1286P - Explore-ALK (GFPC 03-2019): A real-world prospective, multicenter study of advanced ALK rearranged non-small cell lung cancer patients

Background

Non-small cell lung cancer (NSCLC) with ALK rearrangement accounts for around 5% of lung adenocarcinomas. Due the growing number of ALK inhibitors used in first line setting in advanced stage, real-word data are needed.

Methods

Explore ALK GFPC 03-2019 study is a national prospective, non-interventional, multicenter real-world cohort of patients with advanced ALK-rearranged NSCLC. The inclusion period started in july 2020 and the study is still recruiting. A follow-up period of five years is planned. The aims of the study are to better characterize these patients, to assess therapeutic sequences, the efficacy and safety of different lines of treatment, and current practice regarding the search for resistance mechanisms.

Results

For this first interim analysis (cut-off date: April 12, 2024), 242 patients were included by 37 centers. Median age, 65 (29-91) years, 43.6% men, 90.7% PS 0/1, no, former, current smoker, 56.6%, 31.8%, 8.3%; 97.5% adenocarcinoma, 76.4% metastatic at diagnosis (31.9% with brain metastasis (BM)). Alectinib, brigatinib, and lorlatinib were initiated as first-line treatment in 146 (60.3%), 77 (31.8%), 8 (3.3%) pts, respectively. After a median follow up of 16.5 months (95%IC, 13.9-19,2) for the entire cohort, median real world progression free survival (rwmPFS) was 35.8 (95%CI, 23.2-50.3) months), median overall survival (mOS) was 50.3 (95%CI, 50.3-NR) months, and objective response rate (ORR) was 81%. After a median follow-up of 18,4 (95%CI, 15-21.7) months for alectinib, 13.9 (95%CI, 11.5-16.6) for brigatinib and 16.6 (95%CI, 3.4-23.5) for lorlatinib, the rwmPFS and mOS were respectively 35,8 (95% CI : 21,3-50,3) and 50,3 (95%CI : 50,3-NR), NR (95%CI 24,8-NR) and NR (95%CI : NR-NR), 19.3 (95%CI : 1.1-NR) and NR (95%CI : 4.1-NR) months. At time of progression, 20/51 (39.2%) of pts had a new biopsy (86% tissue biopsy). Outcomes according to BM at diagnosis, treatment sequences, details on progression mecanisms, and safety datas will be presented during the meeting.

Conclusions

We present here the preliminary results of Explore ALK project, a large ongoing real world cohort, assessing efficacy and safety of therapeutic management of ALK NSCLC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Groupe Français de Pneumo-Cancerologie (GFPC).

Funding

Takeda and Pfizer.

Disclosure

C. Decroisette: Financial Interests, Personal, Advisory Board: BMS, MSD, Pfizer, Roche, Janssen Cilag; Financial Interests, Personal, Invited Speaker: Takeda, Sanofi, AstraZeneca, Amgen. R. Descourt: Financial Interests, Personal, Advisory Board: Takeda, Roche, Pfizer, AstraZeneca; Financial Interests, Personal, Invited Speaker: Sanofi. G. Rousseau Bussac: Financial Interests, Personal, Invited Speaker: Takeda, BMS; Financial Interests, Personal, Advisory Board: Roche, AZ; Other, congress: Pfizer; Other, hospitality: Boehringer Ingelheim, Lilly, Sanofi. A. Swalduz: Financial Interests, Personal, Advisory Board: Ipsen, AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, MSD, Pfizer, Roche, Takeda; Financial Interests, Personal, Advisory Role: AstraZeneca, BMS, Daiichi Sankyo, Janssen, Roche, Pfizer, Sanofi. O. Bylicki: Financial Interests, Personal, Advisory Board, Expert BOARD: BMS, Roche, Takeda; Financial Interests, Personal, Other, Travel congress: MSD; Financial Interests, Personal, Advisory Board, expert board: AstraZeneca, Janssen; Financial Interests, Personal, Advisory Board, Board: MSD; Financial Interests, Personal, Other, Travel Congress: AstraZeneca. L. Bigay-Game: Financial Interests, Personal, Speaker, Consultant, Advisor: MSD, BMS, AstraZeneca, Takeda, Janssen, Roche, Pfizer, Sanofi, Leopharma, Viatris. H. Doubre: Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Personal, Advisory Board: Amgen; Financial Interests, Institutional, Local PI: Bristol Myers Squibb Foundation, Merck. A.B. Cortot: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, AstraZeneca, MSD, Pfizer, Novartis, Takeda, Roche; Financial Interests, Personal, Advisory Board: Novartis, Roche, Pfizer, Janssen, Exeliom, Amgen; Financial Interests, Institutional, Research Grant: Merck, Roche, AbbVie, Exeliom; Financial Interests, Institutional, Coordinating PI: AstraZeneca; Financial Interests, Institutional, Local PI: Janssen, Roche, Sparta, Amgen, Mirati, AbbVie; Non-Financial Interests, Member of Board of Directors: French Thoracic Intergroup. S. Hominal: Financial Interests, Personal, Non financial benefits: Pfizer. F. Guisier: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, BMS, MSD, Roche, Sanofi, Janssen, Pfizer, Takeda; Financial Interests, Institutional, Research Grant: Pfizer, Roche, Takeda. C. Ricordel: Financial Interests, Personal, Advisory Board: Roche, Takeda, MSD, BMS, Janssen, Sanofi, AstraZeneca. S. Martinez: Financial Interests, Personal, Non financial benefits: Pfizer, Roche. G. Justeau: Non-Financial Interests, Advisory Role: BMS. C. Chouaid: Financial Interests, Personal, Advisory Board: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen; Financial Interests, Institutional, Funding: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen. L. Greillier: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, BMS, MSD, Novartis, Sanofi, Takeda, Roche; Financial Interests, Personal, Invited Speaker: Lilly, Pfizer; Financial Interests, Institutional, Local PI: AstraZeneca, AbbVie, BMS, MSD, Novartis, Takeda, Pfizer, Roche, PharmaMar; Financial Interests, Institutional, Coordinating PI: Sanofi. All other authors have declared no conflicts of interest.