155P - Tarlatamab for patients with small cell lung cancer: 6-8 hour outpatient vs 48 hour inpatient monitoring in cycle 1

Background

Tarlatamab, a bispecific T-cell engager (BiTE®) immunotherapy targeting delta-like ligand 3, has shown promising outcomes in previously treated small cell lung cancer (SCLC). We evaluated the safety of a reduced 6-8 hour (h) monitoring period with tarlatamab in an outpatient setting in the phase 1 DeLLphi-300 study.

Methods

Patients (pts) with previously treated SCLC were enrolled in Part F evaluating 6-8 h outpatient monitoring for cycle 1 doses and received tarlatamab 10 mg Q2W dosing (1 mg on day 1, 10 mg on day 8 and 15 of cycle 1, and Q2W thereafter). Pts needed a caregiver and remained within 1 h of study site or affiliated hospital for 72 h post-dose. Clinic visits on days 2, 3, 5, 9, 16, and 22 were required to mitigate risk of underreporting adverse events (AEs). The primary endpoint was safety and tolerability. Safety outcomes were compared to pts from Part A cohorts who received tarlatamab 10 mg Q2W dosing with 48 h inpatient monitoring for cycle 1 doses. AEs were classified per CTCAE v4.0 and cytokine release syndrome (CRS) graded per Lee DW et al, Blood 2014.

Results

A total of 88 pts (66 years median age; 51% male; median 2 prior lines of therapy) were enrolled, including 30 in the outpatient group and 58 in the inpatient group. The outpatient vs inpatient groups had a similar incidence of treatment-related AEs (93% vs 100%) and serious AEs (20% vs 29%). CRS incidence and time to resolution were similar between groups (Table 1). In the outpatient group, 18 pts had 25 cycle 1 CRS events, all of which resolved. Of the 25 CRS events, 5 events required hospitalization and 2 events involved an emergency room visit. Immune effector cell–associated neurotoxicity syndrome was rare (outpatient: 3.3%; inpatient: 3.4%). The hospitalization rate for any AE in cycle 1 was similar between groups. Table: 155P

^∗Highest grade CRS per subject.

Conclusions

There were no major differences in safety outcomes following tarlatamab administration with 6-8 h outpatient versus 48 h inpatient monitoring in cycle 1.

Clinical trial identification

NCT03319940.

Editorial acknowledgement

Medical writing support for the development of this abstract was provided by Sanna Abbasi, PhD, and Kevin Ryder, PhD, of Red Nucleus, and Alexander Patananan, PhD, an employee of Amgen Inc.

Legal entity responsible for the study

Amgen Inc.

Funding

Amgen Inc.

