PD-1 Inhibitor Keytruda® Combined with Chemotherapy Promising in Lung Cancer Will be Evaluated in Larger Clinical Trials

Posted on June 6th, 2016 by

According to experts at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting in Chicago, new data evaluating Keytruda® (pembrolizumab) in combination with chemotherapy appears promising for the treatment of non-small cell lung cancer (NSCLC). Based on these initial results, two comparative clinical trials have been initiated.

The programmed death (PD-1) inhibitor Keytruda (pembrolizumab) was recently granted approval by the US Food and Drug Administration (FDA) for use in lung cancer, becoming the first PD-1 inhibitor and the second immunotherapy available for treatment of this disease.

PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1, such as Keytruda may enhance the ability of the immune system to fight cancer. In earlier studies Keytruda has demonstrated anticancer activity in lung cancer and has been previously approved for the treatment of advanced melanoma. The FDA’s initial approval of Keytruda was based in part on data from the KEYNOTE-001 trial, which showed that Keytruda alone had an overall response rate of nearly 20% among 495 previously treated and treatment-naive patients with advanced NSCLC and 45.2%, among individuals whose cancers expressed high levels of PD-L1.

Results from a new clinical trial evaluating Keytruda combined with standard treatments in previously untreated patients with NSCLC were reported this week at ASCO. The current study showed overall response rates ranged from 48 to 71 percent in 74 patients who were treated with Keytruda and one of three different chemotherapy regimens.

The highest response rates were observed in a group of 24 patients who received Keytruda in combination with the chemotherapy drugs carboplatin plus pemetrexed. Another group of patients that received Keytruda plus carboplatin and paclitaxel had a 52% response rate.

Based on these findings, Merck has initiated two phase 3 trials in patients with previously untreated NSCLC. KEYNOTE-189 is evaluating the combination of Keytruda plus a platinum/pemetrexed-based chemotherapy regimen in patients with non-squamous NSCLC and KEYNOTE-407 which will study Keytruda combined with carboplatin and paclitaxel or nab-paclitaxel in patients with squamous NSCLC.

Reference:  Gadgeel SM, Stevenson J, Langer C, et al. Pembrolizumab (pembro) plus chemotherapy as front-line therapy for advanced NSCLC: KEYNOTE-021 cohorts A-C. J Clin Oncol 34, 2016 (suppl; abstr 9016).

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Tags: fda, immunotherapy, KEYNOTE-189, keytruda, Lung Cancer, Lung Cancer - Non-Small Cell, News, non-small cell lung cancer, nsclc, PD-1 inhibitor, pembrolizumab

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