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AACR 2015: Pembrolizumab Safe, With Signs of Clinical Benefit, for Patients With Malignant Pleural Mesothelioma

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Key Points

  • Patients with malignant pleural mesothelioma experienced no unexpected side effects on pembrolizumab, and all adverse events could be managed without discontinuing treatment.
  • The disease-control rate among patients whose disease had progressed after standard therapy or who were unable to receive standard therapy was 76%.
  • There are currently no FDA-approved treatments for malignant pleural mesothelioma that has progressed after standard therapy.

Pembrolizumab (Keytruda) was safe, tolerable, and yielded robust antitumor responses in patients with malignant pleural mesothelioma, according to data from the phase Ib KEYNOTE-028 clinical trial presented at the AACR Annual Meeting 2015, held April 18 to 22 in Philadelphia (Abstract CT103).

“Malignant pleural mesothelioma is a rare form of cancer arising in the outer lining of the lungs and internal chest wall. With a median survival of only about 1 year, there is a clear need for new treatment options,” said Evan W. Alley, MD, PhD, Clinical Associate Professor, Co-Director of the Penn Mesothelioma and Pleural Program, and Chief of the Hematology/Oncology Division at Penn Presbyterian Medical Center.

Study Details

“One of the main goals of our study was to establish whether the PD-1 inhibitor pembrolizumab was safe and tolerable for patients with this disease,” continued Dr. Alley. “None of our patients experienced any unexpected side effects, and all adverse events could be managed without discontinuing treatment, so the primary study endpoints of safety and tolerability were met.”

“Our preliminary analysis shows signs of clinical benefit,” he added. “We don’t have survival data yet, but the 76% disease-control rate that we observed among patients with advanced malignant pleural mesothelioma who had disease that had progressed after standard therapy or who were unable to receive standard therapy is very promising. There are no U.S. Food and Drug Administration (FDA)-approved treatments for malignant pleural mesothelioma that has progressed after standard therapy, and response rates to second-line chemotherapy are usually less than 10%.”

KEYNOTE-028 is a phase Ib clinical trial that is evaluating pembrolizumab as a potential treatment for a variety of advanced solid tumors. Only patients who have tumors that are positive for the protein PD-L1 are eligible for enrollment in the trial. According to Dr. Alley, these data on the malignant pleural mesothelioma patient cohort are the first results of KEYNOTE-028 to be reported.

The preliminary data showed that among the 25 patients with malignant pleural mesothelioma who screened positive for PD-L1 and who were assigned pembrolizumab, 7 experienced a partial response and 12 had stable disease. At the time of analysis, 2 patients had not been assessed for response, and 13 patients were still receiving pembrolizumab through the trial.

This study was funded by Merck.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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