Roche Bags EU Nod for a Novel Delivery Method in Breast Cancer Treatment

On December 23rd, Roche announced that it had received approval for the usage of Phesgo, a therapy containing two monoclonal antibodies against the human epidermal growth factor receptor 2 (HER2) and hyaluronidase. Phesgo uses Halozyme Therapeutics’ Enhanze drug delivery technology, which allows for delivering the treatment via subcutaneous injection. This technology successfully reduced the time of administration of the same monoclonal antibody therapies from more than 2 hours to an average of 8 minutes while still maintaining efficacy.

In 2020, it is predicted that almost 280,000 women and almost 3,000 men will be diagnosed with breast cancer. During that same time, more than 40,000 people will succumb to the disease. Approximately 20% of all breast cancer are characterized as “HER2-positive”. The HER2 receptor contributes to tumor growth and can be targeted for treatment.

Two of the treatments currently used for the treatment of HER2-positive breast cancer are Perjeta and Herceptin. Both treatments contain monoclonal antibodies that target different sites of the HER2 receptor. The current standard of care consists of an intravenous injection of a combination of both Perjeta and Herceptin. In early breast cancer, Perjeta and Herceptin treatment significantly reduce the risk of recurrence of invasive disease and death. For patients with metastatic HER2-positive breast cancer, this combination provides significant survival benefits. However, the delivery of the treatment takes approximately 150 minutes for a loading dose and between 60-150 minutes for subsequent infusions. The long times contribute to an increase in healthcare costs and are disruptive for the daily lives of patients. For these reasons, faster delivery methods would be beneficial for patients.

Phesgo and the FeDeriCa Study

Phesgo contains pertuzumab and trastuzumab, the same HER2 targeting monoclonal antibodies found in Perjeta and Herceptin, respectively. Besides, Phesgo contains a recombinant human hyaluronidase enzyme, developed by Halozyme, which aids in the dispersion and absorbance of the treatment. The approval of Phesgo in the EU comes after its approval in the US in June this year.

These approvals are based on the results from an international, multicenter, two-arm, randomized, open-labeled, Phase 3 clinical trial known as the FeDeriCa study. The goal of the study was to determine the levels of antibodies circulating in the blood, as well as the safety and efficacy of Phesgo. Results showed that subcutaneous delivery resulted in comparable (non-inferior) levels of the monoclonal antibodies in the blood when compared to the normal intravenous delivery. Additionally, administration of Phesgo took only 8 minutes for the initial dose and around 5 minutes for the subsequent doses. This is 90% faster than the intravenous injection. More importantly, the efficacy of the treatments was comparable between the two treatments.

“This approval represents a significant step forward in the treatment of HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The innovation of Phesgo significantly reduces the time people spend receiving standard of care therapy with Perjeta and Herceptin, helping to minimize the impact of treatment on their everyday lives. It also addresses the increasing demand across healthcare systems for faster and more flexible treatment solutions.”

By Daniel Ojeda, Ph.D.

Related Article: Roche’s Cobas PIK3CA Mutation Test – A Blessing for Breast Cancer Patients

References

1. https://www.roche.com/media/releases/med-cor-2020-12-23.htm
2. https://www.halozyme.com/investors/news-releases/news-release-details/2020/Halozyme-Announces-Roche-Receives-European-Commission-Approval-For-Phesgo-Fixed-Dose-Combination-Of-Perjeta-And-Herceptin-For-Subcutaneous-Injection-Utilizing-Halozymes-ENHANZE-Technology-For-The-Treatment-Of-Patients-With-HER2-Positive-Breast-Cancer/default.aspx
3. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf
4. https://www.cancer.net/cancer-types/breast-cancer/introduction
5. https://www.fda.gov/news-events/press-announcements/fda-approves-breast-cancer-treatment-can-be-administered-home-health-care-professional

Author

Daniel Ojeda