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Biparatopic HER2-targeting ADC JSKN003 Was Granted Another Breakthrough Therapy Designation for HER2-Positive Advanced Colorectal Cancer

On October 20, 2025 Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (Stock Code: 1093.HK) jointly reported that biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 has been granted another breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the indication of monotherapy for the treatment of HER2-positive advanced colorectal cancer (CRC) in patients who have failed prior treatments with oxaliplatin, fluorouracil and irinotecan (Press release, Alphamab, OCT 20, 2025, View Source [SID1234656989]). Previously, JSKN003 had received breakthrough therapy designation from the CDE for platinum-resistant ovarian cancer (PROC) (not restricted by HER2 expression), as well as clinical trial approval from the U.S. Food and Drug Administration (FDA). It has also been granted Orphan Drug Designation by the U.S. FDA for gastric and gastroesophageal junction cancer. This latest designation in colorectal cancer further underscores its clinical value and global development potential across multiple refractory tumor types.

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Colorectal cancer is among the most common malignancies worldwide. According to data from the International Agency for Research on Cancer (IARC), there were approximately 1.93 million newly diagnosed cases and about 903,900 deaths attributed to CRC globally in 2022, ranking third in incidence and second in mortality among all cancers. In China, CRC has the second-highest incidence after lung cancer, with over 500,000 new cases annually and a continuing upward trend. There are currently no HER2-targeted therapies approved in China for CRC. For patients with HER2-positive advanced CRC who have failed prior treatments with oxaliplatin, fluorouracil and irinotecan, the median progression-free survival (mPFS) of approved therapies is only 2.0 to 3.7 months, and the median overall survival (mOS) is approximately 7 to 10 months. There remains a significant unmet clinical need within this patient population.

Clinical studies demonstrated that JSKN003 monotherapy exhibited notable efficacy and a favorable safety profile in patients with HER2-positive advanced CRC, showing meaningful clinical advantages over existing therapeutic options. As of June 30, 2025, a total of 33 patients with HER2-positive advanced metastatic CRC, were enrolled and received JSKN003 monotherapy in a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in China (JSKN003-102, NCT05744427), with 42.4% of these patients having previously received 3 or more prior lines of antitumor therapy. Among 32 efficacy-evaluable patients , the overall response rate (ORR) was 68.8%, the disease control rate (DCR) was 96.9%. Additionally, among 31 BRAF V600E wild-type patients, the ORR was 71.0%, the DCR was 100%, and median duration of response (DoR) was 9.89 months, the median PFS achieved 11.04 months, with a 9-month PFS rate of 66.6%. In terms of safety, the median follow-up time was 9.26 months. 7 patients experienced Grade 3 or above treatment-related adverse events (TRAEs). There were no TRAEs led to discontinuation or death. Detailed data from the study were presented recently at the 2025 European Society for Medical Oncology Congress (ESMO Congress 2025). By comparison, in a similar patient population, trastuzumab deruxtecan (DS-8201) previously reported an ORR of 37.8 %, a PFS of 5.8 months, and Grade 3 or above adverse events in nearly 50 % of patients.

JSKN003 is currently being evaluated in multiple Phase II and Phase III clinical studies in China for the treatment of various solid tumors including breast cancer, ovarian cancer, and gastric cancer. This latest breakthrough therapy designation for JSKN003 is expected to further accelerate its development and review processes, with the aim of bringing benefits to more cancer patients sooner.

About JSKN003

JSKN003 is Alphamab Oncology’s first bispecific ADC, developed based on HER2-targeting bsAb KN026, and utilizing the proprietary glycan-specific conjugation platform. It binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, exerting anti-tumor effects. Compared to similar ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window.

Clinical data in heavily pretreated advanced solid tumors have shown high-security profile, with promising efficacy of JSKN003, particularly in platinum-resistant ovarian cancer (PROC), HER2-high/low breast cancer (BC), HER2-positive colorectal cancer (CRC)/ gastric cancer (GC) and other HER2-expressing tumors. JSKN003 was granted breakthrough therapy designation by CDE for platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and HER2-positive advanced colorectal cancer that has failed prior oxaliplatin, fluorouracil, and irinotecan therapy. It has also been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for GC and gastroesophageal junction cancer (GEJ). Three Phase III trials in HER2-low expressing BC, PROC, and HER2-positive BC and multiple Phase II studies are underway.

