Durvalumab Demonstrates Unprecedented Survival in Stage III NSCLC with 50% of Patients Reaching Four-Year Overall Survival

Reposted from | Jike Yao Wen

On September 18, AstraZeneca announced the latest results from two clinical trials of durvalumab (Imfinzi) at the 2020 European Society for Medical Oncology (ESMO) Annual Meeting.

• Latest data from the Phase III PACIFIC trial show that approximately 35% of patients with non-small cell lung cancer treated with durvalumab remained progression-free at four years;
• Latest data from the Phase 3 CASPIAN clinical trial demonstrate that durvalumab also confers long-term benefits in a subset of patients with extensive-stage small cell lung cancer (ES-SCLC).

Latest post-hoc analysis results from the Phase 3 PACIFIC trial demonstrate that durvalumab provides sustained, clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with unresectable Stage III non-small cell lung cancer (NSCLC) who did not experience disease progression following concurrent chemoradiotherapy (CRT). The estimated four-year OS rate was 49.6% in the durvalumab group compared to 36.3% in the placebo group. The median OS was 47.5 months for durvalumab versus 29.1 months for placebo. With a maximum treatment duration of one year, an estimated 35.3% of patients treated with durvalumab remained progression-free at four years, compared to 19.5% of those receiving placebo. These data, published in the New England Journal of Medicine (NEJM) in 2018, confirm a significant advantage for durvalumab in terms of the primary endpoint of OS.

Durvalumab is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby inhibiting tumor immune escape and releasing suppressed immune responses. Based on the results of the Phase 3 PACIFIC clinical trial, durvalumab has been approved in the United States, Japan, China, the European Union, and many other countries and regions for the treatment of unresectable Stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy. In the United States and several other countries, durvalumab is also approved for patients with advanced bladder cancer who have received prior treatment. Additionally, it has been approved in the United States for the treatment of extensive-stage small cell lung cancer (ES-SCLC).

Latest Results from the Phase 3 CASPIAN Trial Show That Exploratory Subgroup Analysis Revealed the Proportion of Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Treated with Durvalumab Plus Chemotherapy Who Survived and Remained Progression-Free for One Year or Longer (PFS ≥12 Months) Was More Than Three Times Higher Than That with Chemotherapy Alone. Among All Treatment Regimens, the Subgroup of Patients Who Were Progression-Free at One Year Had a 75% Probability of Survival at Two Years, Compared to a 10% Probability of Survival Within Two Years for the Subgroup Whose Disease Progressed Within One Year (PFS <12 Months). Clinical Characteristics Appeared Unable to Identify Patients Who Would Achieve Long-Term Benefit.

The CASPIAN trial met its primary endpoint of overall survival (OS) in 2019, demonstrating a 27% reduction in the risk of death with durvalumab plus chemotherapy compared with chemotherapy alone in patients with extensive-stage small cell lung cancer (ES-SCLC). The safety and tolerability profile of durvalumab plus chemotherapy was consistent with the known safety profiles of these agents. These results were published in The Lancet in 2019 and formed the basis for approval by regulatory authorities worldwide.

References:

[1] Imfinzi demonstrated unprecedented survival in unresectable, Stage III non-small cell lung cancer with an estimated 50% of patients surviving four years. Retrieved 2020-09-18, from https://www.astrazeneca.com/media-centre/press-releases/2020/imfinzi-demonstrated-unprecedented-survival-in-unresectable-stage-III-nsclc.html

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