Sandoz Enters Licensing Agreement for Trastuzumab Biosimilar

Stefan Hendriks

Stefan Hendriks

Sandoz has entered into an agreement with EirGenix, Inc., to commercialize the proposed trastuzumab (Herceptin) biosimilar EG12014 for use as a treatment of patients with HER2-positive breast and select gastric cancers.¹

EG12014 is currently being explored in a phase III trial (NCT03433313) that is evaluating the efficacy and safety of the biosimilar compared with trastuzumab in patients with HER2-positive early breast cancer.

EirGenix, a biotechnology manufacturing and development company, will be responsible for the development and manufacturing of the biosimilar, Sandoz stated in a press release. Sandoz will then be able to commercialize the agent following regulatory approval in all markets, not including China or Taiwan.

"Every year, approximately 300,000 people worldwide are diagnosed with HER2-positive breast cancer, which tends to spread more quickly than HER2-negative tumors, making swift treatment important,” Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz, said in the press release. “While targeted therapy is available, high out-of-pocket costs lead to limited treatment in the [United States] and reimbursement issues have resulted in varying uptake in Europe. Introducing biosimilars can help create earlier and expanded access to this important medicine, which is why I am so excited about the potential for this collaboration."

EirGenix will receive an upfront payment on signing, milestone payments, and will be permitted to receive profit share payments for sales in these territories as part of the agreement.

The agreement with EirGenix adds to Sandoz’s existing oncology pipeline, which currently comprises 4 oncology biosimilars: the epoetin alfa biosimilar Binocrit, the filgrastim (Neupogen) biosimilar Zarzio/Zarxio, the pegfilgrastim (Neulasta) biosimilar Ziextenzo, and the rituximab (Rituxan) biosimilar Rixathon.

In the international, multicenter, double-blind phase III trial of EG12014, 800 patients will be randomized to receive the biosimilar or trastuzumab with anthracycline/paclitaxel chemotherapy as a neoadjuvant regimen for 12 weeks, followed by surgery and then adjuvant treatment with EG12014 or trastuzumab for up to 1 year. The dosage in both arms is 6 mg/kg after an 8-mg/kg loading dose.

The primary endpoint of the trial, which is currently recruiting, is determination of pathologic complete response (pCR) at time of surgery. Secondary endpoints include pCR at time of surgery, event-free survival up to end of study, overall response prior to surgery, overall survival up to end of study, incidence of adverse events, immunogenicity of EG12014 and trastuzumab, and measure serum trastuzumab concentration at various time points during the study.

To be eligible for enrollment, female patients must be between the ages of 18 and 65 years, have histologically confirmed invasive carcinoma of the breast that is HER2 positive, operable breast cancer with planned surgical resection, an ipsilateral measurable breast tumor that is ≥2 cm in diameter, have known estrogen receptor and progesterone receptor status at study entry, an international normalized ratio ≤1.5 x upper limit of normal (ULN) or prothrombin time ≤1.5xULN, hemoglobin concentrations within normal ranges, an ECOG performance status of 0 or 1, a left ventricular ejection fraction ≥55%, not be pregnant, and have adequate bone marrow, hepatic, and renal function.

Patients with bilateral breast cancer, are pregnant, have metastases beyond sentinel/axillary lymph nodes, received prior treatment for invasive malignant disease, had other serious illnesses or medical disorders, had received prior trastuzumab therapy, numerous cardiologic disorders, investigational therapy <30 days prior to study entry, have a history of hypersensitivity to study treatment or similar treatment, a history of drug and alcohol abuse, or be positive for hepatitis B, hepatitis C, or HIV virus, were excluded.

Phase I findings of EG12014 previously demonstrated bioequivalence with trastuzumab from the United States and the European Union following data unblinding.² In the double-blind, parallel group, 3-arm phase I trial (EGC001; NCT03180242), investigators evaluated the pharmacokinetic similarity between the biosimilar and trastuzumab in 84 healthy male patients.

References

1. Sandoz Enters Agreement for Proposed Trastuzumab Biosimilar, Currently in Phase III Development, to Treat Selected HER2-Positive Cancer Tumors. Novartis. Published April 30, 2019. https://bit.ly/2XWwayU. Accessed April 30, 2019.
2. EirGenix Scores Phase I Success For Its Leading Biosimilar Product EG12014. EirGenix. Published May 4, 2017. https://bit.ly/2IQTYRk. Accessed April 30, 2019.