Breakfast Brief Dr. Curioni – related abstracts
1297O – Randomized results of fixed-duration (1-yr) vs continuous nivolumab in patients (pts) with advanced non-small cell lung cancer (NSCLC)
As of April 2016, 1375 pts were enrolled and treated; 218 pts were randomized after 1 yr of treatment to the continuous-treatment arm (n = 111) or the fixed-duration arm (n = 107). Of these 218 pts, 133 (61%) had received ≥2 prior therapies and 10 (5%) had baseline ECOG PS 2. Data from an upcoming database lock (at which time, the expected post-randomization follow-up ≥10.7 mo) will be presented for randomized pts and will include overall survival, progression-free survival, and safety. In addition, data from pts who were re-treated in the fixed-duration arm will be presented.
The results from CheckMate 153 represent the first insights from a randomized trial evaluating the impact of stopping treatment with a PD-1/PD-L1 inhibitor at 1 yr vs continuing treatment in pts with advanced, previously treated NSCLC.
1296O – Clinical efficacy of atezolizumab (Atezo) in PD-L1 subgroups defined by SP142 and 22C3 IHC assays in 2L+ NSCLC: Results from the randomized OAK study
Among the primary population of 850 pts (ITT850), 400 had results from the 22C3 assay (biomarker-evaluable population [BEP]). Clinical outcomes in the BEP vs ITT850, and prevalence in PD-L1 subgroups are summarized (Table). Among pts with tumors negative by SP142 (TC0 and IC0), most (77%) were also negative by 22C3 (TPS < 1%). Comparable OS benefit with atezo was seen in PD-L1–negative subgroups defined by both assays. Improved clinical benefit was observed in pts with the highest PD-L1 expression by either assay (TC3 or IC3 by SP142, or TPS ≥ 50% by 22C3; Table).
Prevalence of PD-L1 subgroups in the BEP was consistent with previous reports for both assays. Most tumors considered negative by SP142 were also negative by 22C3. An OS benefit (atezo vs doc) was observed in PD-L1–negative subgroups defined by either assay and was consistent with the overall population results from OAK. These data provide evidence of atezo OS benefit in pts with PD-L1–negative tumors irrespective of the PD-L1 IHC assay used.
1295O – Blood-based biomarkers for cancer immunotherapy: Tumor mutational burden in blood (bTMB) is associated with improved atezolizumab (atezo) efficacy in 2L+ NSCLC (POPLAR and OAK)
In POPLAR, improved PFS and OS HRs with atezo vs doc were observed at a range of bTMB cut points compared with the ITT and BEP. In OAK, PFS benefit with atezo vs doc was observed at bTMB cut points ≥ 10 compared with BEP. (Table) Importantly, bTMB did not correlate with PD-L1 expression (SP142 or 22C3).
These exploratory analyses represent the first demonstration of a novel blood-based assay measuring bTMB that may predict atezo clinical efficacy in 2L+ NSCLC. Thus, the bTMB assay may provide a non-invasive biomarker to identify pts who may derive clinical benefit from single agent checkpoint inhibition. Prospective studies using bTMB are currently ongoing in pts with 1L NSCLC (B-F1RST/BFAST).
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