Abstract 76P
Background
Osimertinib, a third-generation, irreversible, central nervous system-active, oral EGFR-tyrosine kinase inhibitor (TKI), is the preferred 1L tx for EGFRm (Ex19del/L858R) advanced NSCLC. We present long-term survival outcomes and subsequent tx patterns from the US cohort of a global rw observational study of pts with EGFRm advanced NSCLC who received 1L osimertinib.
Methods
A retrospective chart review was conducted at five US oncology centres for pts with EGFRm advanced NSCLC initiating 1L osimertinib from April 2018–March 2020. Primary endpoints were rw overall survival (rwOS), time to next tx or death (TTNTD) and second-line (2L) tx patterns. Secondary endpoints were baseline pt characteristics and time to tx discontinuation (TTD). Data were analysed for all pts and a FLAURA-like cohort (pts with common EGFR mutations [Ex19del/L858R with or without other co-occurring EGFR mutations] and ECOG PS 0/1).
Results
Among all 88 pts, median age was 70 y (interquartile range [IQR] 61–77); female, 72%; any smoking history, 43%; ECOG PS 0/1, 66%; common and uncommon EGFR mutations, 81% and 10%, respectively; baseline brain metastases, 40%. Median follow-up was 52.6 months (mos; IQR 43.9–56.4) and 54.2 mos (IQR 38.7–57.6) in all 88 pts and the FLAURA-like cohort (n=50), respectively. The table shows long-term survival outcomes; data by baseline brain metastases status will also be presented. Among 40/88 pts who received 2L tx, the most common tx was platinum-based chemotherapy (40%), followed by immunotherapy-based regimens (23%), other (23%) and TKIs (15%).
Conclusions
1L osimertinib monotherapy provides long-term, durable clinical outcomes in pts with EGFRm advanced NSCLC; rw survival outcomes were consistent with the FLAURA trial. These data further support osimertinib as the preferred 1L therapy option.
Table 76P|
| Overall cohort (n=88) | FLAURA-like cohort* (n=50) | ||
|---|---|---|---|---|
|
| Events, n (%) | Median, mos (95% CI) | Events, n (%) | Median, mos (95% CI) |
| rwOS | 50 (57) | 34.1 (25.6, 52.1) | 26 (52) | 37.2 (28.5, NE) |
| TTNTD | 69 (78) | 18.1 (12.8, 29.8) | 41 (82) | 15.8 (12.5, 32.0) |
| TTD | 70 (80) | 15.6 (12.4, 29.8) | 41 (82) | 15.8 (12.1, 32.0) |
| *A subset of pts aligned with the FLAURA trial (NCT02296125) inclusion criteria CI, confidence interval; mos, months; NE, not evaluable; pts, patients; rwOS, real-world overall survival; TTD, time to treatment discontinuation; TTNTD, time to next treatment or death. | ||||
Editorial acknowledgement
The authors would like to acknowledge Clare McCleverty, PhD, contracted by Ashfield MedComms, an Inizio company, for medical writing support that was funded by AstraZeneca.
Legal entity responsible for the study
AstraZeneca.
Funding
AstraZeneca.
Disclosure
F. Griesinger: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, BeiGene, Regeneron; Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, BeiGene, Regeneron; Financial Interests, Institutional, Other, Coordinating PI: Novartis, Roche; Financial Interests, Institutional, Funding: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, Regeneron; Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, Regeneron, BeiGene; Financial Interests, Institutional, Other, Local PI: 35 studies; Non-Financial Interests, Personal, Member: ASH, ASCO, DKK, DGHO, ESMO; Financial Interests, Institutional, Principal Investigator: 35 studies ongoing; Financial Interests, Personal, Research Grant: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi; Financial Interests, Personal, Other, Speaker, Consultant, Advisor: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, BeiGene; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, BeiGene; Financial Interests, Institutional, Sponsor/Funding: AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSK, Sanofi, Daiichi Sankyo, Regeneron; Financial Interests, Institutional, Other, Steering Committee Member: BMS; Financial Interests, Personal, Writing Engagements: AstraZeneca. P.S. Karia: Financial Interests, Institutional, Full or part-time Employment: AstraZeneca; Financial Interests, Institutional, Stocks/Shares: AstraZeneca. M. Cooper: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. L. Servidio: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Non-Financial Interests, Personal, Member: ASCO, IASLC, ESMO; Financial Interests, Personal, Other, Steering Committee Member: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. J.J. Nieva: Financial Interests, Personal, Advisory Role: ANP Technologies, Aadi Biosciences, BioAtla, G1 Therapeutics, Gilead, Mindmed, Naveris, Nuvation Bio, Kalivir; Financial Interests, Personal, Invited Speaker: Genentech; Financial Interests, Personal, Ownership Interest: Cansera; Financial Interests, Personal, Research Grant: Merck, Genentech; Financial Interests, Personal, Stocks/Shares: Affyimmune, Amgen, Johnson & Johnson, Novartis; Financial Interests, Personal, Writing Engagements: AstraZeneca. D.B. Doroshow: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Takeda, AstraZeneca, Sanofi, G1 Therapeutics, Summit Therapeutics; Financial Interests, Personal, Advisory Role: Sonata Therapeutics; Financial Interests, Personal, Research Grant: Conquer Cancer Foundation, American Cancer Society, National Institutes of Health. All other authors have declared no conflicts of interest.