The European Commission has approved a combination of Keytruda (pembrolizumab) plus standard chemotherapy for the initial treatment of metastatic squamous non-small cell lung cancer (NSCLC), Merck (known as MSD outside the U.S. and Canada) announced.
The approval — which makes the combination available in all 28 member nations of the European Union, along with Iceland, Lichtenstein, and Norway — is based on findings from the KEYNOTE-407 Phase 3 trial (NCT02775435), where the combination extended patients’ lives by 4.6 months and delayed disease progression or death by a median of 1.6 months.
“In KEYNOTE-407, first-line treatment with Keytruda in combination with chemotherapy resulted in significant improvements in overall survival for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression,” Luis Paz-Ares, MD, chair of the medical oncology department, Hospital Universitario Doce de Octubre, Madrid, Spain, said in a press release.
“Lung cancer is the leading cause of cancer death in Europe, so this approval marks an important milestone for the patients and families facing this difficult-to-treat type of lung cancer,” he said.
Keytruda is an immune checkpoint inhibitor that binds to the PD-1 receptor on immune cells and prevents the binding of the PD-L1 ligand produced by cancer cells. Cancer cells use this mechanism to evade immune surveillance, and thus, Keytruda is meant to restore a functional immune system that effectively fights cancer.
KEYNOTE-407 recruited 559 squamous NSCLC patients whose disease had spread to distant organs, to determine whether the Keytruda add-on improved the time patients lived without signs of disease worsening and extended their survival.
Participants were randomly assigned Keytruda plus chemotherapy — Paraplatin (carboplatin) and Taxol (paclitaxel) every three weeks, or weekly Abraxane (nab-paclitaxel) — or a placebo plus chemotherapy.
Chemotherapy was given for four three-week cycles, while Keytruda treatment lasted up to 35 cycles.
Researchers found that Keytruda extended the time patients lived without disease worsening from 4.8 months to 6.4 months, representing a 44% reduction in the risk of disease progression or death. Similarly, the treatment lengthened patients’ lives from a median of 11.3 to 15.9 months, with a 36% reduction in the risk of death.
Keytruda also increased the number of patients responding to treatment — 58% versus 38%, as well as the duration of responses — 7.7 months versus 4.8 months.
This benefit was seen across multiple patient subgroups, regardless of PD-L1 status (a biomarker that often predicts responses to Keytruda), site of recruitment, and type of chemotherapy.
The most frequent adverse reactions among Keytruda-treated patients were nausea, anemia, fatigue, constipation, diarrhea, low levels of neutrophils, and low appetite. However, serious side effects were similar in both groups — 67% versus 66%.
In addition to the recently approved indication, Keytruda is also approved in Europe for first-line treatment of NSCLC patients with metastatic non-squamous disease without EGFR or ALK mutations, and for patients with squamous and nonsquamous disease with high PD-L1 levels.
It is also approved for patients with advanced NSCLC whose tumors produce the PD-L1 factor and who have received at least one prior chemotherapy regimen.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?