- The Food and Drug Administration accepted a filing for approval from Merck for a combination therapy consisting of its checkpoint inhibitor Keytruda (pembrolizumab) and chemotherapy.
- Merck is looking for the combination therapy — the first it has filed for Keytruda — to be a first-line treatment for metastatic non-squamous non-small cell lung cancer (NSCLC). The FDA is scheduled to make an approval decision by May 10 since the combination is under priority review.
- The treatment serves patients with the disease regardless of their levels of PD-L1, a protein that can help cancer cells go unnoticed by the body's immune system. It is not, however, for those with certain types of abnormal tumors.
Combination drugs have long been used in cancer therapy. Different drugs have different mechanisms of action and therefore can reduce the risk of resistance developing. Checkpoint inhibitors, including Keytruda and Bristol Myers Squibb's Opdivo, have caught the industry's attention and are expected to drive a big wave of combination therapies.
Keytruda is already available for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression, as well as patients who express PD-L1 and whose tumors have progressed after platinum-containing chemotherapy. If Merck's combination therapy is approved, it would be the first chemotherapy and immuno-oncology combination approved for advanced NSCLC.
“Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” Roger Dansey, head of Merck Research Laboratories' late stage oncology development, said in a Jan. 10 statement.
While Keytruda paired with chemotherapy is the only combination of Merck's blockbuster cancer drug under FDA review, the company is working in the clinic to flesh out more treatment avenues. Earlier this week, the company announced it is advancing a program testing Keytruda with Incyte's epacadostat for NSCLC, as well as bladder cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck.