Abstract 1533P
Background
MAURIS is a multicenter, open label, single arm, phase IIIb trial conducted in 25 Italian centers, that evaluates the safety and efficacy of ATZ + Cb-Eto in patients with newly diagnosed ES-SCLC, according to the new standard of care from the pivotal trial IMpower133. Patients (pts) with ECOG PS2, untreated asymptomatic brain metastases (BM) were eligible for this study and consolidative and palliative radiotherapy was also allowed. An interim analysis (IA) has been conducted roughly one year from the end of enrolment with a median follow-up of 10.5 months.
Methods
Patients enrolled in the study received ATZ 1200 mg + Cb-Eto every 3 weeks for 4–6 cycles in the induction phase, followed by ATZ maintenance every 3 weeks up to disease progression, unacceptable toxicity or clinical deterioration. The primary endpoints were the incidence of serious adverse events (SAE) and immune-mediated AEs (imAE). The secondary endpoints were 1 year survival, overall survival (OS), progression-free survival (PFS) and overall response rate (ORR).
Results
154 patients (95 males, mean age 65.1 years, 6 pts with PS2, 19 pts with BM) were treated. At data cut-off 28 oct 2021, 139 pts (90.3%) discontinued the treatment: 97 pts (63.0%) due to progressive disease, 17 pts (11.0%) due to AE. Safety data related to the induction phase and efficacy data at data cut-off were analysed overall and by the number of induction cycles. Table: 1533P
| Induction Phase | |||||
| Total n=154 | ≤3 cycles n=22 | 4 cycles n=43 | ≥5 cycles n=89 | ||
| Safety n (%) | |||||
| SAEs | 46 (29.9) | 14 (63.6) | 15 (34.9) | 17 (19.1) | |
| Treatment related SAE | 28 (18.2) | 6 (27.3) | 12 (27.9) | 10 (11.2) | |
| imAE | 23 (14.9) | 4 (18.2) | 5 (11.6) | 14 (15.7) | |
| Treatment related AE | 117 (76.0) | 13 (59.1) | 35 (81.4) | 69 (77.5) | |
| Treatment AE leading to death | 7 (4.5) | 6 (27.3) | 0 (0.0) | 1(1.1) | |
| Efficacy | |||||
| 1 year survival, n (%) | 65 (41.9) | 0 (0.0) | 18 (41.9) | 47 (52.8) | |
| OS (mo), median (95% CI) | 10.7 (9.9-13.7) | 2.7 (1.0-7.6) | 10.4 (8.6-14.2) | 13.8 (10.7-18.2) | |
| PFS (mo), median (95% CI) | 5.5 (5.3-5.8) | 1.8 (1.0-3.9) | 4.5 (4.1-5.5) | 5.8 (5.5-6.5) | |
| ORR, n (%) | 111 (71.6) | 5 (21.7) | 31 (72.1) | 75 (84.3) |
Conclusions
In this interim analysis, safety data observed in the induction phase seem consistent with IMpower133 results considering a patient population closer to clinical practice both for baseline patient characteristics and co-treatments allowed. In terms of efficacy data, we found that PFS and ORR were also aligned. Survival data in relation to the number of cycles in the induction phase, according to the investigator’s choice, might reflect a biased population and they should be confirmed.
Clinical trial identification
NCT04028050.
Editorial acknowledgement
Legal entity responsible for the study
Roche.
Funding
Roche.
Disclosure
E. Bria: Financial Interests, Personal, Advisory Board: AZ, Roche, BMS, MSD, Eli Lilly, Amgen; Financial Interests, Institutional, Research Grant: AZ, Roche. M.C. Garassino: Financial Interests, Personal, Other, several roles: AZ, MSD, BMS, Boehringer Ingelheim Italia SpA, Celgene, Eli Lilly,Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regneron, Merck, Ose Immuno Therapeutics; Financial Interests, Institutional, Other, several roles: Eli Lilly, Pfizer (MISP), AZ, MSD International GmbH, BMS, Boehringer Ingelheim Italia SpA, Celgene, Eli Lilly, Ignyta, Incyte, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine, Glaxo Smith Kline GSK, Spectrum Pharmaceuticals. A. Morabito: Financial Interests, Personal, Speaker’s Bureau: BMS, BI, MSD, Novartis, Roche, AstraZeneca, Pfizer; Takeda, Lilly; Financial Interests, Personal, Advisory Board: BI, MSD, Novartis, Roche, AstraZeneca, Pfizer; Takeda, Lilly . A. Ardizzoni: Financial Interests, Personal, Invited Speaker, Occasional fees for advisory board participation and lectures: BMS; Financial Interests, Personal, Advisory Board, Occasional fees for advisory board participation: MSD, Takeda, Lilly, Bayer; Financial Interests, Personal, Advisory Board, Occasional fee for advisory board participation: Roche; Financial Interests, Personal, Advisory Board, Occasional fees for advisory board participation and lectures: AstraZeneca; Financial Interests, Institutional, Invited Speaker, Financial support to my University for covering 50% costs of a no-profit accademic clinical trial: Ipsen. All other authors have declared no conflicts of interest.