Dr Kelly on Ongoing Trials in Patients With GIST

Ciara Kelly, MBBCh, BAO, interim clinical director, Sarcoma Oncology Service, Memorial Sloan Kettering Cancer Center, discusses ongoing trials to further enhance the treatment of patients with gastrointestinal stromal tumor (GIST).

Several ongoing clinical trials are particularly promising for patients with GIST, offering new treatment avenues, Kelly begins. One exciting development came from the 2024 ASCO Annual Meeting, where data on 2 pan-KIT inhibitors, NB003 and IDRX-42, were presented, she states. These inhibitors have shown promising clinical activity and have been well tolerated across a broad range of GIST genotypes within the KIT-mutant population, according to Kelly. With ongoing expansions in both studies, there is considerable anticipation for further results that could significantly impact treatment strategies for GIST, Kelly explains.

Another critical study is the ongoing phase 3 Peak trial (NCT05208047), which explores sunitinib (Sutent) with or without bezuclastinib (CGT9486) in patients with advanced GIST who have either progressed on or are intolerant to imatinib (Gleevec) in the second-line setting, she continues. Early data from this study have demonstrated promising activity with sunitinib plus bezuclastinib, indicating that this combination could offer a valuable new option for patients with limited treatment choices, Kelly emphasizes. The forthcoming results from the randomized phase 3 portion of the trial are highly anticipated, as they will provide deeper insights into the efficacy of this combination therapy, she states.

Additionally, the phase 2 SARC044 trial (NCT06208748) is examining the same combination of sunitinib and bezuclastinib in patients who have previously progressed on sunitinib, Kelly expands. This combination represents another potential treatment option for those who have exhausted both imatinib and sunitinib, which are standard therapies in GIST management, she notes.

Overall, these trials represent significant advancements in GIST treatment, particularly for patients with limited options after progression on existing therapies, Kelly emphasizes, concluding by stating that results from these studies will be critical in shaping the future of GIST treatment.