In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. ("JMT-Bio"), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK). JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for tumor-related indications in mainland China (excluding Hong Kong, Macau or Taiwan). Alphamab retains exclusive production rights for JSKN003.

Alphamab Oncology Presented Multiple Clinical Data on Biparatopic HER2-targeting ADC JSKN003 at ESMO Congress 2025

On October 20, 2025 Alphamab Oncology (stock code: 9966.HK) reported that two latest clinical data on biparatopic HER2-targeting antibody-drug conjugate (ADC) JSKN003 for the treatment of primary platinum-refractory ovarian cancer (OC) and HER2-positive metastatic colorectal cancer (mCRC), along with the confirmatory study design of the phase III study of JSKN003 versus physician’s choice of chemotherapy in platinum-resistant ovarian cancer (PROC) were presented as posters at the 2025 European Society for Medical Oncology Congress (ESMO Congress 2025) from October 17 to 21, 2025, in Berlin, Germany (Press release, Alphamab, OCT 20, 2025, View Source [SID1234656988]).

Title: Biparatopic anti-HER2 antibody drug conjugate (ADC) JSKN003 in the treatment of primary platinum-refractory ovarian cancer (OC)
Presentation Number: 1079P
Onsite Poster display date: Saturday, 18 October 2025
First author: Xiaohua Wu, Fudan University Shanghai Cancer Center
Speaker: Jiajia Li, Fudan University Shanghai Cancer Center

METHODS

Therapies represented by ADCs have made certain progress in treating platinum-resistant ovarian cancer (PROC), but not for primary platinum-refractory disease (defined as disease that progressed within 3 months after the last dose of first-line platinum-containing therapy) that were excluded from most of trials. Novel therapeutic options are urgently needed for this patient population with poorer prognosis compared to those who are not primary platinum-refractory. JSKN003-102 (NCT05744427) is a phase I/II trial conducted in China, enrolling patients with advanced solid tumors to receive JSKN003 monotherapy. The findings of JSKN003 in treating patients with primary platinum-refractory OC were reported at this ESMO (Free ESMO Whitepaper) Congress.

RESULTS

As of June 13, 2025, a total of 26 patients with primary platinum-refractory OC were enrolled and received JSKN003 at 6.3 mg/kg every three weeks. The median age was 54 years, with 80.8% of them having ECOG PS 1. Among the patients, 15 patients were HER2-negative (IHC 0), 8 had HER2 expression (IHC 1+/2+/3+), with only one being IHC 3+), and 3 patients had no tumor sample available for assessment. All patients had prior treatments, of whom 84.6% had previously been treated with bevacizumab, 26.9% had received PARP inhibitors, and 57.7% had undergone two or more lines of systemic anti-tumor therapies. Additionally, 38.5% of the patients had liver metastases, while 26.9% had lung metastases.

Efficacy: As of June 13, 2025, 25 patients were efficacy evaluable. The overall response rate (ORR) was 32.0%, the disease control rate (DCR) was 72.0%, the median progression-free survival (PFS) was 4.1 months, and the 9-month overall survival (OS) rate was 65.4%. Efficacy was observed across different HER2 expression subgroups.

Safety: Grade 3 or above treatment related adverse events (TRAE) occurred in 15.4% of patients. Serious TRAEs were reported in 1 patient (3.8%). No TRAE led to death. Interstitial lung disease (ILD) was observed in 2 patients and both were Grade 1.

CONCLUSIONS

JSKN003 demonstrated promising efficacy and tolerability in patients with primary platinum-refractory OC who have limited treatment options. Efficacy was observed across different HER2 expression subgroups, offering new hope for this patient population.

Title: Efficacy and Safety of JSKN003, a Biparatopic anti-HER2 Antibody Drug Conjugate (ADC), in Patients with HER2-positive Metastatic Colorectal Cancer (mCRC)
Presentation Number: 806P
Onsite Poster display date: Sunday, 19 October 2025
First author & Speaker: Dan Liu, Peking University Cancer Hospital and Institute

METHODS

JSKN003-102 (NCT05744427) is a phase I (dose escalation and expansion) and phase II (cohort expansion) clinical study in Chinese patients with advanced/metastatic solid tumors. The efficacy and safety data of JSKN003 in HER2-positive (IHC 3+ or 2+/FISH+) mCRC patients were reported at this ESMO (Free ESMO Whitepaper) Congress.

