May 12, 2017
By Mark Terry, BioSpace.com Breaking News Staff
AstraZeneca and its MedImmune division announced that its Imfinzi (durvalumab) has shown positive results in its Phase III trial in non-small cell lung cancer (NSCLC). Company popped to $33.46 at the news.
The Phase III PACIFIC trail is a randomized, double-blinded, placebo-controlled multi-center clinical trial of Imfinzi as sequential treatment for locally-advanced, unresectable (Stage III) NSCLC in patients who had not progressed after standard platinum-based chemotherapy concurrent with radiation therapy. An Independent Data Monitoring Committee (IDMC), after analyzing interim data, concluded that it had already met its primary endpoint, which was statistically significant and clinically meaningful progression-free survival (PFS). It also showed a favorable benefit/risk profile.
The other primary endpoint, overall survival (OS), will continue to be assessed.
“These are highly encouraging results for patients with locally-advanced lung cancer for whom surgery is not an option,” said Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, in a statement. “We look forward to working with regulatory authorities around the world to bring Imfinzi to lung cancer patients as soon as possible. Alongside this, we continue to explore Imfinzi’s full potential as monotherapy as well as in combination with tremelimumab and other medicines in areas of continued unmet need across multiple types of cancer.”
The U.S. Food and Drug Administration (FDA) granted Imfinzi accelerated approval for previously treated patients with advanced bladder cancer on May 1. The drug is also being evaluated as a first-line treatment of patients with NSCLC as monotherapy in the MYSTIC and PEARL Phase III clinical trials. It is also being studied in combination with tremelimumab, a checkpoint inhibitor that targets CTLA-4 in the MYSTIC, NEPTUNE and POSEIDON Phase III trials.
“We are excited to offer Imfinzi as a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer. Imfinzi is the cornerstone of our extensive Immuno-Oncology program, in development across many tumor types, as monotherapy and in combination. This first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated,” Pascal Soriot, AstraZeneca’s chief executive officer, said in a statement at the time.
Imfinzi is a human monoclonal antibody against PD-L1, blocking PD-L1 interaction with PD-1 and CD80 in T cells. In addition to SCLC, it is being evaluated in urothelial bladder cancer, and in head and neck squamous cell carcinoma (HNSCC). In combination with tremelimumab, it is being studied in Phase III trials in urothelial bladder cancer, NSCLC, SCLC and HNSCC. In Phase I/II trials it is being studied in gastric cancer, pancreatic cancer, hepatocellular carcinoma and hematological/blood cancers.
Martin Baccardax, writing for TheStreet, noted, “Durvalumab is a cornerstone of Astra’s oncology portfolio, which could either make or break expectations for the Anglo-Swedish pharma giant’s top line over the coming years, with analysts forecasting ‘all application’ sales of between $1.5 billion and $2.3 billion per year by 2020.”
Lung cancer is the leading cause of cancer death in both men and women, and makes up about one-third of all cancer deaths. That is more than breast, prostate and colorectal cancer deaths combined.
The clinical trials are being conducted in 235 locations in 26 countries, including the U.S., Canada, Europe, South and Central America, Japan, Korea, Taiwan, South Africa and Australia.
