Phase 3 trials of pembrolizumab plus lenvatinib in metastatic NSCLC miss primary endpoints
Click Here to Manage Email Alerts
Two phase 3 trials evaluating a regimen containing pembrolizumab plus lenvatinib for treatment of metastatic non-small cell lung cancer failed to meet their primary endpoints, according to the manufacturers of each agent.
Final analysis results from the phase 3 LEAP-006 trial showed that first-line treatment combining the PD-1 inhibitor pembrolizumab (Keytruda, Merck) plus lenvatinib (Lenvima, Eisai) — a multiple receptor tyrosine kinase inhibitor — with pemetrexed and platinum-containing chemotherapy failed to meet the study’s dual primary endpoint for improvement of OS and PFS.
The trial evaluated the regimen compared with standard therapy in adults with metastatic, nonsquamous NSCLC who are not candidates for targeted treatment, including epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)- or c-ros oncogene 1 (ROS1)-directed therapies.
Likewise, a final analysis from the phase 3 LEAP-008 trial showed the study failed to meet its dual primary endpoints for improvement of OS and PFS. The study evaluated pembrolizumab plus lenvatinib vs. docetaxel — the current standard care regimen — as second-line therapy for adults with metastatic NSCLC who experienced disease progression while or after receiving platinum-containing chemotherapy and one prior anti-PD-1/PD-L1 immunotherapy and were ineligible for EGFR-, ALK- or ROS1-directed therapies.
“As a leader in lung cancer research, we continue to try to advance science for our patients by building upon the standard we set several years ago with Keytruda,” said Gregory M. Lubiniecki, MD, vice president of global clinical development at Merck Research Laboratories, said in a joint Merck/Eisai-issued press release. “While these results are not what we hoped for, we are proud of the foundational role that Keytruda has established in the treatment of certain types of lung cancer, and we are committed to continuing to research how we can further improve responses to our medicines for patients with difficult-to-treat forms of the disease.”
The manufacturers said they would work with study investigators to make data from the study available to the scientific research community.
“Results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the Keytruda plus Lenvima combination or other ongoing trials from the LEAP clinical program,” the manufacturers said in the release.
The combination of pembrolizumab plus lenvatinib is currently approved in the U.S. for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma.
Read more about
Click Here to Manage Email Alerts