On September 5, 2025 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported it has received CE IVDR approval for two label expansions for its VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay (Press release, Hoffmann-La Roche, SEP 5, 2025, View Source [SID1234655795]). HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.

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The VENTANA HER2 (4B5) test is the first and only companion diagnostic approved to identify patients with HR-positive metastatic breast cancer that are HER2-ultralow. These patients may be eligible for treatment with ENHERTU (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca. In addition, this test is now the first and only companion diagnostic to aid in the assessment of HER2-positive status to identify biliary tract cancer patients with an immunohistochemistry score of 3+ who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA (zanidatamab-hrii).

"This is about creating new options for patients facing some of the toughest cancers," said Jill German, Head of Pathology Lab at Roche Diagnostics. "Our understanding of HER2 is rapidly evolving, and this expanded approval ensures our diagnostics are leading the way. We’re enabling clinicians to unlock personalized, life-altering treatments for patients who urgently need them."

Advancing Science in HER2-ultralow Breast Cancer
In Europe this year, more than 564,000 people will be diagnosed with breast cancer, and more than 145,000 are estimated to die from the disease.1 Metastatic breast cancer incidence is rising in younger populations and is the leading cause of breast cancer related death.2,3

HER2 interpretation in breast cancer continues to evolve beyond the traditional "positive" or "negative" classifications. The test now enables the identification of a new patient population designated as "HER2-ultralow," referring to patients who have very low levels of HER2 expression, even lower than the existing HER2-low category. Approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow.4 These patients may now be eligible for ENHERTU.

The VENTANA HER2 (4B5) test was used in the DESTINY-Breast06 trial,5 which demonstrated a significant improvement in progression-free survival with ENHERTU compared to standard of care chemotherapy in patients with HER2-low and HER2-ultralow metastatic breast cancer.6

Addressing Unmet Needs in Biliary Tract Cancer
In Europe, the incidence of biliary tract cancer (BTC) and mortality rates from the disease have been increasing in the past few decades.7 BTC is often diagnosed at an advanced stage, and patients currently have very few treatment options.8 The prognosis for these patients is generally poor.9 The VENTANA HER2 (4B5) test is now approved to identify BTC patients with HER2-positive status who may be eligible for treatment with ZIIHERA.

About VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx
The VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay delivers timely, clear and reliable results, driving diagnostic certainty and enabling therapeutic decisions that can lead to better outcomes for patients. Previously indicated as an aid to identify certain breast cancer patients eligible for HER2-targeted treatment with Herceptin, KADCYLA, PERJETA, or ENHERTU,10 and gastric cancer patients eligible for treatment with Herceptin, the test is used in combination with the fully automated VENTANA BenchMark slide staining instrument.

The assay standardizes all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.10 It also minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones11 and demonstrates high concordance with HER2 FISH,12,13 empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.

For more information about the portfolio, please visit the Roche Diagnostics Pathology Lab companion diagnostics page.

On September 5, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company reported that the U.S. Food and Drug Administration (FDA) has granted IND clearance for its innovative drug candidate Pidnarulex(CX-5461) ina Phase 1b/2 clinical trial in patients with B-cell lymphoma subtypes that harbors MYC gene aberrations (Press release, Senhwa Biosciences, SEP 5, 2025, View Source [SID1234655794]).

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Given that nearly 30% of all cancers are associated with MYC oncogene overexpression, the clinical development of CX-5461 is generating significant anticipation. If the trial delivers positive results, CX-5461 could become the first pan-cancer therapy specifically targeting MYC-driven tumors, unlocking substantial licensing opportunities and market potentials for Senhwa.

MYC as a Cancer Driver – Genetic Aberrants in Nearly One-Third of Patients

MYC is recognized as a critical oncogene, with gene amplification or related alterations present in approximately 28% of tumors across multiple cancer types, including lung, breast, liver, lymphoma, prostate, and endometrial cancers. MYC functions as a transcription factor, notably enhancing glycolysis and biosynthetic pathways to meet the energy and biomass demands of rapidly proliferating cancer cells, which accelerates malignant growth, increases recurrence rates, and reduces overall survival.

First-in-Class G4 Targeting Therapy Against Hard-to-Treat Lymphomas

CX-5461 is the world’s first and most advanced G-quadruplex (G4) stabilizer in clinical development. Preclinical studies have demonstrated its ability to suppress MYC expression and inhibit tumor progression. Moreover, in a blood cancer trial conducted by Senhwa’s clinical partner Peter MacCallum Cancer Center (PMCC) in Australia, CX-5461 delivered promising results in patients with B-cell lymphoma.

