Abstract 499P
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
All pts (N=143) | FLAURA-like cohort (n=130) | |
Median OS (95% CI), months | 37.4 (30.0–NC) | 38.5 (36.4–NC) |
Median TTNTD (95% CI), months | 22.8 (16.2–29.2) | 26.3 (16.2–37.7) |
Median TTD (95% CI), months | 13.4 (9.3–21.4) | 17.7 (13.2–28.3) |
Median OS by EGFR mutation type (95% CI), months | ||
Exon 19 deletion | 37.5 (29.2–NC) | – |
L858R | 37.4 (30.0–NC) | – |
Median rwPFS (95% CI), months | 19.7 (15.6–24.0) | 22.2 (18.4–29.0) |
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.
Resources from the same session
49P - Survival outcomes of HER2-positive breast cancer patients treated with neoadjuvant therapy at a single cancer centre in India
Presenter: Minit Shah
Session: Poster Display
Resources:
Abstract
50P - A nationwide retrospective cohort study of the response to neoadjuvant chemotherapy between HER-2 low and HER-2 negative non-metastatic breast cancer in Qatar: A real-world analysis
Presenter: Ahmed Kardousha
Session: Poster Display
Resources:
Abstract
51P - Four-year outcomes of hypofractionated postmastectomy radiation therapy of 39 Gy in 13 fractionations
Presenter: Sevinj Gahramanova
Session: Poster Display
Resources:
Abstract
52P - A comparative study to assess volumetric and dosimetric profile of heart and lung in patients undergoing left sided post mastectomy radiotherapy: Continuous positive airway pressure (CPAP) versus free breathing (FB) techniques
Presenter: Pritanjali Singh
Session: Poster Display
Resources:
Abstract
29P - HUWE1 inhibition has tumor suppressive effect in triple-negative breast cancer cell lines by modulating glycolytic and immune modulatory markers
Presenter: Shruti Kahol
Session: Poster Display
Resources:
Abstract
53P - Radiotherapy utilization rate for breast cancer in Indonesia: A call for empowering cancer care
Presenter: Donald Manuain
Session: Poster Display
Resources:
Abstract
58P - Safety and pharmacokinetics (PK) of vepdegestrant in Japanese patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)- advanced breast cancer: Results from a Japanese phase I study
Presenter: Hiroji Iwata
Session: Poster Display
Resources:
Abstract
59P - Comprehensive genomic profiling (CGP) unravels druggable targets in breast carcinoma (BC): A single institutional experience
Presenter: Gautam Balaram
Session: Poster Display
Resources:
Abstract
60P - A study of gene alterations in Asian patients with late stage and recurrent breast cancer
Presenter: Po-Sheng Yang
Session: Poster Display
Resources:
Abstract
61P - Tumor cell-released autophagosomes (TRAPs) remodel the breast tumor microenvironment by inducing the formation of inflammatory cancer-associated fibroblasts (CAFs)
Presenter: Chengdong Wu
Session: Poster Display
Resources:
Abstract