PACIFIC-R PFS
PACIFIC-R1
- *Patients had completed platinum-based chemotherapy concurrent or sequential to radiotherapy within the previous 12 weeks without evidence of disease progression; †Spanish data are from an externally sponsored study integrated in April 2021.
- AESI, adverse event of special interest; CRT, chemoradiotherapy; EAP, expanded access programme; IV, intravenously; NSCLC, non-small-cell lung cancer; OS, overall survival; PD-L1, programmed cell death-ligand 1; PFS, progression-free survival; Q2W, every 2 weeks.
Patient Characteristics & Durvalumab Treatment
- Median time to durvalumab initiation from the end of RT = 56 days
- Overall median durvalumab treatment duration = 11 months
- 12 months’ treatment: 19.8%
- 14 months’ treatment: 4.2%
- Patients received a median of 22 durvalumab infusions− 7.1% received >26 infusions
Cut-off date for data extraction: 8 April 2021
*Percentages based on patients for whom the data were available; †PD-L1 expression tested but not clearly reported.
ADisease stage was missing for n=7 and n=74 were diagnosed at a stage <III; BHistologic subtype at stage III diagnosis data was missing or unknown for 21 patients; cSequential CRT is not yet approved in Hong Kong; DPD-L1 was not tested for n=431
CRT, chemoradiotherapy; EAP, expanded access programme; ECOG/WHO PS, Eastern Cooperative Oncology Group/World Health Organization performance status; FAS, full analysis set; PD-L1, programmed cell death-ligand 1; RT, radiotherapy.
PACIFIC-R
*Median follow up 23.5 months (range 0 - 35.6 months); †In the PACIFIC trial, PFS was assessed by blinded independent central review per RECIST v1.1; ‡Per local regulations
CI, confidence interval; FAS, full analysis set; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; rw, real-world; UK, United Kingdom.
- Median rwPFS in PACIFIC-R was higher than the median PFS reported for the durva. arm of the PACIFIC trial1†
- Challenges with collecting rwPFS data limit comparisons between PACIFIC-R and PACIFIC
- RwPFS is likely overestimated as:
- Germany and UK sites did not collect deaths that occurred prior to study enrolment‡ (50 early deaths not counted)
- RECIST criteria for tumour assessments is used heterogeneously across countries
- Assessments for progression in the real world may not occur as frequently or consistently as in clinical trials; the COVID-19 pandemic may also have resulted in fewer hospital visits
Real-world PFS by Subgroup
Supplementary Information on Safety
AE, adverse event; FAS, full analysis set; ILD, interstitial lung disease; EAP, expanded access programme.
References: 1. Girard. N et al. (2022), Treatment Characteristics and Real-World Progression-Free Survival in Patients with Unresectable Stage III NSCLC who Received Durvalumab After Chemoradiotherapy: Findings from the PACIFIC-R Study. Journal of Thoracic Oncology (2022). 2. SpigelDR, et al. J Clin Oncol 2021;39(15_suppl):8511 3. Girard N. (2021), 1171MO - PACIFIC-R Real-World Study: Treatment Duration and Interim Anaysis of Progression-Free Survival in Unresectable Stage III NSCLC Patients Treated with Durvalumab After Chemoradioterapy. 2021 ESMO Congress Presentation.