Therapy Areas: Respiratory
AstraZeneca Touts Imfinzi is the Only Immunotherapy to Demonstrate Overall Survival at Three Years in Unresectable, Stage III Non-Small Cell Lung Cancer
4 June 2019 - - British-Swedish drugmaker AstraZeneca has presented three-year overall survival results from the Phase III PACIFIC trial of Imfinzi (durvalumab) in unresectable, Stage III non-small cell lung cancer (NSCLC) during the 2019 American Society of Clinical Oncology annual meeting in Chicago, the company said.
The latest results from this post-hoc analysis show longer-term OS evidence in patients with unresectable, Stage III NSCLC who had not progressed following concurrent chemoradiation therapy, a previous standard-of-care treatment.
The OS rate was 57% at three years for patients receiving Imfinzi vs. 43.5% for placebo following concurrent CRT. Median OS was not yet reached with the Imfinzi arm versus 29.1 months for placebo.
Results build on the primary two-year OS analysis that was published in The New England Journal of Medicine in September 2018 and demonstrated a significant OS benefit for treatment with Imfinzi vs. placebo after CRT, regardless of PD-L1 expression.
The primary analysis showed Imfinzi reduced the risk of death by 32% (HR 0.68, 99.73% CI 0.47-0.997; p=0.0025).
With the additional year of follow up, the latest results for Imfinzi showed consistent efficacy, maintaining a 31% reduction in the risk of death vs. placebo after CRT (HR 0.69, [95% CI 0.55-0.86]).
Imfinzi can cause serious, potentially fatal adverse events. In the previous two-year OS analysis, the most common adverse reactions (greater than or equal to 20% of patients) for patients receiving Imfinzi versus placebo were cough (35.2% vs. 25.2%), fatigue (24.0% vs. 20.5%), dyspnea (22.3% vs. 23.9%) and radiation pneumonitis (20.2% vs. 15.8%). 30.5% of patients experienced a grade 3 or 4 AE with Imfinzi vs. 26.1% with placebo, and 15.4% of patients discontinued treatment due to AEs with Imfinzi vs. 9.8% of patients on placebo.
AstraZeneca has several ongoing trials focused on testing Imfinzi (durvalumab) in earlier stages of NSCLC (Stage I-III) and in potentially-curative settings.
The Phase III PACIFIC-2 trial design, presented at the ASCO annual meeting, is evaluating Imfinzi given concurrently with CRT in patients with unresectable, Stage III NSCLC.
Imfinzi is approved for the treatment of unresectable, Stage III non-small cell lung cancer in more than 45 countries, including the US, EU and Japan, based on the Phase III PACIFIC trial.
Since the first approval in the US in February 2018, more than 20,000 patients in this setting have been treated with Imfinzi.
The PACIFIC trial is a Phase III, randomized, double-blinded, placebo-controlled, multi-center trial of Imfinzi (durvalumab) as treatment in "all-comer" patients (i.e., regardless of PD-L1 status) with unresectable Stage III NSCLC whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy.
The trial is being conducted in 235 centers across 26 countries involving 713 patients. The primary endpoints of the trial are progression-free survival and overall survival, and secondary endpoints include landmark PFS and OS, overall response rate and duration of response.
Stage III (locally advanced) non-small cell lung cancer (NSCLC) is commonly divided into three sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the possibility of surgery. Stage III disease is different from Stage IV disease, when the cancer has spread (metastasized) to distant organs, as Stage III is currently treated with curative intent.
Approximately one in four patients with NSCLC in the United States present with Stage III disease, which is estimated to affect over 43,000 patients.
The majority of Stage III NSCLC patients are diagnosed with unresectable tumors. Until recently, the standard of care beyond CRT was active surveillance to monitor for progression as there had been no FDA approved treatments following CRT.
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.
Imfinzi is approved for unresectable, Stage III NSCLC in more than 45 countries including the US, EU, and Japan based on the Phase III PACIFIC trial.
As part of a broad development program, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an investigational anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors.
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