Amaria Highlights Phase 1 Trial of OBX-115 in Melanoma

Rodabe N. Amaria, MD, medical oncologist in the Department of Melanoma Medical Oncology, Division of Cancer Medicines, at MD Anderson Cancer Center, explains a trial of OBX-115 (NCT05470283), a novel engineered tumor infiltrating lymphocyte (TIL) therapy, for the treatment of patients with checkpoint inhibitor-resistant metastatic melanoma.

According to Amaria, early data from the phase 1 study, including findings presented at the 2024 American Society of Clinical Oncology Annual Meeting were encouraging, as OBX-115 was shown to be well-tolerated and did not lead to any severe adverse events.

The agent also demonstrated significant antitumor activity, leading to durable responses in half of the patients studied, including 2 complete remissions and 1 partial remission.

Previously in September 2024, the FDA granted a regenerative medicine advanced therapy designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that has been resistant to immune checkpoint inhibitor therapy. In July 2024, the FDA also granted the agent fast track designation.

Transcription:

0:10 | This is a trial specifically focusing on patients with immune checkpoint inhibitor-refractory melanoma. There has been a lot of research in this space. And honestly, it is a bit of an open area, we do not really have a clear directive of how to treat these patients. And so this represents a really active area of research in melanoma. So, my trial specifically is focusing on that patient population because it's the biggest unmet need.

0:34 | This is an early phase study, it really helped us get a sense of what we were dealing with and how we can tweak the regimen to make it better. So currently, there is ongoing optimization of this regimen in a clinical trial, a multicenter clinical trial that's currently enrolling in melanoma, as well as non–small cell lung cancer, where we are doing a little bit more digging into the dosing of the OBX TIL, as well as the duration and dosing of the FDA-approved small molecule inhibitor acetazolamide [Diamox], that turns the cells on.