IMCR 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• Enrollment in the registrational Phase 3 TEBE-AM trial, evaluating tebentafusp as monotherapy and in combination with pembrolizumab, versus a control arm in patients with previously treated advanced cutaneous melanoma, is nearing the target of 540 patients, with topline data that could come as early…

• During the 2026 American Society of Clinical Oncology Meeting in May, we presented two posters:

• 1) "Phase 1 evaluation of the PRAME‑targeted ImmTAC brenetafusp in advanced melanoma": The data showed improved clinical activity of brenetafusp monotherapy, in heavily-pretreated advanced melanoma, with an overall response rate (ORR) of 17% and a disease control rate (DCR) of 67%, in the 160 mcg vs…

• 2) "Effect of IL7 on ImmTAC-mediated killing by T cells in vitro and T-cell fitness in patients": Building on previously disclosed data regarding the importance of T cell fitness for the efficacy of ImmTAC molecules, the new data demonstrated the anti-tumor activity of these therapies may increase w…

• The European Organisation for Research and Treatment of Cancer (EORTC) is now enrolling patients in the United States for the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).

相对上期删除的文字 · 来源:10-Q · 2026-05-06

• We presented the five-year overall survival (OS) from our pivotal Phase 3 trial with KIMMTRAK in unresectable or mUM, in an oral session at the American Association for Cancer Research (AACR) 2026 meeting. This is the longest, prospective Phase 3 randomized trial in patients with unresectable or mUM…

• In the Phase 3 trial, KIMMTRAK doubled the likelihood of being alive at five years, with an OS for KIMMTRAK of 16% versus 8% in the control arm (hazard ratio of 0.67 [95% CI: 0.54-0.85]).

• In the trial, 378 patients were randomized to tebentafusp (252) or investigator’s choice (126; 82% pembrolizumab). The median OS was 21.6 months on KIMMTRAK, versus 16.9 months on investigator’s choice (IC). The Kaplan–Meier survival curves separated early and remained separated over time, confirmin…

• The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase) or tumor location (hepatic only; hepatic and extra-hepatic). OS benefit was also observed in patients with a best response of progressive dise…

• More patients continued treatment beyond progression in the KIMMTRAK arm than in the control arm (57% vs 25%) – with the trial allowing this option in both arms. Patients on KIMMTRAK achieved nearly a 7-fold higher rate of tumor reduction with treatment beyond initial progression compared to IC pati…