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Iambic Presents Updated IAM1363 Clinical Data at ESMO 2026, Showing Durable Responses with a Favorable Tolerability Profile in Heavily Pretreated Participants with HER2-Driven Cancers

$IAMPress releaseOct 26, 2026, 8:00 AM ETRead the release

Iambic presented updated Phase 1/1b data for IAM1363, its AI-discovered brain-penetrant HER2 TKI, at the ESMO 2026 congress in Madrid. In heavily pretreated patients with targetable HER2 alterations dosed at >=960 mg QD, best overall response was 36% systemically (19/53) and 41% intracranially (9/22), including confirmed intracranial partial responses in three HER2-positive breast cancer patients previously treated with T-DXd and tucatinib. Tolerability was favorable: grade 3 TRAEs and TRAE-driven dose modifications each occurred in 5.9% of patients at the recommended dose, with no grade 4 or 5 TRAEs; more than half of 960 mg patients remain on study, some beyond one year.

Key figures

Drug Name
IAM1363
Phase Of Trial
Phase 1/1b
Data cutoff
2026-08-31
Systemic pr
36% (19/53)
Intracranial pr
41% (9/22)
Grade3 trae rate
5.9%
Recommended dose
960 mg QD
Participants dosed
122

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