Pharma To Date

At the European Society for Medical Oncology (ESMO) 2024 annual meeting, Merck’s Keytruda (pembrolizumab) has demonstrated a significant advancement in the treatment of early-stage triple-negative breast cancer (TNBC). This development follows the drug’s initial FDA approval in 2021, which was based on event-free survival (EFS) rather than overall survival (OS) data.

Significant Survival Benefits

The latest data from the KEYNOTE-522 trial, presented at ESMO, provides a robust validation of Keytruda’s efficacy. The study revealed that the combination of Keytruda with neoadjuvant chemotherapy, followed by continued Keytruda therapy post-surgery, resulted in a 34% reduction in the risk of death compared to chemotherapy alone. At a median follow-up of over six years, the five-year OS rate for patients receiving Keytruda was 86.6%, compared to 81.7% for those receiving only chemotherapy.

Reinforcing Clinical Value

The new overall survival data enhances the clinical value of Keytruda as a perioperative treatment in high-risk, nonmetastatic TNBC. Previously, Keytruda’s approval was based on EFS data, which indicated a 37% reduction in the risk of disease recurrence or progression compared to chemotherapy alone. The current OS data not only supports this benefit but underscores the potential of combining immunotherapy with chemotherapy to improve long-term outcomes.

Comparison with Other Therapies

Keytruda’s positive OS results also place it ahead of competing therapies such as Roche’s Tecentriq (atezolizumab). Tecentriq, tested in the IMpassion030 trial, faced challenges in demonstrating similar efficacy, leading to the discontinuation of the trial. The comparison highlights Keytruda’s promising role in enhancing survival rates for TNBC patients.

Implications for Treatment Paradigms

The emergence of Keytruda’s survival benefit is crucial in the evolving landscape of TNBC treatment. This data may shift treatment paradigms, emphasizing the role of immunotherapy in combination with chemotherapy to achieve more favorable outcomes. As the field advances, continued research and clinical trials will be essential to confirm these findings and refine treatment strategies for early-stage TNBC.

The results from ESMO 2024 reaffirm Keytruda’s pivotal role in improving survival for TNBC patients, marking a significant milestone in oncology care.