RESULTS

As of June 30, 2025, a total of 33 patients with HER2-positive mCRC were enrolled and received JSKN003 every three weeks across 2 dose levels, among which 32 patients at the dose 6.3 mg/kg and 1 patient at the dose of 8.4 mg/kg. 69.7% of enrolled patients were male with a median age of 59 (range, 30-69). All enrolled patients were stage IV at screening and 54.5% with liver metastases. 5 (15.2%) patients harbored RAS/RAF mutations, including 1 case of BRAF V600E mutation. All patients were heavily pretreated, and 42.4% had received three or more lines of prior anti-tumor treatments.

Efficacy: 32 patients were efficacy evaluable. The ORR was 68.8%, the DCR was 96.9%. Additionally, among 31 BRAF V600E wild-type patients, the ORR was 71.0%, the DCR was 100%, and median duration of response (DoR) was 9.89 months (95%CI, 5.78 to NE), the median PFS achieved 11.04 months (95%CI, 6.9 to 14.03), with a 9-month PFS rate of 66.6%.

Safety: The median follow-up time was 9.26 months (95%CI: 5.82, 12.35). 7 patients (21.2%) experienced Grade 3 or above TRAEs. There were no TRAEs led to discontinuation or death. Overall, the most common TRAEs were diarrhea and nausea, most of which were Grade 1-2. ILD was reported in 4 patients (12.1%), which were Grade 1-2.

CONCLUSIONS

JSKN003 demonstrated promising efficacy in heavily pretreated HER2-positive CRC with a manageable and predictable safety profile. The biparatopic HER2 antibody design may enhance target binding and contribute to the observed clinical benefit.

Title: Phase III study of JSKN003, a biparatopic anti-HER2 antibody-drug conjugate (ADC), versus physician’s choice of chemotherapy in platinum-resistant ovarian cancer (PROC): JSKN003-306
Presentation Number: 1219TiP
Onsite Poster display date: Saturday, 18 October 2025
First author & Speaker: Lingying Wu, Cancer Hospital Chinese Academy of Medical Sciences

BACKGROUND

Platinum-resistant ovarian cancer (PROC) is known for low efficacy to non-platinum single-agent chemotherapy with or without bevacizumab, the standard-of-care (SOC), with an ORR of 15%, a PFS of 3 months, and an OS of 12 months, posing a significant therapeutic challenge.

Results from the Phase I clinical study JSKN003-101 (NCT05494918) in Australia and the Phase I/II clinical study JSKN003-102 (NCT05744427) in China have demonstrated promising efficacy of JSKN003 monotherapy in PROC. Detailed data were presented at the 2024 ESMO (Free ESMO Whitepaper) Congress for the first time and subsequently updated at the 2025 Annual Meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). As of February 28, 2025, 46 PROC patients were enrolled and received JSKN003 every three weeks. In 46 efficacy-evaluable patients, 45.7% were HER2 no-expressing (IHC 0). 91.3% of patients exhibited tumor shrinkage, the ORR was 63.0%, the median PFS was 7.7 months and the 9-month OS rate was 89.9%. In HER2 expressing (IHC 1+/2+/3+) patients, the ORR and median PFS were 72.2% and 9.4 months, respectively.

Based on the pooled analysis of the two clinical studies, JSKN003 monotherapy has been granted breakthrough therapy designation for the treatment of PROC by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). So far, JSKN003 is the only anti-HER2 ADC to receive this designation without HER2 expression restrictions.

STUDY DESIGN

JSKN003-306 (NCT06751485) is randomized, open-label, parallel-controlled, multi-center Phase III clinical study, enrolling patients with recurrent platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer, irrespective of HER2 expression. Key inclusion criteria include: age≥18 years; having received 1 to 4 prior lines of systemic anti-tumor therapy; disease progression within 6 months after the last dose of platinum-base chemotherapy; an ECOG PS of 0-1; adequate organ function; and measurable disease by RECIST v1.1. Key exclusion criteria include: prior TOPli or TOPli-containing ADC; active central nervous system metastases; interstitial lung disease (ILD); or uncontrollable comorbidities.

