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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. 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). 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: 28PMedian (95% CI),* mosAll pts (N=224)FLAURA-like cohort (n=138)Pts with baseline brain metastases (n=85)rwOS30.1 (23.4, 39.1)39.3 (30.1, NC)23.9 (17.8, 39.3)TTNTD19.0 (16.2, 24.5)24.5 (16.8, NC)16.2 (12.8, 22.5)TTD16.2 (12.9, 18.8)17.7 (13.8, 27.9)13.5 (8.9, 17.1)rwPFS16.7 (13.8, 22.5)22.5 (14.5, 32.6)14.5 (10.3, 20.0)OS by EGFR mutation type- Ex19deln=88 39.1 (30.4, NC)––- L858Rn=76 30.1 (22.5, NC)––- Uncommonn=28 15.6 (3.4, 26.1)––*Per Kaplan–Meier methodology. CI, confidence interval; ex19del, exon 19 deletion; mos, months; NC, not calculable. Open table in a new tab *Per Kaplan–Meier methodology. CI, confidence interval; ex19del, exon 19 deletion; mos, months; NC, not calculable. 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).
Griesinger et al. (Fri,) studied this question.