Health Canada Approves KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as Neoadjuvant Treatment for Adults with High-Risk Early-Stage Triple-Negative Breast Cancer, Followed by Monotherapy as Adjuvant Treatment Post-Surgery

Compiled by Fan Dongdong

Recently, Merck & Co., Inc. announced that Health Canada has approved the anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemotherapy for adjuvant treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC). Additionally, Keytruda can also be used as a single-agent adjuvant treatment post-surgery.

This approval is based on the results of the Phase III KEYNOTE-522 trial, which showed a statistically significant improvement in event-free survival (EFS) and pathological complete response rate (pCR) after patients received the therapy. This is a Phase III randomized, double-blind clinical trial, recruiting a total of 1,174 patients. The patient inclusion criteria for this study were newly diagnosed, previously untreated high-risk early-stage TNBC patients (tumor size >1 cm but diameter ≤2 cm with lymph node involvement, or tumor size >2 cm regardless of lymph node involvement, regardless of PD-L1 expression).

The primary efficacy outcome measures of the trial are pathological complete response rate (pCR) and event-free survival (EFS). The results of the KEYNOTE-522 trial demonstrated that patients who received Keytruda in combination with chemotherapy and adjuvant treatment with Keytruda after surgery showed statistically significant improvements in pCR and EFS.

It is reported that Keytruda was first approved in Canada in 2015 and currently has indications in multiple disease areas, including advanced renal cell carcinoma, bladder cancer, non-small cell lung cancer, primary mediastinal B-cell lymphoma, classical Hodgkin lymphoma, colorectal cancer, endometrial cancer, esophageal cancer, triple-negative breast cancer, melanoma, and squamous cell carcinoma of the head and neck, among others.

In 2021, more than 28,000 people were diagnosed with breast cancer in Canada, making it one of the most common cancers among Canadian women. Triple-negative breast cancer is an aggressive subtype that tends to grow and spread quickly. Another characteristic of this disease is a higher recurrence rate within the first five years after diagnosis. Many breast cancers have receptors for common treatment targets such as estrogen, progesterone, or HER2, but triple-negative breast cancer tests negative for all three. With fewer treatment options available, patients with this type often face significant treatment challenges.

Reference Source: Health Canada Approves KEYTRUDA® (pembrolizumab) for the Treatment of Adult Patients with High-Risk Early-Stage TNBC in Combination with Chemotherapy as Neoadjuvant Treatment, and Then Continued as Monotherapy as Adjuvant Treatment After Surgery