Patients will be randomized 1:1 and stratified by platinum-free interval (≤3 months vs. 3 to 6 months), number of prior lines of therapy (1/2 lines vs. 3/4 lines), and HER2 status (expressing vs. non-expressing) as assessed by a central laboratory. The experimental group will receive JSKN003 at 6.3 mg/kg once every 3 weeks, while the control group will receive the investigator’s choice of chemotherapy (paclitaxel, liposomal doxorubicin, or topotecan). The primary endpoints are PFS by blind independent central review (BICR) as per RECIST v1.1 and OS. Secondary endpoints include other efficacy outcomes assessed by BICR (ORR, DoR, DCR), investigator-assessed efficacy endpoints, safety, and others.

The JSKN003-306 study plans to enroll 556 patients across 80 sites in China. The first patient was successfully dosed in February 2025, and the study is currently in the patient enrollment phase. This study aims to further validate the superiority of JSKN003 over current therapies, potentially representing a breakthrough in treating PROC.

About JSKN003

BriaCell Presents Phase 3 Clinical Biomarker Data at ESMO 2025

On October 20, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported encouraging clinical biomarker data in its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer. The findings are being presented in BriaCell’s poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 Annual Meeting taking place October 17 – 21, 2025 in Berlin, Germany. The Phase 3 data shown is for all patients evaluated regardless of treatment assignment (i.e. is blinded).

"We are encouraged by the early constructive clinical biomarker data which could allow us to predict clinical and survival outcomes in our patients and would help guide treatment decisions for metastatic breast cancer patients with limited options," stated Dr. William V. Williams, BriaCell’s President and CEO.

Poster #3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)

In BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer, patients are randomized 1:1:1 to Bria-IMT + CPI, Treatment of Physician’s Choice, or Bria-IMT monotherapy. As of the time of the poster submission, pooled data was available in 113 patients, with a median of 6 prior lines of treatment (2–13). Evaluable only pertains to imaging. All 113 are evaluated for safety, PFS, etc.

As reported in the Phase 2 study , Neutrophil to Lymphocyte Ratio (NLR) continues to be a potential biomarker of clinical benefit as progression free survival (PFS) was significantly higher in patients with NLR of 0.7 – 2.3 (4.5 months) vs those with NLR < 0.7 or > 2.3 (2.5 months) {(HR) of 0.5 (95% CI 0.3–0.8, p=0.005)}.

In the Phase 3 study, PFS data comparing BriaCell’s Bria-IMT combination regimen versus those treated with physician’s choice remains blinded at this time. Bria-IMT has been well tolerated in the Phase 3 study with no treatment-related discontinuations due to adverse events (AEs). The most common AEs are minor, including fatigue, anemia, and nausea.

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

A copy of the poster presentation is posted on View Source

(Press release, BriaCell Therapeutics, OCT 20, 2025, View Source [SID1234656936])

Primary Endpoint Met in EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma and Data Presented at ESMO Congress 2025

On October 20, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported positive data from the EFTISARC-NEO Phase II trial were shared in a Proffered Paper oral presentation by Katarzyna Kozak, M.D., Ph.D., Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland, at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany.

The investigator-initiated Phase II study evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) met the primary endpoint and significantly exceeded the study’s prespecified 35% tumour hyalinization/fibrosis. In the evaluable patient population (N=38), the novel combination with efti reached a median 51.5% tumour hyalinization/fibrosis (p<0.001).

This impressive outcome, over three times greater than 15% from standard-of-care radiotherapy alone based on historical data, may hold significance in terms of future outcomes as tumour hyalinization/fibrosis serves as an early surrogate endpoint correlated with enhanced overall survival and recurrence-free survival in STS patients.1,2

These promising results were achieved across multiple STS subtypes and the study proved a very good safety profile for the therapy, with only one grade ≥3 toxicity related to immunotherapy.

