A patient has died in a clinical trial testing an Alpine Immune Sciences cancer immunotherapy, prompting the FDA to place the study under a partial hold. This limited suspension of the clinical trial means that patients already in the study may continue to receive the experimental Alpine treatment, davoceticept, but no additional patients may be enrolled until the questions about the patient death are resolved.
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According to Alpine, the death was attributed to cardiogenic shock, a condition in which the heart can’t pump enough blood to vital organs. This condition was considered by the treating physicians to be likely related to inflammation of the heart muscle or infection. Alpine’s stock price opened at $6.86 on Monday, down 11.2% from Friday’s closing price.
Seattle-based Alpine develops protein-based immunotherapies for both cancer and autoimmune diseases. Davoceticept, previously known as ALPN-202, is Alpine’s most advanced cancer program. The drug is a fusion protein that targets two “checkpoint” proteins that stop immune cells from recognizing cancer cells and attacking them. At the same time, the Alpine drug also targets a protein on T cells called CD28, which has the effect of promoting an immune response. Alpine previously reported preclinical research showing that dual blocking of checkpoint proteins combined with increased T cell activation from targeting CD28 led to better efficacy than checkpoint blocking alone.
The Phase 1 test now under a partial hold is testing the Alpine drug in combination with another checkpoint inhibitor, the Merck drug Keytruda. The open-label study is designed to enroll patients with solid tumors or blood cancers have advanced or spread and cannot be treated by surgery. According to Alpine, the patient who died had choroidal melanoma, a type of cancer that affects the eye. This patient was previously treated with the combination of two Bristol Myers Squibb cancer immunotherapies, the checkpoint inhibitors Opdivo and Yervoy.
Alpine is running a separate clinical trial testing davoceticept as a monotherapy. The company said that this Phase 1 clinical trial is unaffected by the partial hold on the study testing the drug in combination with Keytruda. In a prepared statement, Alpine CEO Mitchell Gold said the company will work with the FDA, Merck, and the study’s independent safety monitoring committee to understand the patient death.
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“Given the strong scientific rationale for the combination of davoceticept and [Keytruda] to benefit treatment-refractory patients, we are hopeful that the study will soon be resumed after appropriate safety review, and with appropriate safety precautions in place,” Gold said.
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