On September 23, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", HKEX: 6990) reported it will present results from multiple clinical studies at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress will take place in Berlin, Germany, from October 17 to 21, including data from its TROP2 ADC sacituzumab tirumotecan (sac-TMT), HER2 ADC A166 (trastuzumab botidotin), and CLDN18.2 ADC SKB315 (Press release, Kelun, SEP 23, 2025, View Source [SID1234656179]). Among these, two Phase III clinical studies of sac-TMT were selected for the Latest Breakthrough Abstracts (LBA) and presented as oral reports, including one featured in the Presidential Symposium; one Phase III clinical study of A166 was selected for LBA and presented as oral report.

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

                  Schedule Your 30 min Free Demo!

Abstract titles of these studies have been published on the official website of ESMO (Free ESMO Whitepaper). The study results to be presented include:

Title: Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase 3 OptiTROP-Lung04 study
Presentation Type: Presidential Symposium
Presentation #: LBA5
Date and Lecture Time: October 19, 4：52 PM to 5:04 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) vs investigator’s choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): results from the randomized, multi-center phase 3 OptiTROP-Breast02 study
Presentation Type: Proffered Paper
presentation #: LBA23
Date and Lecture Time: October 18, 10:45 AM to 10:55 AM local time

Title: Trastuzumab botidotin vs trastuzumab emtansine (T-DM1) in HER2-positive unresectable or metastatic breast cancer: results from a randomized phase 3 study
Presentation Type: Proffered Paper
presentation #: LBA24
Date and Lecture Time: October 18, 10:55 AM to 11:05AM local time

Title: SKB315, a novel Claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors including gastric/ gastroesophageal junction cancer (GC/GEJC): a phase 1 study
Presentation Type: Poster
Presentation #: 2139P
Date and Session Time: October 19, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) in Participants (pts) with Previously Treated, Advanced KRAS-Mutant NSCLC: Results from Cohort 5d of the SKB264-II-08 Study
Presentation Type: Poster
Presentation #: 1945P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) + pembrolizumab[1] (pembro) for treatment-naïve advanced PD-L1 positive NSCLC: results from the Phase 2 MK-2870-003/SKB264-II-04 study
Presentation Type: Poster
Presentation #: 1949P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (sac-TMT) + Pembrolizumab in Metastatic Castration-Resistant Prostate Cancer (mCRPC): Results from Phase 2 MK-2870-002/SKB264-II-06 Study
Presentation Type: Poster
Presentation #: 2421P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Endometrial Carcinoma (EC): Results from a Phase 1/2 Study (MK-2870-001/KL264-01)
Presentation Type: Poster
Presentation #: 1111P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

Title: Efficacy and Safety of sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Cervical Cancer: Results from a Phase 1/2 Study (MK-2870-001/KL264-01)
Presentation Type: Poster
Presentation #: 1168P
Date and Session Time: October 18, 9:00 AM to 5:00 PM local time

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, 2 indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the Center for Drug Evaluation of NMPA, and were included in the priority review and approval process. As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

About Trastuzumab Botidotin (A166)

Trastuzumab botidotin is a differentiated HER2 ADC in new drug application (NDA) registration stage to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, MMAF derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

Based on the results of a randomized, controlled, open-label Phase III study, the New Drug Application (NDA) for trastuzumab botidotin was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in January 2025 for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) compared with T-DM1.

Currently, Kelun-Biotech has initiated an open, multi-center Phase II clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

About SKB315

SKB315 is a novel CLDN18.2 ADC targeting advanced solid tumors configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. Currently, Kelun-Biotech has initiated the exploration in combination with immunotherapy for gastric/gastroesophageal junction cancer (GC/GEJC) while advancing monotherapy studies for tumors expressing CLDN18.2, such as GC/GEJC and pancreatic cancer.

