FDA Grants Fast Track Designation of Seribantumab for NRG1+ Advanced Solid Tumors


Seribantumab has been granted fast track designation by the FDA for those who have positive locally advanced or metastatic solid tumors with NRG1 gene fusions.

The FDA has granted fast track designation to seribantumab as a tumor-agnostic treatment for patients with advanced solid tumors that harbor NRG1 gene fusions, according to a press release from Elevation Oncology.

Seribantumab is currently being assessed in the ongoing phase 2 CRESTONE trial (NCT04383210) in adult patients with NRG1 fusions in recurrent, locally advanced, or metastatic solid tumors. Initial data from the trial will be presented at the upcoming American Society of Clinical Oncology 2022 Annual Meeting.

“There are currently no approved therapies that specifically target NRG1 fusions, and therefore, receipt of fast track designation in a tumor-agnostic setting is a significant step in addressing this unmet need,” Shawn M. Leland, PharmD, RPh, founder and chief executive officer at Elevation Oncology, said in the press release.

Seribantumab is a fully human IgG2 monoclonal antibody that binds to HER3, which is activated through the binding of NRG1 gene fusion when activated. Moreover, the NRG1 fusion protein canto activate the HER3 pathway and cause unregulated cell growth and proliferation.

The trial has an estimated enrollment of 75 patients who will be divided into 1 of 3 cohorts. Cohort 1 has a minimum of 55 adults with NRG1 fusions who have received prior standard treatment, except for ERBB-directed therapy. They will receive seribantumab in 1-hour intravenous infusions once a week during induction, every 2 weeks during consolidation, and every 3 weeks during maintenance. Cohort 2 will enroll up to 10 patients, including those with prior ERBB-directed therapy. Cohort 3 will enroll up to 10 patients who may have had prior ERBB-directed therapy. Both cohorts 2 and 3 will receive the same dosing schedules as cohort 1.

The primary end point is objective response rate.

Inclusion criteria included having a locally advanced or metastatic solid tumor with an NRG1 fusion that was identified through a molecular assay; fresh or archived formalin-fixed, paraffin-embedded tumor samples; and 1 prior standard therapy appropriate for their tumor type and stage. Additionally, patients needed to have an ECOG performance status of 0 to 2, and at least 1 measurable extra-cranial lesion.

Exclusion criteria included having other known or actionable driver mutations, a life expectancy of less than 3 months, and those who are pregnant or lactating. In cohort 1, patients were not able to have had prior treatment with ERBB3 or HER3 directed therapy or prior treatment with pan-ERBB– or any ERBB-, HER2-, or HER3-directed therapy, specific to cohort 1.

NRG1 fusions are a type of genomic alteration that causes unregulated cell growth and proliferation in a variety of solid tumors, and we look forward to working closely with the FDA as we continue exploring the potential of seribantumab to improve outcomes for patients whose tumor harbors this unique oncogenic driver,” Leland concluded.


Elevation Oncology announces FDA fast track designation granted to seribantumab for the tumor-agnostic treatment of solid tumors harboring NRG1 gene fusions. News Release. Elevation Oncology. May 25, 2022. Accessed May 25, 2022. https://prn.to/3wOtDtz

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