Inhibrx Awaits Ozekibart Clinical Data in October

Inhibrx Biosciences expects to announce clinical data for Ozekibart, a precision-engineered antibody, in late October 2025. The data will come from a phase II trial in unresectable or metastatic conventional chondrosarcoma and a phase I trial in Ewing sarcoma and colorectal adenocarcinoma. The company had cash and cash equivalents of $186.6 million as of June 30, 2025.

Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company, announced that it will present pivotal data from the ARROS-1 clinical trial of zidesamtinib at the 2025 World Conference on Lung Cancer (WCLC 2025). The data, which will be presented during the Presidential Symposium on September 7, 2025, includes results for zidesamtinib in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive NSCLC (non-small cell lung cancer).

The ARROS-1 trial, a Phase 1/2 clinical study, is investigating zidesamtinib, a novel ROS1-selective inhibitor, in patients who have previously been treated with at least one ROS1 TKI. The trial aims to evaluate the safety, tolerability, and efficacy of zidesamtinib in this patient population. The ongoing Phase 2 portion of the trial also includes patients who have not been pre-treated with TKIs.

Nuvalent has initiated its rolling New Drug Application (NDA) submission for zidesamtinib in TKI pre-treated patients with advanced ROS1-positive NSCLC. The FDA has agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, which allows for earlier submission of topline efficacy and safety results. The company aims to complete the NDA submission by the third quarter of 2025.

The presentation at WCLC 2025 will be led by Alexander Drilon, M.D., from Memorial Sloan Kettering Cancer Center. The session is titled "Pivotal ARROS-1 efficacy and safety data: zidesamtinib in TKI pre-treated patients with advanced/metastatic ROS1+ NSCLC" and will be held on Sunday, September 7, 2025, from 8:15 a.m. to 10:30 a.m. CEST.

Nuvalent's zidesamtinib is designed to overcome limitations observed with currently available ROS1 inhibitors and has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors. It also has orphan drug designation for ROS1-positive NSCLC.

The company continues to engage with the FDA on potential opportunities for line-agnostic expansion and is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

References:
[1] https://www.morningstar.com/news/pr-newswire/20250813ne48451/nuvalent-to-present-pivotal-data-from-arros-1-clinical-trial-of-zidesamtinib-for-tki-pre-treated-patients-with-advanced-ros1-positive-nsclc-at-wclc-2025-presidential-symposium
[2] https://www.nasdaq.com/articles/inhibrx-biosciences-beats-earnings