Merck Keytruda gets European approval for adjuvant treatment for adults with NSCLC at high risk of recurrence following complete resection and platinum-based chemotherapy

Merck, known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2023 and was based on results from the phase 3 KEYNOTE-091 trial. At a median follow up time of 46.7 months, Keytruda demonstrated a clinically meaningful improvement in disease-free survival (DFS) in patients who received adjuvant chemotherapy, reducing the risk of disease recurrence or death by 24% (HR=0.76 [95% CI, 0.64-0.91]). At an earlier prespecified interim analysis, with a median follow-up of 32.4 months, Keytruda demonstrated a statistically significant and clinically meaningful improvement in DFS in the overall population (HR=0.76 [95% CI, 0.63-0.91]; p=0.0014) compared to placebo in patients with NSCLC who are at high risk of recurrence (stage IB [T2a =4 centimeters]), II or IIIA by American Joint Committee on Cancer seventh edition (AJCC 7th edition).

“In the unfortunate scenario that non-small cell lung cancer recurs after surgery, most patients have to face limited palliative treatment strategies, underscoring the need to improve treatment outcomes for earlier stages of NSCLC,” said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. “This approval of Keytruda marks the first immunotherapy option approved in the EU for patients with non-small cell lung cancer who are at high risk of disease recurrence following surgery and chemotherapy, regardless of PD-L1 expression.”

This approval allows marketing of this Keytruda regimen in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

“Today’s approval demonstrates our continued progress to help more patients living with certain types of lung cancer in Europe, treating them earlier in their disease when it may be the most impactful,” said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. “We are proud that in Europe, Keytruda now has five approved indications in non-small cell lung cancer, in both earlier and advanced stages of disease.”

The approval was based on data from KEYNOTE-091, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, a randomized, Phase 3 trial (ClinicalTrials.gov, NCT02504372) sponsored by Merck and conducted in collaboration with European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP). The study evaluated Keytruda compared to placebo for the adjuvant treatment of patients with NSCLC who are at high risk (stage IB [T2a = 4 centimeters], II or IIIA by AJCC 7th edition) of recurrence following complete resection, regardless of tumor PD-L1 expression status, who may or may not have received adjuvant chemotherapy as recommended by their physician. The dual primary endpoints were DFS in the overall population and in patients whose tumours express PD-L1 (tumour proportion score [TPS] =50%). Disease-free survival is calculated as the time from randomization to the date of disease recurrence, occurrence of second primary lung cancer, occurrence of second malignancy or death from any cause, whichever occurs first.

An additional efficacy outcome was overall survival (OS). Overall survival results were not mature, with only 58% of pre-specified OS events in the overall population.

The study randomized 1,177 patients (1:1) to receive either Keytruda (200 mg intravenously [IV] every three weeks [Q3W] for one year or maximum 18 doses; n=590); or placebo (IV Q3W for one year or maximum 18 doses; n=587). The median number of doses was 17 for Keytruda and 18 for placebo.

Lung cancer is the leading cause of cancer death worldwide. In 2020 alone, there were more than 2.2 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 81% 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. Only 5.8% of people in the U.S. who are eligible were screened for lung cancer in 2021.

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 five 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.

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 has the industry’s largest immuno-oncology clinical research programme. 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.

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