Merck’s PD-1 Inhibitor Keytruda Granted FDA Priority Review for Adjuvant Treatment of High-Risk Stage IIB/IIC Melanoma

On August 5, 2021, MSD announced that the U.S. FDA has granted Priority Review designation to the supplemental Biologics License Application (sBLA) for its blockbuster PD-1 antibody therapy, Keytruda, as adjuvant treatment for adult and pediatric (12 years of age and older) patients with stage IIB or IIC melanoma following complete resection. The PDUFA date for this application is December 4, 2021.

This approval is based on the positive results from the Phase 3 clinical trial KEYNOTE-716, which met its primary endpoint of recurrence-free survival (RFS). Interim analysis demonstrated that, compared with placebo, Keytruda monotherapy as adjuvant treatment following surgery in patients with high-risk Stage II melanoma showed a statistically and clinically significant improvement in RFS. Regarding safety, no new safety signals were observed. These results will be presented at an upcoming medical conference.

Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes and enhancing the immune system's ability to detect and combat tumor cells. In the field of skin cancer, Keytruda was first approved in 2014 for the treatment of advanced melanoma. Based on positive results from the phase 3 clinical trial EORTC1325/KEYNOTE-054, Keytruda has been established as an important treatment option for adjuvant therapy following surgical resection in patients with stage III melanoma.

The randomized, double-blind, open-label phase 3 KEYNOTE-716 trial enrolled a total of 954 patients aged 12 years and older with high-risk stage II melanoma who had undergone complete resection. The primary endpoint was recurrence-free survival (RFS), and secondary endpoints included distant metastasis-free survival, overall survival (OS), safety, and quality of life.

Melanoma is the most serious type of skin cancer, a rare yet highly aggressive malignancy. It is characterized by the uncontrolled growth of pigment-producing cells. Melanoma can develop on normal skin or within pre-existing moles. It may present as irregular flat or raised patches on the skin with uneven pigmentation, or as firm black or gray nodules. Over the past few decades, the incidence of melanoma has been steadily increasing, with nearly 325,000 new cases diagnosed worldwide in 2020.

Note: The original text has been abridged.

References:

[1] Merck’s Keytruda^® (pembrolizumab) Significantly Prolonged Recurrence-Free Survival (RFS) Compared to Placebo as Adjuvant Therapy for Patients With Stage II Resected High-Risk Melanoma in Phase 3 KEYNOTE-716 Trial. Retrieved August 5, 2021, from https://www.merck.com/news/mercks-Keytruda-pembrolizumab-significantly-prolonged-recurrence-free-survival-rfs-compared-to-placebo-as-adjuvant-therapy-for-patients-with-stage-ii-resected-high-risk-melanoma-in/

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