Herceptin HYLECTA was approved based on two Phase 3 clinical studies in HER2+ EBC: HannaH (non-inferiority study versus IV trastuzumab based on co-primary PK and efficacy endpoints) and SafeHER (safety and tolerability study).1

*In the PrefHER study, 86% (199/231) of patients preferred administration of Herceptin HYLECTA over IV trastuzumab. See data below.
EBC=early breast cancer; HER2=human epidermal growth factor receptor 2; IV=intravenous; pCR=pathological complete response; PK=pharmacokinetics.

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HannaH study1

  • In the randomized open-label HannaH trial, 596 patients with HER2+ EBC (operable or locally advanced breast cancer, including inflammatory breast cancer) received 8 cycles of either Herceptin HYLECTA or IV trastuzumab concurrently with chemotherapy, followed by surgery and continued therapy with either Herceptin HYLECTA or IV trastuzumab, as treated prior to surgery for an additional 10 cycles
  • HannaH demonstrated non-inferiority between Herceptin HYLECTA and IV trastuzumab based on co-primary endpoints of pCR and PK
    • pCR was observed in 118 patients (45.4%) on the Herceptin HYLECTA arm and in 107 patients (40.7%) receiving IV trastuzumab (95% Cl for difference in pCR: -4.0; 13.4)
    • Ctrough predose Cycle 8, showed non-inferiority of Herceptin HYLECTA (78. 7 mcg/mL) compared to IV trastuzumab (57.8 mcg/ml), with a geometric mean ratio of 1.3 (90% Cl: 1.2-1.4)
  • The most common adverse reactions of any grade (occurring in ≥10% of patients) with Herceptin HYLECTA were alopecia, nausea, administration-related reactions, neutropenia, diarrhea, asthenia, fatigue, vomiting, myalgia, decreased appetite, stomatitis, arthralgia, headache, rash, constipation, radiation skin injury, pyrexia, cough, anemia, dyspnea, incision site pain, peripheral sensory neuropathy, leukopenia, mucosal inflammation, hot flush, and upper respiratory tract infection

SafeHER study1

  • SafeHER was a prospective, two-cohort, non-randomized, multinational, open-label trial assessing the overall safety and tolerability of Herceptin HYLECTA with chemotherapy in 1,864 patients with HER2+ breast cancer. Patients received a fixed dose of 600 mg/10,000 units Herceptin HYLECTA every 3 weeks for 18 cycles
  • The most common adverse reactions of Herceptin HYLECTA observed in at least 10% of patients were fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity

Patients preferred Herceptin HYLECTA administration over IV trastuzumab1

The PrefHER study was a randomized, cross-over trial conducted in 240 patients with HER2+ EBC undergoing neoadjuvant or adjuvant treatment. 121 patients in arm A received 4 cycles of Herceptin HYLECTA followed by 4 cycles of IV trastuzumab and 119 patients in arm B received 4 cycles of IV trastuzumab followed by 4 cycles of Herceptin HYLECTA. Both arms received a total of 18 cycles. After Cycle 8, 231 patients were surveyed about their preferred route of administration.

  • 86% (n=199) preferred Herceptin HYLECTA
  • 13% (n=29) preferred IV trastuzumab
  • 1% (n=3) had no preference
  • Most common reason cited for preference of Herceptin HYLECTA1
    • 77% (179/231) of patients reported that subcutaneous administration required less time (~2-5 minutes)
  • Most common reason cited for preference of IV trastuzumab1
    • 13% (29/231) of patients reported fewer local injection reactions with IV administration
  • 3.8% (9/231) of patients withdrew from treatment prior to completion and did not complete the post-study preference questionnaire 1

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