JERUSALEM, Nov. 3, 2021 /PRNewswire/ -- Alpha Tau Medical Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, announced today that it has enrolled its first patient in the combination study of Alpha DaRT and pembrolizumab (Keytruda®) at Hadassah Medical Center in Jerusalem, Israel.

The clinical trial is designed to test the benefit of the Alpha DaRT in combination with pembrolizumab, an immunotherapy drug, for the treatment of recurrent unresectable or metastatic squamous cell carcinoma of the head and neck. The primary objective of the study is to evaluate efficacy of the combination, as measured by the confirmed Best Overall Response rate determined by using the RECIST criteria. Patients enrolled in the trial will receive pembrolizumab cycles every three weeks both before and after receiving Alpha DaRT treatment. The study uses a two-stage adaptive design and can recruit up to 48 patients, with a planned interim analysis after the first 18 patients have been treated.

"We are excited to begin our much-anticipated first human clinical trial combining the Alpha DaRT with a checkpoint inhibitor," said Alpha Tau CEO Uzi Sofer. "This initiative is a major component of the vision and future direction of Alpha Tau, as we look to evaluate our locally administered Alpha DaRT therapy for its potential to provide local treatment of tumors and also contribute to a systemic response in untreated tumors throughout the body."
Alpha Tau CMO Dr. Robert Den remarked, "The novel adaptive two-stage trial design will allow us to determine very quickly whether we have observed an improved systemic response from the combination of Alpha DaRT with pembrolizumab, and at the same time allow for a meaningful enough patient population to support decision-making with respect to our clinical pathway. We are looking forward to seeing the data from this trial, particularly in light of our pre-clinical data showing that the combined use of Alpha DaRT with immunomodulators resulted in decreased metastatic burden and improved survival in treated animals, and that this activity was modulated by activation of the immune system."

Prof. Aron Popovtzer, Head of the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, and principal investigator of the study, commented, "We are excited to be leading this trial, the first one to combine Alpha DaRT with an immunotherapy in humans. We believe this patient population presents a serious unmet need, and we are looking forward to seeing whether this combination can provide a new source of relief for these patients."

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