‘Caution over safety’: Adding concurrent pembrolizumab to CRT
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Patients with resectable stage IIIA non-small cell lung cancer treated with concurrent pembrolizumab plus neoadjuvant concurrent chemoradiation had high pathologic complete response rate at resection, however safety is a concern, according to data presented at the virtual ASCO Annual Meeting.
“When we designed the trial, there wasn’t a whole lot of evidence of either safety or efficacy of combining immune checkpoints inhibitors with chemotherapy and radiation, and nothing related to surgery, for stage III disease,” Nathan A. Pennell, MD, PhD, medical oncologist at the Cleveland Clinic and associate professor medical oncology at the Cleveland Clinic Lerner College, told Healio. “Our trial is supportive of other studies combining chemotherapy and/or radiation with immune checkpoints inhibitors.”
A thoracic surgeon determined that nine patients were resectable. These patients received neoadjuvant concurrent chemoradiation (CRT), which included cisplatin, etoposide and 200 mg of concurrent pembrolizumab every 3 weeks, with 45 Gy in 25 fractions. Following this, patients without progression underwent resection and received consolidation pembrolizumab (Keytruda, Merck) for 6 months.
“There was a high complete pathologic response rate in our limited number of patients who underwent resection,” Pennell said.
The pathologic complete response (pCR) rate was 67% for the six patients who underwent resection, according to the abstract.
“This is very supportive and a promising idea to combine this, but the second major message is that this is not a trivial treatment in terms of risk and toxicity for these patients,” Pennell said.
All nine patients included in the study reported serious adverse events, including two grade 5 events. Despite the still unknown relationship between the grade 5 events and concurrent pembrolizumab, the trial was halted because the stopping rule for infeasibility was met and other, larger trials are underway.
“Caution over safety, that’s the main message,” Pennell said.
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Lemmon C, et al. Abstract 9009. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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