Abstract 1539P
Background
Lurbinectedin was approved in the US in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. This study describes RW progression-free survival (rwPFS), time to discontinuation (rwTTD), and time to next treatment or death (rwTTNT/D) in patients treated with lurbinectedin in a RW setting.
Methods
This study used a cohort of 2L SCLC patients treated with single-agent lurbinectedin in the nationwide Flatiron Health US electronic health record-derived de-identified database from 15/06/20 to 31/03/22. rwPFS, rwTTD, and rwTTNT/D were assessed from start of 2L (index date) until event or censor using Kaplan-Meier methods. Results were evaluated among all patients and the subsets with chemotherapy-free interval (CTFI) ≥ 90 days and ≥ 180 days. CTFI was measured as the time from last platinum therapy dose to progression or start of 2L (in the absence of progression).
Results
Of the 396 patients included, 222 (56.1%) had a CTFI ≥ 90 days and 49 (12.4%) had a CTFI ≥ 180 days. Median age was 67 years and 84.6% of patients had extensive stage disease at initial diagnosis. 24.5% had an ECOG score of 0, 43.2% had a score of 1, 17.2% had a score of 2, and 14.1% of patients did not have a documented ECOG status in the 30 days prior to index date. Platinum therapy + etoposide with or without immunotherapy was the 1L treatment in >99% of patients. Median rwPFS was longer in the subsets of patients with CTFI ≥ 90 days and ≥ 180 days (overall: 2.5 months, ≥ 90 days: 3.1 months, ≥ 180 days: 4.6 months). Similar trends were seen for rwTTD and rwTTNT/D.
Conclusions
Patients treated with lurbinectedin as 2L monotherapy in this RW setting had outcomes consistent with those seen in the phase 2 clinical trial. Lurbinectedin provides an additional treatment option for relapsed SCLC patients, including those with platinum-sensitive disease. Table: 1539P
| Overall | CTFI ≥ 90 days | CTFI ≥ 180 days | |
| N (%a) | 396 | 222 (56.1%) | 49 (12.4%) |
| Median age at index | 67.0 | 66.0 | 67.0 |
| ECOG status at indexb | |||
| 0 | 97 (24.5%) | 56 (25.2%) | 16 (32.7%) |
| 1 | 171 (43.2%) | 93 (41.9%) | 18 (36.7%) |
| 2 | 68 (17.2%) | 39 (17.6%) | 5 (10.2%) |
| 3 | 4 (1.0%) | 1 (0.5%) | 0 (0.0%) |
| Missing | 56 (14.1%) | 33 (14.9%) | 10 (20.4%) |
| 1L Platinumc + etoposide alone | 59 (14.9%) | 36 (16.2%) | 9 (18.4%) |
| 1L Platinumc + etoposide + immunotherapy | 334 (84.3%) | 184 (82.9%) | 40 (81.6%) |
| Median time to event (95% CI) (months) | |||
| rwPFS | 2.5 (2.2, 2.8) | 3.1 (2.7, 3.9) | 4.6 (4.0, 6.2) |
| rwTTD | 2.5 (2.1, 3.5) | 3.7 (3.5, 4.1) | 4.8 (3.6, 5.6) |
| rwTTNT/D | 3.6 (3.2, 4.1) | 4.7 (4.1, 5.2) | 5.8 (4.4, 8.2) |
a% of overall bAssessed within 30 days prior to index cPlatinum-based chemotherapy.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Aetion Inc., and Jazz Pharmaceuticals.
Funding
Jazz Pharmaceuticals.
Disclosure
A. Estrin: Financial Interests, Personal, Other, Employee: Aetion. X. Wang: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. A. Boccuti: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. P. Prince: Financial Interests, Personal, Other, Employee: Aetion. N. Gautam: Financial Interests, Personal, Other, Employee: Aetion. B. Rengarajan: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. W. Li: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. T. Lu: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. Y. Cao: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. N. Naveh: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Institutional, Stocks/Shares: Jazz Pharmaceuticals. R. D'Agostino: Financial Interests, Personal, Advisory Role: Jazz Pharmaceuticals. R. Ben-Joseph: Financial Interests, Personal, Other, Employee: Jazz Pharmaceuticals; Financial Interests, Personal, Stocks/Shares: Jazz Pharmaceuticals. A.K. Ganti: Financial Interests, Personal, Advisory Board, SCLC consultant: AstraZeneca; Financial Interests, Personal, Other, DSMC Chair: YMAbs Therapeutics; Financial Interests, Personal, Advisory Board: Cardinal Health, Mirati Therapeutics, BeiGene Therapeutics, Sanofi Genzyme; Financial Interests, Personal, Advisory Board, Scientific Advisor: Flagship Biosciences; Financial Interests, Personal, Invited Speaker, CME speaker: Plexus Communications; Financial Interests, Personal, Other, Associate Editor of JCO-OP: American Society of Clinical Oncology; Financial Interests, Personal, Other, DSMB member: Hoosier Cancer Research Network; Financial Interests, Personal, Royalties, Lung cancer Book Editor: Oxford University Press; Financial Interests, Institutional, Invited Speaker: Merck, TAB Biosciences, NEKTAR Therapeutics, Mirati Therapeutics; Non-Financial Interests, Other, Clinical Advisor on a current project: Jazz Pharmaceuticals; Non-Financial Interests, Institutional, Product Samples, Drug supply for a research project: Takeda Pharmaceuticals; Non-Financial Interests, Leadership Role, Board of Directors: Academic and Community Cancer Research United.