Benzinga | Jul 13, 2020 06:08AM EDT

NextCure Says Does Not Plan to Advance the Non-small Cell Lung Cancer (Nsclc) and Ovarian Cancer Cohorts Into the Stage 2 Portion of the Simon 2-stage Trial

NextCure, Inc. (NASDAQ:NXTC) today provided an interim update for the Phase 2 portion of its NC318 monotherapy phase 1/2 trial.

Based on the current enrollment criteria and clinical response data, at this time the company does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete. The company will evaluate whether to pursue additional monotherapy studies in NSCLC and ovarian cancer after a review of that information. The company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts. One confirmed partial response has been observed in HNSCC and this indication has been advanced to the stage 2 portion of the Simon 2-stage trial. The company is continuing to assess Siglec-15 (S15) biomarker data as a basis for patient selection.

"While the monotherapy data in the NSCLC and ovarian cancer cohorts are disappointing, we continue to evaluate patient selection criteria for our ongoing NC318 clinical trials," said Michael Richman, NextCure's president and chief executive officer. "We expect to provide an NC318 clinical data update and additional biomarker data in the fourth quarter of 2020."

NextCure also announced that Kevin N. Heller, M.D., the company's chief medical officer, has resigned, effective August 4, 2020 to pursue a new opportunity. Dr. Heller will serve as a consultant to the company. The company has initiated a search for a new chief medical officer.

"We thank Kevin for all of his work on behalf of the company and look forward to his continued support as a clinical consultant," said Mr. Richman.