AstraZeneca’s Imfinzi Demonstrates Significant Overall Survival Benefit in Unresectable, Stage III Lung Cancer

MedImmune, AstraZeneca’s global biologics research and development unit, revealed data on overall survival (OS) in the Phase III Pacific Trial of Imfinzi for the treatment of unresectable, stage III lung cancer.

According to AstraZeneca, the updated data, which demonstrated that Imfinzi reduced the risk of death by nearly one third (32 percent) compared to standard care, confirms that Imfinzi achieved unprecedented improvement in progression-free survival of more than 11 months.

Sean Bohen, executive vice president, Global Medicines Development and chief medical officer, commented on the significance of the results, saying, “[The] announcement brings new hope to patients in a setting where survival rates have not changed in decades.”

Scott J. Antonia, MD, Ph.D., chair of the Thoracic Oncology Department at Moffitt Cancer Center in Tampa, Florida, USA and principal investigator in the PACIFIC trial added, “The five-year survival rate in this setting has historically been around 15 percent after concurrent chemoradiation therapy. The significant survival benefit observed using the Pacific regimen provides confidence and clear rationale for a new standard of care.”

Summary of Primary Endpoints

	*Imfinzi* (n=476)	Placebo (n=237)
OS (primary endpoint)¹
Number of deaths (%)	183 (38.4%)	116 (48.9%)
Hazard ratio (99.73% CI)^2,3	0.68 (0.47, 0.997)
p-value^2-4	0.0025
Median in months (95% CI)	NR⁵ (34.7, NR)	28.7 (22.9, NR)
PFS (primary endpoint)^1,6
Number (%) of patients with event	243 (51.1%)	173 (73.0%)
Hazard ratio (95% CI)^2,7	0.51 (0.41, 0.63)
Median in months (95% CI)	17.2 (13.1, 23.9)	5.6 (4.6, 7.7)

Imfinzi

(n=476)

Placebo

(n=237)

OS (primary endpoint)¹

Number of deaths (%)

183 (38.4%)

116 (48.9%)

Hazard ratio

(99.73% CI)^2,3

0.68 (0.47, 0.997)

p-value^2-4

0.0025

Median in months

(95% CI)

NR⁵

(34.7, NR)

28.7

(22.9, NR)

PFS (primary endpoint)^1,6

Number (%) of patients with event

243 (51.1%)

173 (73.0%)

Hazard ratio

(95% CI)^2,7

0.51 (0.41, 0.63)

Median in months

(95% CI)

17.2

(13.1, 23.9)

5.6

(4.6, 7.7)

About Imfinzi

Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

Currently, Imfinzi is approved in the U.S, E.U., Canada, Switzerland, India, Japan, and Brazil based on the Phase III Pacific trial. Imfinzi is also approved for the treatment of patients with locally-advanced or metastatic urothelial carcinoma in the US, Canada, Brazil, Israel, Hong Kong, and India.

Imfinzi is also being tested as a monotherapy and in combination with chemotherapy, radiation therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal antibody, as a first or second-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumors.

References

[1] The data cut-off date for analysis of OS and updated analysis of PFS was 22 March 2018.

[2] Stratified by sex, age, and smoking history.

[3] Confidence interval adjusted for interim analysis.

[4] Criteria for statistical significance at the interim analysis of OS was a p-value ≤ 0.00274 (using Lan DeMets spending function approximating O’Brien Fleming boundary).

[5] Not Reached (NR).

[6] Assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1.

[7] No formal statistical comparison was made because the study had achieved significance for PFS at the first planned interim analysis (data cutoff of Feb 13, 2017).

(Source: AstraZeneca)