Phesgo
Oncology· 487 cited findings· 1 source document
Company: Roche Holding AG
What the regulatory reviews say
Phesgo is a fixed-dose combination of pertuzumab and trastuzumab for subcutaneous administration. It is indicated for the treatment of HER2-positive early breast cancer and metastatic breast cancer. In the CLEOPATRA trial, pertuzumab demonstrated an overall survival (OS) improvement of 16 months in metastatic breast cancer, with a median OS of 5 years.
Efficacy was also assessed by comparing the geometric mean Cycle 7 pertuzumab Ctrough between the PH FDC SC arm (88.7 µg/mL) and the P+H IV arm (72.4 µg/mL), resulting in a Geometric Mean Ratio (GMR) of 1.22 (90% CI: 1.14, 1.31). The non-inferiority margin for pertuzumab Ctrough was 0.8. Similarly, the GMR of Cycle 7 trastuzumab Ctrough (SC/IV) was 1.33 (90% CI: 1.24, 1.43), with a non-inferiority margin of 0.8. The tpCR rate for Asian patients in the PH FDC SC arm was 60.8%.
Common safety findings included Alopecia (79.0% in PH FDC SC arm vs 73.0% in P+H IV arm), Diarrhoea (61.7% in PH FDC SC arm vs 59.1% in P+H IV arm), and Nausea (61.3% in PH FDC SC arm vs 61.9% in P+H IV arm). The application for Phesgo was submitted on 9 January 2020, with a CHMP positive opinion issued on 12 November 2020.
Key figures — cited to the source page
| OS improvement with pertuzumab in MBC (CLEOPATRA trial) | 16 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.14 |
| Median OS with pertuzumab in MBC (CLEOPATRA trial) | 5 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.14 |
| Geometric mean Cycle 7 pertuzumab Ctrough (PH FDC SC arm) | 88.7 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.41 |
| Geometric mean Cycle 7 pertuzumab Ctrough (P+H IV arm) | 72.4 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.41 |
| GMR of Cycle 7 pertuzumab Ctrough (SC/IV) | 1.22 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.41 |
| Overall incidence of Alopecia in PH FDC SC arm | 79.0 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.86 |
| Overall incidence of Alopecia in P+H IV arm | 73.0 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.86 |
| CHMP positive opinion date | 12 November 2020 | Roche Holding AG — Phesgo EMA EPAR public assessment report, p.11 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.