Abstract 37P
Background
Alectinib is a preferred first-line treatment for pts with advanced ALK+ NSCLC and the sequence of post-alectinib treatments used in the real-world is not well characterised. ReAlec (NCT04764188) is a real-world, observational, multicentre, cohort study of the clinical management and outcomes of pts treated with alectinib. We report results from the primary interim analysis of cohort 1 (pts treated with first-line alectinib).
Methods
Eligible pts were ≥18 years old with advanced ALK+ NSCLC and initiated on-label, first-line alectinib after (arm A) or before (arm B) enrolment. Pts will be followed for up to 6 years. Retrospective medical history was collected at enrolment and additional data were recorded during routine visits. Co-primary objectives were progression-free survival and next line of therapy post-alectinib. Key secondary objectives were demographics, disease characteristics and safety.
Results
In total 745 pts were enrolled; demographics and disease characteristics are reported in the table. At data cutoff (10 May 2023), median treatment duration on the study was 8.3 months (arm A) and 13.8 months (arm B). Rates of alectinib discontinuation were 21.9% (arm A) and 15.3% (arm B); 73.2% (arm A) and 86.7% (arm B) of these pts discontinued alectinib due to progressive disease. The most common next line of therapy was lorlatinib (arm A: 60.5%; arm B: 67.7%). Treatment-related adverse events (TRAE) occurred in 26.3% of pts and were mostly Grade 1–2 and non-serious. TRAEs leading to dose modification/interruptions and treatment discontinuation occurred in 6.4% and 0.9% of pts, respectively. Grade 5 events unrelated to treatment occurred in 20 (2.7%) pts.
Table: 37P
| Arm A (n=256) | Arm B (n=489) | |
| Median age, years (range) | 58 (22–86) | 58 (24–91) |
| Male, % | 46.5 | 43.4 |
| Race, %AsianWhiteOther | 26.662.910.5 | 14.576.39.2 |
| ECOG PS, %0123 | n=21737.852.59.20.5 | n=42160.836.12.90.2 |
| Stage at initial diagnosis, %IIIIIIIVMissing | 2.02.016.479.70 | 3.52.710.682.60.6 |
| Metastatic disease at baseline, % | 90.6 | 93.7 |
| Prior therapy at any stage, %Cancer therapyRadiotherapySurgery | 16.416.422.7 | 16.621.526.8 |
| Median time from metastatic diagnosis to alectinib, days (95% CI) | 28.0 (24.0–32.0) | 28.0 (26.0–31.0) |
| Median time from ALK test (at initial diagnosis) to alectinib, days (95% CI) | 10.5 (9.0–14.0) | 14.0 (12.0–16.0) |
Conclusions
Real-world demographics and disease characteristics of pts with advanced ALK+ NSCLC, and the safety profile of alectinib, were in line with clinical experience. Post-alectinib treatments and their effectiveness will continue to be evaluated.
Clinical trial identification
NCT04764188.
Editorial acknowledgement
Third-party medical writing assistance, under the direction of the authors, was provided by Neave Baldwin, BSc and Claire White, PhD of Ashfield MedComms, an Inizio company, and was funded by F. Hoffmann-La Roche Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
E. Bria: Financial Interests, Personal, Invited Speaker: AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, MSD, BMS; Financial Interests, Personal, Advisory Board: AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, Eli Lilly, MSD, BMS; Other, Personal, Research Grant: AstraZeneca, F. Hoffmann-La Roche Ltd, AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca, F. Hoffmann-La Roche Ltd. J. Bar: Financial Interests, Personal, Invited Speaker: BMS, Medison, Pfizer; Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, MSD, Merck Serono, F. Hoffmann-La Roche Ltd, Takeda; Financial Interests, Institutional, Research Grant: Immunai, OncoHost, MSD, F. Hoffmann-La Roche Ltd, AbbVie; Financial Interests, Institutional, Invited Speaker: AstraZeneca; Non-Financial Interests, Institutional, Principal Investigator: F. Hoffmann-La Roche Ltd, MSD, AbbVie, AstraZeneca, Merck, Bayer; Non-Financial Interests, Institutional, Leadership Role: Lung Ambition. M.J. Hochmair: Financial Interests, Personal, Speaker’s Bureau: F. Hoffmann-La Roche Ltd, BMS, MSD, Eli Lilly and Company, Amgen, Takeda; Financial Interests, Personal, Advisory Board: F. Hoffman-La Roche Ltd, BMS, MSD, Eli Lilly and Company, Amgen, Takeda. J. Fecker: Financial Interests, Personal, Full or part-time Employment: Roche Pharma AG; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd; Financial Interests, Personal, Affiliate: Roche Pharma AG. J. Ojaimi, V. Smoljanovic: Financial Interests, Personal, Full or part-time Employment: F. Hoffmann La-Roche Ltd; Financial Interests, Personal, Stocks/Shares: F. Hoffmann-La Roche Ltd. M. Itchins: Financial Interests, Personal, Invited Speaker: Pfizer, AstraZeneca, F. Hoffmann-La Roche Ltd, Novartis, BMS, MSD; Financial Interests, Personal, Advisory Board: Pfizer, Takeda, Bayer, MSD, Amgen, Merck, F. Hoffmann-La Roche Ltd, BeiGene, Janssen, Gilead; Financial Interests, Institutional, Research Grant: Pfizer; Financial Interests, Personal, Advisory Role: F. Hoffmann-La Roche Ltd, Merck, Janssen; Financial Interests, Personal, Other: F. Hoffmann-La Roche Ltd. All other authors have declared no conflicts of interest.