Abstract 46P
Background
Platinum-based chemotherapy plus immune check point inhibitors (ICIs) have become a front-line standard treatment in NSCLC, but no prospective data of DTX plus RAM following front-line chemotherapy plus ICIs are available. Previous research has proven residual ICIs efficacy beyond 20 weeks after termination of ICIs, and VEGF-R2 blockade could enhance antitumor immunity by improving T-cell function. Here, we report the results of multicenter, phase II study of DTX plus RAM following front-line chemotherapy plus ICIs.
Methods
The primary end point of the study was objective response rate (ORR), and secondary endpoints were disease control rate (DCR), progression-free survival (PFS), and safety etc. Patients were treated with 60 mg/m2 of DTX and 10 mg/kg of RAM on day 1 with strong recommendation of pegfilgrastim on day 2 every 3 weeks. A null and alternative hypothesis of ORR were set as 10% and 30% with α error of 0.1 and β error of 0.1.
Results
Thirty-three patients were recruited from 8 institutions. Patient characteristics were as follows: median age (range): 66 (42–79) y; ECOG-PS 1, n = 13 (39%); interval after last administration of ICIs<6 weeks, n = 21 (64%). In the efficacy analysis population (n = 32), the primary endpoint was met as 11 patients achieved PR with ORR at 34.4% (80%CI, 23.1–47.2%). Another 15 patients achieved SD and the DCR was 81.3% (95%CI, 63.6–92.8%). Median PFS was 6.5 months. Grade≥3 anemia and febrile neutropenia was observed in 2 (6%) and 3 patients (9%). No treatment-related deaths and no new safety signals were observed.
Conclusions
DTX plus RAM demonstrated encouraging antitumor activity with a manageable safety profile in patients who have failed with front-line chemotherapy plus ICIs.
Clinical trial identification
jCRTs041190077.
Legal entity responsible for the study
M. Morise.
Funding
Eli Lilly.
Disclosure
M. Morise: Financial Interests, Institutional, Research Grant: Eli Lilly, Boehringer Ingelheim; Financial Interests, Institutional, Principal Investigator: Roche, Chugai, AstraZeneca, Taiho, Merck Serono, AbbVie, Ono. K. Ito: Financial Interests, Personal, Invited Speaker: Eli Lilly. All other authors have declared no conflicts of interest.