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Merus, Caris Life Sciences Partner to ID NRG1 Fusion-Positive Cancer Patients for Clinical Trial

NEW YORK – Drug developer Merus said on Monday that it will work with molecular testing firm Caris Life Sciences to test cancer patients for NRG1 fusions and potentially enroll patients who have the genetic alterations into its Phase I/II eNRGy trial for the bispecific antibody zenocutuzumab.

The NRG1 gene fusion is driver of cancer cell growth that can be present in lung, pancreatic and other solid tumors. Zenocutuzumab blocks the interaction between the NRG1 fusion protein and its receptor HER3. In preclinical models, zenocutuzumab stopped tumor growth in mice and xenograft models harboring NRG1 fusion-positive tumors.

Additionally, preliminary data presented at a medical conference last year found that three NRG1 fusion-positive patients — two with pancreatic ductal adenocarcinoma and one with non-small cell lung cancer — treated with zenocutuzumab saw their tumors shrink. The drug also appeared to be well tolerated, with less than 5 percent of patients reporting grade 3 or higher adverse events.

"Initial data from these three patients suggest that it is important to look for NRG1 fusions in tumors, particularly in KRAS-negative pancreatic cancer and invasive mucinous adenocarcinoma of the lung, and when identified, patients should consider treatment in a clinical trial targeting this alteration," Alison Schram, an oncologist at Memorial Sloan Kettering and an investigator on the study, said in a statement.

The Phase I/II eNRGy trial will assess the safety and antitumor activity of zenocutuzumab monotherapy in NRG1 fusion-positive cancers. The study will have three cohorts: NRG1 fusion-positive pancreatic cancer, NRG1 fusion-positive NSCLC, and NRG1 fusion-positive solid tumors that are not pancreatic cancer or NSCLC. 

Under the agreement, Caris will provide whole-exome DNA sequencing and whole transcriptome RNA sequencing to identify the presence of NRG1 fusions and support patient identification and trial enrollment. It will mainly focus on testing patients with pancreatic cancer.

"While genomic sequencing is more commonly being used in the healthcare setting, it is not sufficiently employed in the diagnosis and management of pancreatic and other cancers where treatment options have been limited," Merus CEO Bill Lundberg said in a statement, adding that the collaboration with Caris will help raise awareness in this regard and enhance enrollment in the eNRGy trial and the early access program for zenocutuzumab.