Disclosure

A.C. Chiang: Financial Interests, Personal, Advisory Role: AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Catalyst Pharmaceuticals, Daichi, Flatiron Health, Genentech, Genentech/Roche, Jazz Pharmaceuticals, regeneron, Sanofi/Regeneron; Financial Interests, Institutional, Research Funding: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Lilly, Millennium, OncoMed, Onyx, Stem CentRx; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: AbbVie, AstraZeneca, Genentech/Roche. J. Carlisle: Financial Interests, Institutional, Research Funding: AstraZeneca. A. Dowlati: Financial Interests, Personal, Advisory Role: AbbVie/Stemcentrx, AstraZeneca, Bristol Myers Squibb, Ipsen, Merck, Tempus; Financial Interests, Institutional, Research Funding: Lilly/ImClone, Amgen, Bristol Myers Squibb, Tesaro, Takeda, Mirati Therapeutics, AbbVie/Stemcentrx, Bayer, Seagen, Ipsen, Pionyr, Coordination Pharmaceuticals, Astellas Pharma, Bicycle Therapeutics, Gilead Sciences. N. Reguart: Financial Interests, Personal, Advisory Board: Roche, MSD, Takeda, Bayer, Boehringer, Pfizer, Novartis, Sanofi, Janssen, AstraZeneca, Amgen, Novartis, Merck, Janssen, AbbVie; Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, BMS, Amgen, Novartis, Sanofi, Merck; Non-Financial Interests, Personal, Principal Investigator, PI of Investigator Initiated Trial (PEERS) sponsored by MSD: MSD. E. Felip: Financial Interests, Personal, Advisory Board: AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Gilead, Glaxo Smith Kline, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, Peptomyc, Regeneron, Sanofi, Takeda, Turning Point, Pfizer, Genmab; Financial Interests, Personal, Invited Speaker: Amgen, Daiichi Sankyo, Genentech, Janssen, Medical Trends, Medscape, Merck Serono, Peervoice, Pfizer, Sanofi, Takeda, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Merck Sharp & Dohme; Financial Interests, Personal, Member of Board of Directors, Independent member: Grifols; Financial Interests, Institutional, Local PI, Clinical Trial: AstraZeneca AB, AbbVie, Amgen, Bayer Consumer Care AG, Beigene, Boehringer Ingelheim GmbH, Bristol Myers Squibb International Corporation, Daiichi Sankyo Inc., Exelixis Inc., F. Hoffmann-La Roche Ltd., Genentech Inc., Glaxo Smith Kline Research and Development Limited, Janssen Cilag International NV, Merck Sharp & Dohme Corp, Merck KGAA, Mirati Therapeutics Inc., Novartis Pharmaceutica SA, Pfizer, Takeda Pharmaceuticals International; Financial Interests, Institutional, Local PI: Nuvalent; Non-Financial Interests, Personal, Leadership Role, President (2021-2023): SEOM (Sociedad Espanola de Oncologia Medica); Non-Financial Interests, Personal, Member, Member of Scientific Committee: ETOP (European Thoracic Oncology Platform); Non-Financial Interests, Personal, Member, Member of the Scientific Advisory Committee: CAC Hospital Universitari Parc Taulí. P.J. Jost: Financial Interests, Personal, Advisory Role: AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Pfizer, Servier, Roche, BMS/Celgene, Johnson and Johnson (Janssen), Merck, Sanofi/Aventis, Ipsen, Amgen, Cycuria Therapeutics; Financial Interests, Personal, Other, Online registration/travel/accommodation expenses: MSD, Pierre Fabre; Financial Interests, Personal, Advisory Board: Cycuria Therapeutics, Vessel; Financial Interests, Personal, Stocks/Shares: Vessel, Daiichi Sankyo, Cycuria Therapeutics; Financial Interests, Personal, Royalties: Venetoclax and MLKL Royalties, WEHI Australia; Financial Interests, Institutional, Funding: Boehringer, Novartis, Roche, Pierre Fabre, Stemline; Non-Financial Interests, Institutional, Principal Investigator: Boehringer, Novartis, Pierre Fabre, Stemline; Financial Interests, Personal, Full or part-time Employment: Cycuria Therapeutics; Financial Interests, Personal, Invited Speaker: Cycuria Therapeutics, Bayer, Boehringer, Novartis, Pfizer, Amgen, Ipsen, MSD, Janssen/Johnson&Johnson, Merck, Sanofi/Aventis, Pierre Fabre, Servier, Roche, BMS and Celgene; Financial Interests, Personal, Other, Received honoraria, travel/accommodation: AstraZeneca. N. Steeghs: Financial Interests, Institutional, Advisory Board: Boehringer Ingelheim, Bristol Myers Squibb, Ellipses Pharma; Financial Interests, Personal, Advisory Board: GSK, Incyte; Financial Interests, Institutional, Local PI: AbbVie, Actuate Therapeutics, Amgen, Anaveon, Ascendis Pharma, AstraZeneca, Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Cellcentric, Cogent Biosciences, Crescendo Biologics, Deciphera, Exelixis, Genentech, GSK, IDRx, Immunocore, Incyte, Janssen, Kling Biotherapeutics, Merck, Merck Sharp & Dohme, Merus, Molecular Partners, Novartis, Pfizer, Revolution Medicine, Roche, Sanofi, Sanofi, Seattle Genetics, Seattle Genetics, Taiho, Takeda; Financial Interests, Institutional, Research Grant: AstraZeneca, Blueprint Medicines, Deciphera, GSK, Lixte, Merck, Novartis, Pfizer, Roche, Zentalis. S. Gadgeel: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, Amgen, Genentech/Roche, Bristol Myers Squibb, Pfizer, Novartis, Gilead, Nuvation, Daiichi Sankyo Financial Interests, Personal, Other, Data Safety Monitoring Board: AstraZeneca. H.H.F. Loong: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Eli-Lilly, Novartis, Takeda, Bayer, Guardant Health, Celgene, Eisai, GSK, Illumina, Roche/Genentech; Financial Interests, Personal, Speaker’s Bureau: Guardant Health, Ignyta, Novartis; Financial Interests, Institutional, Research Funding: MSD Oncology (Inst).; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bayer, MSD Oncology, Pfizer, Roche. W. Jiang, A. Parkes: Financial Interests, Personal, Full or part-time Employment: Amgen; Financial Interests, Personal, Stocks/Shares: Amgen. A. Hamidi: Financial Interests, Personal, Stocks/Shares: Amgen; Financial Interests, Personal, Full or part-time Employment: Amgen. L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AZ, Lilly, PharmaMar, Beigene, Daiichi Sankyo, Medscape, PER; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati, Boehringer; Financial Interests, Personal, Other, Board member: Genomic, Altum sequencing; Financial Interests, Personal, Other, lectures: AICME; Financial Interests, Personal, Other, Lectures: CCO; Financial Interests, Personal, Member of Board of Directors, Board member: Stab Therapeutics; Financial Interests, Personal, Other, spin off (I have around 8% of stocks): Altum sequencing; Financial Interests, Personal, Ownership Interest, spin-off (10%): Stab Therapeutics; Financial Interests, Institutional, Coordinating PI: Daiichi Sankyo, AstraZeneca, Merck Sharp & Dohme Corp, BMS, Janssen-Cilag international NV, Novartis, Roche, Sanofi, Tesaro, Alkermes, Lilly, Takeda, Pfizer, PharmaMar, Cantargia; Financial Interests, Personal, Coordinating PI: Amgen; Financial Interests, Personal, Other, Member: AACR, ASCO, ESMO; Financial Interests, Personal, Other, Foundation Board Member: AECC; Financial Interests, Personal, Other, President. ASEICA (Spanish Association of Cancer Research): ASEICA; Financial Interests, Personal, Other, Foundation president: ONCOSUR; Financial Interests, Personal, Other, member: Small Lung Cancer Group; Non-Financial Interests, Personal, Other, Board member of this anti-cancer Charity: AECC; Non-Financial Interests, Personal, Member, Past-President: ASEICA (Spanish Cancer Research Association); Non-Financial Interests, Personal, Leadership Role, President: Oncosur Foundation. All other authors have declared no conflicts of interest.