IMA401 Shows 33% Response in Head and Neck Cancer as Phase 1 Finds No MTD
Updated
Updated · Oncodaily · Jun 1
IMA401 Shows 33% Response in Head and Neck Cancer as Phase 1 Finds No MTD
8 articles · Updated · Oncodaily · Jun 1
55 heavily pretreated patients with more than 15 advanced solid tumor types received IMA401, and investigators reported favorable tolerability plus early antitumor activity in the first-in-human phase 1 study.
38 efficacy-evaluable patients at target doses of at least 1 mg produced confirmed response rates of 25% in head and neck cancer and 29% in melanoma; after cutoff, head and neck ORR rose to 33% (4/12).
No grade 3 or higher cytokine release syndrome or any ICANS was reported, while low-grade CRS was the most common toxicity; three dose-limiting toxicities appeared at 2.5 mg, but the maximum tolerated dose was not reached.
A 1-2 mg recommended phase 2 dose range was set, with all confirmed responses ongoing beyond 6 months and combination testing with pembrolizumab showing a safety profile consistent with monotherapy.
The data support further development, including planned combination strategies with PRAME-directed IMA402 in squamous NSCLC and other solid tumors.
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IMA401 Delivers Durable Responses in Heavily Pretreated Solid Tumors: Phase 1 Results from ASCO 2026 and Nature Medicine
Overview
Recent clinical trial data presented at the 2026 ASCO Annual Meeting and published in Nature Medicine highlight IMA401 as a promising, off-the-shelf immunotherapy for patients with advanced cancers who have limited treatment options. The Phase 1 trial showed that IMA401 can induce durable responses and is well tolerated, especially in heavily pretreated patients with solid tumors like advanced melanoma and head and neck cancer. These positive results not only offer hope to patients who have exhausted conventional treatments but also validate the platform technology behind IMA401, paving the way for future developments in off-the-shelf immunotherapies.