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 session1352P - Real-world second-line outcomes of NSCLC patients receiving first-line chemotherapy plus immunotherapyPresenter: Marco Russano Session: Poster session 06 1353P - Efficacy and safety of docetaxel in combination with nintedanib or ramucirumab following immune checkpoint-Inhibitor treatment in patients with non-small cell lung cancerPresenter: Konstantinos Ferentinos Session: Poster session 06 1354P - Retrospective audit to determine the effect of antibiotic therapy on immune checkpoint inhibitor efficacy in stage IV NSCLCPresenter: Deevyashali Parekh Session: Poster session 06 1356P - Transcriptomic inflammatory profiling of non-small cell lung cancer: Insights from a 7-gene expression analysisPresenter: Elba Marin Session: Poster session 06 1357P - Multicenter phase II study of cisplatin and gemcitabine plus necitumumab in patients with unresectable, advanced lung squamous cell carcinoma who have progressed on or after initial treatment with immune checkpoint inhibitors plus platinum-based chemotherapy: WJOG14120L NESSIE studyPresenter: Hiroshige Yoshioka Session: Poster session 06 1358P - Plinabulin/docetaxel versus docetaxel in survival benefits of 2L/3L EGFR wild-type NSCLC after platinum regimens (DUBLIN-3): A randomized phase III trialPresenter: Trevor Feinstein Session: Poster session 06 1359P - Lack of Abscopal effect and radiotherapy-induced lymphocyte depletion in advanced non-small cell lung cancer (NSCLC) patients treated with atezolizumab and radiotherapyPresenter: Alexander Meisel Session: Poster session 06 1361P - The Stereotactic Radiosurgery-Brain Prognostic Index (SRS-BPI): A novel prognostic index for lung cancer patients with brain metastases eligible for SRSPresenter: Andreas Koulouris 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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