Boehringer Ingelheim has received fast-track approval from the US Food and Drug Administration (FDA) for its targeted therapy, Hernexeos (zongertinib tablets), to treat non-small cell lung cancer (NSCLC).
This approval succeeds the positive results of the Phase Ib Beamion-LUNG 1 trial (NCT04886804), with the oral tyrosine kinase inhibitor (TKI) demonstrating an objective response rate (ORR) of 75% in patients with HER2-positive NSCLC who had received prior lines of platinum-based chemotherapy. Its FDA approval makes it the first oral treatment for HER2-positive NSCLC.
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Hernexeos also triggered a duration of response (DOR) of more than six months in 58% of the 71 patients previously treated with chemotherapy alone, while 27% of the 34 individuals with prior exposure to chemotherapy and a HER2 targeted therapy experienced a DOR of this length.
Impacting 2%-4% of patients diagnosed with NSCLC, HER2 mutations are associated with poor prognosis and a higher risk of brain metastasis, while treatment options are highly limited in this population.
Due to Hernexeos’ potential to fulfil unmet needs in this indication, the FDA granted Boehringer priority review and breakthrough therapy designation last year.
The therapy’s full approval will likely rely on verification of clinical benefit in a confirmatory trial.
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By GlobalDataDr John Heymach, co-ordinating investigator on the Beamion-LUNG 1 trial and chair of thoracic/head and neck medical oncology at the MD Anderson Cancer Centre, said: “The approval of zongertinib offers an effective and targeted treatment option for patients with HER2-mutant NSCLC in the US that not only elicits a durable response, but also 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.”
HER2-targeted therapy race heats up
Though the current standard of care (SoC) for patients with HER2-mutated NSCLC still revolves around a platinum-based chemotherapy regimen, physicians are increasingly prescribing targeted therapies to improve outcomes.
A notable example of this is AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan), which became the first HER2-targeting therapy to receive approval for NSCLC in 2022.
Following its accelerated FDA approval, the drug has already reached blockbuster status – raking in $4.1bn in 2024 for the company, according to Pharmaceutical Technology’s parent company, GlobalData.
GlobalData predicts that the drug is on track to pull in $14.6bn by 2031, highlighting the lucrative nature of the targeted oncology market.
However, Hernexeos has demonstrated a higher ORR of 75% compared with Enhertu’s 56% in the DESTINY-Lung02 trial. The TKI has also proved efficacious in patients who had previously received treatment with an ADC, suggesting that the TKI could absorb some of Enhertu’s market share.
Looking ahead, the drug may also face competition from other targeted therapies currently in Phase III clinical trials, with GlobalData giving Bayer’s TKI sevabertinib a likelihood of approval (LoA) score of 81% in this indication.
