On October 17, 2025 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono"), reported the two-year efficacy and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option will be presented as a poster during the 2025 European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), taking place October 17-21 in Berlin, Germany.

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"These long-term Phase 3 MOTION results add to the established body of evidence supporting vimseltinib as a best-in-class treatment for TGCT," said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. "TGCT often causes debilitating pain, stiffness and impaired mobility and these results demonstrate the durable benefit that vimseltinib can offer patients."

Summary of Data and Findings from the 2-year results of the MOTION Phase 3 Study

Methods

The global Phase 3 MOTION study (NCT05059262) aims to evaluate the efficacy and safety of vimseltinib for the treatment of TGCT in cases where surgical removal of the tumor is not an option.

The study consists of two parts. In Part 1, eligible study participants were assigned to receive either vimseltinib or matching placebo for 24 weeks. Participants assigned to placebo in Part 1 had the option to receive vimseltinib for Part 2. Part 2 was a long-term treatment phase in which all participants received open-label vimseltinib. Patients received vimseltinib 30 mg twice weekly in all periods. Objective response rate (ORR) based on best overall response was assessed by independent radiological review (IRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and per Tumor Volume Score (TVS). Duration of response (DOR) and safety were also evaluated.

Efficacy

In these two-year results from the MOTION Phase 3 trial, vimseltinib continued to demonstrate robust and durable antitumor efficacy with a manageable safety profile that was consistent with prior reports. These long-term results support vimseltinib as a treatment option for patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability, where it is approved. These results are reported with two years of follow-up in patients randomized to vimseltinib in Part 1 and crossed over from placebo to vimseltinib in Part 2. The data cutoff for this analysis was February 22, 2025.

In total, 118 patients received vimseltinib. At data cutoff, 51% (60/118) remained on treatment. With at least 2 years of follow-up, results demonstrate robust and durable antitumor activity with vimseltinib per RECIST v1.1 and per TVS, including in patients who crossed over to vimseltinib in Part 2.

Of 83 patients randomized to vimseltinib in Part 1, 73 continued open-label treatment in Part 2. Median (range) treatment duration was 23.6 months (2 to 36).
Of the 40 patients randomized to placebo in Part 1, 35 crossed over to vimseltinib in Part 2. Median treatment duration for this group was 19.1 months (1 to 30).
ORR on study per RECIST v1.1 was 48% (40/83) for patients randomized to vimseltinib and 54% (19/35) for those who crossed over to vimseltinib. ORR on study per TVS was 81% (67/83) for patients randomized to vimseltinib and 71% (25/35) for those who crossed over to vimseltinib.
The corresponding median DOR per RECIST v1.1 and per TVS was still not reached.
Safety

Vimseltinib continued to have a manageable safety profile that was consistent with prior reports with no new safety signals.

Most treatment-emergent adverse events (TEAEs) were grade 1/2, and grade 3/4 TEAEs were similar between randomized vimseltinib and crossover groups.
There were no new TEAEs in ≥15% of patients receiving vimseltinib and no new serious adverse events in more than one patient.
Serum enzyme elevations were consistent with the known mechanism of action of CSF1R inhibition, and there was no evidence of cholestatic hepatotoxicity or drug-induced liver injury.
About Vimseltinib

Vimseltinib is an oral, switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform. It has been approved in the United States for adult patients with symptomatic TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is caused by a dysregulation in colony-stimulating factor 1 (CSF1) gene leading to overproduction of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion.1 TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS). TGCT is a rare, locally aggressive neoplasm that can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients, surgical resection will potentially cause worsening functional limitation or severe morbidity. Systemic treatment options are limited and new therapeutic options are needed.

(Press release, Ono, OCT 17, 2025, View Source [SID1234656755])

On October 17, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the Company’s human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate (ADC) trastuzumab botidotin (also known as A166) was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (BC) who have received one or more prior anti-HER2 therapy.

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The approval is based on a multi-center, randomized, open-label, controlled, Phase 3 KL166-III-06 study that evaluates the efficacy and safety profile of trastuzumab botidotin versus T-DM1 in patients with HER2-positive unresectable or metastatic BC who have received prior trastuzumab and taxane-containing regimens. 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; the beneficial trend for overall survival (OS) of trastuzumab botidotin was also observed. Results from this study will be presented as an oral report at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress held in Berlin, Germany (Presentation # LBA24, Proffered paper session 1: Breast cancer, metastatic).

The Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC.