"From preclinical models to haematologic malignancies study, CX-5461 has demonstrated potential efficacy in MYC gene-driven tumors. With FDA’s clearance for this Phase 1b/2 trial, we are excited to broaden its potential application from refractory lymphomas to multiple cancer indications in the future, offering patients a truly groundbreaking treatment option," said Jason Huang, Chief Medical Officer of Senhwa.

B-cell Lymphoma Market Potential Exceeds USD 10 Billion

According to BioSpace, the global B-cell lymphoma therapeutics market reached USD 4.9 billion in 2024, and is projected to grow to USD 8.9 billion by 2035, representing a steady CAGR of 5.79% over the next decade. Demand for innovative targeted therapies is particularly strong among relapsed and refractory lymphoma patients, underscoring an unmet medical need.

With its differentiated mechanism of action and precision oncology potential, CX-5461 could significantly enhance Senhwa’s global licensing value and emerge as a next-generation standard of care in B-cell lymphoma treatment.

On September 5, 2025 Glenmark Pharmaceuticals Ltd., a research-led, global pharmaceutical company, reported the initiation of a multi-country (ex-China) Phase 3 Clinical Trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant setting (Press release, Glenmark, SEP 5, 2025, View Source [SID1234655793]). The Company has received approval from the Drugs Controller General of India (DCGI) to begin patient enrollment and dosing in the country.

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In parallel, Glenmark has submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico, further expanding the global footprint of this pivotal study.

The randomized, multi-center, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC, while a parallel Phase 3 study of Envafolimab sponsored by 3D Medicines Inc., was initiated in December 2023 and is actively recruiting in China.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC comprising approximately 80-85%1 of cases, and 20-30% diagnosed at Stage III2. Despite surgical options for a subset of Stage III patients, five-year survival remains poor, ranging from 36% and 26% at Stage IIIA and IIIB3 respectively. These outcomes highlight the urgent need for innovative, accessible immunotherapy options like Envafolimab to improve prognosis in resectable Stage III NSCLC.

Commenting on the announcement, Dr. Monika Tandon, Global Head of Clinical Development, Glenmark Pharmaceuticals Limited, said, "The initiation of this pivotal Phase 3 study for Envafolimab marks an important milestone in Glenmark’s journey to reimagine possibilities in oncology. With its novel subcutaneous administration, Envafolimab has the potential to make cutting-edge immunotherapy more accessible and convenient for patients worldwide, especially in regions where healthcare resources are constrained. By advancing this trial across multiple geographies, we are reinforcing our commitment to transforming the standard of care in Stage III NSCLC and addressing one of the greatest unmet needs in cancer treatment today."

1&2 PubMed Central

3 PubMed

About Envafolimab

Envafolimab is a novel anti-PD-L1 inhibitor (recombinant single domain anti-PD-L1 fused with Fc portion of human IgG1) administered subcutaneously, invented by Alphamab Oncology, and co-developed with 3D Medicines Inc. since 2016. Envafolimab Injection is approved by National Medical Products Agency (NMPA) in China in November 2021, as a global-first subcutaneous anti-PD-L1, for the treatment of advanced unresectable or metastatic solid tumors with MSI-H/dMMR. More than 40,000 cancer patients have already benefited in China from this innovative drug. The product has also been included in the ‘List of breakthrough therapies’ by the NMPA. In 2024, Alphamab Oncology and 3D Medicines Inc. entered into a licensing agreement with Glenmark Pharmaceuticals for Envafolimab, pursuant to which Glenmark was granted an exclusive license for development, registration and commercialization of oncology indications of Envafolimab in India, Asia Pacific (except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, Commonwealth of Independent States and Latin America. Currently, Envafolimab is also undergoing clinical development in multiple Phase 2 and Phase 3 trials for the treatment of various tumors e.g., resectable non-small cell cancer, advanced/metastatic biliary tract cancer, metastatic endometrial cancer, renal cell cancer, etc. Availability of this novel immune-oncology therapy will help reduce the burden on patients, caregivers and health care system because of its unique subcutaneous administration (faster administration within 30 seconds, like a regular subcutaneous injection).

On September 5, 2025 Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection, reported an oral presentation in partnership with University Health Network’s (UHN) Princess Margaret Cancer Centre at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer on September 6-9, 2025, in Barcelona, Spain (Press release, Foresight Diagnostics, SEP 5, 2025, View Source [SID1234655792]). The presentation will feature analysis of MRD performance in a cohort of stage I lung cancer patients from the ctDNA-Lung DETECT study using Foresight CLARITY, the company’s ultrasensitive circulating tumor DNA (ctDNA) assay with a reported detection limit of less than one part per million.1

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Foresight CLARITY demonstrated high ctDNA-MRD detection rates at both pre- and post-operative timepoints. Highlights include:

Pre-operative MRD detection was 68% and post-operative MRD detection was 38%.
Clinical sensitivity for relapse detection at post-surgical landmark was 55%, with a median lead time of 10 months prior to clinical recurrence.
Post-operative MRD detection was significantly associated with worse recurrence-free survival (RFS) at both post-operative landmark (HR = 3.14, p = 0.0425) and at the one-year timepoint (HR = 8.20, p = 0.0001).
"The field has historically recognized the challenges of using ctDNA-MRD assays in early-stage lung cancer, particularly due to the low-shedding nature of these tumors. However, based on the results of our study, ultrasensitive assays can offer actionable insights and may help us achieve personalized treatment strategies, such as adjuvant therapy escalation in high-risk patients," said Dr. Natasha Leighl, Division Head, Medical Oncology and Hematology, UHN’s Princess Margaret Cancer Centre, Toronto.

"Detecting MRD in early-stage lung cancer patients before or after surgery may open new clinical applications not possible with current tools," said David Kurtz, Md, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We look forward to continuing to support innovative studies that advance precision medicine for lung cancer."

Presentation Details:

Ultrasensitive MRD improves detection in resectable stage I NSCLC

Presenter: Natasha Leighl, BSc, MMSc, MD (Division Head, Medical Oncology and Hematology, UHN’s Princess Margaret Cancer Centre, Toronto, Canada)
Date: Sunday, September 7th, 2025
Time: 3:15pm – 4:30pm CEST
Session: MA03. New Advances in Circulating Biomarkers
To meet with the Foresight Diagnostics team at IASLC 2025, please contact us here or email [email protected].

On September 5, 2025 Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) detection, reported an oral presentation in partnership with University Health Network’s (UHN) Princess Margaret Cancer Centre at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer on September 6-9, 2025, in Barcelona, Spain (Press release, Foresight Diagnostics, SEP 5, 2025, View Source [SID1234655792]). The presentation will feature analysis of MRD performance in a cohort of stage I lung cancer patients from the ctDNA-Lung DETECT study using Foresight CLARITY, the company’s ultrasensitive circulating tumor DNA (ctDNA) assay with a reported detection limit of less than one part per million.1

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Foresight CLARITY demonstrated high ctDNA-MRD detection rates at both pre- and post-operative timepoints. Highlights include:

Pre-operative MRD detection was 68% and post-operative MRD detection was 38%.
Clinical sensitivity for relapse detection at post-surgical landmark was 55%, with a median lead time of 10 months prior to clinical recurrence.
Post-operative MRD detection was significantly associated with worse recurrence-free survival (RFS) at both post-operative landmark (HR = 3.14, p = 0.0425) and at the one-year timepoint (HR = 8.20, p = 0.0001).
"The field has historically recognized the challenges of using ctDNA-MRD assays in early-stage lung cancer, particularly due to the low-shedding nature of these tumors. However, based on the results of our study, ultrasensitive assays can offer actionable insights and may help us achieve personalized treatment strategies, such as adjuvant therapy escalation in high-risk patients," said Dr. Natasha Leighl, Division Head, Medical Oncology and Hematology, UHN’s Princess Margaret Cancer Centre, Toronto.

"Detecting MRD in early-stage lung cancer patients before or after surgery may open new clinical applications not possible with current tools," said David Kurtz, Md, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We look forward to continuing to support innovative studies that advance precision medicine for lung cancer."

Presentation Details:

Ultrasensitive MRD improves detection in resectable stage I NSCLC

Presenter: Natasha Leighl, BSc, MMSc, MD (Division Head, Medical Oncology and Hematology, UHN’s Princess Margaret Cancer Centre, Toronto, Canada)
Date: Sunday, September 7th, 2025
Time: 3:15pm – 4:30pm CEST
Session: MA03. New Advances in Circulating Biomarkers
To meet with the Foresight Diagnostics team at IASLC 2025, please contact us here or email [email protected].