MANEUVER is a Phase III, randomized, placebo-controlled, double-blind, multi-region study sponsored by Abbisko. This study consists of three parts. In Part 1, eligible participants were randomized in a 2:1 ratio to receive either pimicotinib 50 mg QD or matching placebo for 24 weeks (28-day cycles). Part 2 is an open-label treatment phase and all participants entering this phase will receive open-label pimicotinib until completion of 24 weeks of dosing or withdrawal from the study. Participants who complete Part 2 are given the option to enter the open-label extension treatment phase, namely Part 3, which facilitates prolonged treatment. In addition, upon the completion of Part 1, patients will be invited by the investigator to participate in an optional qualitative interview to reflect the patient's assessment of clinical efficacy. The MANEUVER study is the first global trial to enroll both Asian and Western patients with TGCT in balanced proportions across multiple regions including China, North America and Europe. This robust representation allows for detailed outcome comparisons by stratification factor – China sites versus non-China sites – thereby facilitating a deeper understanding of disease characteristics and potential variations in response across different populations. Based on early clinical research data, Pimicotinib may effectively reduce tumor size, alleviate joint pain and stiffness, and improve joint mobility. If approved, it would provide an additional treatment option for patients with TGCT.

The approval to conduct this Phase III trial was received by the China NMPA in October 2022, the U.S. FDA in March 2023, and the EMA in September 2023. The completion of patient enrollment for this study by March 29 2024. It is the first global Phase III trial of TGCT simultaneously conducted in China, the U.S., Canada and Europe. Pimicotinib has obtained the Breakthrough Therapy Designation (BTD) from China NMPA and the U.S. FDA, as well as the PRIME designation from EMA. Furthermore, the U.S. FDA granted Fast Track Designation (FTD), and Orphan Drug Designation (ODD) granted by EMA in January 2024, for the treatment of TGCT patients who are not amenable to surgery.

Future Oncology is a hybrid open-access journal with a JCR Quartile ranking of Q2 and an impact factor of 3.0. It is a Science Citation Index Expanded (SCIE) -indexed, peer-reviewed publication that provides insights into cancer treatments, personalized strategies, and their clinical implications. The journal offers analyses on topics such as new anticancer agents, ongoing study protocols, immunotherapy, and advancements in radiotherapy, while also addressing policy debates and real-world outcomes research.