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NeoImmuneTech Starts Phase II Trial of NT-17, Tecentriq in PD-L1-Positive NSCLC

NEW YORK – Drugmaker NeoImmuneTech on Monday said the first PD-L1-positive advanced non-small cell lung cancer patient has received its long-acting IL-7 drug, dubbed NT-17, with Roche's checkpoint inhibitor atezolizumab (Tecentriq) within a trial exploring the combination's activity.

The single-arm Phase II trial will enroll up to 83 stage IV or locally advanced NSCLC patients with PD-L1 expression in at least 1 percent of tumor cells. All patients will receive NeoImmuneTech's investigational NT-17 with atezolizumab, and the company will track patients' objective response rates as the primary endpoint. Duration of response, disease control rate, progression-free survival, and overall survival are secondary endpoints in the study.

According to Se Hwan Yang, president and CEO of NeoImmuneTech, the company decided to advance the latest Phase II trial last year after seeing promising anti-tumor activity of the NT-17-atezolizumab combination in preclinical studies.

Atezolizumab is already approved in the US as a first-line treatment for metastatic NSCLC in combination with bevacizumab (Roche's Avastin) and platinum-based chemotherapy, with just platinum chemo, or as a single agent for those who have progressed on this type of chemo. Advanced NSCLC patients with PD-L1 expression in at least 50 percent of tumor cells or at least 10 percent of immune-infiltrating tumor cells can receive single-agent atezolizumab. The checkpoint inhibitor can also be given as adjuvant treatment to patients with stage II to IIIA NSCLC and PD-L1 expression in at least 1 percent of tumor cells after surgical resection and platinum chemo.

"NT-I7's T-cell-amplifying properties may make it an excellent partner in combination with a checkpoint inhibitor, like atezolizumab, and this study could bring us closer to a new chemo-free treatment option for patients with PD-L1-expressing NSCLC," Yang said in a statement.

NT-17, also called efineptakin alfa, is designed to enhance and maintain T-cell responses against tumor antigens. NeoImmuneTech is evaluating NT-17 as a monotherapy in glioblastoma patients but also in combination with various immunotherapies.

The Rockville, Maryland-based firm is investigating NT-17 with atezolizumab in high-risk skin cancers and with Merck's PD-1 inhibitor pembrolizumab (Keytruda) in patients with various solid tumors and triple-negative breast cancer. In 2020, NeoImmuneTech said it would study the efficacy of NT-17 with the CD19 CAR T-cell therapy tisagenlecleucel (Novartis' Kymriah) in relapsed or refractory large B-cell lymphoma patients.