Roche's Phesgo improves convenience, accessibility in HER2-positive breast cancer: oncologists

"No one should die from breast cancer. Our vision is that no one does," Ezat Azem, President of Roche Korea, said in his opening statement during Roche Korea’s press conference on Wednesday.

The press event marked a breakthrough for Roche Korea as they announced the inclusion of Phesgo (trastuzumab, pertuzumab)—a  fixed dose combination of two monoclonal antibodies for the treatment of early and metastatic HER2-positive breast cancer—under Korea’s National Health Insurance (NHI).

The battle against HER2-positive breast cancer, which once struck fear as one of the most daunting diagnoses due to its high recurrence and metastasis rates, has seen significant advancements. 

Initial treatments with taxanes, followed by breakthroughs with Herceptin (trastuzumab) and Perjeta (pertuzumab), have dramatically improved patient outcomes.

Today, patients with HER2-positive breast cancer are seeing median overall survival rates reach five years—an impressive improvement from where things stood just 20 years ago.

"Roche Korea is set to make history as the first to offer a combination of pertuzumab, trastuzumab, and taxane as a first-line treatment for metastatic breast cancer," Professor Im Seock-ah, a breast cancer specialist in the Department of Hemato-Oncology at Seoul National University Hospital, said at the press conference.

Phesgo, a novel treatment that combines trastuzumab and pertuzumab into a single subcutaneous (SC) injection, has been approved by the Ministry of Food and Drug Safety (MFDS) in 2021 as a biobetter for treating HER2-positive early-stage and metastatic breast cancer. Taxane, in combination with trastuzumab plus pertuzumab, is recommended in guidelines as standard first-line treatment.

As of  Aug. 1, Phesgo patients' out-of-pocket costs started to match those of Perjeta. 

Specifically, the cost-sharing rate is set at 30 percent for patients receiving Phesgo alongside chemotherapy as a neoadjuvant therapy for locally advanced or early-stage HER2-positive breast cancer. For those with metastatic or unresectable locally recurrent HER2-positive breast cancer who have not previously received anti-HER2 treatment or chemotherapy, the rate drops to 5 percent when Phesgo is combined with docetaxel.

However, patients with HER2-positive and lymph node-positive breast cancer receiving Phesgo as adjuvant therapy post-surgery will bear the full cost of treatment.

Phesgo includes a loading dose of 1,200 mg of pertuzumab and 600 mg of trastuzumab, followed by maintenance doses of 600 mg of each.

Previously, administering Perjeta and Herceptin required intravenous (IV) access, with infusion times totaling 150 minutes—90 minutes for Perjeta and 60 minutes for Herceptin. "Patients had to remain in the hospital for the entire infusion period, which was both time-consuming and inconvenient," Im said.

Phesgo, however, allows the loading dose to be administered subcutaneously in just eight minutes. Maintenance doses, previously needing 90 minutes, are now delivered in only five minutes, offering a major boost in convenience for patients.

"By reducing administration time from hours to minutes, SC chemotherapy enhances efficiency and patient convenience, aligning with the need for more adaptable healthcare solutions and easing the burden on both patients and healthcare facilities," said Park Yeon-hee, Professor of Hematology and Oncology at Samsung Medical Center.

Park, who highlighted the rapid changes in the clinical trial landscape since the Covid-19 pandemic and the growing trend of decentralized clinical trials (DCTs), introduced Roche's ProHer study, which she is currently leading. 

This study compares patient preferences for Phesgo treatment administered in hospitals versus at home with the support of a visiting nurse for early or locally advanced, inflammatory HER2-positive breast cancer patients. The study aims to transition chemotherapy from hospital to home settings.

Despite the challenges in implementing this trial, Park is optimistic about its potential to advance more efficient, patient-centered healthcare and clinical trial systems in Korea. 

“The Covid-19 pandemic has underscored the uncertainty of hospital visits,” Park said. “It has introduced practices such as home delivery of investigational products and remote patient monitoring, even in regions with strong healthcare systems like Korea. We are entering an era where disruptions to routine hospital visits may become more common, making flexible treatment options increasingly critical.”

In countries like France, Spain, Italy, and the U.K., the SC form of Phesgo supports home-based administration or treatment at smaller local hospitals, advancing decentralized healthcare systems. 

Meanwhile, Phesgo, which has proven beneficial for patients, healthcare facilities, and society, is already covered by health insurance in major countries, including the U.S., France, Germany, Italy, Switzerland, the U.K., and Japan.