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 session1393TiP - A phase II/III study to evaluate the optimal dose, safety, and efficacy of livmoniplimab (Livmo) in combination with budigalimab (Budi) plus chemotherapy (CT) vs pembrolizumab (Pembro) plus CT in untreated metastatic non-small cell lung cancer (mNSCLC)Presenter: Nicolas Girard Session: Poster session 06 1394TiP - KRYSTAL-7: A phase III study of first-line adagrasib plus pembrolizumab versus pembrolizumab alone in patients with advanced NSCLC with KRASG12C mutationPresenter: Marina Garassino Session: Poster session 06 1395TiP - A randomized phase III trial evaluating oral BAY 2927088, compared with standard of care, as first-line treatment of locally advanced or metastatic NSCLC harboring HER2-activating mutations (SOHO-02)Presenter: Antonio Passaro Session: Poster session 06 1397TiP - Phase III trial of the therapeutic cancer vaccine OSE2101 versus docetaxel in patients with metastatic non-small cell lung cancer and secondary resistance to immunotherapyPresenter: Stephen Liu Session: Poster session 06 Resources: Abstract 1398TiP - Be6A Lung-01, a phase III study of sigvotatug vedotin (SV), an investigational antibody-drug conjugate (ADC) versus docetaxel in patients (pts) with previously treated non-small cell lung cancer (NSCLC)Presenter: Solange Peters Session: Poster session 06 1399TiP - Phase III, double-blind study of cannabis sativa extract in pain management and quality of life in patients with metastatic lung cancer: Protocol of a study (IPElife trial)Presenter: Danielli Matias Session: Poster session 06 1728P - Results of TNT: A phase II study using talimogene laherparepvec, nivolumab and trabectedin for advanced leiomyosarcoma and liposarcoma [NCT# 03886311]Presenter: Sant Chawla Session: Poster session 06 1729P - Update on SAINT: A phase II study using trabectedin (T) in combination with ipilimumab (I) and nivolumab (N) in previously treated soft tissue sarcomaPresenter: Anmol Dia Agarwal Session: Poster session 06 1730P - Preliminary results of phase II study on preoperative intensity-modulated radiotherapy with concurrent PARP inhibitor for patients with non-metastatic inoperable or borderline operable extremity and trunk soft tissue sarcomaPresenter: NingNing Lu Session: Poster session 06 Resources: Abstract 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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