European Commission approves Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for people with HER2-positive breast cancer - Seite 3

About Phesgo
Phesgo combines the same monoclonal antibodies as Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze drug delivery technology in a novel formulation for subcutaneous (SC) use.^4,11  This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.

Halozyme’s Enhanze drug delivery technology may enable and optimise SC drug delivery for appropriate co-administered therapeutics. The technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – to aid in the dispersion and absorption of other injected therapeutic drugs.¹¹

Pertuzumab in Phesgo is the same monoclonal antibody as in intravenous (IV) Perjeta, and trastuzumab in Phesgo is the same monoclonal antibody as in IV Herceptin. The mechanisms of action of Perjeta and Herceptin are believed to complement each other as both bind to the HER2 receptor, but in different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of the HER signalling pathways.^12,13

Phesgo is approved in the US for the treatment of early and metastatic HER2-positive breast cancer. The approved indications for Phesgo mirror those of Perjeta.

The standard IV formulation of Perjeta in combination with IV Herceptin and chemotherapy (the Perjeta-based regimen) is approved in more than 100 countries for the treatment of both early and metastatic HER2-positive breast cancer. In the neoadjuvant (before surgery) early breast cancer (eBC) setting, the Perjeta-based regimen has been shown to almost double the rate of pathological complete response compared to Herceptin and chemotherapy.¹⁴ Additionally, the combination has been shown to significantly reduce the risk of recurrence of invasive disease or death in the adjuvant (after surgery) eBC setting.¹⁵ In the metastatic setting, the combination has shown an unprecedented survival benefit in previously untreated (first-line) patients with HER2-positive metastatic breast cancer.¹⁶


About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for more than 30 years and is committed to improving the health, quality of life and survival of people with both early and metastatic HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 25-30% of patients.¹⁷ Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin, Perjeta and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test which identifies people who will likely benefit from these medicines at the onset of their disease.