Regulatory Decision Summary for Trodelvy

Authorization was primarily based on a multicentre, open-label, randomized pivotal study ASCENT (IMMU-132-05) in 529 patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who had relapsed after at least two prior chemotherapies for breast cancer (one of which could be in the neoadjuvant or adjuvant setting). Patients were randomized 1:1 to receive Trodelvy 10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21-day treatment cycle (n = 267) or treatment of physician’s choice (TPC) single agent chemotherapy per the authorised labeling (n = 262). Patients were treated until disease progression or unacceptable toxicity. The major efficacy outcome was progression-free survival (PFS). At the date cutoff for the submission, the study demonstrated a statistically significant improvement in PFS in Trodelvy group. The median PFS was 4.8 months for Trodelvy treatment group as compared to 1.7 months for TPC group. There was also a statistically significant improvement in overall survival (OS) in Trodelvy group. The median OS was 11.8 months for Trodelvy group as compared to 6.9 months for TPC group. In the context of the recommended condition of use and the available treatment options, these efficacy results are considered substantial evidence of clinical effectiveness.

The safety of Trodelvy was evaluated in a pooled analysis of 366 patients with mTNBC who received at least one dose of Trodelvy at dose of 10 mg/kg. The most common adverse reactions (incidence >25%) reported in patients receiving Trodelvy were: neutropenia (64.0%), diarrhea (65.1%), nausea (62.4%), fatigue (51.6%), alopecia (46.9%), anemia (39.5%), constipation (37.2%), vomiting (33.3%), and decreased appetite (27.5%). Serious adverse reactions in >1% of patients receiving Trodelvy were febrile neutropenia (5.0%), diarrhea (3.5%), neutropenia (2.7%), pneumonia (2.7%), anemia (1.2%), and abdominal pain (1.2%). Fatal adverse reactions occurred in 0.8% of patients who received Trodelvy, including respiratory failure (0.4%). The safety findings are adequately described in the final approved Product Monograph including the Patient Medication Information.

Trodelvy represents a new treatment option for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior therapies, at least one of them for metastatic disease. Based on the evidence reviewed, the benefit/risk profile is considered favorable for Trodelvy under the recommended condition of use.

The recommended dose of Trodelvy is 10 mg/kg given as an intravenous infusion on days 1 and 9 of a 21 days treatment cycle.

For more information on Health Canadas decision, please view the Summary Basis of Decision.