Dive Brief:
- 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.
Dive Insight:
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.