Advantages of SC HER2 Therapy Over IV Administration in Breast Cancer

EP: 1.Subcutaneous Regimen Shows Noninferiority to Intravenous in HER2+ Breast Cancer

EP: 2.Patients Prefer Subcutaneous Regimen for HER2-Positive Breast Cancer

EP: 3.Subcutaneous Regimen Shows Non-Inferiority for HER2+ Breast Cancer

EP: 4.Pharmacokinetics of Subcutaneous HER2 Therapy Noninferior in BC

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EP: 5.Advantages of SC HER2 Therapy Over IV Administration in Breast Cancer

Rebecca A. Shatsky, MD, associate professor of medicine at UC San Diego School of Medicine, discusses the benefits of a subcutaneous (SC) injection of pertuzumab (Perjeta), trastuzumab (Herceptin), and hyaluronidase-zzfx (Phesgo) compared with intravenous (IV) trastuzumab and pertuzumab for patients with HER2-positive breast cancer.

According to Shatsky, the 5-minute injection of the SC formulation compared with the hours-long IV formulation has allowed for easier treatment and for patients to get back to their daily lives without the same impact as waiting at an infusion center. However, she cautioned that not all patients will want a SC injection over the more common IV treatment. Thus it’s important to consider the patients wants and needs, alongside factors like insurance coverage and efficacy.

The SC formulation was compared with the IV formulation in the randomized, multicenter, open-label phase 3 FeDeriCa study (NCT03493854), which had a primary end point of noninferior pharmacokinetics of the SC formulation. Researchers found that the approved SC loading dose of 1200/600 mg of pertuzumab/trastuzumab with 600 mg of pertuzumab/trastuzumab and 2000 U/mL of recombinant human hyaluronidase given as maintenance therapy for every 3 weeks provided a positive benefit to risk profile comparable with the IV formulation. The study demonstrated that no dose adjustments were necessary for the SC formulation.

At cycle 7 of exposure with the SC formulation, they found a geometric mean ratio of pertuzumab serum trough concentration of the SC vs IV was 1.22 (90% CI, 1.14-1.31). Further, the pathologic complete response rate was similar between the 2 methods at 59.7% in the SC group and 59.5% in the IV group.

TRANSCRIPTION

0:08 | I do also consider chair time, as far as how long infusions are going to take a patient because for a lot of my busy working patients, the idea of having a much shorter chair time is really appealing. So, in the neoadjuvant setting it can really shorten infusion times by hours to give Phesgo instead of IV trastuzumab and pertuzumab.

0:33 | Especially in the adjuvant setting when patients are already done with their neoadjuvant therapy, they've completed their surgery and potentially radiation, and they're really looking to get back to their daily lives, the idea of having a 5-minute injection vs having an hour-long infusion that they need to have a port accessed for and...spend a significant amount more time in our infusion center, are big considerations as well. So I very much discuss the preference of the patient with them to determine which therapy is to be used. Some patients, of course, are not comfortable with the idea of an injection that is given subcutaneously that could have some mild injection site pain, and they just really prefer the IV formulation. But some [patients] are really excited about not having to be in the infusion center as long.