KEYNOTE-010 in Advanced NSCLC: Long-Term Survival Benefit With Pembrolizumab
Posted: Thursday, January 17, 2019
Previously treated patients with non–small cell lung cancer (NSCLC) experienced significantly longer overall survival with pembrolizumab than with docetaxel, according to the results of the KEYNOTE-010 trial. Roy S. Herbst, MD, PhD, of Yale University School of Medicine, and colleagues presented these long-term study findings at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2018 in Geneva (Abstract LBA4) and also published them in the Annals of Oncology.
The global, open-label, phase II/III study enrolled adult patients with previously treated advanced NSCLC with PD-L1 tumor proportion scores (TPSs) of less than 1%. They were randomly assigned 1:1:1 to receive 10 mg or 2 mg of pembrolizumab every 3 weeks up to 35 cycles or 75 mg/m2 of docetaxel every 3 weeks for the maximum amount of allowed per local guidelines until disease progression or intolerable toxicity. Response was tested every 9 weeks using Response Evaluation Criteria in Solid Tumors version 1.1 by independent review, and overall survival was evaluated every 2 months post treatment.
After an average follow-up of 43 months, overall survival in the study population of 1,033 patients was improved with immunotherapy over chemotherapy. Patients with PD-L1 with a TPS of at least 50% experienced improvement in overall survival as well with pembrolizumab over docetaxel. The median overall survival was 16.9 months with pembrolizumab compared with 8.2 months with docetaxel (P < .00001). In this group, the 36-month overall survival rates were 35% versus 13%, respectively.
Sixteen percent of patients had grade three to five treatment-related adverse events, compared to 37 percent in docetaxel patients.
Of the 79 patients who received 35 cycles or 2 years of treatment with pemrolizumab, 95% achieved a complete or partial response; an ongoing response was observed in nearly two-thirds of them (48 patients).
Disclosure: The study authors’ disclosure information may be found at academic.oup.com.
