RAHWAY, N.J. - Merck & Co., Inc., operating as MSD outside the United States and Canada, has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its cancer drug, KEYTRUDA. This recommendation supports the use of KEYTRUDA in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by KEYTRUDA as a monotherapy for adjuvant treatment, in adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence.
The CHMP opinion is based on the Phase 3 KEYNOTE-671 trial results, which showed significant improvements in overall survival and event-free survival compared to a neoadjuvant placebo plus chemotherapy followed by an adjuvant placebo. The trial included patients with untreated and resectable NSCLC at high risk of recurrence, regardless of tumor PD-L1 expression levels.
The positive CHMP opinion is a pivotal step toward potential marketing authorization in the European Union (EU), with a final decision from the European Commission expected in the first half of 2024. This marks the first time an anti-PD-1/L1 therapy has been recommended for approval in the EU based on positive overall survival results in resectable NSCLC.
Dr. Marjorie Green, senior vice president and head of oncology global clinical development at Merck Research Laboratories, expressed optimism about the CHMP’s recommendation, highlighting it as a step closer to aiding patients with earlier stages of NSCLC in Europe.
In the U.S., KEYTRUDA was approved in October 2023 for a similar indication in patients with resectable NSCLC. Lung cancer remains the leading cause of cancer death worldwide, with NSCLC accounting for approximately 80% of all lung cancer cases. Improvements in survival rates have been attributed to advancements in detection, screening, and new therapies.
Merck is actively engaged in nearly 200 clinical trials evaluating KEYTRUDA across various cancers and treatment settings, underscoring its commitment to advancing lung cancer research. The company's immuno-oncology clinical research program is one of the industry's largest, with over 1,600 trials studying KEYTRUDA's role in cancer treatment.
The information contained in this article is based on a press release statement from Merck & Co., Inc.
InvestingPro Insights
Merck & Co., Inc. (NYSE:MRK), a global healthcare leader, has been making significant strides not only in clinical advancements but also in its financial performance. The company's steadfast commitment to innovation and growth is reflected in its strong financial metrics and strategic market position.
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As Merck continues to advance its portfolio of cancer treatments, such as KEYTRUDA, and receives positive opinions from regulatory bodies, its financial metrics and market position suggest a solid foundation for continued success in the healthcare sector.
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