Subcutaneous Regimen Shows Non-Inferiority for HER2+ 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

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

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

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

Andrew Seidman, MD, medical director of the Bobst International Center at Memorial Sloan Kettering Cancer Center, discusses the FeDeriCa trial (NCT03493854) of intravenous (IV) versus subcutaneous (SC) trastuzumab (Herceptin) and pertuzumab (Perjeta) for neoadjuvant treatment of HER2-positive breast cancer.

The phase 3 FeDeriCa trial randomized 500 patients 1:1 to receive either an IV regimen or the SC regimen, called Phesgo. Patients in the IV arm received 840 mg of pertuzumab plus 8 mg/kg of trastuzumab followed by a maintenance dose of 420 mg of pertuzumab and 6 mg/kg of trastuzumab, while those in the SC arm received a fixed-dose combination of 1200 mg of pertuzumab and 600 mg of trastuzumab in 15 mL, followed by 600 mg of pertuzumab plus 600 mg of trastuzumab maintenance doses in 10 mL. Each arm was administered every 3 weeks along with neoadjuvant chemotherapy.

The primary end point was based on the serum trough levels of pertuzumab at the end of theseventh cycle, according to Seidman. The investigators found the geometric mean ratio of pertuzumab in the SC arm versus the IV arm to be 1.22 (90% CI, 1.14–1.31), meaning Phesgo demonstrated non-inferior efficacy to an IV infusion. The secondary end point of pathological complete response (pCR) rate was 59.7% (95% CI, 53.3%-65.8%) for SC versus 59.5% (95% CI, 53.2%-65.6%) for IV.

TRANSCRIPTION:

0:08 | Cycle 7 trough levels of both trastuzumab and pertuzumab were measured and it was shown that there was noninferiority of the PK of both trastuzumab and pertuzumab. When administered subcutaneously, as compared [with] intravenously, a very important secondary end point was the pCR rate that patients experienced at the time of surgery. And here for Phesgo, it was 59.7%; for IV administration of antibodies, it was 59.5%. So basically, [they were] virtually identical, and certainly [Phesgo] was non-inferior. So that was very supportive of the ultimate approval of this agent as an option for patients with breast cancer.