FDA Grants Priority Review to Sevabertinib in HER2-Mutant NSCLC
This priority review designation for sevabertinib in previously treated HER2-mutant non–small cell lung cancer is supported by data from the phase 1/2 SOHO-01 study.
US FDA
- The FDA has granted priority review to sevabertinib (BAY 2927088) for the treatment of advanced HER2-mutant non–small cell lung cancer (NSCLC).
- This designation is supported by the ongoing phase 1/2 SOHO-01 study (NCT05099172).
- Data from SOHO-01 showed an objective response rate (ORR) of 70.5% in patients with pretreated disease.
Priority review has been granted to sevabertinib by the FDA for the treatment of adult patients with HER2/ERBB2-mutant NSCLC who have received prior systemic therapy.1
“Patients with HER2-mutant NSCLC are predominantly women, may be of younger age and nonsmokers. The FDA’s decision to grant priority review designation to our application for sevabertinib is a significant milestone that validates both the unmet need and the potential for sevabertinib to fulfill that need,” said Christine Roth, executive vice president, global product strategy and commercialization and member of the pharmaceutical’s leadership team at Bayer, in a press release. “If approved, sevabertinib will help address critical unmet needs and improve outcomes for these patients, who currently have a poor prognosis and limited treatment options.”
Priority review is granted to agents that, if approved, would provide a significant improvement in safety or efficacy over existing therapies.
The priority review is supported by data from the phase 1/2 SOHO-01 study investigating sevabertinib, an oral, small molecule tyrosine kinase inhibitor (TKI) in patients with NSCLC harboring a HER2 mutation that have experienced disease progression following at least 1 prior line of systemic therapy and who have not received a HER2-directed TKI (cohort D) or were previously treated with a HER2-directed antibody-drug conjugate (cohort E).
Holographic concept of lung cancer: © catalin - stock.adobe.com
As of October 14, 2024, 44 patients from cohort D and 34 patients from cohort E had been treated. The investigator-assessed ORR was 70.5% (95% CI, 54.8%-83.2%) in D and 35.3% (95% CI, 19.7%-53.5%) in cohort E. The disease control rates were 81.8 and 52.9%, and the median duration of response was 8.7 months (95% CI, 4.5-not estimable [NE]) and 9.5 months (95% CI, 4.1-NE), respectively.
The safety profile of sevabertinib was tolerable and consistent with previous reports. Treatment-related adverse events (TRAEs) were reported in 97.4% of patients, with diarrhea being the most common TRAE leading to dose reduction. However, no patients discontinued treatment due to diarrhea. Further, there were no cases of interstitial lung disease.
In 2024, the FDA and Center for Drug Evaluation in China granted breakthrough therapy designation, intended to expedite the development and review of agents to fill serious unmet needs, to sevabertinib in this patient population supported by data from SOHO-01.
The ongoing phase 3 SOHO-02 trial (NCT06452277) is assessing sevabertinib as a first-line treatment option for patients with HER2-mutant NSCLC. Sevabertinib is also being evaluated in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations (excluding advanced NSCLC) in the phase 2 panSOHO study (NCT06760819).