Dr. Michael Ge, CEO of Kelun-Biotech said, "We are thrilled to see our first HER2 ADC drug, trastuzumab botidotin, successfully approved for market. This marks a significant advancement in the treatment of HER2-positive breast cancer. As China’s first domestically developed HER2 ADC capable of broadly covering 2L+ HER2 BC patients, trastuzumab botidotin leverages its differentiated structural design to deliver superior efficacy while addressing unmet clinical needs in this population."

About HER2+ BC

Breast cancer, as the most common malignant tumor, poses a serious threat to women’s health. Among its subtypes, HER2-positive breast cancer accounts for approximately 15%–20% of all breast cancer cases[1], and is characterized by its aggressiveness and high malignancy. According to the 2025 CSCO guidelines, first-line treatment for HER2-positive breast cancer primarily consists of trastuzumab and pertuzumab in combination with taxane-based chemotherapeutic agents. Second-line treatment regimens comprise tyrosine kinase inhibitors (TKIs, such as pyrotinib) and antibody-drug conjugates (ADCs, such as T-DM1 and T-DXd). Following disease progression on second-line therapy, subsequent treatment strategies are determined based on prior second-line regimens, the patient’s tolerance to therapy, tumor burden, and other relevant factors. Despite recent advances in anti-HER2 therapeutics, a significant number of patients still experience drug resistance or severe adverse effects, highlighting an urgent need for agents with improved safety profiles to address the treatment requirements of patients with recurrent or drug-resistant HER2-positive breast cancer.

A bout trastuzumab botidotin

Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a drug-to-antibody-ratio (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.

(Press release, Kelun, OCT 17, 2025, View Source [SID1234656754])

On October 17, 2025 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation & immunology (I&I), reported the first disclosure of interim data from the ongoing Phase 2 trial of its lead program, invikafusp alfa, during a late-breaking oral session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2025 Annual Meeting, taking place October 17-21, 2025, in Berlin, Germany.

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These highly anticipated results continue to validate Marengo’s first-in-class precision T cell activation platform – a novel approach aimed at fully addressing the significant unmet need for both PD-1 resistant and refractory patients, as well as those for whom PD-1 therapy is not currently indicated.

"The compelling single-agent activity and tumor regression we’re observing across multiple tumor types, particularly in PD-1-resistant tumors, underscore the potential of invikafusp alfa as a new pan-tumor backbone immunotherapy," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo Therapeutics. "By selectively activating Vβ6/Vβ10 T-cell subsets, we are unlocking distinct immune biology that can reprogram the tumor microenvironment and reinvigorate anti-tumor T cell responses in patient populations who have exhausted current immunotherapies."

As of the July 29, 2025 data cutoff, 55 patients with advanced solid tumors harboring high mutational burden (TMB-H or MSI-H/dMMR) were enrolled across 21 histologies; 44 were efficacy-evaluable. Additional outcomes from the Phase 2 study are outlined below.

Tumor shrinkage: 52% of patients experienced target-lesion regression.
In the TMB-H patients, there was a 20.5% overall response rate (ORR) (9/44) and a 79.5% disease control rate (DCR) (35/44) across six tumor types, including colorectal, gastric, lung, breast, GEJ, and head and neck cancers.
In the MSI-H/dMMR patients, there was a 30% ORR (3/10) and 70% DCR (7/10).
Clinical efficacy was observed in PD-1-resistant/refractory tumors and PD-1 naive tumors where PD-1 was not approved as standard of care, confirming PD-1-independent activity.
The safety profile was consistent with selective T cell activation mechanism of action, and treatment-related AEs were transient and manageable with supportive care.
Building on these clinical data, Marengo is advancing a post-PD-1, biomarker-enriched strategy for invikafusp alfa – continuing the Phase 2 monotherapy expansion in TMB-H or MSI-H/dMMR solid tumors to further characterize the depth and durability of responses across priority indications. In parallel, Marengo is pursuing ongoing regulatory interactions, including recently securing U.S. FDA Fast Track designation in TMB-H mCRC.

To reach broader, frontline populations beyond biomarker TMB-H in large indications, the company is also progressing a Phase 2 combination with Trodelvy (TROP2-directed ADC) in TNBC and HR+/HER2– breast cancer to evaluate synergy in ADC and IO settings.

Invikafusp alfa is a first-in-class, bispecific dual T-cell agonist designed to selectively activate and expand Vβ6/Vβ10 T-cell subsets, which represent ~10% of tumor-infiltrating lymphocytes (TILs). Marengo’s lead asset was designed to restore and amplify anti-tumor immunity in patients who have progressed on or are insensitive to prior immune checkpoint blockade, and it has demonstrated rapid progress to date. Phase 1/2 results of the STARt-001 clinical trial evaluating invikafusp alfa in antigen-rich solid tumors were first presented at SITC (Free SITC Whitepaper) 2024, followed by disclosure of the recommended Phase 2 dose (RP2D) selection rationale and early clinical activity at AACR (Free AACR Whitepaper) 2025.

