FDA Approves Keytruda as First Immunotherapy for High-Risk Early-Stage Triple-Negative Breast Cancer, Marking Its 30th U.S. Indication

On July 27, 2021, MSD announced that the U.S. FDA approved its blockbuster PD-1 antibody therapy, Keytruda, in combination with chemotherapy as a neoadjuvant treatment prior to surgery, and as a single-agent adjuvant therapy following surgery, for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC). This marks the 30th indication for Keytruda approved in the United States. The press release noted that this Keytruda-based combination regimen is the first immunotherapy approved for the treatment of patients with high-risk, early-stage TNBC.

Notably, MSD also announced positive overall survival (OS) results from a Phase 3 clinical trial evaluating Keytruda in combination with chemotherapy for the treatment of patients with metastatic TNBC. In patients with metastatic TNBC whose tumors express PD-L1 (CPS > 10), Keytruda plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared with chemotherapy alone.

Triple-negative breast cancer is an aggressive subtype of breast cancer characterized by a high risk of disease recurrence within the first five years following diagnosis. Due to the lack of expression of estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (HER2), patients are ineligible for targeted therapies directed against these receptors, resulting in limited treatment options.

This approval is based on the results of KEYNOTE-522, a randomized, double-blind, placebo-controlled phase 3 clinical trial. The trial was conducted in 1,174 newly diagnosed, treatment-naïve patients with high-risk early-stage triple-negative breast cancer (TNBC). The results demonstrated that in patients with previously untreated stage II or stage III TNBC, compared with the same neoadjuvant chemotherapy regimen alone, preoperative administration of Keytruda in combination with chemotherapy followed by continued postoperative monotherapy significantly prolonged event-free survival (EFS), reducing the risk of disease progression by 37% (HR=0.63 [95% CI, 0.48–0.82]; p=0.00031).

Furthermore, based on data from the KEYNOTE-522 trial, the U.S. FDA converted the accelerated approval of Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥ 10) to full approval.

Note: The original text has been abridged.

References:

[1] FDA Approves KEYTRUDA^® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery. Retrieved July 27, 2021, from https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-treatment-of-patients-with-high-risk-early-stage-triple-negative-breast-cancer-in-combination-with-chemotherapy-as-neoadjuvant-treatment-then-continued/

[2] KEYTRUDA Is the First Anti-PD-1 Therapy in Combination With Chemotherapy to Show Statistically Significant OS for This Patient Population. Retrieved July 27, 2021, from https://www.merck.com/news/merck-announces-phase-3-keynote-355-trial-met-primary-endpoint-of-overall-survival-os-in-patients-with-metastatic-triple-negative-breast-cancer-whose-tumors-expressed-pd-l1-cps-%e2%89%a510/

▽Follow 【WuXi KangGermany】WeChat Official Account