Andrew Seidman, MD, discusses the FeDeriCa trial of intravenous versus subcutaneous trastuzumab and pertuzumab for neoadjuvant treatment of HER2-positive 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.
Key Takeaways From QOL and Use of Steroids With IO-Based RCC Regimens
May 6th 2024During a Case-Based Roundtable® event, Ulka Vaishampayan, MBBS, discussed the safety and quality-of-life data for ipilimumab plus nivolumab in patients with advanced renal cell carcinoma in the second article of a 2-part series.
Read More
Comparing Choices for IO/TKI Combinations in Advanced RCC
May 2nd 2024During a Case-Based Roundtable® event, Shilpa Gupta, MD, led a discussion on the combination of immunotherapy and tyrosine kinase inhibitors for patients with advanced renal cell carcinoma in the second article of a 2-part series.
Read More
SELECT Trial Establishes Lenvatinib’s Role in RAI-Refractory DTC
May 2nd 2024In an interview with Targeted Oncology, Lori J. Wirth, MD, delved into how the data from SELECT signals lenvatinib effectiveness as a frontline therapy for patients with RAI-refractory differentiated thyroid cancer.
Read More