626MO - Tarlatamab in previously treated small cell lung cancer (SCLC): Subgroup analysis of patients from the Asia region in the phase II DeLLphi-301 study

Background

Tarlatamab (IMDELLTRA™) is a bispecific T-cell engager (BiTE®) immunotherapy that binds delta-like ligand 3 (DLL3) on the surface of SCLC cells and CD3 on T cells, facilitating T-cell-mediated cancer cell lysis. In the phase II DeLLphi-301 study primary analysis, tarlatamab showed a favorable benefit-to-risk profile with durable objective responses and promising survival outcomes in patients (pts) with previously treated SCLC. Here, the phase II data for the Asia region (AR) subgroup are presented.

Methods

Pts with previously treated SCLC received 10 mg or 100 mg tarlatamab every two weeks (Q2W). The primary endpoint was objective response rate (ORR) by blinded independent central review (RECIST 1.1). Other endpoints were duration of response (DoR), progression-free survival (PFS), overall survival (OS), and safety. Patients were enrolled in Asia, Europe, and North America. A subgroup analysis by region (AR vs non-Asia region [NAR]) was performed.

Results

Of the 100 pts in the tarlatamab 10 mg Q2W group, 41 were from Asia. The median follow-up was 16.6 months (mo). Platinum sensitivity duration < 90 days (AR, 36.6%; NAR, 22.0%), ECOG performance status of 1 (AR, 85.4%; NAR, 66.1%), and never smokers (AR, 17.1%; NAR, 1.7%) were assessed at baseline. At the 10 mg dose for the AR, ORR was 46.3%, mDoR was 7.2 mo, mPFS was 5.4 mo, and mOS was 19.0 mo (Table). Of the 133 pts treated with tarlatamab 10 mg in the safety analysis set (includes pts in safety substudy [n = 34]), the most common treatment-emergent adverse event (AE) was cytokine release syndrome ([CRS]; AR, 48.8%; NAR, 54.4%) which was mostly grade 1 or 2. Incidence of grade 3 CRS was low (AR, 0%; NAR 1.1%) with no grade 4 or 5 events. Discontinuations due to treatment-related AEs were infrequent (AR, 0%; NAR, 5.6%) Table: 626MO

*Does not include patients in safety substudy (n = 34). ^†One patient did not receive tarlatamab. AR = Asia region; NAR = non-Asia region; NE = not estimable.

Conclusions

Tarlatamab demonstrated durable responses and a manageable safety profile in this post hoc analysis of patients with previously treated SCLC from the Asia region.

Clinical trial identification

NCT05060016.

Editorial acknowledgement

Sharraya Guirguis, Amgen Inc.

Legal entity responsible for the study

Amgen, Inc.

Funding

Amgen.

Disclosure

B.C. Cho: Financial Interests, Personal, Other, Consulting role: Abion, BeiGene, Novartis, AstraZeneca, Boehringer-Ingelheim, Roche, BMS, CJ, CureLogen, Cyrus therapeutics, Ono, Onegene Biotechnology, Yuhan, Pfizer, Eli Lilly, GI-Cell, Guardant, HK Inno-N, Imnewrun Biosciences Inc., Janssen, Takeda, MSD, Medpacto, Blueprint medicines, RandBio, Hanmi; Financial Interests, Personal, Advisory Board: KANAPH Therapeutic Inc, Bridgebio therapeutics, Cyrus therapeutics, Guardant Health, Oscotec Inc, J INTS Bio, Therapex Co., Ltd, Gilead, Amgen; Financial Interests, Personal, Member of Board of Directors: J INTS BIO; Financial Interests, Personal, Full or part-time Employment: Yonsei University Health System; Financial Interests, Personal, Stocks/Shares: TheraCanVac Inc, Gencurix Inc, Bridgebio therapeutics, KANAPH Therapeutic Inc, Cyrus therapeutics, Interpark Bio Convergence Corp., J INTS BIO; Financial Interests, Personal, Royalties, PDX, PDO, PDC Licensing Contract – not patent: Champions Oncology, Crown Bioscience, Imagen, PearlRiver Bio GmbH; Financial Interests, Institutional, Research Grant: CHA Bundang Medical Center, MOGAM Institute, LG Chem, Oscotec, GIInnovation, GI-Cell, Abion, AbbVie, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Champions Onoclogy, CJ bioscience, CJ Blossom Park, Cyrus, Dizal Pharma, Genexine, Janssen, Lilly, MSD, Novartis, Nuvalent, Oncternal, Ono, Regeneron, Dong-A ST, Bridgebio therapeutics, Yuhan, ImmuneOncia, Illumina, Kanaph therapeutics, JINTSbio, Hanmi, Vertical Bio AG, National Research Foundation of Korea, KHIDI, Therapex; Other, Personal, Other, Founder: DAAN Biotherapeutics; Other, Personal, Other, Invited speaker: ASCO, AstraZeneca, Guardant, Roche, ESMO, IASLC, Korean Cancer Association, Korean Society of Thyroid-Head and Neck Surgery, Korean Cancer Study Group, Novartis, MSD, The Chinese Thoracic Oncology Society, Pfizer, Liangyihui Network Technology Co., Ltd. K. Ohashi: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Eli Lilly Japan, Kyowa-Kirin, Novartis Japan; Non-Financial Interests, Institutional, Local PI: Amgen, BeiGene, Daiichi Sankyo, Eli Lilly ; Financial Interests, Personal, Research Grant: Chugai Pharmaceutical Co., Daiichi Sankyo, Eli Lilly Japan. H. Izumi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Eli Lilly, Takeda; Financial Interests, Institutional, Principal Investigator: AstraZeneca, Amgen, AbbVie, Takeda, Arrivent, Daiichi Sankyo, Ono; Financial Interests, Personal, Advisory Board: Amgen. J. Han: Financial Interests, Personal, Advisory Board: Novartis, Lantern, Takeda, Janssen, Merck, Pfizer, Amgen, AstraZeneca, Oncobix, AbbVie; Financial Interests, Personal, Invited Speaker: AstraZeneca, Janssen, Merck, Roche, Yuhan, Pfizer, Novartis. C.L. Chiang: Financial Interests, Personal, Other, Honorarium: AstraZeneca, Boehringer Ingelheim, Chugai, MSD, Pfizer, Roche. H. Akamatsu: Financial Interests, Personal, Other, Honoraria: Amgen Inc., AstraZeneca K.K., Boehringer Ingelheim Japan Inc, Bristol Myers Squibb, Chugai Pharmaceutical Co., Daiichi Sankyo, Eli Lilly Japan K.K, MSD K.K., Nippon Kayaku, Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer Inc, Takeda Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd.; Financial Interests, Personal, Advisory Role: Amgen Inc., Janssen Pharmaceutical K.K., GSK, Sandoz; Financial Interests, Institutional, Research Funding: Amgen Inc., Chugai Pharmaceutical Co. Ltd., MSD K.K. S. Huang, A. Hamidi, S. Mukherjee, K.L. Xu: Financial Interests, Institutional, Full or part-time Employment: Amgen; Financial Interests, Institutional, Stocks/Shares: Amgen. M. Ahn: Financial Interests, Personal, Advisory Board: AstraZeneca, Takeda, MSD, Yuhan, Amgen, Alpha Pharmaceutical, Janssen, Bristol Myers Squibb, Roche, Daiichi Sankyo, Merck, Boronoi. All other authors have declared no conflicts of interest.