KIMMTRAK Data Shows Comparable Outcomes for Stable Disease and Partial Response Patients

Immunocore Holdings plc, a biotechnology company focused on developing innovative immunotherapies, showcased significant clinical data at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. The data presented involved KIMMTRAK® (tebentafusp-tebn), demonstrating its efficacy in treating patients with unresectable or metastatic uveal melanoma (mUM).

The company highlighted three key posters that collectively reinforced the effectiveness of KIMMTRAK, even in patients with stable disease and any confirmed tumor reduction. These findings indicated that patients with such outcomes had similar clinical benefits to those with partial response, as established by RECIST criteria.

In detail, the Phase 2 trial (IMCgp100-102) involved 127 patients, 25% of whom experienced some tumor reduction with at least one subsequent scan confirming this observation. Among them, 20% achieved stable disease (SD) and 5% had partial responses (PR). Remarkably, the clinical outcomes for patients with stable disease were comparable to those with partial responses. This included similar durations of tumor reduction or response, ctDNA molecular response, and overall survival rates.

The Phase 3 trial (IMCgp100-202) echoed these results, showing that patients with stable disease and confirmed tumor reduction had a similar duration of tumor reduction—around 11 months—as those with partial or complete responses.

Dr. Mohammed Dar, Immunocore’s Senior Vice President of Clinical Development and Chief Medical Officer, emphasized that this data builds on growing evidence that disease control is a reliable early indicator of clinical benefit. Ralph Torbay, the company’s Chief Commercial Officer, highlighted that KIMMTRAK is now established as the standard of care in many countries for HLA-A*02:01-positive mUM patients. The ASCO data is expected to enhance patient-physician discussions, especially regarding those with stable disease and minor tumor reductions.

KIMMTRAK, a bispecific protein targeting gp100 in melanocytes and melanoma, represents the first molecule developed using Immunocore’s ImmTAC technology platform. It aims to redirect and activate T cells to identify and destroy tumor cells. The drug has received approval in the U.S., European Union, Canada, Australia, and the United Kingdom for treating HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.

Immunocore also presented data from a Phase 1 trial involving brenetafusp (IMC-F106C) in advanced cutaneous melanoma, underlining the company’s broader commitment to developing TCR bispecific immunotherapies for various diseases, including cancer and autoimmune conditions.

The company is actively advancing its clinical and pre-clinical programs across multiple therapeutic areas. Immunocore’s most advanced product, KIMMTRAK, underscores its pioneering approach in developing ImmTAX—a novel class of immune-modulating TCR therapies designed to treat a broad spectrum of diseases.

As with any medical treatment, KIMMTRAK has associated risks and side effects. Notable among these is Cytokine Release Syndrome (CRS), which can be serious or life-threatening. Skin reactions and elevated liver enzymes are other common adverse effects. It’s crucial for healthcare providers to monitor these side effects closely and manage them accordingly. Additionally, KIMMTRAK presents embryo-fetal toxicity risks, necessitating caution for pregnant patients and those of reproductive potential.

Overall, Immunocore's presentations at ASCO 2024 underscore the clinical promise of KIMMTRAK in treating metastatic uveal melanoma, providing new hope for patients with this challenging condition. The data presented reinforce the potential of Immunocore’s ImmTAC platform in delivering transformative therapies across various medical needs.