Abstract 1310P
Background
In 2019, first line treatment for advanced NSCLC was based on chemotherapy, except for patients harboring specific oncogenic driver or PDL-1 status superior to 50%. In the second-line setting, patients (pts) were often treated with immunotherapy, with efficacy in only a minority of pts. A synergic action between immunotherapy and chemotherapy have emerged recently. MOV is defined as low-dose and frequent chemotherapy administration.
Methods
An open label, multicenter, single arm, phase II trial was designed in two steps. The primary outcome was progression-free survival at 4 months. Secondary outcomes were safety, median overall survival, objective response rate, disease-control rate at 4 months and quality of life. Pts with relapsed NSCLC after platin based chemotherapy, without any oncogenic driver, age≥18 years, PS≤2 were included and received MOV in combination with ATZ. The run-in phase aimed to ensure the safety of the fixed dose ATZ included the first 12 patients and the independent committee recommended MOV dose at 40 mg 3 times a week. The second step used the exact single-stage was based on a statistical design model defined by according to a A’hern. Minimal efficacy hypothesis (p1) was set at 55% event-free rate of PFS at 4 months. P0 (ineffective strategy) was set at 40% PFS rate. With a 5% alpha risk (unilateral perspective) and a 20% beta risk, number of assessable pts was set at 71.
Results
The second step started in 16 centers on 2019 April 17th until 2020 February 5th. 80 pts were included, 71 pts were analyzed. In terms of safety, 230 adverse events (AE) were recorded in 59 pts. The number (nb) of grade (gr) ≥ 3 events were 52/230 (22.6%) including 40/52 (76.9%) gr3, 7/52 (13,5%) gr 4, 5/52 (9.6%) gr 5. Severe AE linked to the drugs were 18/52 (34.6%) in 18 pts with 13 grade 3, 3 grade 4 and 2 grade 5 (respiratory failures) Table: 1310P
| Age * | Sex (M/F) | NS/ES/smoker | PS(0/1/2) | histology NSQ/SQ/other | meta<=1/>1 | PDL-1>50/1-49/0/UK | CT platin doublet/other | length 1st line * | |
| number | 64y (42-84) | 47/24 | 10/42/19 | 19/45/7 | 56/13/2 | 19/52 | 3/29/36/3 | 63/8 | 6.2m (1-27) |
| percentage | 66.2/33.8 | 14.1/59.2/26.8 | 26.8/63.4/9.9 | 78.8/18.3/2.9 | 26.8/73.2 | 4.25/40.8/50.7/4.25 | 88.7/11.3 |
Conclusions
Combination between MOV and ATZ was feasible without unacceptable toxicity. Efficacy will be presented at the meeting.
Clinical trial identification
NCT 03801304.
Editorial acknowledgement
Legal entity responsible for the study
Brest University Hospital.
Funding
Roche S.A.S and Pierre Fabre Laboratories.
Disclosure
A. Vergnenegre: Advisory/Consultancy: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: Roche SAS; Advisory/Consultancy: Pierre Fabre Oncology; Advisory/Consultancy: Boehringer Ingelheim. R. Gervais: Advisory/Consultancy, Travel/Accommodation/Expenses: SAS Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer. F. Guisier: Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD/Merck US; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Boehringer Ingelheim; Advisory/Consultancy, Travel/Accommodation/Expenses: Chugai; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer. S. Hominal: Travel/Accommodation/Expenses: Amgen SAS; Travel/Accommodation/Expenses: Boehringer Ingelheim. C. Chouaid: Advisory/Consultancy, Travel/Accommodation/Expenses: AZ; Advisory/Consultancy, Travel/Accommodation/Expenses: BI; Advisory/Consultancy, Travel/Accommodation/Expenses: GSR; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (institution), Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Aventis; Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: TAKEDA; Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Amgen. G. Robinet: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Pierre Fabre Oncology. All other authors have declared no conflicts of interest.