Following the PACIFIC trial, consolidation D for up to 12 months became a global SoC for pts with unresectable Stage III NSCLC and no disease progression after platinum-based CRT. We report the first planned analysis of OS from PACIFIC-R (NCT03798535), an international study assessing the effectiveness of D in pts from an early access programme (EAP).
PACIFIC-R is an observational, retrospective study of a cohort of pts with unresectable Stage III NSCLC who received ≥1 dose of D (10 mg/kg IV Q2W) within an AstraZeneca-initiated EAP between September 2017 and December 2018. The primary endpoints are investigator-assessed real-world progression-free survival (rwPFS; reported previously) and OS, assessed by Kaplan–Meier method.
As of 30 November 2021, the full analysis set included 1154 pts from 10 countries. The median (range) follow-up duration in pts censored at the end of data extraction was 38.7 (13.6–49.0) months. Overall, 446 (38.6%) pts had died; median OS (95% CI) was not reached (46.3 months–not estimable) and 2- and 3-year OS rates (95% CI) were 72.3% (69.7–74.8) and 63.2% (60.3–65.9), respectively. OS rates were numerically higher in pts who received concurrent vs sequential CRT, pts with programmed cell death-ligand 1 (PD-L1) expression ≥1% vs <1%, and pts who started D ≤42 vs >42 days after finishing RT (Table). In total, 666 (57.7%) pts had progression events; updated median rwPFS (95% CI) was 24.1 months (20.2–27.8) and 2- and 3-year rwPFS rates (95% CI) were 50.1% (47.2–53.0) and 42.2% (39.2–45.1), respectively. *Measured from the PACIFIC-R index date (i.e., the date of the first dose of D received within the EAP). TC, tumour cell.
OS by subgroup* Group (n) 2-year OS rate, % (95% CI) 3-year OS rate, All patients (1154) 72.3 (69.7–74.8) 63.2 (60.3–65.9) CRT Concurrent (900) 73.8 (70.8–76.6) 64.8 (61.5–67.9) Sequential (163) 67.8 (60.0–74.5) 57.9 (49.8–65.2) PD-L1 expression level TC ≥1% (573) 76.0 (72.3–79.3) 67.0 (63.0–70.8) TC <1% (138) 64.3 (55.6–71.7) 54.4 (45.7–62.4) Unknown (79) 70.8 (59.4–79.5) 61.6 (49.8–71.4) Timing of D initiation relative to the end of RT ≤42 days (398) 74.8 (70.2–78.8) 66.0 (61.1–70.5) >42 days (732) 71.2 (67.8–74.4) 61.8 (58.1–65.2)
PACIFIC-R data continue to provide evidence for the effectiveness of consolidation D after CRT in a large, diverse, real-world population, consistent with the PACIFIC trial. Favourable OS results were observed across subgroups, including pts who received sequential CRT and pts with PD-L1 <1%, with consistent rwPFS outcomes.
NCT03798535.
Medical writing support, under the direction of the authors, was provided by Aaron Korpal, PhD, of Ashfield MedComms (Manchester, UK), an Inizio company, and was funded by AstraZeneca.
AstraZeneca.
AstraZeneca.
