Merck announced that new data from the company’s anti-PD-1 cancer drug Keytruda (pembrolizumab) will be presented at the upcoming 17th World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer, Dec. 4-7 in Vienna, Austria.
The seven abstracts selected for oral presentation will feature data of Keytruda in patients with intrathoracic malignancies, including small cell lung cancer, non-small cell lung cancer, and malignant pleural mesothelioma (MPM).
“Based on the meaningful results already obtained in studies evaluating the use of Keytruda in certain patients with PD-L1 positive non-small cell lung cancer, we have asked whether similar benefits might be associated with Keytruda use in treating other intrathoracic malignancies, including small cell lung cancer and malignant pleural mesothelioma,” Dr. Roger M. Perlmutter, president of Merck Research Laboratories, said in a news release. “We look forward to sharing our recent findings with the scientific community as we seek to help patients facing these difficult diseases.”
For malignant mesothelioma, the oral presentation “Long-Term Overall Survival for Patients with Malignant Pleural Mesothelioma on Pembrolizumab Enrolled in KEYNOTE-028” will be given by Evan W. Alley, MD, on Dec. 6.
The open-label, nonrandomized, multi-cohort, Phase 1 KEYNOTE-028 trial (NCT02054806) was designed to assess the effectiveness of Keytruda in patients with PD-L1-positive advanced solid tumors. The trial enrolled 25 patients with MPM who were treated with Keytruda (10 mg per kg body weight every two weeks) for up to two years or until disease progression or intolerable toxicity.
The study’s primary endpoint was objective response rate (ORR), with patients’ response having been assessed every eight weeks for the first six months and then every 12 weeks. Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and tolerability.
After a median follow-up of 18.7 months, 28 percent of patients responded to treatment, and 12 achieved stable disease, resulting in a disease control rate of 76 percent. The median duration of response to Keytruda was 9.2 months and median PFS was 5.8 months. Six-month and one-year PFS were 50 percent and 25 percent, respectively.
Importantly, median OS in this patient cohort was 18 months, with six-month and one-year OS rates of 83.5 percent and 62.6 percent. Given that only 40 percent of mesothelioma patients live for a year or longer after diagnosis with current therapies, Keytruda looks very promising for these patients, and the research warrants further studies investigating Keytruda in MPM patients.
Keytruda also showed a promising safety profile. Sixty-four percent of patients experienced a drug-related adverse event, and 20 percent experienced grade 3 or grade 4 adverse events, but there were no deaths or patients discontinuing therapy due to drug-related adverse events. Three patients had to interrupt treatment due to immune-related adverse events. This suggests that long-term administration of Keytruda is feasible in MPM patients.