Boehringer Ingelheim’s Hernexeos (zongertinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat a subset of non-small cell lung cancer (NSCLC) patients.
The kinase inhibitor has been authorised to treat unresectable or metastatic NSCLC in adults whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations and who have previously received systemic therapy.
Approximately 226,650 people are expected to be diagnosed with lung cancer in the US this year, with NSCLC accounting for around 87% of cases. HER2 (ERBB2) mutations affect up to 4% of NSCLC patients and are associated with a poor prognosis and higher incidence of brain metastases.
Boehringer’s Hernexeos is designed to selectively inhibit HER2 (ERBB2) and is now the first orally administered targeted therapy approved by the FDA for this patient population, the company said.
The US regulator’s decision was supported by results from the phase 1b Beamion-LUNG 1 trial, in which Hernexeos demonstrated an objective response rate (ORR) of 75% in patients who had received prior platinum-based chemotherapy but not a HER2-targeted tyrosine kinase inhibitor or antibody-drug conjugate (ADC), with 58% experiencing a duration of response (DOR) of at least six months.
Among a smaller cohort of patients previously treated with platinum-based chemotherapy and a HER2-targeted ADC, ORR was 44% and 27% had a DOR of at least six months.
Coordinating investigator for Beamion-LUNG 1, John Heymach, said: “With the approval of [Hernexeos], we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant NSCLC in the US that not only elicits a durable response but, importantly, has a manageable safety profile.
“In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.”
In line with the FDA’s accelerated approval pathway, continued approval for Hernexeos in this indication may be contingent on the verification of clinical benefit in a confirmatory trial.
Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim, added: “We are grateful to be able to bring forward Hernexeos, which has the potential to reset the benchmark for those living with HER2-mutant advanced NSCLC, a condition associated with a particularly poor prognosis.”