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

At 24 months, the overall survival rate was 73% with IMFINZI vs 54% with placebo
At 24 months, the overall survival rate was 73% with IMFINZI vs 54% with placebo

In a post-hoc analysis IMFINZI demonstrated a sustained 5-year OS* improvement in the ITT population vs placebo (HR=0.72; 95% CI, 0.59-0.89) 2

OS rate at 5 years in the ITT population:

At 24 months, the overall survival rate was 73% with IMFINZI vs 54% with placebo
At 24 months, the overall survival rate was 73% with IMFINZI vs 54% with placebo

The median OS for the ITT population was 47.5 months vs. 29.1 months for the placebo arm (HR=0.72; 95% CI 0.59-0.89). As of January 11, 2021 median follow-up duration of 24.2 months in all patients: range, 0.2 - 74.7 months). *This updated 5-year analysis was a planned exploratory analysis and was not designed to show statistical significance between arms. The p-value was not measured.

Testing

Co-Primary Endpoint: Progression Free Survival in the ITT population of the PACIFIC study:

  • 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%:

12.2 month improvement in median PFS vs placebo was seen in the IMFINZI arm (17.8 months vs 5.6 months)

17.8 months median PFS with IMFINZI vs 5.6 months with placebo
17.8 months median PFS with IMFINZI vs 5.6 months with placebo

Testing

IMFINZI patients had similar symptoms, function and HRQoL compared to placebo1

No clinically meaningful difference from baseline (average over 12 months) in patient-reported key lung cancer symptom scores with IMFINZI vs placebo.1

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

In the PACIFIC study, patients received at least 2 cycles of platinum-based CT overlapping with RT. After 1 to 42 days, patients who did not show signs of progression were randomised 2:1 to receive 10 mg/kg of IMFINZI via IV every 2 weeks for up to 12 months or placebo via IV every 2 weeks for up to 12 months. Co-primary endpoints included OS and PFS, while secondary endpoints included OS at 24 months, PFS at 12 and 18 months, HRQoL, and safety and tolerability
In the PACIFIC study, patients received at least 2 cycles of platinum-based CT overlapping with RT. After 1 to 42 days, patients who did not show signs of progression were randomised 2:1 to receive 10 mg/kg of IMFINZI via IV every 2 weeks for up to 12 months or placebo via IV every 2 weeks for up to 12 months. Co-primary endpoints included OS and PFS, while secondary endpoints included OS at 24 months, PFS at 12 and 18 months, HRQoL, and safety and tolerability
  • 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: February 2021 2. Spigel, D. R, et al. J Clin Oncol 39, 2021 (suppl 15; abstr 8511) 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.

 

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