Immatics Unveils Promising Clinical Results for Next-Gen TCR Bispecifics—30% Confirmed Response Rate for IMA402 in Advanced Solid Tumors

Key Clinical Findings Signal Step Forward in Bispecific Cancer Therapies

Immatics (NASDAQ: IMTX) has reached a milestone with new data from its TCR Bispecific (TCER®) pipeline, achieving clinical proof-of-concept for both IMA402 (targeting PRAME) and IMA401 (targeting MAGEA4/8). In heavily pre-treated, last-line solid tumor patients—many of whom had few remaining options—the confirmed objective response rate (cORR) reached 30% for IMA402 within the recommended Phase 2 dose (RP2D) range. These results were highlighted during a company webcast today, emphasizing Immatics' commitment to pushing the boundaries of precision immunotherapy for cancer patients facing significant unmet needs.

Clinical Data: Deep and Durable Responses for IMA402 and IMA401

IMA402’s Phase 1a dose escalation enrolled 80 patients with advanced metastatic solid tumors. Within the RP2D range (10–30 mg), 20 patients were efficacy-evaluable, including 14 with melanoma and 3 with ovarian carcinoma. Confirmed response rates included:

Importantly, all six confirmed responders with IMA402 had ongoing responses as of data cutoff, including complete metabolic responses persisting up to 18 months. These patients included individuals whose tumors were resistant to prior immune checkpoint inhibitors and, for ovarian carcinoma, to platinum-based therapies.

For IMA401, 38 efficacy-evaluable patients (at =1 mg) included focus cohorts in head and neck cancer, melanoma, and sqNSCLC. Highlights at these doses were:

• Head and Neck Cancer: 25% cORR, 63% disease control rate
• Melanoma: 29% cORR, 57% disease control rate
• sqNSCLC: Confirmed partial response in one heavily pre-treated, ICI-resistant patient; additional stable disease over four months in another

Tolerability Profile Supports Further Expansion

Safety data across both agents underscored favorable tolerability—key for late-stage cancer patients. For IMA402, the most common adverse events were transient lymphopenia and low-grade cytokine release syndrome, with only 1% experiencing a Grade 4 event and none at Grade 5. For IMA401, cytokine release syndrome remained mostly low-grade, with tolerability at the RP2D (1–2 mg) considered well-managed even in combination settings.

Broader Implications: Expanded Trials and Potential Combinations Target Key Unmet Needs

The path forward includes Phase 1b dose expansion for IMA402—exploring both monotherapy and combination approaches (notably with immune checkpoint inhibitors) in melanoma and gynecologic cancers. A strategic combination of IMA402 and IMA401 is under investigation for squamous non-small cell lung cancer (sqNSCLC), addressing a potential patient population of 40,000 annually across the U.S. and EU5. Notably, more than 90% of sqNSCLC cases express either PRAME or MAGEA4/8, with 60% expressing both, positioning Immatics’ bispecific strategy for substantial clinical impact.

What to Watch: Ongoing Trials Could Define the Future of Bispecific Immunotherapies

The results highlight not only promising efficacy signals, but also the prospect for longer-lasting tumor control in patients otherwise out of treatment options. With ongoing response durations exceeding a year for some patients and plans for registration-directed trials on the horizon, Immatics' approach may help reshape the treatment landscape for a range of solid tumors. For those following cancer immunotherapy, the evolving story of Immatics’ bispecifics—and particularly the early combination data in difficult-to-treat lung cancer—will be one to watch closely in the coming year.

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