(Press release, Marengo Therapeutics, OCT 17, 2025, View Source;resistant-solid-tumors-as-a-late-breaking-oral-presentation-at-esmo-2025-302587142.html [SID1234656753])

On October 17, 2025 Multitude Therapeutics, Inc., a clinical-stage company focused on the development of antibody-drug-conjugate (ADC) drugs, reported initial data from its ongoing phase I/II open-label, multicenter dose escalation and expansion study evaluating AMT-116, a CD44v9-directed ADC, in patients with EGFR wild-type NSCLC and other advanced solid tumors. The data are being presented on October 17th at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting being held in Berlin, Germany.

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Phase I/II clinical trials are being conducted across Australia, US and China. This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase II Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in patients with advanced solid tumors. The Phase Ia portion will determine the recommended doses for expansion, and the Phase Ib/II portion will focus on further characterizing safety and efficacy in select tumor types.

As of July 17th, 2025, safety data are available for 164 patients who have received AMT-116 once every two weeks (Q2W) at doses ranging from 1.5 to 5.0 mg/kg. Primary tumor types are NSCLC, NPC (nasopharyngeal carcinoma), anal carcinoma and salivary gland cancer. In heavily pretreated EGFR Wild-type NSCLC patients, with prior lines of therapy ranging from 1-5, promising efficacy was observed regardless CD44v9 expression status. The overall response rate (ORR) was 40% (6/15), and the disease control rate (DCR) was 93% (14/15), in EGFR Wild-type NSCLC at dose levels >3 mg/kg. Among five EGFR Wild-type NSCLC patients at 5.0 mg/kg, ORR was 80% (4/5) and DCR was 100% (5/5). Preliminary antitumor activity was also observed in patients with NPC, anal carcinoma and salivary gland cancer at >3mg/kg, with ORRs of 50% (3/6), 60% (3/5) and 33% (2/6), respectively. Antitumor activity was observed across patients with varying levels of CD44v9 expression. The safety profile of AMT-116 was consistent with that of other Topoisomerase I inhibitor-based ADCs, with manageable hematologic toxicities as the most common treatment-related adverse events. Only low-grade and infrequent mucosal and skin toxicities were observed, demonstrating a favorable tolerability profile.

"We are excited by the impressive and durable efficacy shown in the early results of AMT-116, especially in unselected heavily pretreated EGFR Wild-type NSCLC and several other advanced solid tumors. The efficacies of AMT-116 observed so far are consistent with its broad tumor expression profile observed in preclinical studies, while the greatly reduced mucosal and skin toxicities reflect the desired outcome of a carefully selected linker-payload platform aimed at mitigating potential on-target toxicities from normal tissue expression. With these encouraging results, we are further expanding the clinically efficacious dose levels of 4 mg/kg Q2W and 5 mg/kg Q2W cohorts in select tumor types to explore the full potential of this novel ADC for greater patient benefit in NSCLC and beyond," said Dr. Shu-Hui Liu, co-founder and CSO of Multitude Therapeutics.

Mini Oral Presentation Details:

Title: Updated ongoing Phase I/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors
Mini Oral Session Title: Developmental therapeutics
Date and Time: October 17th – 04:05 PM
Location: Heidelberg Auditorium – Hall 6.2
Presentation number: 922MO

About AMT-116
AMT-116, a CD44v9 ADC, is composed of a proprietary antibody with high CD44v9 binding affinity, a hydrolysable linker, and a belotecan derivative payload (a novel and clinically validated topoisomerase-1 inhibitor, named KL610023, collaborating with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK)). CD44v9 is involved in broad biological pathways and has an implicated role in cancer stem cells. The target is a highly abundant protein and is overexpressed broadly in solid tumors with a restrictive normal tissue expression. AMT-116 has a drug-to-antibody ratio of 7-8. AMT-116 is being evaluated in a phase I/II study in patients with EGFR Wild-type NSCLC and other advanced solid tumors. Additional information on the Australia/US Phase I (NCT05725291) and China Phase I/II (NCT06782334) trials can be found at clinicaltrials.gov.

