Merck (NYSE:MRK) has announced the results from the ongoing late-stage AMBASSADOR/KEYNOTE-123 study evaluating Keytruda as an adjuvant treatment for patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma (UC).
Data from the study has shown that treatment with Keytruda led to a statistically significant and clinically meaningful improvement in the primary endpoint of disease-free survival (DFS) compared to observation. The safety profile of the drug was consistent with what was reported in previous studies.
The management will continue to assess the study for its other dual primary endpoint, overall survival (OS).
According to the American Cancer Society, UC is the most common type of bladder cancer. Approximately half of bladder cancer patients who undergo surgery experience disease recurrence within a year of the surgery. By introducing Keytruda as an adjuvant therapy, patients with localized MIUC or locally advanced UC now have a new treatment option that has the potential to prevent recurrence after surgery.
Merck’s shares have experienced a 6.6% decrease year-to-date, while the industry has seen a 3.8% growth.
Keytruda has received FDA approval for three indications in UC. In April, Keytruda, in combination with Seagen’s (SGEN) Padcev (enfortumab vedotin), received accelerated approval as a first-line treatment for patients with locally advanced or metastatic UC who are ineligible for cisplatin-containing chemotherapy.
Last month, Merck and Seagen reported positive top-line results from a late-stage study (KEYNOTE-A39/EV-302) on the Keytruda-Padcev combination for the treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Conducted in collaboration with Seagen, the study achieved its co-primary endpoints of overall survival (OS) and progression-free survival (PFS). The Merck/Seagen conducted study aims to serve as a confirmatory study seeking to convert the accelerated approval into a full one.
Keytruda, an anti-PD-1 therapy, stands as Merck’s blockbuster oncology drug and accounts for approximately 40% of MRK’s pharmaceutical sales. Keytruda is currently approved for seven indications in earlier-stage cancers in the United States. Merck’s Keytruda continues to grow and expand into new indications and markets globally.
Keytruda, being the primary revenue generator for Merck, has already received approvals for the treatment of various cancers worldwide. In the first half of 2023, Merck recorded $12.1 billion in sales from Keytruda, marking a 20% year-over-year increase. The drug’s sales benefit from continued strong momentum in metastatic indications and rapid adoption across recent earlier-stage launches. Keytruda’s expansion into new indications and markets globally remains an ongoing growth strategy.
Merck is actively assessing Keytruda across numerous indications, with positive progress. Keytruda is currently undergoing studies for more than 30 types of cancer indications across over 1600 studies, including combination studies. If approved, label expansions for new cancer indications have the potential to significantly boost sales.
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