On October 16, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported 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 (Press release, Merck & Co, OCT 16, 2023, View Source [SID1234636004]).

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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."

About KEYNOTE-091

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 tumors express PD-L1 (tumor 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.

About lung cancer

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.