Abstract 336P
Background
The global, phase III, double-blind ADRIATIC trial (NCT03703297) assessed D ± tremelimumab (T) vs placebo (P) as consolidation therapy for patients (pts) with LS-SCLC who had not progressed after concurrent chemoradiotherapy (cCRT). At the first interim analysis (data cutoff 15 Jan 2024), D significantly improved overall survival (OS; hazard ratio [HR] 0.73 [95% CI 0.57–0.93]; p=0.0104) and progression-free survival (PFS; HR 0.76 [95% CI 0.61–0.95]; p=0.0161) vs P; the D+T arm remained blinded. We report a prespecified subgroup analysis of D vs P in pts enrolled in China.
Methods
Pts with stage I–III LS-SCLC (stage I/II inoperable) and no progression after cCRT were randomised 1–42 days after cCRT to D 1500 mg (N=264), D 1500 mg + T 75 mg (4 doses only; N=200), or P (N=266) every 4 weeks for ≤24 months (mo), stratified by disease stage (I/II vs III) and receipt of prophylactic cranial irradiation (PCI). Dual primary endpoints were OS and PFS by blinded independent central review for D vs P.
Results
Of the global D vs P population, 95 pts (17.9%)were enrolled in China and randomised to D (n=49) vs P (n=46); all were treated. In these pts, median age was 59.0 vs 55.0 years and 59.2% vs 67.4% had WHO performance status 1. For prior cCRT, 93.9% vs 95.7% of pts received 4 cycles of chemotherapy, 69.4% vs 69.6% received cisplatinetoposide, and 53.1% vs 69.6% had once-daily radiotherapy; 2.0% vs 10.9% had a complete response to cCRT. Post-cCRT, 55.1% vs 67.4% of pts received PCI. After median follow-up for OS and PFS in censored pts of 35.5 and 27.7 mo, OS HR for D vs P was 0.71 (95% CI 0.37–1.37), with median OS not reached in either arm (36-mo OS 63.7% vs 55.4%), and PFS HR for D vs P was 0.67 (95% CI 0.39–1.14), with median PFS of 22.9 vs 14.3 mo (24-mo PFS 45.8% vs 37.6%).With D vs P, 16.3% vs 17.4% of pts had maximum grade 3/4 adverse events (AEs), 42.9% vs 21.7% had serious AEs, 10.2% vs 13.0% discontinued treatment due to AEs, and no pts died due to AEs; 55.1% vs 63.0% had pneumonitis/radiation pneumonitis (grade 3/4 in 4.1% vs 4.3%).
Conclusions
Consolidation D showed a favourable benefit/risk profile in Chinese pts with LS-SCLC with no progression after cCRT, with OS and PFS benefits and safety profile consistent with the global ADRIATIC study population.
Clinical trial identification
NCT03703297. Release date: 27 September 2018.
Editorial acknowledgement
Medical writing support for this abstract, under the direction of the authors, was provided by Steve Hill of Ashfield MedComms, an Inizio company, and was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
S. Lu: Financial Interests, Personal, Advisory Role: AstraZeneca, Pfizer, Hutchison MediPharma, ZaiLab, GenomiCare, Novartis, Yuhan Corporation, Menarini, Mirati Therapeutics Inc, Daiichi Sankyo, Inc., D3 Bio Limited, Simcere, Takeda and Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Roche, Hansoh; Financial Interests, Personal, Member of Board of Directors: Innovent Biologics, Inc.; Financial Interests, Personal, Research Grant: AstraZeneca, Hutchison, BMS, Heng Rui BeiGene, Roche, Hansoh; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Roche, Hansoh. Y.S. Olivo: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. S. Senan: Financial Interests, Personal, Advisory Board: AstraZeneca, MSD; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD; Financial Interests, Personal, Officer: ETOP IBCSG Partners Foundation; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Advisory Role: MSD. All other authors have declared no conflicts of interest.