An experimental cancer drug called invikafusp alfa (invika) halted disease progression in a majority of patients with advanced tumors that had resisted standard immunotherapy, according to early clinical trial results announced by researchers at the National Institutes of Health, Mass General Brigham, and Memorial Sloan Kettering.
The findings address a critical gap in cancer treatment. While immunotherapies have transformed care for some cancers, many patients benefit only briefly or not at all, as tumors frequently develop resistance to checkpoint blockade drugs like pembrolizumab. Existing strategies to activate T cells broadly often produce severe side effects.
Invika was designed to target a narrow subset of T cells rather than activate them indiscriminately, aiming to drive anti-tumor activity while reducing severe complications. The drug engages two groups of tumor-infiltrating lymphocytes specifically.
In the trial's phase 1 and initial phase 2 results, researchers treated 27 patients at the optimal dose. Disease did not progress in 16 patients (59.3%). Four patients (14.8%) experienced greater than 30% reductions in targeted tumors, including two with metastatic colorectal cancer who were receiving invika as their seventh-line therapy and another with stage 4 non-small cell lung cancer.
Most participants experienced flu-like side effects that were manageable with additional medication and supportive care. When given at non-optimal doses, invika did not show significant benefit.
The U.S. Food and Drug Administration granted a Fast Track designation to invika to accelerate its evaluation for treatment-resistant colorectal cancer, and more recently extended the same designation for similar solid tumors following prior therapy including checkpoint inhibitors. The ongoing clinical trial is still recruiting participants.