Keytruda Fails Lung and Skin Cancer Trials, Halting Expansion

Merck & Co.'s drug Keytruda has encountered setbacks in two recent clinical trials testing its effectiveness as an adjunctive treatment for early-stage lung and skin cancers. According to the company's announcement on Thursday, both trials were halted prematurely based on recommendations from independent data analysts, who concluded that adding Keytruda to standard treatments was unlikely to improve patient survival rates.

These developments are a significant blow to Merck's ambitions to broaden Keytruda's application before its patent expires in 2028. Over more than a decade, Merck has invested $46 billion in the development of Keytruda and plans to allocate an additional $20 billion by 2030, as stated by CEO Robert Davis at the American Society of Clinical Oncology's annual meeting.

Keytruda has been a major success story for Merck, quickly becoming one of the best-selling pharmaceuticals globally, generating $14 billion in sales in the first half of 2024 alone. Initially approved for skin cancer, Keytruda's application has since been extended to over a dozen types of cancer, with lung cancer accounting for a significant portion of its growth. However, its expansion into new indications has faced obstacles in recent years, as clinical trial outcomes have been less favorable.

The latest trials focused on early-stage non-small cell lung cancer and cutaneous squamous cell carcinoma, a type of skin cancer. In the lung cancer study, Keytruda was combined with radiation therapy for patients whose cancer had not spread beyond the lungs or who had localized lymph node involvement and were either ineligible for surgery or opted against it. The results showed that the Keytruda combination did not delay relapse or disease progression nor improve overall survival when compared to radiotherapy and a placebo. Additionally, the combination was associated with more severe side effects, including adverse events leading to death, prompting the decision to terminate the study.

Similarly, in the skin cancer trial, Keytruda was administered to patients after surgery and radiation to evaluate its potential to delay cancer recurrence relative to a placebo. At a preplanned data analysis, Keytruda did not demonstrate a statistically significant improvement in recurrence-free survival. Although overall survival was not a primary endpoint in this interim analysis, preliminary indicators did not suggest a benefit for Keytruda in this secondary measure.

These setbacks come on the heels of other recent failures. Merck ended 2023 with three unsuccessful Keytruda combination trials, including one involving a new type of immunotherapy. Earlier in the year, two combination trials also failed to show benefits for lung and skin cancer patients.

The recent negative outcomes are challenging for Merck as it seeks to extend Keytruda's market presence. Despite these obstacles, Merck remains committed to its extensive research and development efforts for Keytruda, aiming to maximize its therapeutic potential across various cancer types. The company will likely re-evaluate its strategic approach to future clinical trials to mitigate risks and enhance the likelihood of successful outcomes.

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