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Robin Jones, MD, MRCP, discusses the treatment armamentarium for patients with gastrointestinal stromal tumors.
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"The exciting thing here is that [investigational agents such as] NB003 and IDRX-42, will be further evaluated in randomized trials. Hopefully over the next few years, we'll see the approval of even more treatments for patients with metastatic GIST."
Robin Jones, MD, MRCP, a consultant medical oncologist, professor of medical oncology, and head of the Sarcoma Unit at The Royal Marsden NHS Foundation Trust, outlined developments in the evolving treatment landscape for patients with gastrointestinal stromal tumor (GIST), spanning both the adjuvant and metastatic settings.
In the adjuvant setting, Jones highlighted data from the French Sarcoma Group's phase 3 IMADGIST trial (NCT02260505), which randomly assigned patients with high-risk GIST to receive an additional 3 years of imatinib (Gleevec) following completion of the standard 3-year course, compared with patients who discontinued therapy at 3 years. With a median follow-up of 55 months (IQR, 46-59) post randomization, 3 additional years of maintenance imatinib significantly improved disease-free survival, with a HR of 0.40 (95% CI, 0.20-0.69; P = .0008) favoring the 6-year arm. However, follow-up remains relatively early, and longer-term data will be needed to fully characterize the benefit, he noted. A complementary phase 3 trial (NCT02413736), led by the Scandinavian Sarcoma Group, has completed accrual and randomly assigned patients with very high-risk GIST to 3 vs 5 years of adjuvant imatinib; results are pending and expected to further inform optimal treatment duration, Jones shared.
In the metastatic setting, Jones emphasized several ongoing and recently completed trials. The phase 3 INSIGHT trial (NCT05734105) is currently enrolling patients with advanced or metastatic GIST and KIT exon 11, 17, or 18 mutations following progression on imatinib. Patients are randomly assigned to receive either ripretinib (Qinlock) or sunitinib (Sutent), with progression-free survival (PFS) as the primary end point. This trial builds on a prior second-line study of ripretinib vs sunitinib, the phase 3 INTRIGUE trial (NCT03673501), which did not meet its primary end point overall but suggested potential benefit in patients with specific KIT mutations based on circulating tumor DNA analyses, Jones explained.
Additionally, the phase 3 PEAK trial (NCT05208047), now closed to recruitment, investigated sunitinib alone vs sunitinib plus the TKI bezuclastinib (CGT9486) in the second-line setting, with PFS as the primary end point. Beyond these, Jones pointed to several promising investigational agents, including NB003 and IDRX-42, which are being explored in early-phase studies and are anticipated to move into randomized trials. These efforts collectively reflect a robust pipeline of therapies aimed at improving outcomes for patients with metastatic GIST, he concluded.
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