FDA Approves Keytruda (Pembrolizumab)for Advanced Non-Small Cell Lung Cancer
~ Dr. Kumudini Rao
The U.S. Food and Drug Administration granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease has progressed after other treatments and with tumors that express a protein called PD-L1 early October 2015. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.
This implicates better understanding of the molecular basis of cancer and gives us the ability to target specific patients who may be most likely to benefit from this drug.
Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells.
The effectiveness of Keytruda for this use was demonstrated in a subgroup of 61 patients enrolled within a larger multicenter, open-label, multi-part study. The subgroup consisted of patients with advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR). This subgroup also had PD-L1 positive tumors based on the results of the 22C3 pharmDx diagnostic test. Study participants received 10 mg/kg of Keytruda every two or three weeks. The major outcome measure was overall response rate (percentage of patients who experienced complete and partial shrinkage of their tumors). Tumors shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months.
Keytruda was approved last year to treat patients with advanced melanoma following treatment with Ipilimumab and more recently in combination with Ipilimumab for advanced melanoma.
We at Andrews and Patel are well versed using Keytruda in advanced melanoma with good results and look forward to help patients with advanced non-small cell lung cancer