On September 23, 2025 Foundation Medicine, Inc., a precision medicine company transforming lives in cancer care and beyond, reported the addition of a tissue-informed whole genome sequencing molecular residual disease (Tissue-informed WGS MRD) test to its portfolio of high-quality testing solutions (Press release, Foundation Medicine, SEP 23, 2025, View Source [SID1234656180]). The test is currently available for research use in retrospective clinical trials.

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

                  Schedule Your 30 min Free Demo!

Foundation Medicine’s FlexOMx Lab now offers highly sensitive Tissue-informed WGS MRD test results for early and late-stage cancer research studies. The test monitors hundreds to thousands of tumor-specific variants, enabling accurate quantification of circulating tumor DNA (ctDNA) in patients with cancer for a more complete picture after treatment. Foundation Medicine’s method offers high sensitivity and specificity in detecting potential cancer recurrence, even in samples with low tumor burden where other methods might misinterpret the signal as noise. In a feasibility study, Foundation Medicine’s test was able to find tumor DNA at low levels, down to 1 part per 100,000 (10ppm, 0.001%).

"Foundation Medicine is setting a new standard for how our biopharmaceutical partners can monitor and understand cancer," said Troy Schurr, chief biopharma business officer at Foundation Medicine. "Our new Tissue-informed WGS MRD test gives partners a new tool for exploratory analysis in early to late-stage cancers, that offers highly specific and deep insights into a patient’s response and resistance to therapy."

Foundation Medicine’s Tissue-informed WGS MRD test allows biopharmaceutical partners to unlock rich multi-omics insights with an expanded monitoring portfolio that includes FoundationOneMonitor for research use, a tissue-free treatment monitoring test.

For an even deeper look, biopharmaceutical partners can leverage Foundation Medicine’s Tissue-informed WGS MRD test with the clinical trial assays based on FoundationOneCDx or FoundationOneLiquid CDx for comprehensive genomic profiling and identification of resistance mutations.

On September 22, 2025, Nuvalent, Inc. reported the completion of its New Drug Application submission to the U.S. Food and Drug Administration for zidesamtinib in tyrosine kinase inhibitor pre-treated patients with advanced ROS1-positive non-small cell lung cancer (Press release, Nuvalent, SEP 22, 2025, View Source [SID1234656148]).

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

                  Schedule Your 30 min Free Demo!

On September 22, 2025 OGT, a leading global provider of genomic diagnostic and research solutions, reported that the U.S. Food and Drug Administration (FDA) has granted their De Novo Classification Request for the CytoCell KMT2A Breakapart FISH Probe Kit PDx as a companion diagnostic (CDx) for Syndax’s first-in-class menin inhibitor, REVUFORJ (revumenib) (Press release, Sysmex, SEP 22, 2025, View Source [SID1234656163]). Revuforj is FDA approved for the treatment of relapsed or refractory (R/R) acute leukaemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and paediatric patients one year and older.

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

                  Schedule Your 30 min Free Demo!

OGT’s CytoCell KMT2A Breakapart FISH Probe Kit PDx detects clinically relevant rearrangements that occur in patients with acute leukaemia, providing a robust, accessible, rapid turnaround test for KMT2Ar detection that will maximize the ability for clinicians to quickly identify patients who may be eligible for treatment with Revuforj. It is estimated that more than 95% of patients with KMT2Ar acute leukaemia have a KMT2A translocation, a type of rearrangement that occurs when part of one chromosome breaks and fuses to a different chromosome.

"We are delighted that our CytoCell KMT2A Breakapart FISH Probe Kit PDx has received marketing authorization as a CDx for Revuforj." said Dr. Leila Luheshi, VP of Pharma Partnering at OGT. "The development and subsequent authorization of this new CDx is an important demonstration of the skill and commitment of our clinical scientists and regulatory specialists to deliver safe and effective diagnostics for patients with one of the most devastating forms of leukaemia."

