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Label indication PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: Use in combination with chemotherapy as: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. FDA label
Also known as PH FDC SC, PH, Pertuzumab-Trastuzumab FDC SC, RO7198574, RG6264
Phesgo · 2 trials · 2 indications
To determine the rate of patients with absence of disease progression or death from any cause at 1 year after the treatment initiation with T-DXd followed by PHESGO, as determined locally by the investigator using RECIST v.1.1
To determine the rate of patients alive at 3 years after treatment initiation with T-DXd followed by PHESGO.
| Arm | Type | Description |
|---|---|---|
| Induction Therapy: Phesgo plus Taxane-Based Chemotherapy | OTHER | - |
| Arm A, Maintenance Therapy: Phesgo | ACTIVE_COMPARATOR | - |
| Arm B, Maintenance Therapy: Giredestrant plus Phesgo | EXPERIMENTAL | - |
| T-DXd induction treatment phase followed by PHESGO maintenance treatment phase | EXPERIMENTAL | All patients will receive a 6-cycle induction phase with T-DXd 5.4 mg/kg body weight administered as an intravenous (IV) infusion on day 1 (D1) of each 21-day cycle (Q3W). Participants may continue with PHESGO if T-DXd is discontinued prematurely due to unacceptable toxicity prior to disease progression and following recovering to Grade ≤ 1 toxicity, to Grade 0 in case of ILD/pneumonitis, or to Grade 2 for alopecia/other toxicities not considered a safety risk. If any T-DXd unacceptable toxicity occurs during the first 6 cycles of induction phase with T-DXd, participants may receive taxane-based chemotherapy concomitantly with PHESGO treatment at the discretion of the investigator. During the maintenance phase, all participants will receive PHESGO with a loading dose of 1200 mg pertuzumab/600 mg trastuzumab as a SC injection for 8 minutes on D1 of the first 21-day cycle, and with a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab as a SC Q3W. |
| Name | Type | Description |
|---|---|---|
| Phesgo | DRUG | Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase \[rHuPH20\]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W). |
| Giredestrant | DRUG | A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle. |
| Docetaxel | DRUG | During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Docetaxel will be administered at 75 milligrams per metre squared of body surface area (mg/m2) intravenously over 60 (±10) minutes on Day 1 of each cycle for 4 to 8 cycles (a cycle is 21 days); this dose may be escalated to 100 mg/m2 if the initial dose was well tolerated. |
| Paclitaxel | DRUG | During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Paclitaxel will be administered at 80 milligrams per metre squared of body surface area (mg/m2) intravenously over a minimum of 1 hour on Days 1, 8, and 15 of each cycle for 4 to 8 cycles (a cycle is 21 days); this weekly regimen is considered as one complete cycle whenever 3 weekly doses are given. |
| LHRH Agonist | DRUG | A luteinizing hormone-releasing hormone (LHRH) agonist will be administered every 28 days to pre- and peri-menopausal women and all male participants while receiving giredestrant in Arm B. An LHRH agonist may be administered to male participants and pre- and peri-menopausal female participants receiving tamoxifen in Arm A, and should be administered to those receiving an aromatase inhibitor in Arm A. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information. |
| Optional Endocrine Therapy of Investigator's Choice | DRUG | For participants in Arm A, optional endocrine therapy of investigator's choice is allowed based on the standard of care, and it can include an aromatase inhibitor or tamoxifen with or without an LHRH agonist, or gonadal ablation. The decision to include or exclude this option must be made prior to randomization. |
| Trastuzumab deruxtecan | DRUG | 10 mL type 1 amber borosilicate glass vial sealed with a fluoro-resin laminated butyl rubber stopper, and a polypropylene/aluminium yellow flip-off crimp cap. One vial of powder for concentrate for solution for IV infusion contains 100 mg of T-DXd. The drug product also contains L-histidine, L-histidine hydrochloride monohydrate, Sucrose, and Polysorbate 80. |
| Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection | DRUG | 20 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper sealed with aluminum and covered by a cool green plastic flip-off cap, containing 15 mL solution of 1200 mg of pertuzumab and 600 mg of trastuzumab. |
| Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection | DRUG | 15 mL type I borosilicate glass vial tapered with fluororesin-laminated rubber stopper sealed with aluminum and covered by a cool green plastic flip-off cap, containing 10 mL solution of 600 mg of pertuzumab and 600 mg of trastuzumab. |
Inclusion Criteria: * Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection * At least one measurab...
Phesgo is used to treat HER2-positive breast cancer, including locally advanced or metastatic breast cancer. It is being studied as a maintenance treatment after short induction with T-DXd in HER2-positive unresectable locally recurrent or metastatic breast cancer, and in combination with giredestrant for locally advanced or metastatic disease.
Phesgo targets HER2, a receptor that drives growth in HER2-positive breast cancer. By binding HER2, it aims to block signaling that promotes tumor cell proliferation. The drug is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf, given as a subcutaneous injection.
Phesgo is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical trials evaluating Phesgo in HER2-positive breast cancer, including the Phase 3 heredERA Breast Cancer study.
Phesgo is in Phase 2 and Phase 3 clinical development for HER2-positive breast cancer. It is investigational and has not been approved by the FDA for these uses. The Phase 3 trial is evaluating Phesgo with or without giredestrant in locally advanced or metastatic breast cancer.
Phesgo is being studied in two active trials. NCT06172127 is a Phase 2 trial of Phesgo maintenance after T-DXd short induction in HER2-positive unresectable locally recurrent or metastatic breast cancer, enrolling 165 patients. NCT05296798 is a Phase 3 trial of giredestrant plus Phesgo versus Phesgo in locally advanced or metastatic breast cancer, enrolling 922 patients.