499P - Long-term survival and treatment (tx) patterns after first-line (1L) osimertinib in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive (m) advanced non-small cell lung cancer (NSCLC): Japanese cohort of a global real-world (rw) observational study

Background

Osimertinib (osi), a third-generation, irreversible, central nervous system-active, EGFR-tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits EGFR-TKI sensitising and EGFR T790M resistance mutations, is the preferred 1L tx for EGFRm advanced NSCLC. In this observational study, we report outcomes from a Japanese cohort of pts with advanced EGFRm NSCLC after 1L osi, and their second-line (2L) tx patterns.

Methods

Data for adult pts with EGFRm advanced NSCLC, who initiated 1L osi in Japan (21 Aug 2018–31 Dec 2020) were identified from clinical databases using the CyberOncology® data platform, operated by PRiME-R®. Primary endpoints were overall survival (OS), 2L tx patterns and time to next treatment or death (TTNTD). Secondary endpoints were baseline pt characteristics and time to tx discontinuation (TTD). Exploratory endpoints included OS by EGFR mutation type and rw progression-free survival (rwPFS). OS, TTNTD, TTD and rwPFS were also assessed in a group of pts aligned with the FLAURA trial (NCT02296125) inclusion criteria (FLAURA-like cohort).

Results

Of 143 pts, median age was 70 years (interquartile range [IQR]: 64–75), 69% were female, 96% had exon 19 deletion or L858R, 60% had never smoked and 80% had an Eastern Cooperative Oncology Group performance status score of 0/1. At data cutoff (31 Dec 2022), median follow-up was 32.3 months (IQR: 24.8–39.4) and time-to-event outcomes were comparable in all pts and the FLAURA-like cohort (Table). Of the 50 (35%) pts who received subsequent tx, 54% received EGFR-TKIs, 32% chemotherapy, 12% immunotherapy and chemotherapy and 2% other tx. Table: 499P

CI, confidence interval; EGFR, epidermal growth factor receptor; NC, not calculable; OS, overall survival; pts, patients; rwPFS, real-world progression-free survival; TTD, time to treatment discontinuation; TTNTD, time to next treatment or death.

Conclusions

Median OS and rwPFS in all pts were comparable with results from the FLAURA trial (Ramalingam NEJM 2020; Soria NEJM 2018). Our results reinforce the effectiveness of 1L osi in a rw setting.

Clinical trial identification

Editorial acknowledgement

The authors would like to acknowledge Lucy Lettin, BSc, of Ashfield MedComms, an Inizio Company, for medical writing support that was funded by AstraZeneca in accordance with Good Publications Practice (GPP) guidelines (https://www.ismpp.org/gpp-2022).

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

D. Fujimoto: Financial Interests, Personal, Financially compensated role: Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Eli Lilly Japan K.K., AstraZeneca K.K., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Merck Sharp & Dohme K.K., Boehringer Ingelheim Japan Inc., Kyowa Kirin, Daiichi Sankyo, Novartis K.K. Inc. Y. Takiguchi: Other, Personal, Advisory Role, External membership for IRB: Oncolys Biopharma; Financial Interests, Personal, Funding: Ono Pharmaceutical, Bristol Myers Squibb, AstraZeneca, Merck Sharp & Dohme, Takeda; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bristol Myers Squibb, Taiho Pharmaceutical, Chugai Pharmaceutical, AstraZeneca, Pfizer, Merck Sharp & Dohme, Novartis, Daiichi Sankyo, Eli Lilly, Boehringer Ingelheim, Kyowa Kirin Pharmaceutical, Takeda; Financial Interests, Personal, Local PI: Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, AstraZeneca, Takeda, Merck Sharp & Dohme; Financial Interests, Personal, Research Grant: Taiho Pharmaceutical, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly, Boehringer Ingelheim, Eisai; Financial Interests, Personal, Steering Committee Member: Chugai Pharmaceutical. S. Matsumoto: Financial Interests, Personal, Other, Honoraria: Novartis, Ono Pharmaceutical. N. Yamamoto: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly Japan, Guardant Health Japan, Janssen Pharmaceutical, Life Technologies Japan, Merck Sharp & Dohme, Nippon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, Takeda; Financial Interests, Personal, Funding: AstraZeneca, Boehringer Ingelheim, Bristol Myer Squibbb, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, GSK, Hisamitsu Pharmaceutical, Merck, Merck Sharp & Dohme, Nippon Kayaku, Novartis, Ono Pharmaceutical, Pfizer, Sanofi, Taiho Pharmaceutical, Takeda, Thermo Fisher Scientific; Financial Interests, Personal, Leadership Role: Japan Lung Cancer Society, Japanese Association of Supportive Care in Cancer, West Japan Oncology Group. G. Saito: Financial Interests, Personal, Funding: Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical, AstraZeneca, Novartis, Merck Sharp & Dohme K.K., Pfizer, Daiichi Sankyo, Taiho Pharmaceutical. Y. Nishimura, S. Sugiyama, A. Oku, P. Karia: Financial Interests, Personal, Full or part-time Employment: 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; Financial Interests, Personal, Stocks/Shares: AstraZeneca. E. Martin: Financial Interests, Personal, Full or part-time Employment, Contracted through PHASTAR: AstraZeneca. P. Okhuoya: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks or ownership: AstraZeneca. M. Muto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd., Bristol Myers Squibb, Ono Pharmaceutical, Illumina, Takeda, Novartis, Lilly, Oncolys Pharmaceutical, Meiji Seika Pharmaceutical, Daiichi Sankyo, Bayer; Financial Interests, Personal, Research Funding: Chugai Pharmaceutical, Co., Ltd., Taiho Pharmaceutical, NTT, Canon Medical, HU holdings, Intage Healthcare, NTT data, Nihon Shashin Insatsu. All other authors have declared no conflicts of interest.