- The Food and Drug Administration has expanded its approval of Merck & Co's Keytruda, clearing the immunotherapy for first-line use in patients with Stage 3 non-small cell lung cancer (NSCLC) not treatable by surgery or chemoradiation and whose tumors express PD-L1.
- Regulators based their decision on data from the KEYNOTE-042 study, which showed Keytruda monotherapy improved median overall survival by more than four months compared to chemo in NSCLC patients expressing PD-L1 levels greater than 1%. Survival benefit was most pronounced, however, in patients whose tumors had 50% or more cells expressing PD-L1.
- In 2016, Keytruda was the first anti-PD-1 therapy to secure U.S. approval as a first-line treatment for metastatic NSCLC. The immunotherapy is currently under investigation in more than 950 clinical trials across different cancers and lines of therapy.
Approvals for Keytruda (pembrolizumab) in lung cancer continue to pile up. Particularly key to the the drug's growth, however, have been its victories in the first-line setting.
The first such approval came in 2016 for a certain subset of patients who expressed high levels of a biomarker called PD-L1. In 2017, Keytruda in combination with chemotherapy was also OK'd as an initial treatment for all non-squamous NSCLC patients, regardless of PD-L1 expression.
Those regulatory clearances helped Keytruda rake in more than $7 billion last year and surpass Bristol-Myers Squibb's rival immunotherapy Opdivo (nivolumab) in sales.
Until now, AstraZeneca's Imfinzi (durvalumab) has been the only immuno-oncology drug to secure approval for unresectable Stage 3 NSCLC.
Previously, patients whose disease had not progressed following chemoradiation therapy received active surveillance. Imfinzi provided a new option, with a reduction of nearly half in the risk of disease worsening or death compared to placebo.
Keytruda's Stage 3 approval, while adding the drug to the treatment armory, is for a different subgroup: those patients who are not candidates for surgical resection or definitive chemoradiation.
Though Thursday's announcement was a win for Merck, not all Keytruda news this year has been so positive. In February, Merck announced that the drug had failed in a Phase 3 study in advanced liver cancer.