• 26 Feb 2024
• Admin
• News Article

Ema Recommends Merck’s Keytruda Combo with Chemotherapy

EMA committee recommends approval of Merck Keytruda in combo with chemotherapy for certain non-small cell lung carcinoma

Merck, known as MSD outside of the United States and Canada, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a monotherapy as adjuvant treatment, for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

About KEYNOTE-671

• The recommendation is based on results from the phase 3 KEYNOTE-671 trial, in which neoadjuvant Keytruda plus chemotherapy followed by adjuvant Keytruda as a single agent after surgical resection demonstrated statistically significant and clinically meaningful improvements in overall survival and event-free survival, the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients. 
• Key eligibility criteria for KEYNOTE-671 included: patients with previously untreated and resectable NSCLC at high risk of recurrence (stage II, IIIA, or IIIB [N2] by American Joint Committee on Cancer eighth edition), regardless of tumour PD-L1 expression. 
• The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and a final decision is expected in the first half of 2024.

Positive Sign for Cancer Patients (Europe)

• The CHMP’s positive opinion puts us another step closer to helping certain patients in Europe with earlier stages of non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. 
• We look forward to the European Commission’s decision, as we continue to build on the legacy of Keytruda in certain types of lung cancer and pursue meaningful advances that may help extend the lives of patients.

US Approval

In October 2023, Keytruda was approved in the US for the treatment of patients with resectable (tumours =4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

Lung Cancer: Epidemiology

• Lung cancer is the leading cause of cancer death worldwide. 
• In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. 
• Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. 
• In recent decades, the overall five-year survival rate for patients diagnosed with lung cancer increased from 11% to 15% on average across

EU Countries

• Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. 
• Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.

Merck on Lung Cancer

• Merck is advancing research aimed at transforming the way lung cancer is treated, with a goal of improving outcomes for patients affected by this deadly disease. 
• Through nearly 200 clinical trials evaluating more than 36,000 patients around the world, Merck is at the forefront of lung cancer research. 
• In NSCLC, Keytruda has six approved US indications and is approved for advanced disease in more than 95 countries. 
• Among Merck’s research efforts are trials focused on evaluating Keytruda in earlier stages of lung cancer as well as identifying new combinations and coformulations with Keytruda.
• Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. 
• Building on the strong understanding of the role of Keytruda in later-stage cancers, Merck is studying Keytruda in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

About Keytruda

• Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. 
• 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 which may affect both tumour cells and healthy cells.

Merck’s Clinical Program

• Merck has the industry’s largest immuno-oncology clinical research program. 
• There are currently more than 1,600 trials studying Keytruda across a wide variety of cancers and treatment settings. 
• The Keytruda clinical programme seeks to understand the role of Keytruda across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.