pimicotinib (ABSK021) / Abbisko, EMD Serono - LARVOL DELTA

Tenosyovial giant cell tumor (TGCT): From the physiopathology to the emergence of new targeted therapies (PubMed, Bull Cancer) - "This disease, although not lethal, has major functional and psychosocial consequences. Surgery is the main treatment ; CSF1R inhibitors are emerging for unresectable or recurrent disease and are available since March 2026 requiring a rethink of the patient care journey."

Journal • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Pimicotinib in patients with tenosynovial giant cell tumour (TGCT): 2-year analysis of the phase 3 MANEUVER trial (ESMO 2026) - No abstract available

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

The impact of pimicotinib on quality of life (QoL) in patients with tenosynovial giant cell tumour (TGCT): EQ-5D-5L findings from the Phase 3 MANEUVER trial (ESMO 2026) - No abstract available

Clinical • HEOR • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Expert Perspectives on TGCT and the Outcomes of the Phase 3 MANEUVER Study of Pimicotinib Presented at ASCO and ESMO 2025: A Podcast Discussion. (PubMed, Adv Ther) - "In this podcast article, the authors share their perspectives on current TGCT treatment, discuss the patient care journey in the US, and highlight the clinical significance of the MANEUVER study findings.Podcast, infographics and plain language summary available for this article [ https://doi.org/10.6084/m9.figshare.32938235 ]. The Podcast (MP4 269658 KB) SHORT INFOGRAPHIC."

Clinical • Journal • P3 data • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Pain • Tenosynovial Giant Cell Tumor

NEXPERT: Neoadjuvant Pimicotinib Combined With Surgery Versus Upfront Surgery for Diffuse Tenosynovial Giant Cell Tumor (clinicaltrials.gov) - P2 | N=84 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P2 trial • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Pimicotinib: Regulatory approval in US for tenosynovial giant cell tumor in H2 2026 (EMD Serono) - Jefferies DACH Corporate Conference in Baden

FDA approval • Oncology • Tenosynovial Giant Cell Tumor

Effect of pimicotinib on tumor response and physical function (PF) by tumor location in patients with tenosynovial giant cell tumor (TGCT): Results from the phase 3 MANEUVER trial. (ASCO 2026) - P3 | "Pimi provided sustained, clinically meaningful benefits in pts with TGCT, including durable tumor shrinkage and improved ROM and PF, regardless of tumor location. These results support pimi as an effective treatment option for patients with unresectable TGCT. Longer-term PROMIS-PF scores per item from baseline to week 49."

Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Adverse events and their management in patients with tenosynovial giant cell tumor (TGCT) treated with pimicotinib, after longer-term follow-up from the global phase 3 MANEUVER trial. (ASCO 2026) - P3 | "This analysis confirmed the distinct and manageable safety profile of pimi. Most TEAEs were low grade and managed through dose modifications and standard concomitant medications, enabling sustained dosing and minimal discontinuations. These findings support the longer-term tolerability of pimi in TGCT."

Adverse events • Clinical • P3 data • Giant Cell Tumor of Bone • Oncology • Pruritus • Tenosynovial Giant Cell Tumor

Effects of colony stimulating-factor 1 receptor inhibitors in an in vitro cell culture model using synovial fluids from tenosynovial giant cell tumor patients (EULAR 2026) - "The remaining cells were cultured in plates with or without exposure to a CSF1R inhibitor (kinase inhibitor (Imatinib, Pexidartinib, Vimseltinib, Pimicotinib) or neutralizing antibody (Emactuzumab)). Analyses on more samples are required to confirm these results and identify predictive factors of response to inhibitors. Image(s), graphic(s), or table(s)"

Preclinical • Giant Cell Tumor of Bone • Immunology • Inflammatory Arthritis • Oncology • Psoriatic Arthritis • Seronegative Spondyloarthropathies • Tenosynovial Giant Cell Tumor • CD14 • CD163 • CEACAM8 • MERTK • NCAM1 • PTPRC • THY1

Longer-term safety of pimicotinib in tenosynovial giant cell tumor (TGCT): Integrated analysis of phase 1 and phase 3 MANEUVER trial data. (ASCO 2026) - P1, P3 | "Pimi showed sustained tolerability with no new safety signals, confirming a favorable safety profile in Phase 1 and 3 trials during extended treatment of >1 year in a larger TGCT population. Summary of TEAEs. DR, drug related."

Clinical • P1 data • P3 data • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Oncology • Pruritus • Tenosynovial Giant Cell Tumor

CHANGES IN PAIN AND STIFFNESS EXPERIENCED BY PATIENTS WITH TENOSYNOVIAL GIANT CELL TUMOR (TGCT) IN THE MANEUVER PHASE 3 TRIAL: INSIGHTS FROM EXIT INTERVIEWS (ISPOR 2026) - P3 | "This study highlights the baseline impact of pain and stiffness on patients with TGCT, with most patients treated with pimicotinib reporting improvements at exit interview. Results support the content validity of Worst Pain and Stiffness NRS and suggest a two-point change in both scales as clinically meaningful for improvement and worsening."

Clinical • Interview • P3 data • Giant Cell Tumor of Bone • Oncology • Pain • Tenosynovial Giant Cell Tumor

INSIGHTS INTO RANGE OF MOTION (ROM) AND PHYSICAL FUNCTION (PF) CHANGES EXPERIENCED BY PATIENTS WITH TENOSYNOVIAL GIANT CELL TUMOR (TGCT) IN THE MANEUVER PHASE 3 TRIAL: RESULTS FROM EXIT INTERVIEWS (ISPOR 2026) - P3 | "Most patients treated with pimicotinib reported improvements from baseline in ROM and PF. All confirmed the relevance of ROM and PROMIS-PF assessments, and most confirmed their understanding of PROMIS-PF measures at exit interview."

