New Small Cell Lung Cancer Indication for Keytruda
June 18, 2019 – The U.S. FDA has approved a new small cell lung cancer (SCLC) indication for Keytruda® (pembrolizumab), manufactured by Merck. The drug is now indicated as a monotherapy for the treatment of metastatic SCLC in patients who have disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The indication is Keytruda’s first for SCLC.
SCLC accounts for an estimated 10%-15% of all lung cancers. It is generally more aggressive than the more commonly diagnosed non-small cell lung cancer (NSCLC), and has often already metastasized when diagnosed. Five-year survival rates for SCLC are typically poor – just 6% for all SCLC stages combined, according to the American Cancer Society.
In clinical trials, Keytruda achieved a 19% overall response rate (ORR) in patients diagnosed with SCLC. Ninety-four percent of patients who responded to treatment had a duration of response (DOR) of at least six months. The majority (63%) of patients who responded to treatment had a DOR of at least 12 months, and 56% had a DOR of 18 months or longer. Responses ranged from 4.1 months to more than 35 months.
Recommended dosing under the new indication is 200mg administered via intravenous (IV) infusion over the course of 30 minutes every three weeks for a maximum of 24 months, or until disease progression or unacceptable toxicity.
Because the FDA granted accelerated approval to Keytruda for SCLC, continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.