N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi; Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer, Novartis, Sanofi, AbbVie, Amgen, Lilly, Grunenthal, Takeda, Owkin; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS; Non-Financial Interests, Personal, Officer, International Thymic malignancy interest group, president: ITMIG; Other, Personal, Other, Family member is an employee: AstraZeneca. D.C.C. Christoph: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, GSK, Roche, Sanofi Aventis, Bristol Myers Squibb, Merck Sharp & Dohme, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen, Amgen; Financial Interests, Personal, Funding: AstraZeneca, Boehringer Ingelheim, GSK, Roche, Sanofi Aventis, Bristol Myers Squibb, Merck Sharp & Dohme, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen, Amgen; Financial Interests, Personal, Other, Honoraria: AstraZeneca, Boehringer Ingelheim, GSK, Roche, Sanofi Aventis, Bristol Myers Squibb, Merck Sharp & Dohme, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen, Amgen. M.C. Garassino: Financial Interests, Personal, Other: AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, Inivata, MedImmune, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regerenon, Merck; Financial Interests, Institutional, Other: Eli Lilly, MSD, Pfizer (MISP); AstraZeneca, MSD International GmbH, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Ignyta, Incyte, MedImmune, Novartis, Pfizer, Roche, Takeda, Tiziana, Foundation Medicine, Glaxo Smith Kline GSK, Spectrum pharm; Other, Personal and Institutional, Other: AIRC, AIFA, Italian Moh, TRANSCAN, research fundings. F. McDonald: Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Boehringer Ingelheim; Financial Interests, Personal and Institutional, Advisory Board: Boehringer Ingelheim. J.K. Field: Financial Interests, Personal, Advisory Board: Epigenomics, NUCLLEIX Ltd., AstraZeneca, iDNA, Qure.ai; Financial Interests, Personal, Research Grant: Janssen Research & Development, Llc. R. Fietkau: Financial Interests, Personal and Institutional, Advisory Board: Merck Darmstadt, AstraZeneca, MSD; Financial Interests, Personal and Institutional, Funding: Merck Darmstadt, AstraZeneca, MSD, Siemans/Varian; Financial Interests, Personal and Institutional, Other, Honoraria: Merck Darmstadt, AstraZeneca, MSD, Sennewald, Siemens/Varian; Financial Interests, Personal and Institutional, Invited Speaker: Merck Darmstadt, AstraZeneca, Siemens/Varian; Financial Interests, Personal and Institutional, Advisory Role: MSD. P. Garrido Lopez: Financial Interests, Personal and Institutional, Advisory Board: AbbVie, Amgen, Bayer, AstraZeneca, BMS, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Takeda; Financial Interests, Personal and Institutional, Principal Investigator: Amgen, Bayer, AstraZeneca, BMS, GSK, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Takeda; Financial Interests, Personal and Institutional, Invited Speaker: AstraZeneca, Janssen, MSD, Novartis, Pfizer, Roche, Takeda, Medscape, TouchTime; Financial Interests, Personal and Institutional, Other, Travel/Accommodation/Expenses: AstraZeneca, BMS; Financial Interests, Personal and Institutional, Speaker’s Bureau: BMS; Financial Interests, Personal and Institutional, Training: Janssen; Financial Interests, Personal and Institutional, Full or part-time Employment: Teva. V.D. Haakensen: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS; Financial Interests, Personal, Other, Honoraria: AstraZeneca, BMS, Takeda, Pfizer. S. Siva: Other, Institutional, Research Grant: Bayer Pharmaceuticals, Varian Industries; Financial Interests, Personal, Invited Speaker: AstraZeneca. M. van den Heuvel: Financial Interests, Personal, Advisory Board: AZD; Financial Interests, Personal, Invited Speaker: AZD; Financial Interests, Personal, Research Grant: AZD. J. Bar: Financial Interests, Personal, Advisory Board: AbbVie, MSD, Roche, Takeda, AstraZeneca, Amgen, BMS, Novartis; Financial Interests, Personal, Invited Speaker: AbbVie; Financial Interests, Personal, Principal Investigator: AbbVie; Financial Interests, Personal, Research Grant: AbbVie; Non-Financial Interests, Personal, Principal Investigator: MSD, Roche, Takeda, AstraZeneca. C. Chouaid: Financial Interests, Personal, Advisory Board: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen; Financial Interests, Personal, Funding: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen; Financial Interests, Personal, Other, Honoraria: AZ, BI, GSK, Roche, Sanofi Aventis, BMS, MSD, Lilly, Novartis, Pfizer, Takeda, Bayer, Janssen and Amgen. P. Vercauter: Financial Interests, Personal, Advisory Board: AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bayer, Bristol Meyers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Roche; Financial Interests, Personal, Research Grant: Chiesi. P. Chander: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. M. Licour: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. S. Anand: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. A.R.M.D. de Lima: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. A.R.R. Filippi: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Role: AstraZeneca, Roche; Financial Interests, Personal, Funding: AstraZeneca, Roche; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Principal Investigator: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Roche, Ipsen. All other authors have declared no conflicts of interest.