Onco360® Has Been Selected as a Specialty Pharmacy Partner for HERNEXEOS® (zongertinib)
LOUISVILLE, K.Y., Aug. 20, 2025 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Boehringer Ingelheim for Hernexeos® (Zongertinib). The Food and Drug Administration approved Hernexeos for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TDK) activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.1 This indication received accelerated approval based on the Phase Ib BEAMION LUNG-1 study (NCT04886804) which assessed the efficacy and safety of zongertinib in patients with advanced or metastatic, non-squamous NSCLC with human epidermal growth factor receptor 2 (HER2; also known as ErbB-2 receptor tyrosine kinase 2 [ERBB2]) mutations who had received prior systemic therapy.2 This indication is approved under accelerated approval based on objective response rate and duration of response.
“Through continued innovation and advancement, patients battling HER2-mutant advanced NSCLC who have faced limited treatment options now have access to another therapy that has demonstrated meaningful response rates with a manageable safety profile,” said Ben Fernandez, Chief Commercial Officer. “We are honored to work with the team at Boehringer Ingelheim and serve as a national dispensing pharmacy for Hernexeos, further expanding our portfolio of limited distribution therapies.”
Zongertinib is a kinase inhibitor of human epidermal growth factor receptor 2 (HER2). In vitro, zongertinib inhibited phosphorylation of HER2, downstream signaling of HER2 (phosphorylation of ERK), and proliferation of lung cancer cells harboring HER2 tyrosine kinase domain activating mutations.1 HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases.2
The Phase Ib BEAMION-LUNG 1 trial demonstrated an objective response rate of 75% (N=71), with 6% of patients having a complete response and 69% of patients having a partial response. Duration of response was achieved in 58% of patients (n=53). Overall, the median duration of response was 5.3 months (95% CI, 2.8 to not evaluable).2
Zongertinib demonstrated a manageable safety profile with a 2.9% discontinuation rate. In the pooled safety population, the most common (> 20%) adverse reactions were diarrhea, cough, hepatotoxicity, rash, fatigue, musculoskeletal pain, upper respiratory tract infections, and nausea.1
Please read the full prescribing information for Hernexeos
About Onco360 Oncology Pharmacy
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.fernandez@onco360.com
516-640-1332
References:
1Hernexeos® (Zongertinib) [Package Insert]. Ridgefield, CT. Boehringer Ingelheim. 2025.
2Heymach, John V. et al. Zongertinib in Previously Treated HER2-Mutant Non–Small-Cell Lung Cancer. NEJM, 2025-06, Vol.392 (23), p.2321-2333.
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