medwireNews: Adding pembrolizumab to docetaxel may delay disease progression in immunotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC) who progress after platinum-based chemotherapy, phase 2 study data show.
The immunotherapy–chemotherapy combination was well tolerated and was associated with an improved response rate relative to chemotherapy alone, irrespective of EGFR variation status, Oscar Arrieta (National Cancer Institute, Mexico City) and co-authors report in JAMA Oncology.
They say their research highlights “the potential role for this therapeutic combination in the second-line setting and warrants the design of larger, phase 3 trials that use immunotherapy as the control.”
The PROLUNG trial included 78 patients (41% men, 44% never smokers) with advanced NSCLC who were randomly assigned to receive docetaxel 75 mg/m2 on day 1 of each 3-week cycle as monotherapy (n=38) or in combination with pembrolizumab 200 mg on day 8 of each 3-week cycle (n=40) for a maximum of six cycles.
After a median 8.9 months of follow-up, the overall response rate (ORR) by independent review was 42.5% among the patients who received pembrolizumab plus docetaxel. This was significantly higher than the ORR of 15.8% observed after a median 7.9 months of follow-up among the patients who received docetaxel monotherapy and corresponded to a fourfold increased likelihood for a response with the combined treatment.
The median duration of response was significantly longer with the combination relative to monotherapy, at 11.0 versus 5.2 months, as was progression-free survival (PFS), at 9.5 versus 3.9 months, giving a hazard ratio of 0.24.
Almost one-third (32%) of the study participant had an EGFR/ALK alteration, and these patients derived similar benefits from the combined therapy as the overall cohort. In this group, the ORR was nonsignificantly higher with pembrolizumab plus docetaxel than docetaxel alone, at 58.3% versus 30.8%, while PFS was significantly longer, at 6.8 versus 3.5 months.
For the individuals without an EGFR/ALK alteration the corresponding ORRs were 57.1% and 28.0% and the PFS times were 9.5 and 4.1 months, where both were significant differences.
In all, 65% of study participants experienced an adverse event, with a safety profile that was “consistent with the individual agents,” the investigators remark.
They note that two immune-mediated adverse events – pneumonitis and hypothyroidism – were significantly more common in in the pembrolizumab plus docetaxel arm than in the docetaxel arm, but all events were grade 1 or 2 in severity.
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