Steve Chatters, OGT’s EVP of Regulatory and Medical Affairs noted "Our strong foundation in haematology diagnostics has been a key factor in our success bringing the KMT2Ar CDx to market as a Class II device, as opposed to the more common Class III classification for companion diagnostics. We have decades of experience developing regulated FISH products, gained from our prior development of IVDR-certified and FDA-cleared FISH probes. Combined with our extensive customer partnerships in haematology labs in the USA, we have refined insights into the application of these products and are able to access a wealth of real-world data across a multitude of clinical and analytical factors, which is invaluable for product development. This is a core pillar of our success."

The emergence of precision therapies, such as the menin inhibitor Revuforj (an oral inhibitor of the menin–KMT2A interaction), offers new avenues for potentially improving outcomes for patients with these challenging acute leukaemia cases.

"Accurately identifying acute leukaemia patients with KMT2Ar is a key factor in selecting appropriate therapeutic options for a group of patients who have traditionally had a very poor prognosis" said Adrian Smith, CEO of OGT. "We are optimistic that the authorization of OGT’s CDx will help this underserved patient group benefit from developments in precision oncology."

On September 22, 2025 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, reported a research collaboration with the Rutgers Cancer Institute to evaluate the use of Haystack MRD, a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease (MRD) test, to help optimize postoperative therapy decisions in patients with stage II/III non-small cell lung cancer (NSCLC) (Press release, Quest Diagnostics, SEP 22, 2025, View Source [SID1234656149]). Rutgers Cancer Institute together with RWJBarnabas Health is the state’s only National Cancer Institute-designated Comprehensive Cancer Center.

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

                  Schedule Your 30 min Free Demo!

"Trial of ctDNA Guidance to Determine Post Operative Radiation Therapy (PORT) for Minimal Residual Disease (MRD) for Lung Cancer: the MRD-PORT Trial (NCT06979661)" is a prospective phase II study that will use the Haystack MRD test to assess whether the presence of residual tumor DNA after surgery can help guide the use of radiation and systemic therapies.

"Circulating tumor DNA is a pivotal marker to figure out how best to individualize patient care for lung cancer," said Salma Jabbour, MD, Vice Chair of Clinical Research and Faculty Development, Department of Radiation Oncology and Associate Director Faculty Affairs and Development, Rutgers Cancer Institute. "Studying new ways to detect this marker are important for helping improve patient outcomes."

Personalizing postoperative therapy in NSCLC

The study will evaluate ctDNA in patients with stage II/III NSCLC in the adjuvant setting. Patients who test positive for ctDNA after surgery—indicating potential residual disease—will be considered for adjuvant radiation and systemic therapy, including chemotherapy, immunotherapy, or targeted therapy, based on tumor biology and clinical context.

"The ability to identify residual disease following curative-intent treatment opens the door to more precise, personalized interventions, moving us closer to truly individualized cancer care," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "While existing data supports the prognostic value of ctDNA in lung cancer, this innovative study will now address the question of how ctDNA-based testing can guide and optimize adjuvant treatment decisions."

The study is the second by Rutgers Cancer Institute involving Haystack MRD. In 2023, the two parties announced a study to evaluate the test for use in patients being treated for early-stage triple-negative breast cancer.

Why ctDNA MRD matters

A growing body of research underscores the potential role of ctDNA MRD tests to identify residual or recurring cancer in patients with solid tumors. In April 2025, a study1 published in The New England Journal of Medicine (NEJM) found that ctDNA testing, using Haystack MRD, was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months compared to over 6 months using imaging tests. Nearly all oncologists (96%) in a recent survey2 by Harris Poll for Quest Diagnostics said MRD testing has the potential to identify cancer recurrence earlier than other current methods. In August 2025, the FDA granted Breakthrough Device Designation to Haystack MRD for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling.

About Lung Cancer

Lung cancer is the leading cause of cancer-related deaths in the U.S3. Despite advances in surgery and systemic therapies, recurrence rates remain high, especially for patients with stage II and III NSCLC.4 Studies show that patients who test positive for ctDNA after surgery have dramatically worse progression-free survival and overall survival compared to ctDNA-negative patients.