Abstract 28P
Background
Osi, a 3rd-generation, central nervous system-active, EGFR-TKI, is the preferred 1L tx for EGFRm advanced NSCLC. We report interim results from a German cohort of a global rw prospective, observational study of long-term survival and tx patterns in pts with EGFRm advanced NSCLC who received 1L osi.
Methods
Data for pts aged ≥18 yrs with EGFRm advanced NSCLC initiating 1L osi in Germany (1 Jun 2018–31 Dec 2020) were extracted from the CRISP registry. Primary endpoints: rw overall survival (OS), time to next tx or death (TTNTD) and tx patterns; secondary endpoints: baseline characteristics and time to tx discontinuation (TTD). Exploratory endpoints included rw progression-free survival (PFS; defined as time from 1L initiation to disease progression or death) and rwOS by EGFR mutation type. Outcomes were also assessed in a pt subset to approximate the FLAURA trial population (NCT02296125; FLAURA-like cohort) and pts with baseline brain metastases (mets).
Results
In 224 pts, median age was 68 yrs (interquartile range [IQR] 59–77; 66% were female, 47% had never smoked, 38% had baseline brain mets and 39/34/13% had Ex19del/L858R/uncommon EGFR mutations (including ex20ins; G719X; L861Q; S768I; Group I; T790M). At data cutoff (30 Jun 2022), median follow-up was 23.8 mos (IQR 21.7–27.5) and 124/224 (55%) pts had a progression event. The table shows outcomes in all pts, the FLAURA-like cohort and pts with baseline brain mets. Overall, 80/224 (36%) pts remained on osi and 50 (22%) pts received second-line tx (most commonly immunotherapy + chemotherapy [n=26], TKIs [n=11] and chemotherapy [n=9]). Table: 28P
| Median (95% CI),* mos | All pts (N=224) | FLAURA-like cohort (n=138) | Pts with baseline brain metastases (n=85) |
| rwOS | 30.1 (23.4, 39.1) | 39.3 (30.1, NC) | 23.9 (17.8, 39.3) |
| TTNTD | 19.0 (16.2, 24.5) | 24.5 (16.8, NC) | 16.2 (12.8, 22.5) |
| TTD | 16.2 (12.9, 18.8) | 17.7 (13.8, 27.9) | 13.5 (8.9, 17.1) |
| rwPFS | 16.7 (13.8, 22.5) | 22.5 (14.5, 32.6) | 14.5 (10.3, 20.0) |
| OS by EGFR mutation type | |||
| - Ex19del | n=88 39.1 (30.4, NC) | – | – |
| - L858R | n=76 30.1 (22.5, NC) | – | – |
| - Uncommon | n=28 15.6 (3.4, 26.1) | – | – |
*Per Kaplan–Meier methodology. CI, confidence interval; ex19del, exon 19 deletion; mos, months; NC, not calculable.
Conclusions
Our results reinforce the effectiveness of 1L osi for EGFRm advanced NSCLC in a rw setting. Median rwOS and rwPFS in this German cohort were comparable with results from the FLAURA trial (Ramalingam NEJM 2020; Soria NEJM 2018).
Editorial acknowledgement
The authors would like to acknowledge Caroline Allinson, BSc, 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, Institutional, Research Grant: ASTRA, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSKD, Sanofi; Financial Interests, Personal, Other, Consulting fees; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events; Support for attending meetings and/or travel; Participation on a Data Safety Monitoring Board or Advisory Board: ASTRA, Boehringer Ingelheim, BMS, Lilly, Novartis, Roche, MSD, Pfizer, Takeda, Siemens, Amgen, GSKD, Sanofi, Daiichi Sankyo, BeiGene. P. Steffens: Other, Institutional, Full or part-time Employment: AstraZeneca. R. Schuh: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. M. Cooper: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. J. Chapaneri: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. R.J. Salomonsen: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. P.S. Karia: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca; Financial Interests, Personal, Royalties: UpToDate. M. Thomas: Other, Personal, Advisory Board, Financial and non-financial (travel cost) interests: Amgen; Other, Personal, Advisory Board: AstraZeneca, BeiGene, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Daiichi Sankyo, GSK, Janssen Oncology, Lilly, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Takeda; Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Merck, Roche, Takeda. All other authors have declared no conflicts of interest.