develop more effective and safer next-generation ADCs. We look forward to supporting Earendil Labs in accelerating the R&D and commercialization of their ADCs through our integrated, end-to-end CRDMO service platform, ultimately benefiting patients worldwide."

Jian Peng, PhD, CEO of Earendil Labs, said, "Partnering with WuXi XDC represents a critical step in our mission to transform biopharmaceutical R&D through AI. WuXi XDC possesses a globally recognized and validated ADC technology platform and end-to-end manufacturing capabilities. This collaboration is a powerful alliance between frontier AI exploration and WuXi XDC’s integrated CRDMO services. We eagerly anticipate working closely with WuXi XDC to drive innovative breakthroughs through technological integration, empowering high-quality development in the global biopharma industry and contributing to the health of patients globally."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added, "ADCs are emerging as a promising class of therapeutics in the treatment of cancer and many other human diseases. At Earendil Labs, we are developing a rich pipeline of bispecific / multi-specific ADCs utilizing our cutting-edge AI and high-throughput biology plaforms. We believe WuXiTecan-2 payload-linker technology will significantly enhance the success rate and speed of our novel ADC development, ultimately bringing these potentially life-transforming treatments to patients worldwide as soon as possible."

(Press release, Earendil Labs, FEB 27, 2026, View Source [SID1234663135])