Abstract 1384P
Background
Anti-programmed death 1 inhibitors including cemiplimab have been shown to be effective in global populations for the treatment of aNSCLC. The multicentre phase 1/2 expansion study (NCT03233139) in treatment-naïve Japanese patients (pts) with aNSCLC assessed safety, tolerability, pharmacokinetics and efficacy of 1L cemiplimab as monotherapy or with chemotherapy.
Methods
Japanese pts aged ≥20 years who had program death ligand 1 (PD-L1) expression ≥50% (Cohort A; n=60, safety; n=50, efficacy) received cemiplimab monotherapy, or any PD-L1 expression (Cohort C; n=50) received cemiplimab in combination with 4 cycles of chemotherapy. Cemiplimab was administered at 350 mg Q3W for up to 108 weeks. The primary analysis was performed when all pts had 3 post-baseline tumour assessments (∼28 weeks). Data cutoff was 5 Sep 2023 for Cohort A and 18 Oct 2023 for Cohort C.
Results
Baseline characteristics were similar across cohorts: median age was 65–70 years old and 76–80% were male. Median duration of follow up was 13.2 and 9.0 months in Cohorts A and C, respectively. In Cohort A, objective response rate (ORR) was 60% and median progression-free survival (PFS) was not reached (NR). Higher PD-L1 expression was associated with improvements in ORR and PFS. In Cohort C, ORR was 42% and median PFS was 8 months (Table). Median (95% CI) overall survival was 44.5 months (27.0–54.4) and NR (13.4–not evaluable) for Cohorts A and C, respectively. Immunogenicity was low in both cohorts. No new safety signals were identified in either cohort; adverse events ≥Grade 3 were experienced by 51.7% and 68.0% of pts in Cohorts A and C, respectively (Table).
Conclusions
Cemiplimab demonstrated consistent efficacy in Japanese pts as monotherapy for PD-L1 ≥50% and in combination with chemotherapy irrespective of PD-L1 expression. Safety was consistent with known safety profile of cemiplimab. Overall, cemiplimab demonstrated a favourable benefit-risk profile in Japanese pts. Table: 1384P
Summary of results from cohorts A and C
| Cohort A (n=50) | Cohort C (n=50) | |
| ORR | ||
| Overall, n (%) | 30/50 (60.0) | 21/50 (42.0) |
| 90% CI, % | 48.6–71.4 | 30.5–53.5 |
| PD-L1 ≥90%, n (%) | 18/29 (62.1) | – |
PD-L1 >60–Clinical trial identificationNCT03233139. Editorial acknowledgementThe study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi. Editorial support was provided by Rachel McGrandle, MSc, of Alpha (a division of Prime, Knutsford, UK) funded by Regeneron Pharmaceuticals, Inc. Responsibility for all opinions, conclusions, and data interpretation lies with the authors. Legal entity responsible for the studyRegeneron Pharmaceuticals, Inc. FundingRegeneron Pharmaceuticals, Inc. DisclosureY. Sato: Financial Interests, Personal, Other, Personal fees: AstraZeneca, Chugai Pharmaceutical, MSD, Ono Pharmaceutical, Novartis, Pfizer, Taiho Pharmaceutical, Nippon Kayaku, Bristol Myers Squibb, Eli Lilly, Takeda, Kyowa Kirin. H. Ishii: Financial Interests, Personal, Other, Honoraria: AstraZeneca. S. Katakura: Financial Interests, Personal, Other, Personal fees: AstraZeneca, Chugai Pharmaceutical, Taiho Pharmaceutical, Bristol Myers Squibb, Merck Sharp & Dohme, Eli Lilly, Takeda. M. Oki: Financial Interests, Personal, Research Funding: AbbVie Inc., Janssen Pharmaceutical K.K., MSD K.K., Parexel International Corporation, Sanofi K.K. T. Yokoyama: Financial Interests, Personal, Other, Honoraria: Takeda Pharmaceutical Co. Ltd; Financial Interests, Personal, Research Funding: MSD, Chugai Pharmaceutical Co., Ltd., Bristol Myers Squibb Co. Ltd., Boehringer Ingelheim Japan Inc., Takeda Pharmaceutical Co., Ltd., Delta-Fly Pharma, Janssen Pharmaceutical K.K., AbbVie GK, Daiichi Sankyo Co., Ltd. J. Pouliot, A.J. Paccaly, E. Kim, J. Mani, S. Li, I. Lowy, F. Seebach, M.D. Mathias: Financial Interests, Personal, Full or part-time Employment: Regeneron Pharmaceuticals, Inc.; Financial Interests, Personal, Stocks or ownership: Regeneron Pharmaceuticals, Inc. S. Ikeda: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Bristol Myers Squibb, Ono Pharmaceutical, Chugai Pharmaceutical Co. Ltd., Pfizer; Financial Interests, Personal, Research Funding: AstraZeneca, Chugai Pharmaceutical Co. Ltd. All other authors have declared no conflicts of interest. Resources from the same session1362P - Evaluation of imaging-based prognostication (IPRO) for advanced non-small cell lung cancer (aNSCLC) using deep learning applied to computed tomography (CT)Presenter: Omar Khan Session: Poster session 06 1363P - An AI-derived tool to pre-screen lung cancer candidates for clinical trialsPresenter: Mihaela Aldea Session: Poster session 06 1364P - Federated analysis of overall survival (OS) by location of metastases (mets) in patients (pts) with metastatic NSCLC (mNSCLC) from the Digital Oncology Network for Europe (DigiONE)Presenter: Åsa Öjlert Session: Poster session 06 1365P - Does cancer care differ for older adults with lung cancer living with and without Alzheimer disease and related dementias (ADRD)?Presenter: Lorinda Coombs Session: Poster session 06 1366P - Natural Language Processing (NLP) as promising artificial intelligence (AI) tool to improve patients (pts) enrollment in clinical trials (CT): Analysis in real-world conditions on a lung cancer cohortPresenter: Julien Mazieres Session: Poster session 06 1367P - Sex disparities in patient and tumour characteristics, and overall survival in advanced non-small cell lung cancer (NSCLC) within the precision oncology era: A Danish nationwide observational studyPresenter: Matilde Frost Session: Poster session 06 1368P - Correlation between depth of response at 6 months and survival in patients (pts) with metastatic non-small cell lung carcinoma (mNSCLC): SPORE trialPresenter: Fabien Moinard-Butot Session: Poster session 06 1369P - Trilaciclib combined with intraventricular injection chemotherapy in the treatment of advanced NSCLC with leptomeningeal metastasis: A prospective, single-arm, phase II clinical trialPresenter: Shen Cun Fang Session: Poster session 06 1370P - Survival of de novo metastatic non-small cell lung cancer according to biomarker status in Denmark and Norway: A register-based cohort studyPresenter: Johan Liseth Hansen Session: Poster session 06 This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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