1171MO - PACIFIC-R real-world study: Treatment duration and interim analysis of progression-free survival in unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy

Background

Durvalumab consolidation therapy for up to 12 months (PACIFIC regimen) is now standard of care in patients (pts) with unresectable Stage III non-small-cell lung cancer (NSCLC) without disease progression after platinum-based chemoradiotherapy (CRT). PACIFIC-R assesses the effectiveness of durvalumab in this pt population in a real-life setting.

Methods

PACIFIC-R (NCT03798535) is a large international, observational study in pts who received ≥1 dose of durvalumab (10 mg/kg Q2W) as part of an AstraZeneca-initiated expanded access program. Pts had completed platinum-based chemotherapy concurrent or sequential to radiotherapy within the previous 12 weeks without evidence of disease progression.

Results

Outcomes were assessed in the full analysis set (N=1155). Median time to durvalumab initiation after the end of RT was 52 days. Overall median durvalumab treatment duration was 337 days (11 months); 232 (20.1%) pts received treatment for >12 months (50 [4.3%] for >14 months). Pts received a median of 22 infusions. Reasons for/median time to treatment discontinuation included completion of treatment (47.6%/11.8 months; investigator decision per country protocol), disease progression (25.8%/5.1 months) and adverse event (AE; 17.5%/2.8 months). Pneumonitis was the most common AE leading to discontinuation (temporary: 5.1%; permanent: 8.7%). 214 (18.5%) pts had any-grade pneumonitis and/or interstitial lung disease (median time from durvalumab start: 74 days [2.4 months]). Of these, most events were moderate (8.8%) in severity; 2 (0.2%) and 1 (0.1%) pts had a life-threatening or fatal event, respectively. Interim analysis (51.8% of events) showed a median real-world PFS (rwPFS) of 22.5 months (95% CI, 19.7–25.5). rwPFS by baseline PD-L1 status and prior CRT will be included in the final presentation.

Conclusions

These results demonstrate the effectiveness of consolidation durvalumab after CRT in a real-world cohort of pts with unresectable Stage III NSCLC; pneumonitis events were mostly moderate in severity. Additional data from an externally sponsored study with similar enrolment criteria in Spain will be included in the final presentation.

Clinical trial identification

NCT03798535; Release date: 10 January 2019.

Editorial acknowledgement

Medical writing support for the development of this manuscript, under the direction of the authors, was provided by Carole Mongin-Bulewski, PhD, of Ashfield MedComms (Manchester, UK), an Ashfield Health company, and was funded by AstraZeneca.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

