1993P - Phase IIIb study of durvalumab plus platinum–etoposide in first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): Safety results

Background

Most patients (Pts) with small-cell lung cancer (SCLC) have extensive-stage (ES) disease at diagnosis and poor prognosis. First-line (1L) durvalumab (D) plus platinum–etoposide (EP) significantly improved overall survival in pts with ES-SCLC vs control group in CASPIAN study. CANTABRICO study assess safety and effectiveness of D+EP in a real-world ES-SCLC population in Spain.

Methods

CANTABRICO is a phase IIIb, single arm, multicentre study (NCT04712903). Eligible Pts were ≥18 years old with treatment-naive ES-SCLC, ECOG PS 0-2, ≥1 measurable lesion. D (1500 mg) was concurrently administered with 1L cisplatin or carboplatin (CP) d1 plus etoposide d1-3 every 3 weeks (q3w) for 4-6 cycles, followed by maintenance (q4w) until progressive disease/unacceptable toxicity. Safety results [incidence of grade (G) 3 adverse events (AEs) and immune-mediated AEs (imAEs)] are presented.

Results

Between December 2020 and April 2021, 101 pts from 35 sites in Spain were included. By March 2, 2023 all pts had finished chemotherapy (87% CP) and 15 pts were still receiving D. 56% of pts were ≥ 65 years old, 67% were men, 94% had ECOG 0-1. 34%, 37% and 11% of pts had liver, bone or brain metastases, respectively. 98% were current/former smokers and 10% had limited stage diagnosis. 30% received 6 cycles of EP+D and 81% started D monotherapy. Median number of D doses were 8 (Interquartile range 5-11). AEs occurred in 99% of pts; G3-4 AEs in 74%; and AEs leading to discontinuation 8%. Most common G3-4 AEs were neutropenia (22%) and anemia (23%). Deaths due to any cause AEs occurred in 8% of pts (respiratory infection, hemoptysis, sepsis (2), cardiorespiratory arrest, COVID-19, intracranial hemorrhage and immune-mediated neurological syndrome). imAEs were reported in 32% of pts. Most were G1-2; G3-5 imAEs occurred in 10% of pts. Deaths due to imAEs occurred in 1 pt (immune-mediated neurological syndrome). Main imAEs were hypothyroidism (13%), pneumonitis (5%) and diarrhea (4%), among others.

Conclusions

CANTABRICO safety profile appeared consistent with that seen in the CASPIAN study, providing real-world evidence regarding safety of D+EP in ES-SCLC.

Clinical trial identification

NCT04712903 EudraCT 2020-002328-35.

Editorial acknowledgement

Authors thanks Juan Luis Sanz (APICES) for his editorial assistance.

Legal entity responsible for the study

AstraZeneca Spain.

Funding

AstraZeneca Spain.

Disclosure

M.D. Isla Casado: Financial Interests, Personal, Other, Consulation Honoraria: Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, F. Hoffmann-La Roche, Janssen, Lilly, Merck, MSD, Pfizer, Sanofi, Takeda; Financial Interests, Personal, Invited Speaker: Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, F. Hoffmann-La Roche, Janssen, MSD, Novartis, Pfizer, Takeda; Financial Interests, Institutional, Other, Clinical Trials: Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, F. Hoffmann-La Roche, GSK, Janssen, Lilly, Merck, Mirati Therapeutics, Novartis, Pfizer, Sanofi; Financial Interests, Institutional, Research Grant: AstraZeneca, BMS, F. Hoffmann-La Roche, GSK. E. Arriola: Financial Interests, Personal, Advisory Board: Roche, Boehringer Ingelheim, Lilly; Financial Interests, Personal, Invited Speaker: Takeda, MSD, AstraZeneca, BMS, Thermo Fisher Scientific, Guardant Health, Pfizer; Financial Interests, Personal, Other, Co-founder: Trialing Health; Financial Interests, Institutional, Research Grant: AstraZeneca. P. Diz Tain: Financial Interests, Personal, Invited Speaker: BMS, AstraZeneca, Boehringer Ingelheim, Roche, MSD, Takeda, Pfizer, Amgen; Financial Interests, Personal, Advisory Role: BMS, Boehringer Ingelheim, Roche, MSD, Takeda; Financial Interests, Personal, Training: BMS, Boehringer Ingelheim, Roche, MSD, Takeda, Pfizer; Financial Interests, Personal and Institutional, Training: AstraZeneca; Financial Interests, Personal and Institutional, Advisory Role: AstraZeneca; Financial Interests, Personal and Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Principal Investigator: Roche, Mirati. C. Marti Blanco: Financial Interests, Personal, Invited Speaker: MSD, BMS, AstraZeneca; Financial Interests, Personal, Other, Travel/accommodation expenses: Merck, MSD, BMS. A.L. Moreno Vega: Financial Interests, Personal, Invited Speaker: PharmaMar, Roche, AstraZeneca, Takeda, MSD, Pfizer; Financial Interests, Personal, Research Grant: FIBICO (IMIBIC). L.A. Leon Mateos: Financial Interests, Personal, Other, travel, accommodations, expenses: Lilly; Financial Interests, Personal, Other, Travel, accommodations, expenses: Novartis, Pfizer, Merck, Roche, BMS; Financial Interests, Personal, Other, Educational activities: Lilly, Novartis, Pfizer, AstraZeneca, Merck, Roche, BMS; Financial Interests, Personal, Speaker, Consultant, Advisor: PharmaMar, Bayer, AstraZeneca. J.M. Oramas Rodriguez: Financial Interests, Personal, Invited Speaker: MSD, BMS, Roche. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca, Takeda, Janssen, Cassen Recordati, BMS; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche. A. Sanchez Hernandez: Financial Interests, Personal, Other, Honoraria: Roche, MSD, BMS, AstraZeneca, Janssen, Takeda, Pfizer, Amgen; Financial Interests, Personal, Advisory Role: Roche, MSD, AstraZeneca, BMS, Takeda, Pfizer, Amgen; Financial Interests, Personal, Speaker’s Bureau: Roche, MSD, AstraZeneca, Janssen, BMS, Takeda, Pfizer, Amgen. C. Aguado: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, MSD, BMS, Roche, Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, Roche, Novartis; Financial Interests, Personal, Principal Investigator: AstraZeneca, MSD, Mirati. A. Moreno Paul: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Ipsen; Non-Financial Interests, Personal, Other: MSD. J.L. Firvida Perez: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Boehringer Ingelheim, Pfizer, Roche, Takeda; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Boehringer Ingelheim, Pfizer, Roche, Takeda. Á Callejo Mellén, L. Baez: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. L. Paz-Ares: Financial Interests, Personal, Advisory Board, Speaker fees: Roche, MSD, BMS, AstraZeneca, Lilly, PharmaMar, BeiGene, Daiichi Sankyo, Medscape, PER; Financial Interests, Personal, Advisory Board: Merck Serono, Pfizer, Bayer, Amgen, Janssen, GSK, Novartis, Takeda, Sanofi, Mirati; Financial Interests, Personal, Other, Board member: Genomica, Altum sequencing; 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; Financial Interests, Personal, Coordinating PI: Amgen; Financial Interests, Other, Member: AACR, ASCO, ESMO; Financial Interests, Other, Foundation Board Member: AECC; Financial Interests, Other, President. ASEICA (Spanish Association of Cancer Research): ASEICA; Financial Interests, Other, Foundation president: ONCOSUR; Financial Interests, Other, member: Small Lung Cancer Group. All other authors have declared no conflicts of interest.