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
Author(s)
Vinod Ravi, MD1, Paul Kamudoni, PhD2, Andrea Phillips Beyer, PhD2, Niki Karachaliou, MD, PhD2, Qingping Zou, PhD3, Amy Clark, PhD4, Agkreta Leventi, MSc4, Savita Bakhshi Anand, PhD4, Carla Dias Barbosa, MSc5, Hans Gelderblom, MD6;
1The University of Texas MD Anderson Cancer Center, Houston, TX, USA, 2Merck Healthcare KGaA, Darmstadt, Germany, 3Abbisko Therapeutics Co. Ltd., Shanghai, China, 4PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, London, United Kingdom, 5PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, Ivry-sur-Seine, France, 6Leiden University Medical Center, Leiden, Netherlands
1The University of Texas MD Anderson Cancer Center, Houston, TX, USA, 2Merck Healthcare KGaA, Darmstadt, Germany, 3Abbisko Therapeutics Co. Ltd., Shanghai, China, 4PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, London, United Kingdom, 5PPD Evidera Patient-Centered Research, Thermo Fisher Scientific, Ivry-sur-Seine, France, 6Leiden University Medical Center, Leiden, Netherlands
OBJECTIVES: TGCT is a life-limiting disease that causes joint destruction, pain, stiffness, and impaired PF. We characterized patient-reported changes in TGCT symptoms and PF experienced by patients with TGCT treated with pimicotinib or placebo in the Phase 3 MANEUVER trial (NCT05804045).
METHODS: Patients with TGCT from 6 countries participated in 90-minute semi-structured exit interviews that explored changes in TGCT-related symptoms and PF limitations, after the 24-week, double-blind, placebo-controlled phase of MANEUVER. Qualitative data analysis was performed using thematic analysis of verbatim interview transcripts and involved evaluation of conceptual saturation.
RESULTS: Twenty patients were interviewed (pimicotinib: n=12; placebo: n=8). Most were female (65.0%), 50.0% resided in The Netherlands or US; mean age was 43.0 years (SD 13.5). Most had a lower extremity affected by TGCT (95.0%; n=19); 1 reported an affected upper extremity. At baseline, most patients reported “restriction/reduction in ROM” (90.0%; n=18/20), “swelling” (85.0%; n=17/20), and “feeling unstable or weak” (65.0%; n=13/20) in the affected joint. Of 11 patients reporting on the relevance of ROM at exit interview, 72.7% (n=8/11) perceived relevance to their knee, 18.2% (n=2/11) to their foot, and 9.1% (n=1/11) to their hip. Improvement in ROM compared to baseline was noted by 10/11 patients treated with pimicotinib and 3/7 patients treated with placebo. At baseline, 19/20 patients reported at least one impact on PF. During interviews, improved PF compared to baseline was reported by 11/11 patients treated with pimicotinib and 3/7 patients treated with placebo. Of 17 patients questioned about patient-reported outcomes measurement information system-PF (PROMIS-PF) (lower extremity) measures, all confirmed its relevance; 11 questioned further confirmed their understanding of the measure.
CONCLUSIONS: 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.
METHODS: Patients with TGCT from 6 countries participated in 90-minute semi-structured exit interviews that explored changes in TGCT-related symptoms and PF limitations, after the 24-week, double-blind, placebo-controlled phase of MANEUVER. Qualitative data analysis was performed using thematic analysis of verbatim interview transcripts and involved evaluation of conceptual saturation.
RESULTS: Twenty patients were interviewed (pimicotinib: n=12; placebo: n=8). Most were female (65.0%), 50.0% resided in The Netherlands or US; mean age was 43.0 years (SD 13.5). Most had a lower extremity affected by TGCT (95.0%; n=19); 1 reported an affected upper extremity. At baseline, most patients reported “restriction/reduction in ROM” (90.0%; n=18/20), “swelling” (85.0%; n=17/20), and “feeling unstable or weak” (65.0%; n=13/20) in the affected joint. Of 11 patients reporting on the relevance of ROM at exit interview, 72.7% (n=8/11) perceived relevance to their knee, 18.2% (n=2/11) to their foot, and 9.1% (n=1/11) to their hip. Improvement in ROM compared to baseline was noted by 10/11 patients treated with pimicotinib and 3/7 patients treated with placebo. At baseline, 19/20 patients reported at least one impact on PF. During interviews, improved PF compared to baseline was reported by 11/11 patients treated with pimicotinib and 3/7 patients treated with placebo. Of 17 patients questioned about patient-reported outcomes measurement information system-PF (PROMIS-PF) (lower extremity) measures, all confirmed its relevance; 11 questioned further confirmed their understanding of the measure.
CONCLUSIONS: 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.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR58
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Oncology, SDC: Rare & Orphan Diseases