IMFINZI EFFICACY
Testing
Co-Primary Endpoint: Overall Survival in the ITT population of the PACIFIC Study:
- IMFINZI demonstrated a 32% reduction in the risk of death vs placebo (HR: 0.68; 95% CI, 0.53-0.87)1
Following a post hoc subgroup analysis of the PACIFIC study; in patients with PD-L1 ≥1%:
A 47% reduction in the risk of death vs placebo was seen in the IMFINZI arm
In a post-hoc analysis IMFINZI demonstrated a sustained 3-year OS improvement in patients with PD-L1 ≥1% vs placebo (HR: 0.59; 95% CI, 0.41-0.83) 2
IMFINZI not reached (95% CI, NR-NR) vs placebo 29.1 months (95% CI, 17.7-NR)
Testing
In the ITT population of the PACIFIC study (co-primary endpoint):
- IMFINZI demonstrated an 11.2-month improvement in median PFS vs placebo (16.8 months vs 5.6 months)1
Following a post hoc subgroup analysis of the PACIFIC study; in patients with PD-L1 ≥1%:
A 12.2 months longer median PFS vs placebo was seen in the IMFINZI arm (17.8 months vs 5.6 months)
Testing
PACIFIC: Pivotal Phase III study of IMFINZI in unresectable Stage III NSCLC1
A randomised, double-blind, placebo-controlled, international study1
PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED (STAGE III*) NSCLC1,3,6
- CT included cisplatin or carboplatin (or both) plus one of the following: etoposide, vinorelbine, paclitaxel, vinblastine, docetaxel, or pemetrexed5
- 92% of patients had received a total dose of 54-66 Gy of radiation1
- Selected patient characteristics at study start: median age 64 years; 70% male; 53% Stage IIIA; 46% squamous1,7
Patients were enrolled regardless of PD-L1 expression or EGFR/ALK status1,3
ALK: anaplastic lymphoma kinase; CT: chemotherapy; EGFR: epidermal growth factor receptor; IV: intravenous; RT: radiation therapy; HRQoL: Health-related Quality of Life; CRT: Chemoradiotherapy
*According to the Staging Manual in Thoracic Oncology, version 7, of the International Association for the Study of Lung Cancer; the study included patients who are now classified as Stage IIIC.4,6
†PFS was based on blinded independent central review (BICR) using the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.1
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References: 1.IMFINZI - UK Summary of Product Characteristics. Date: September 2020 2. Data on File, REF-55959, AstraZeneca Pharmaceuticals LP. 3. Antonia SJ, Villegas A, Daniel D, et al. PACIFIC investigators. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. [published online September 25,2018]. N Engl J Med. 2018;379(24):2342-2350. 4. Detterbeck FC, Boffa. DJ, Kim. AW, et al. The Eighth Edition Lung Cancer Stage Classification Chest. 2017;151(1):193-203. 5. Antonia SJ, Villegas. A, Daniel. D, et al; PACIFIC investigators Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer. N Engl J Med. 2017;377(20):1919-1929. 6. International Association for the Study of Lung Cancer. Staging Manual in Thoracic Oncology, Version 7. https://cancerstaging.org/references-tools/quickreferences/Documents/LungMedium.pdf. (Accessed June 2020). 7. Antonia SJ, Villegas A, Daniel D, et al. PACIFIC investigators. Overall survival with durvalumab after chemoradiotherapy in stage III NSCLC. [published online September 25,2018]. N Engl J Med. 2018;379(24):2342-2350. Supplementary Appendix.