Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing firstname.lastname@example.org or calling +44 (0)1707 367554.
PHESGO safety profile – FeDeriCa study
- The safety profile of PHESGO vs PERJETA IV and trastuzumab IV was investigated during the Phase 3 FeDeriCa study1
- PHESGO has a safety profile which was consistent with that of PERJETA IV and trastuzumab IV1,2
Adapted from Tan et al. 2021 (Supplementary Appendix).
*Death was unrelated to HER2 treatment. The cause of death was reported as urosepsis.
†The cause of death was reported as acute myocardial infarction and occurred prior to the start of anti-HER2 treatment with PHESGO.
Most common adverse events (AEs)¹
- Most common AEs (occurring in >30% of patients) were balanced between the two treatment arms
Adapted from Tan et al. 2021.
*Multiple occurrences of the same AE in an individual are counted only once.
Injection site reactions (ISRs)
- The only additional AE associated with PHESGO was ISRs (14.9% vs 0.4% with PERJETA IV and trastuzumab IV)
• All ISRs were grade 1–2 in severity
• Most ISRs were either injection site pain or injection site erythema
- Severe hypersensitivity reactions, including anaphylaxis have been observed with IV PERJETA plus trastuzumab and chemotherapy
• The majority of anaphylactic reactions occurred within the first 6-8 cycles of treatment
- Overall, there was no meaningful difference in cardiac safety between treatment arms1,2
Adapted from Tan et al. 2021 and Tan et al. 2021 (Supplementary Appendix).
*Significant LVEF decline defined as a drop in LVEF of ≥10 percentage points from baseline and to <50%.
†Secondary cardiac events defined as asymptomatic or mildly symptomatic significant LVEF declines by initial assessment or confirmed by second assessment.
‡The event resolved.
§One cardiac death occurred prior to start of anti-HER2 treatment.
Observing and managing left ventricular dysfunction4
- Assess LVEF prior to initiation of PHESGO and at regular intervals during treatment (e.g. once during neoadjuvant treatment and every 12 weeks in the adjuvant and metastatic setting) to ensure that LVEF is maintained within normal limits
• If the LVEF has declined and has not improved, or has declined further at the subsequent assessment, and/or the patient is symptomatic, permanently discontinue PHESGO
Adapted from PHESGO Summary of Product Characteristics
*For patients receiving anthracycline-based chemotherapy, an LVEF of ≥50% is required after completion of anthracyclines before starting PHESGO.
PHranceSCa study design³
- PHranceSCa was a multicentre, open-label, randomised, Phase 2 crossover study conducted to assess preferences for adjuvant treatment with subcutaneous PHESGO vs PERJETA IV plus trastuzumab IV in 160 patients with HER2-positive eBC
Adapted from O’Shaughnessy J et al. 2021.
*pCR was defined as absence of invasive tumour residues in the breast and lymph nodes.
Safety during crossover period³
- AE rates before and after switching between IV PERJETA plus trastuzumab and PHESGO were similar and did not reveal any new or clinically relevant safety concerns compared with the overall analysis from the PHranceSCa study
Adapted from O’Shaughnessy J et al. 2021.
Multiple occurrences of the same event in one individual were counted only once except for the ‘Total number of AEs’ in which multiple occurrences of the same event were counted separately.
ADR, adverse drug reaction; AE, adverse event; eBC, early breast cancer; HCP, healthcare professional; HER2, human epidermal growth factor receptor 2; HRQoL, health-related quality of life; ISRs, injection site reactions; IV, intravenous; LVEF, left ventricular ejection fraction; mBC, metastatic breast cancer; MedDRA, Medical Dictionary for Regulatory Activities; NYHA, New York Heart Association; pCR, pathological complete response; q3w, every 3 weeks; SC, subcutaneous.
- Tan AR et al. Lancet Oncol. 2021;22(1):85–97.
- Tan AR et al. Lancet Oncol. 2021;S1470–2045 (Supplementary Appendix).
- O'Shaughnessy et al. European Journal of Cancer. 2021;152:223–232.
- PHESGO Summary of Product Characteristics.
Date of preparation: September 2021