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
Key Highlights
- ➤IAM1363 systemic partial responses reached 36% in targetable HER2-altered cancers
- ➤Intracranial partial responses reached 41% among participants with targetable HER2 alterations
- ➤More than half of participants at 960 mg QD remain on treatment
- ➤Three previously treated HER2-positive breast cancer participants achieved confirmed intracranial responses
- ➤Grade 3 treatment-related adverse events and dose modifications each affected 5.9% at 960 mg
Expert Statements
Tom Miller, PhD, Co-Founder and CEO, Iambic
“Last year at ESMO we shared the first clinical data for IAM1363. Today's update shows that data set maturing in the ways that matter most for patients: durability, higher rate of best overall response, and consistent tolerability at the recommended dose”
Tom Miller, PhD, Co-Founder and CEO, Iambic
“The intracranial responses, including in participants with extensive brain metastases who had already been treated with T-DXd and tucatinib, reflect what we set out to build: a potentially differentiated selective HER2 inhibitor that is brain penetrant, brought to the clinic years faster than industry norm.”
Neil Josephson, MD, Chief Medical Officer, Iambic
“We believe that these data support continued development of IAM1363, which has been generally well-tolerated and has shown anti-tumor activity across a wide range of HER2 altered cancers at the recommended monotherapy dose of 960 mg,”
Neil Josephson, MD, Chief Medical Officer, Iambic
“Especially promising are the intracranial responses in participants with HER2-positive breast cancer who had previously received T-DXd and tucatinib. Patients with brain metastases have limited options, so we are encouraged by early evidence of anti-tumor activity in this setting with a significant unmet need. We are grateful to the participants and investigators who are taking part in this Phase 1/1b study and look forward to continuing evaluation of IAM1363 as a monotherapy and in combination with standard of care therapies.”
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
* IAM1363, now in a Phase 1/1b study, was designed using Iambic’s molecular superintelligence platform and brought to clinical development in approximately two years * Data presented at ESMO 2026 demonstrates IAM1363 was well tolerated with low rates of Grade 3 or higher treatment-related adverse events, serious adverse events, and dose modifications * More than half of participants dosed at 960 mg remain on study with some participants on treatment beyond one year * Intracranial responses were observed in participants with HER2-positive breast cancer who have previously received T-DXd and tucatinib Iambic Therapeutics, Inc. (Iambic) (Nasdaq: IAM), a clinical-stage life sciences and technology company developing novel medicines using its AI-driven platform, today announced updated clinical data for IAM1363, a selective and brain-penetrant HER2 tyrosine kinase inhibitor (TKI), from its ongoing Phase 1/1b clinical trial. The data, which showed durable anti-tumor activity, intracranial responses and a favorable tolerability profile in heavily pretreated participants with HER2-altered advanced cancers, were presented in a poster at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid on October 23, 2026.
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