|The following article features coverage from the IASLC 2019 World Conference on Lung Cancer meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Nivolumab produced a 5-fold improvement in the rate of 5-year OS in advanced non-small cell carcinoma (NSCLC) when compared with docetaxel, according to the results of a pooled analysis of the CheckMate 017 and CheckMate 057 phase 3 clinical trials. The findings of this analysis were presented at the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.1,2
The study designs of the randomized, open-label CheckMate 017 (ClinicalTrials.gov Identifier: NCT01642004) and CheckMate 057 (ClinicalTrials.gov Identifier: NCT01673867) are similar, except the former trial was conducted in patients with squamous NSCLC, whereas the latter study enrolled patients with nonsquamous NSCLC.
Both trials involved random study arm assignment in a 1:1 ratio, had a primary outcome measure of OS, and following the primary analyses of these studies, patients in the docetaxel arms who were no longer experiencing a therapy benefit were allowed to cross over to receive nivolumab.
The pooled analysis included 854 patients.
A key finding of this analysis was that 50 patients treated with nivolumab and 9 patients treated with docetaxel patients were alive at 5-year follow-up, representing 5-year OS rates of 13.4% and 2.6%, respectively. In comparison, historical data show the 5-year OS rate of patients with advanced NSCLC treated with chemotherapy is less than 5%.
Baseline characteristics of long-term survivors treated with either nivolumab or docetaxel were similar to those in the overall population who survived less than 1 year, except those in the nivolumab group more likely to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or a tumor programmed cell death-ligand 1 (PD-L1) expression level of 1% or higher, and those in the docetaxel group were more like to have an ECOG performance status of 0 or stage IIIB disease.
Interestingly, for patients who achieved an objective response to treatment (ie, 20% of patients receiving nivolumab and 11% of patients treated with docetaxel), response at 5 years was maintained in 32% and 0% of patients in the nivolumab and docetaxel groups, respectively. The median duration of response was 19.9 months for the nivolumab responders compared with 5.6 months for those responding to docetaxel.
For the 5-year survivors, 36% of patients treated with nivolumab were still receiving study drug compared with 0% of those treated with docetaxel. Furthermore, 10% of the long-term survivors who were treated with nivolumab remained progression free following cessation of nivolumab therapy and no further treatment. By comparison, no patients treated with docetaxel met these criteria.
Regarding the safety of nivolumab at 3 to 5 years’ follow-up, grade 3/4 adverse events were reported in only 3% of patients. Of those adverse events with a potential immunologic cause, skin-related adverse events (all lower than grade 3) were most common, occurring in 13% of patients.
In their concluding remarks, the study authors noted that these results represent “the longest survival follow-up for randomized phase 3 trials of an immune checkpoint inhibitor in advanced NSCLC.”
Read more of Cancer Therapy Advisor‘s coverage of the IASLC annual meeting by visiting the conference page.
- Gettinger S, Borghaei H, Brahmer JR, et al. Five-year outcomes from the randomized, phase 3 trials CheckMate 017/057: Nivolumab vs docetaxel in previously treated NSCLC. Presented at: IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer; September 7-10, 2019; Barcelona, Spain. Abstract OA14.04.
- International Association for the Study of Lung Cancer. Patients taking nivolumab experience five-fold increase in overall survival compared to chemotherapy [press release]. Published September 10, 2019. Accessed September 10, 2019.