N. Girard: Financial Interests, Personal, Other: AstraZeneca; Non-Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Bristol Myers Squibb; Non-Financial Interests, Personal, Other: Bristol Myers Squibb; Financial Interests, Personal, Other: Merck Sharp & Dohme; Non-Financial Interests, Personal, Other: Merck Sharp & Dohme. H.J.M. Smit: Other, Personal, Invited Speaker, Independent, paid: AstraZeneca; Other, Personal, Invited Speaker, Independent, paid: Bristol Myers Squibb; Other, Personal, Invited Speaker, Independent, paid: MSD; Other, Personal, Invited Speaker, Independent, paid: Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Lilly; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Principal Investigator: MSD; Financial Interests, Personal, Principal Investigator: Bristol Myers Squibb; Financial Interests, Personal, Principal Investigator, Local PI: Bayer. A. Sibille: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: Boehringer Ingelheim; Financial Interests, Personal, Advisory Role: Bristol Myers Squibb; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Other, Travel grant: Bristol Myers Squibb; Financial Interests, Personal, Other, Travel grant: Boehringer Ingelheim; Financial Interests, Personal, Other, Travel grant: MSD; Financial Interests, Personal, Other, Travel grant: Roche. F. McDonald: Financial Interests, Personal, Other, Honoraria and consulting fees: AstraZeneca; Financial Interests, Personal, Other, Honoraria: Elekta; Financial Interests, Personal, Other, Consulting fees: Accuray; Financial Interests, Personal, Funding, Grant funding: MSD; Financial Interests, Personal, Other, Consulting fees: AstraZeneca. M.C.C. Garassino: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Celgene; Financial Interests, Personal, Advisory Role: Novartis; Financial Interests, Personal, Advisory Role: Pfizer; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Takeda; Financial Interests, Personal, Advisory Role: Seattle Genetics; Financial Interests, Personal, Advisory Role: Mirati; Financial Interests, Personal, Advisory Role: Daiichi Sankyo; Financial Interests, Personal, Advisory Role: Bayer; Financial Interests, Personal, Advisory Role: GlaxoSmithKline; Financial Interests, Institutional, Other, Honoraria: Sanofi-Aventis; Financial Interests, Personal, Advisory Role: Blueprint Medicine. A.R. Filippi: Financial Interests, Personal, Other, Scientific consultancy: AstraZeneca; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Ipsen; Financial Interests, Personal, Speaker’s Bureau: MSD. S. Peters: Consultation / Advisory role: AbbVie, Amgen, AstraZeneca, Bayer, Beigene, Biocartis, Bio Invent, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, Daiichi Sankyo, Debiopharm, Eli Lilly, Elsevier, F. Hoffmann-La Roche/Genentech, Foundation Medicine, Illumina, Incyte, IQVIA, Janssen, Medscape, Merck Sharp & Dohme, Merck Serono, Merrimack, Mirati, Novartis, PharmaMar, Phosplatin Therapeutics, Pfizer, Regeneron, Sanofi, Seattle Genetics, Takeda, Vaccibody Talk in a company’s organized public event: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, e-cancer, Eli Lilly, F. Hoffmann-La Roche/Genentech, Illumina, Medscape, Merck Sharp & Dohme, Novartis, PER, Pfizer, Prime, RTP, Sanofi, Takeda. Receipt of grants/research supports: (Sub)investigator in trials (institutional financial support for clinical trials) sponsored by Amgen, AstraZeneca, Biodesix, Boehringer Ingelheim, Bristol Myers Squibb, Clovis, F. Hoffmann-La Roche/Genentech, GSK, Illumina, Lilly, Merck Sharp & Dohme, Merck Serono, Mirati, Novartis, Pfizer, Phosplatin Therapeutics. J.K. Field: Financial Interests, Personal, Other, Received Honoraria: AstraZeneca. D.C. Christoph: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Writing Engagements: AstraZeneca; Financial Interests, Personal, Expert Testimony: AstraZeneca; Financial Interests, Personal, Expert Testimony: Bayer; Financial Interests, Personal, Expert Testimony: Boehringer Ingelheim; Financial Interests, Personal, Expert Testimony: Bristol Myers Squibb; Financial Interests, Personal, Expert Testimony: Chugai; Financial Interests, Personal, Expert Testimony: MSD; Financial Interests, Personal, Expert Testimony: Novartis; Financial Interests, Personal, Expert Testimony: Pfizer; Financial Interests, Personal, Expert Testimony: Roche; Financial Interests, Personal, Expert Testimony: Sanofi; Financial Interests, Personal, Expert Testimony: Takeda; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Bayer; Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim; Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: MSD; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Roche; Financial Interests, Personal, Speaker’s Bureau: Sanofi; Financial Interests, Personal, Speaker’s Bureau: Takeda; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Chugai; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Takeda; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca; Non-Financial Interests, Personal, Principal Investigator: Bristol Myers Squibb; Non-Financial Interests, Personal, Principal Investigator: MSD; Non-Financial Interests, Personal, Principal Investigator: Roche; Non-Financial Interests, Personal, Member: ASCO; Non-Financial Interests, Personal, Member: DGHO; Non-Financial Interests, Personal, Member: ESMO; Non-Financial Interests, Personal, Member: IASLC. R. Fietkau: Financial Interests, Personal, Other, Grants and personal fees: AstraZeneca; Financial Interests, Personal, Other, Grants and personal fees: Merck Serono; Financial Interests, Personal, Other, Grants and personal fees: MSD; Financial Interests, Personal, Other, Grants and personal fees: Novocure; Financial Interests, Personal, Other, Personal fees: Brainlab; Financial Interests, Personal, Other, Personal fees: Bristol Myers Squibb; Financial Interests, Personal, Other, Personal fees: Fresenius Kabi. C. Chouaid: Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: AstraZeneca; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Boehringer Ingelheim; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: GlaxoSmithKline; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Roche; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Sanofi-Aventis; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Bristol Myers Squibb; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: MSD; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Lilly; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Novartis; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Pfizer; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Janssen; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Takeda; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Bayer; Financial Interests, Personal, Other, Attending Scientific Meetings, Speaking, Organizing Research, or Consulting: Amgen. S. Kao: Financial Interests, Personal, Advisory Board: Pfizer; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Takeda; Financial Interests, Personal, Advisory Board: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb. W. Sawyer: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. A. Allen: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. M. Licour: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. P. Garrido: Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: AstraZeneca; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: MSD; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Roche; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Bristol Myers Squibb; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Boehringer Ingelheim; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Pfizer; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: AbbVie; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Novartis; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Lilly; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Janssen; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Blueprint Medicines; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Takeda; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Gilead; Financial Interests, Personal, Other, Received personal fees for advisory role and/or talks: Rovi. All other authors have declared no conflicts of interest.