Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab (Herceptin) for the treatment of patients with HER2-positive breast and metastatic gastric cancers.¹

The biosimilar, known as EG12014, is intended to be administered intravenously at a dose of 150 mg. The indication would cover the same indications as the reference biologic.

The positive opinion was supported by data from a phase 3 study (NCT03433313) that examined EG12014 vs trastuzumab in patients with HER2-positive, early-stage breast cancer. The opinion was also based on findings from a phase 1 trial (NCT03180242) that evaluated EG12014 vs trastuzumab sourced from both the United States and Europe in healthy male volunteers.

Findings showed that the phase 3 study met its primary end point, with EG12014 demonstrating equivalent efficacy compared with trastuzumab regarding pathological complete response (pCR). Safety findings for EG12014 and trastuzumab were also comparable.² The phase 1 study also met its primary end point for bioequivalence between EG12014 and trastuzumab.³

“Breast and gastric cancers are among the most frequently occurring in Europe and combined, are responsible for nearly 200,000 deaths annually,” Pierre Bourdage, chief commercial officer of Sandoz, stated in a news release.¹ “Biosimilars have enormous potential to improve cancer care by substantially increasing access to these critical medicines.”

The phase 3, international, multicenter, randomized, double-blinded study enrolled 807 female patients with early-stage, HER2-positive breast cancer who were randomized in a 1:1 fashion.² All patients received anthracycline-based chemotherapy once every 3 weeks for 12 weeks in cycles 1 to 4, followed by EG12014 or trastuzumab in combination with paclitaxel once every 3 weeks for 12 weeks in cycles 5 to 8.

All patients were scheduled for tumor removal surgery 3 to 6 weeks following the completion of neoadjuvant therapy. Two to 6 weeks after surgery, eligible patients continued with adjuvant EG12014 or trastuzumab for up to 13 cycles. After the final dose of treatment, patients then were observed for 20 weeks as long-term safety follow-up.

The phase 1 study was a double-blind, randomized, 3-arm trial that included 84 healthy male volunteers between 18 and 55 years of age.^3,4 Patients needed to be nonsmokers or ex-smokers, have a body-mass index between 18.5 to 30.0 kg/m², and have a body weight of no more than 105.0 kg.⁴

Patients were randomly assigned to receive EG12014, United States–sourced trastuzumab, or European Union–sourced trastuzumab. All 3 were administered as a single-dose intravenous infusion at 6 mg/kg over 90 minutes. Pharmacokinetics data served as the primary end point of the study.

References

1. Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab. News release. Novartis. September 18, 2023. Accessed September 18, 2023. https://www.novartis.com/news/media-releases/sandoz-receives-positive-chmp-opinion-breast-and-gastric-cancer-biosimilar-trastuzumab
2. Positive phase III clinical results for EirGenix’s proposed trastuzumab biosimilar. News release. EirGenix. March 23, 2021. Accessed September 18, 2023. https://www.eirgenix.com/data-21276
3. EirGenix scores phase I success for its leading biosimilar product EG12014. News release. EirGenix. May 2, 2017. Accessed September 18, 2023. https://www.biospace.com/article/releases/eirgenix-scores-phase-i-success-for-its-leading-biosimilar-product-eg12014-/
4. A pharmacokinetic study comparing EG12014 and Herceptin (trastuzumab) in healthy male volunteers. ClinicalTrials.gov. Updated June 8, 2017. Accessed September 18, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT03180242