1530P - Durvalumab (D) + platinum-etoposide (EP) in first-line extensive-stage SCLC (ES SCLC): Effect of age and platinum agent on outcomes in CASPIAN

Background

In the Phase 3 CASPIAN trial in pts with ES-SCLC, first-line D+EP significantly improved overall survival (OS) vs EP alone, and OS benefit was sustained after >3 yrs median follow-up (HR 0.71; 95% CI 0.60‒0.86; nominal p=0.0003). Many pts present with ES-SCLC at ≥70 yrs of age, and pts in CASPIAN could receive investigator’s choice of cisplatin (cis) or carboplatin (carbo); here we assess outcomes in CASPIAN subgroups (subgps) defined by age and planned platinum.

Methods

Pts with treatment-naïve ES-SCLC received 4 cycles of D+EP q3w followed by maintenance D q4w until progression, or up to 6 cycles of EP q3w. In exploratory analyses, OS and safety (median follow-up 39.4 and 25.1 months, respectively) were assessed in age subgps (<70 or ≥70 yrs; post-hoc subgps) and planned platinum subgps (cis or carbo; prespecified subgps and stratification factor).

Results

Of 537 pts randomised to D+EP and EP, 433 (81%) were <70 yrs and 104 (19%) were ≥70 yrs; 135 (25%) were assigned to receive cis and 402 (75%) to receive carbo. Baseline characteristics were generally balanced between arms within each subgp. More pts received cis in the <70 yrs subgp vs ≥70 yrs subgp (28% vs 11%). In the cis subgp, more pts received ≥4 cycles of EP in the D+EP arm vs the EP arm (Table). In age subgps, median OS in the D+EP arm vs the EP arm was consistent in pts aged <70 and ≥70 yrs, and OS benefit was maintained over time in both subgps. In the D+EP arm, median OS was numerically higher in the cis subgp (wide CI) vs carbo subgp; OS benefit was maintained over time in both subgps. There were more AEs leading to treatment discontinuation in the cis subgp vs carbo subgp. Table: 1530P

*Based on etoposide

Conclusions

In CASPIAN, similar OS benefit was evident across age and platinum subgps, sustained over time, and consistent with the intent-to-treat population. D+EP was generally well tolerated across subgps. These data further support the use of D+EP as first-line standard of care in ES-SCLC regardless of age or platinum agent.

Clinical trial identification

NCT03043872, release date February 6, 2017.

Editorial acknowledgement

Medical writing support for the development of this abstract, under the direction of the authors, was provided by Helen Kitchen of Ashfield MedComms (Macclesfield, UK), an Ashfield Health company.

Legal entity responsible for the study

AstraZeneca PLC.

Funding

AstraZeneca.

Disclosure

N. Reinmuth: Financial Interests, Personal and Institutional, Invited Speaker: Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, Daiichi Sankyo, Hoffmann-La Roche, Lilly, MSD, Merck, Pfizer, Takeda; Financial Interests, Personal and Institutional, Advisory Board: Amgen, AstraZeneca, Bristol-Myers Squibb, Hoffmann-La Roche, MSD, Pfizer; Financial Interests, Institutional, Advisory Role: Symphogen (IDMC). J.W. Goldman: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, Bristol-Myers Squibb, Genentech, Janssen, Pfizer; Financial Interests, Personal, Research Grant: AbbVie, Advaxis, Array/Pfizer, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Merck, Pfizer, Puma, Spectrum, Tesaro, Vaccinex; Non-Financial Interests, Personal, Principal Investigator: AbbVie, Advaxis, Array/Pfizer, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Merck, Pfizer, Puma, Spectrum, Tesaro, Vaccinex. Y. Chen: Financial Interests, Personal, Writing Engagements: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Bristol-Myers Squibb, Amgen, Pfizer, Takeda, Jazz Pharmaceutical, Guardant Health; Financial Interests, Personal, Advisory Board: AstraZeneca, Bristol Myers Squibb, Amgen, Mirati; Financial Interests, Personal, Principal Investigator: AstraZeneca, Merck, Amgen, EMD Serono. K. Hotta: Financial Interests, Personal, Speaker’s Bureau: Pfizer, AstraZeneca, Chugai, Lilly, Takeda, MSD, BMS, Ono, Taiho, Boehringer Ingelheim; Financial Interests, Personal, Research Grant: MSD, AstraZeneca, Chugai, Lilly, BMS, AbbVie. G. Statsenko: Financial Interests, Personal, Principal Investigator: AstraZeneca, MCD, AbbVie, BeiGene. M.J. Hochmair: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Roche, Boehringer Ingelheim, Takeda, Lilly, Pfizer; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, MSD, Roche, Boehringer Ingelheim, Takeda, Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Roche, Boehringer Ingelheim, Takeda, Lilly. M. Ozguroglu: Non-Financial Interests, Personal, Invited Speaker: AstraZeneca, Regeneron; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Regeneron, Bayer; Other, Personal, Principal Investigator: AstraZeneca, MSD, Roche, Bayer, Gilead, Novartis, Sanofi, Janssen, Regeneron; Other, Personal, Member, Steering committee Membership: AstraZeneca, Bayer, Regeneron. J. Ji: Non-Financial Interests, Personal, Member of the Board of Directors, Executive secretary: Korean Cancer Study Group; Financial Interests, Personal, Project Lead: JW Pharmaceutics; Financial Interests, Institutional, Principal Investigator: Roche, AstraZeneca, JW Pharmaceutics, Celltrion, Hyundai Pharm, Daewoong Pharma; Financial Interests, Personal, Training: Samsung Medical Center; Financial Interests, Personal, Member: KSMO, KCA; Financial Interests, Personal, Affiliate: Sungkyunkwan University; Financial Interests, Personal, Leadership Role, Associate Professor: Associate Professor. M.C. Garassino: Financial Interests, Personal, Other: AstraZeneca, MSD International GmbH, Bristol Myers Squibb, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regerenon; Financial Interests, Institutional, Other: Eli Lilly, Merck Sharp & Dohme, Pfizer (MISP), AstraZeneca, MSD International GmbH, Bristol Myers Squibb Italia S.p.A, Celgene, Incyte, Ignyta, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine, GlaxoSmithKline, Spectrum Pharmaceuticals, Boehringer Ingelheim Italia S.p.A; Financial Interests, Personal and Institutional, Other: AIRC, AIFA, Italian Moh, Transcan. F. Verderame: Non-Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca. H. Mann: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. P. Chugh: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. T.B. Dalvi: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. L. Paz-Ares: Financial Interests, Personal, Research Grant: AstraZeneca, Bristol Myers Squibb, MSD, Pfizer; Financial Interests, Personal, Advisory Role, Consulting fees: Amgen, AstraZeneca, Bayer, Blueprint Medicines, Bristol Myers Squibb, Ipsen, Lilly, Merck, Mirati, MSD, Novartis, Pfizer, PharmaMar, Roche, Sanofi, Servier; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Janssen, Merck, Mirati, Sanofi; Financial Interests, Personal, Leadership Role: Genomica, Altum Sequencing. All other authors have declared no conflicts of interest.