(Press release, Multitude Therapeutics, OCT 17, 2025, View Source;302587390.html [SID1234656752])

On October 17, 2025 Boehringer Ingelheim reported positive results from the Beamion LUNG-1 trial evaluating HERNEXEOS (zongertinib tablets) in treatment-naïve patients (N=74) with advanced non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) activating mutations in the tyrosine kinase domain (TKD). HERNEXEOS demonstrated efficacy with a confirmed objective response rate (ORR) of 77%. The data were featured at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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"Non-small cell lung cancer with HER2 activating mutations is a highly heterogeneous and aggressive disease which in the past has made it hard to find a targeted treatment offering significant clinical benefit," said the presenting author, Prof. Sanjay Popat, MD, PhD, Consultant Medical Oncologist, Head of the Lung Unit, and Lead for the Lung Cancer Research Programme at the Royal Marsden Hospital. "A response rate of 77% regardless of mutation subtype and a median time to response of 1.4 months indicate that zongertinib elicited a rapid response in treatment-naïve patients with HER2 TKD-mutant NSCLC, making it a promising future targeted treatment option in this setting."

Of the responders (77%), 8% of patients achieved complete response, 69% achieved partial response and 96% of patients achieved disease control. At data cut-off, median values for duration of response (DoR) and progression-free survival (PFS) were not yet mature, with 47% of patients remaining on treatment and encouraging 6-month rates for DoR of 80% and PFS of 79%.

Data presented at ESMO (Free ESMO Whitepaper) demonstrated a manageable safety profile for HERNEXEOS in treatment-naïve patients, with a similar pattern of adverse events (AEs) to that observed and reported in previously treated patients. Adverse events led to dose reductions in 11 patients (15%) and dose discontinuations in 7 patients (9%). The most commonly reported AEs were grade 1 diarrhea and rash.

HERNEXEOS was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) in China for the first-line treatment of adult patients with unresectable or metastatic NSCLC whose tumors have HER2 TKD activating mutations.

Beamion LUNG-2 (NCT06151574), a Phase III randomized study evaluating HERNEXEOS as a first-line therapy versus standard of care in patients with unresectable, locally advanced or metastatic HER2-mutant NSCLC, is currently enrolling.

"We see a significant unmet need in the first-line setting for patients with HER2-mutant advanced NSCLC where there are currently no targeted treatments approved. These data are extremely encouraging and reinforce our belief in the potential of HERNEXEOS for treatment-naïve patients with advanced non-small cell lung cancer with activating HER2 mutations," said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim. "Employing our dual approach to oncology, we are advancing both cancer cell and immune cell-directed therapies to pioneer breakthroughs for patients."

HER2 (ERBB2)-mutant NSCLC is a disease characterized by its aggressive nature and poor prognosis. Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.3

About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type4 and the incidence is set to increase to over 3 million cases worldwide by 2040.5 NSCLC is the most common type of lung cancer.4 The condition is often diagnosed at a late stage,6 and fewer than 3 in 10 patients are alive five years after diagnosis.6 People living with advanced NSCLC can experience a detrimental physical, psychological, and emotional impact on their daily lives.7,8,9 There remains a high unmet need for additional treatment options for people living with advanced NSCLC. Up to 4% of lung cancers are driven by HER2 (ERBB2) mutations (or gene alterations).2 Mutations in HER2 (ERBB2) can lead to overexpression and overactivation, which can in turn result in uncontrolled cell production, inhibition of cell death and promotion of tumor growth and spread.3

About HERNEXEOS (zongertinib tablets)
HERNEXEOS (zongertinib tablets) is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 (ERBB2). HERNEXEOS was recently approved by the U.S. Food and Drug Administration (FDA) as the first orally administered, targeted therapy for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The U.S. FDA also granted Breakthrough Therapy Designation for HERNEXEOS for use in a first-line setting.

About the Beamion clinical trial program
Beamion LUNG-1 (NCT04886804): An open-label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib as monotherapy in people with advanced or metastatic solid tumors and NSCLC with activating HER2 (ERRB2) alterations. The study has two parts. The first part is open to adults with different types of advanced cancer (solid tumors with changes in the HER2 (ERRB2) gene) for whom previous treatment was not successful. The second part is open to people with advanced NSCLC with a specific mutation in the HER2 (ERBB2) gene. Beamion LUNG-2 (NCT06151574) is a Phase III, open label, randomized, active-controlled study in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 (ERBB2) TKD mutations to evaluate zongertinib compared with standard of care. The study will enroll 416 patients who will be randomly assigned to receive either zongertinib or standard of care treatment. Beamion LUNG-3 (NCT07195695) is an interventional Phase III, randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable NSCLC that has HER2 TKD mutations. Its objective is to test whether zongertinib helps people with surgically removed NSCLC with HER2 mutations compared with standard treatment and will enroll 400 patients.

(Press release, Boehringer Ingelheim, OCT 17, 2025, View Source [SID1234656751])