Abstract 1344P
Background
Osimertinib, a third-generation, irreversible, central nervous system-active, EGFR tyrosine kinase inhibitor (TKI) that selectively inhibits EGFR-TKI sensitising and EGFR T790M resistance mutations, is the preferred 1L treatment for EGFRm advanced NSCLC. We present results from the US cohort of a global rw observational study of LTS and treatment patterns after 1L osimertinib in advanced EGFRm NSCLC.
Methods
Adults with stage IIIB–IV EGFRm NSCLC who initiated 1L osimertinib monotherapy between Apr 2018–Mar 2020 were identified from the Flatiron Health database. Primary endpoints: overall survival (OS), time to next treatment or death (TTNTD) and treatment patterns; secondary endpoints: baseline characteristics and time to treatment discontinuation (TTD; a rw progression-free survival [PFS] surrogate). OS, TTNTD and TTD were also assessed in a subset of pts aligned with the FLAURA trial (NCT02296125) inclusion criteria (FLAURA-like cohort). Endpoints were reported descriptively.
Results
Among 773 pts, median age was 70 yrs (interquartile range [IQR] 61–78), 68% were female, 59% were White, 54% had no/unknown smoking history, 64% had ECOG PS 0 or 1 and 89% had Exon 19 deletion or L858R EGFR mutations. With a median follow-up of 24 mos (IQR 10–36), median OS, TTNTD and TTD (95% confidence interval [CI]) for all pts were 29.8 mos (27.2–32.1), 18.5 mos (17.0–21.3) and 16.3 mos (15.0–18.1), and for the FLAURA-like cohort (n=453) were 33.3 mos (30.0–37.2), 22.3 mos (18.5–25.2) and 19.4 mos (16.4–23.0), respectively. Overall, 39% of pts received subsequent therapy (Table). Table: 1344P
Subsequent therapy received, n (%) | All pts (N=773) |
Yes | 299 (39) |
No | |
Remained on 1L osimertinib | 173 (22) |
Discontinued 1L osimertinib | 50 (6) |
Died | 251 (32) |
Therapy received | |
2L therapy | (n=299) |
IO + CT | 74 (25) |
Osimertinib + CT | 47 (16) |
CT | 39 (13) |
1G or 2G EGFR-TKI | 33 (11) |
IO | 28 (9) |
Other | 78 (26) |
3L therapy | (n=138) |
IO + CT | 24 (17) |
Osimertinib + CT | 15 (11) |
CT | 28 (20) |
1G or 2G EGFR-TKI | 14 (10) |
IO | 11 (8) |
Other | 46 (33) |
Percentages have been rounded to the nearest whole number and may not sum to 100%. 1G, first-generation; 1L, first-line; 2G, second-generation; 2L, second-line; 3L, third-line; CT, chemotherapy; EGFR-TKI, epidermal growth factor receptor-tyrosine kinase inhibitor; IO, immunotherapy; pts, patients.
Conclusions
In a large rw cohort of pts with EGFRm advanced NSCLC treated with 1L osimertinib, median OS and TTD were consistent with median OS and PFS in FLAURA (Ramalingam NEJM 2020 ; Soria NEJM 2018), reinforcing the effectiveness of osimertinib in the real world.
Clinical trial identification
Editorial acknowledgement
Medical writing support for the development of this abstract was provided by Alice Walter, BSc, of Ashfield MedComms, an Inizio company, and was funded by AstraZeneca in accordance with Good Publications Practice (GPP) guidelines.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
J. Nieva: Financial Interests, Personal, Advisory Board: KaliVir; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson, Amgen; Financial Interests, Personal, Funding: Merck, Genentech; Financial Interests, Personal, Advisory Role: Mindmed, BioAtla, Ypsomed, AstraZeneca, Fujirebio, G1 Therapeutics, Aadi Biosciences, ANP Technologies, Sanofi. P. Okhuoya: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. M. Berktas: Financial Interests, Personal, Speaker, Consultant, Advisor, Consultancy fees: AstraZeneca. R.J. Salomonsen, L. Servidio, J. Chapaneri: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. K. De Silva: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. E. Martin: Financial Interests, Personal, Full or part-time Employment, Contracted through Phastar: AstraZeneca. F. Griesinger: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, GSK, Janssen, Sanofi; Financial Interests, Personal, Writing Engagements: AstraZeneca, Merck, Novartis; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, GSK, Janssen, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, GSK, Janssen, Sanofi; Financial Interests, Personal, Research Grant: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, GSK, Janssen, Sanofi; Financial Interests, Personal, Funding: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Siemens, Amgen, GSK, Janssen; Financial Interests, Personal, Project Lead: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Siemens, Amgen, GSK, Janssen; Financial Interests, Personal, Principal Investigator: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Siemens, Amgen, GSK, Janssen; Financial Interests, Personal, Other, Honoraria for presentations: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, Amgen, GSK, Janssen, Sanofi. All other authors have declared no conflicts of interest.
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