MAIA Biotechnology (NYSEA:MAIA) announced preliminary survival data in the Part A safety lead-in of its ongoing Phase 2 trial, THIO-101, evaluating THIO in patients with advanced non-small cell lung cancer (NSCLC).
The first 2 patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months, respectively, from treatment initiation. Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therapy, respectively, after previously failing treatment with an immune checkpoint inhibitor.
The company previously reported that the first six evaluable patients in Part A of THIO-101 cleared the THIO high dose followed by the standard 350 mg dose of cemiplimab on day five, with no dose limiting toxicities.
Treatment has been generally well tolerated and enrollment is underway in Part B. As of now, the first 2 patients continue to be progression free following their last dose, seven and six months, respectively, with no new treatment.
“In real-world clinical practice, observed survival in such heavily pretreated patients is three-to-four months. These preliminary survival results are very encouraging for patients with lung cancer,” Vlad Vitoc, MAIA’s CEO, said in a statement.
THIO-101 is a multicenter, open-label, dosing finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients receiving THIO in advance of an immune checkpoint inhibitor, allowing for immune activation and PD-1 sensitivity to take effect.
