AstraZeneca’s (AZN) Checkpoint Inhibitor Imfinzi significantly improved Overall Survival (OS) for Stage III Non-Small Cell Cancer
Imfinzi (durvalumab) achieved positive overall survival (OS) results for the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose cancer did not progress following platinum-based chemotherapy and radiation. An Independent Data Monitoring Committee concluded that the trial met the second of two primary endpoints by showing statistically-significant overall survival OS benefit with clinically meaningful improvement in patients receiving Imfinzi compared to placebo.
One year ago, in May 2017, AstraZeneca had announced that the PACIFIC trial met its first primary endpoint of progressive-free survival (PFS) with a median improvement of 11.2 months vs. placebo.
Stage III (locally-advanced) NSCLC is divided into three sub-categories (IIIA, IIIB, and IIIC) defined by how much the cancer has spread locally and the possibility of surgery. This differentiates it from Stage IV cancer when cancer has metastasized to distant organs.
Incidence and prior treatment: Lung cancer is the leading cause of death among both men and women, accounting for about one-third of all cancer deaths. Stage III NSCLC represents approximately one-third of NSCLC incidence and was estimated to affect around 105,000 patients in the top-eight countries (China, France, Germany, Italy, Japan, Spain, UK, US) in 2017. The majority of Stage III NSCLC patients are diagnosed with unresectable tumors.
Imfinzi (durvalumab) is a human checkpoint inhibitor monoclonal antibody. It binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and easing the inhibition of immune responses.
Latest Good News
– AstraZeneca achieved 16 regulatory approvals across major markets, including the United States; the European Union; Japan and China.
– Earlier this month, Imfinzi received a Canadian approval for unresectable Stage III NSCLC following chemoradiation therapy (CRT).
– In February 2018, Imfinzi received regulatory approval from the FDA for unresectable Stage III NSCLC who had not progressed following concurrent platinum-based CRT.
– Six new oncology products were launched since 2014.
AstraZeneca’s oncology programs comprise the treatment of lung, ovarian, breast and blood cancers. In addition, the firm is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by its investment in Acerta Pharma in hematology.
AstraZeneca has recently enjoyed the upbeat news that, although ignored by negative investors, the firm’s achievements are otherwise undeniable. Imfinzi good news should be music in the ears of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose cancer did not progress following platinum-based chemotherapy and radiation therapy (CRT). Imfinzi, which proved to extend progressive-free survival (PFS) has now scored statistically significant overall survival (OS).
AstraZeneca has a lot to say at the upcoming June ASCO meeting.
Genentech, a member of the Roche (RHHBY) group announced that results from the Phase III IMpower130 study demonstrate that a combination of Tecentriq® (atezolizumab) plus chemotherapy (carboplatin and ABRAXANE® met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in advanced non-squamous non-small cell lung cancer (NSCLC).
Safety of the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual products with no new safety signals were identified with the combination.
These data will be presented at an upcoming oncology congress.
Currently, Genentech has eight Phase III lung cancer studies underway evaluating Tecentriq alone or in combination with other products. This is the third positive Phase III study evaluating Tecentriq alone or in combination to demonstrate an OS benefit for people with NSCLC.
Immuno-oncology checkpoint inhibitors are proving to be a game changer in the treatment of cancer in general. Improving survival in various lung cancers was far from being expected prior to the approval of checkpoint inhibitors and their incessant trials in monotherapy and in various combinations with other oncology chemotherapy products, targeted small molecule products, immunotherapy, and antibody targeted products.
The revolution that led to the improvement in the treatment of chronic and deadly diseases is still speeding towards understanding more about the body secrets, including the pathways of diseases and creating diagnostic procedures that differentiate between the various pathways of the same cancers and pathways of the same chronic diseases.
We are optimistic.
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