Clinical • Interview • P3 data • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Integrative bioinformatics and molecular simulations identify HMGB3 as a key immune modulator in triple negative breast cancer. (PubMed, Discov Oncol) - "This work identifies HMGB3 as a promising immunotherapeutic target in the MLIA subtype of TNBC and highlights Pimicotinib, CID17584963, and CID1763476 as potential HMGB3 inhibitors for drug repurposing strategies."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • MIR214 • NEAT1

Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Not yet recruiting ➔ Recruiting

Enrollment open • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

CSF-1R inhibition with Pimicotinib (ABSK021) enhanced anti-tumor efficacy of KRASG12C inhibitors in preclinical non-small cell lung cancer mouse models (AACR 2024) - "Here, we conducted in vivo experiments to explore the combined effects of KRASG12C and CSF-1R inhibitors. In vivo efficacy studies were performed to evaluate the combined treatment of KRASG12C inhibitors (AMG510 and ABSK071, a next-generation inhibitor targeting KRASG12C with better inhibitory activity) and CSF-1R inhibitor (ABSK021) in NCI-H2122 PBMC humanized mice and LLC syngeneic mice. For the first time, we demonstrate that the combined inhibition of KRASG12C and CSF-1R leads to superior therapeutic efficacy in preclinical NSCLC mouse models. This results suggests a potential novel therapeutic regimen that could yield improved clinical benefit to patients."

Late-breaking abstract • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • KRAS

Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER) (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

New P2 trial • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

Manageable longer-term safety with the highly-selective colony stimulating factor-1 receptor (CSF-1R) inhibitor pimicotinib in patients with tenosynovial giant cell tumor (TGCT) in the global MANEUVER trial (Sarcoma-RC 2026) - P3 | "Ltd., Shanghai, China. Merck KGaA, Darmstadt, Germany, holds the rights to commercialize pimicotinib worldwide."

Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

The Lancet Publishes Global Phase 3 MANEUVER Study Results of Pimicotinib (Abbisko Therap Press Release) - "The MANEUVER study enrolled 94 patients across more than 30 clinical centers worldwide, with patients from outside China accounting for more than half of the study population. The data show that pimicotinib achieved significant efficacy along with a generally favorable safety profile in patients with tenosynovial giant cell tumor (TGCT)."

P3 data • Tenosynovial Giant Cell Tumor

Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial. (PubMed, Lancet) - P3 | "Pimicotinib showed robust antitumour activity with clinically meaningful improvements in TGCT-related functional limitations and symptom burden, offering an effective treatment option with a manageable safety profile for this underserved condition."

Journal • P3 data • Dermatology • Fatigue • Giant Cell Tumor of Bone • Hepatology • Liver Failure • Musculoskeletal Pain • Oncology • Pain • Pruritus • Solid Tumor • Tenosynovial Giant Cell Tumor

Pimicotinib: a new agent for an orphan disease. (PubMed, Lancet) - No abstract available

Journal

Management of tenosynovial giant cell tumor: approved and investigational therapies. (PubMed, Expert Rev Anticancer Ther) - "Pexidartinib and vimseltinib demonstrate comparable efficacy in TGCT with objective response rates (ORR) of 39% and 40%, respectively, at week 25 of treatment; however, vimseltinib offers improved hepatic safety and tolerability, supporting its use as the preferred first-line systemic therapy. Emerging agents, including pimicotinib and emactuzumab, show potential for higher response rates and favorable safety profiles and may further reshape the TGCT treatment paradigm pending phase 3 trial results."

Journal • Review • Giant Cell Tumor of Bone • Oncology • Tenosynovial Giant Cell Tumor

FDA Accepts New Drug Application for Pimicotinib for the Treatment of Tenosynovial Giant Cell Tumor (Businesswire) - "The application is based on the primary results and longer-term follow-up of the global Phase 3 MANEUVER study, which demonstrated deep and durable tumor responses and meaningful improvements in clinical outcomes with pimicotinib."

FDA filing • Tenosynovial Giant Cell Tumor

Pimicotinib Approved as Systemic Treatment in China for Tenosynovial Giant Cell Tumor (Businesswire) - "First regulatory approval in the world for pimicotinib based on positive data from global Phase 3 MANEUVER study."

China approval • Tenosynovial Giant Cell Tumor

A Phase II Study to Evaluate the Efficacy and Safety of Pimicotinib (ABSK021) in Chronic Graft Versus Host Disease (cGvHD) after 1 or More Lines of Systemic Treatment (ASH 2024) - P2 | "Pts had received a median of 4 prior systemic treatment (range, 1-9), including ruxolitinib (67.9%, n=19), ibrutinib (10.7%, n=3), and belumosudil (3.6%, n=1); with a median of 4 organs involved at baseline (range, 2-7). Conclusions The efficacy and safety results are in favor of Pimi as a promising Tx option for cGvHD, addressing significant unmet medical needs, especially in heavily pre-treated pts. Further explorations are warranted to confirm these findings with long-term outcomes."

Clinical • P2 data • Cardiovascular • Chronic Graft versus Host Disease • Fibrosis • Giant Cell Tumor of Bone • Graft versus Host Disease • Hypertension • Immunology • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Scleroderma • Systemic Sclerosis • Tenosynovial Giant Cell Tumor

A Study to Evaluate the Relative Bioavailability of Pimicotinib Capsules Containing Free Base in Different Proportions in Healthy Subjects (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Abbisko Therapeutics Co, Ltd | Active, not recruiting ➔ Completed

Trial completion