Dr. Katarzyna Kozak, said: "The novel combination with neoadjuvant efti has significantly exceeded the originally established target for the trial’s primary endpoint in resectable soft tissue sarcoma. These outcomes achieved in a diverse population of multiple STS subtypes further substantiate the hypothesis that efti’s unique stimulation of antigen-presenting cells, resulting in a robust adaptive and innate immune response, contributes to modifying the immunosuppressed tumour microenvironment and achieving notable anti-cancer efficacy in soft tissue sarcomas. We hope these findings can help pave a path to a new therapeutic option for the substantial unmet medical need in this challenging indication."

Marc Voigt, CEO of Immutep, noted: "We sincerely thank the principal investigators leading this study, as well as the patients and their families for taking part in this important trial. There is a significant unmet medical need for novel therapies in STS that have the potential to provide better outcomes for patients than the current standard of care radiotherapy."

STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.3

The EFTISARC-NEO study has been primarily funded with a grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on EFTISARC-NEO, visit clinicaltrials.gov (NCT06128863).

The presentation slides can be found on the Posters & Publications page of Immutep’s website.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, OCT 20, 2025, View Source [SID1234656867])

Successful IMvigor011 Trial Achieves 41% Improvement in Overall Survival for Bladder Cancer Patients

On October 20, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported results from the randomized, double-blind, phase 3 IMvigor011 clinical trial in muscle-invasive bladder cancer (MIBC). The findings demonstrate that Signatera can expand the adjuvant treatment window and guide the use of adjuvant atezolizumab (Tecentriq) in MIBC, resulting in improved disease-free survival (DFS) and overall survival (OS). Results will be presented today during a Presidential Symposium at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Bladder cancer is the sixth most common cancer in the United States1 and MIBC represents 20-25% of the newly diagnosed cases.2 Radical cystectomy (with or without neoadjuvant therapy) is curative for approximately half of these patients, but until now it has been very challenging to identify which patients are likely to recur and to offer them effective, personalized therapy while sparing the others from unnecessary treatment.3,4 The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, was designed to address that challenge.

IMvigor011 prospectively evaluated adjuvant atezolizumab versus placebo in patients with MIBC who were identified as Signatera-positive based on serial testing up to 7 times in the first year post-cystectomy.

Study highlights:

761 patients were enrolled in surveillance, of whom half tested Signatera-positive and 250 were randomized to atezolizumab vs. placebo.

Signatera-positive patients treated with atezolizumab experienced a >2x increase in median DFS compared to placebo. Median DFS was 9.9 months for patients treated with atezolizumab vs 4.8 months for placebo (HR: 0.64; P=0.005). Signatera-positive patients in the treatment arm also had a statistically significant and clinically meaningful improvement in OS (median of 32.8 months vs. 21.1 months; HR: 0.59; P=0.01).

Signatera-negative patients had excellent outcomes without adjuvant immunotherapy. Patients who remained persistently Signatera-negative during surveillance without adjuvant treatment had very low recurrence risk (DFS of 95.4% at 1 year and 88.4% at 2 years). OS outcomes were also incredibly strong, sparing patients from unnecessary treatment and potentially associated toxicity.
"IMvigor011 has delivered practice-changing evidence in bladder cancer," said Professor Thomas Powles, lead principal investigator of IMvigor011, professor of genitourinary oncology, chair of Barts Cancer Centre at St. Bartholomew’s Hospital. "Patients who tested Signatera-positive clearly benefitted from atezolizumab, while those who remained Signatera-negative had excellent outcomes without additional treatment. This is the most impactful data to date for personalized MRD testing, reinforcing Signatera’s predictive abilities to transform care."

"This is the first study to demonstrate that the adjuvant treatment decision window can be safely extended to one year post-surgery, minimizing overtreatment and allowing therapy to be precisely guided by Signatera results," said Alexey Aleshin, M.D., general manager of oncology and corporate chief medical officer at Natera. "These findings can redefine the standard of care in muscle-invasive bladder cancer and also underscore the broader potential for Signatera-guided management across multiple tumor types."

Data from IMvigor011 will support Natera’s premarket approval application to the U.S. Food and Drug Administration for Signatera as a companion diagnostic for the selection of patients with MIBC to be treated with atezolizumab after cystectomy.

(Press release, Natera, OCT 20, 2025, View Source [SID1234656851])