
Phase 1 Trial Indicates Pembrolizumab Safe in Aggressive Small-Cell Lung Cancer
A small phase 1b trial of pembrolizumab in patients with small-cell lung cancer shows that the immunotherapy drug had a favorable safety profile and demonstrated “promising” antitumor activity.
A small phase 1b trial of pembrolizumab in patients with small-cell lung cancer (SCLC) shows that the immunotherapy drug had a favorable safety profile and demonstrated “promising” antitumor activity.
The results,
“With treatment options for SCLC patients receiving platinum-based therapies becoming limited when their disease progresses, it is imperative to explore new therapy options for this population,” explained senior investigator Janice M. Mehnert, MD,
In the international trial, participants received pembrolizumab every 2 weeks for 2 years or until they experienced disease progression or intolerable toxicity. Investigators measured the primary endpoints of safety, tolerability, and objective response every 8 weeks for the first 6 months of the trial and every 12 weeks after that.
After a median follow-up of 9.8 months, all 24 patients in the trial had experienced adverse events, with the most common being asthenia (n = 7), fatigue (n = 7), and cough (n = 6). Just 2 patients experienced grade 3 to 5 treatment-related adverse events, indicating more severe effects. Of these, 1 patient had high levels of bilirubin, and the other experienced asthenia, grade 5 colitis, and intestinal ischemia.
According to the study authors, these findings were “consistent with the known safety profile in other tumor types.” They also noted that 7 of the patients demonstrated partial tumor response to pembrolizumab and 1 had a complete response, for an objective response rate of 33%.
“These results also show pembrolizumab demonstrates promising anti-tumor activity in SCLC patients who received prior treatment and have a large presence of the PD-L1 protein in their tumor,” summarized Mehnert in the press statement.
As with other immuno-oncology drugs, scientists are now aiming to determine what characteristics or biomarkers make an SCLC patient more likely to respond to pembrolizumab. Other clinical trials are assessing the safety and efficacy of pembrolizumab for SCLC in combination “with other modes of treatment including chemotherapy, radiation and other immunotherapy regimens,” according to the press release.
Meanwhile, pembrolizumab continues to be tested for not only SCLC, but also other types of cancer. This past May,
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