AstraZeneca Announce Imfinzi as the First Immunotherapy to Show Both Significant Survival Benefit and Improved, Durable Responses in Extensive-Stage Small Cell Lung Cancer
Posted on September 10, 2019
AstraZeneca today presented detailed results from the Phase III CASPIAN trial, showing Imfinzi (durvalumab) significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC).
Imfinzi in combination with four cycles of standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically-significant and clinically-meaningful improvement in OS vs. SoC consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).
The risk of death was reduced by 27% (equal to a hazard ratio of 0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed a prolonged OS benefit with an estimated 33.9% of patients alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients following SoC.
Across all efficacy endpoints, benefits were observed in patients treated with Imfinzi plus chemotherapy vs. SoC. Results showed a significantly higher progression-free survival (PFS) rate at 12 months (17.5% vs. 4.7%), a 10.3% increase in confirmed objective response rate (ORR) (67.9% vs. 57.6%), and improved duration of response (DOR) at 12 months (22.7% vs. 6.3%).
The results were presented at the Presidential Symposium of the IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.
José Baselga, Executive Vice President, Oncology R&D said: “We are encouraged to see more than a third of small cell lung cancer patients treated with Imfinzi plus chemotherapy alive at the 18-month landmark, which is remarkable given the aggressive nature of the disease. It is also noteworthy that these results may enable physicians to choose Imfinzi in combination with either cisplatin or carboplatin chemotherapy backbones. We look forward to working with regulatory authorities to bring Imfinzi to patients with small cell lung cancer around the world as soon as possible.”
Luis Paz-Ares, MD, Ph.D., Chair, Medical Oncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator in the Phase III CASPIAN trial said: “Patients have had limited treatment options for small cell lung cancer, a devastating disease where the five-year survival rate has been as low as 6%. The significant survival benefit demonstrated with Imfinzi combined with only four cycles of a choice of chemotherapy compared to a robust control arm, provides evidence and hope of a new treatment option for these patients.”
SCLC is an aggressive, fast-growing cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.
|EP + Imfinzii
|OS (primary endpoint)ii|
|Number of deaths (%)||155 (57.8%)||181 (67.3%)|
|0.73 (0.591, 0.909)|
|Median in months
|OS rate (18 months)||33.9%||24.7%|
|PFS (secondary endpoint)ii,iii|
|Number (%) of patients with event||226 (84.3%)||233 (86.6%)|
|0.78 (0.645, 0.936)|
|Median in months
|PFS rate (12 months)||17.5%||4.7%|
|ORR (secondary endpoint)ii,iv|
|Number (%) of patients with response||182 (67.9%)||155 (57.6%)|
|1.56 (1.095, 2.218)|
|DOR at 12 months (secondary endpoint)||22.7%||6.3%|
i Etoposide plus investigator choice of cisplatin or carboplatin chemotherapy.
ii The data cut-off date for analysis of OS, PFS and ORR was 11 March 2019.
iii PFS was not formally tested for statistical significance.
iv Confirmed responses according to investigator assessment per RECIST v1.1.
The safety and tolerability of Imfinzi in combination with SoC etoposide and platinum-based chemotherapy was consistent with previous trials. Results showed that 61.5% of patients experienced a Grade 3 or 4 AE with Imfinzi plus SoC (all causes) vs. 62.4% with SoC, and patients discontinuing treatment due to AEs were similar between arms (9.4% vs. 9.4%).
Imfinzi is also being tested following concurrent chemoradiation therapy in limited-stage SCLC in the Phase III ADRIATIC trial.
Imfinzi is approved in the curative-intent setting of unresectable, Stage III non-small cell lung cancer after chemoradiotherapy in 49 countries, including the US, Japan and across the EU, based on the Phase III PACIFIC trial.
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