AstraZeneca ties its future to a promising drug pipeline
Oncology is one of the most exciting, promising and contentious areas of therapeutic research and development. Although cancer care costs only represent about 5% of the total health care budget, according to an article published in the Journal of the National Cancer Institute in 2011, cancer care expenditures are expected to grow from $125 billion in 2010 to $175 billion in 2020.
Patients, physicians and payers frequently balk at the cost of drugs used to treat cancer. In fact, eight of 10 of the most expensive drugs covered by Medicare are cancer drugs. From the manufacturers’ perspective, innovation is what it takes to continually make incremental gains in the treatment of cancer--and innovation is expensive. There is a high rate of failure of experimental drugs and no way to recoup those investments.
One way to lower development costs is to make drug research more targeted--to identify biologic markers in specific tumor types. Focusing research on targeted therapy lowers development costs, and potentially the cost of the drug as well.
This spring two big stories dovetailed—the meeting of the American Society of Clinical Oncologists (ASCO), which is always a news-intense event, and the rejection of Pfizer’s merger overtures by AstraZeneca. Citing its rich pipeline, AstraZeneca confirmed its independent stance and predicted an almost $20 billion increase in annual revenues by 2023---up to $45 billion.
AstraZeneca predicts that much of this revenue growth will come directly from its oncology pipeline. According to Pascal Soriot, AstraZeneca CEO, this was a good year for AstraZeneca at ASCO with respect to presenting positive data on oncology candidates, and next year will be even better.
One area where AstraZeneca has focused its cancer research is non-small cell lung cancer (NSCLC), an area with a very high five-year mortality rate and a 10-year survival rate around 5 percent. One drug that was highlighted at ASCO is AZD9291, a tyrosine kinase inhibitor, which showed positive early-stage results in patients with specific subtypes of NSCLC. In a phase 1 study, AZD9291 shrank the tumors of 51% of patients with EGFR mutation-positive NSCLC, who had developed a resistance to tyrosine-kinase inhibitors, and 94% of patients with the T790 mutation. This drug has already been granted Breakthrough Therapy status by the FDA and will be filed for approval within a year.
In addition to its small molecule candidates in oncology, AstraZeneca also presented a drug in the immuno-oncology category that it co-developed with MedIummune—MEDI4736, a human monoclonal antibody that is directed against programmed cell death ligand 1 (PD-L-1) and has demonstrated activity against a range of tumor types, including NSCLC. Phase 1 study data showed reduction of tumor burden in the first six weeks, with duration of clinical activity maintained over a 12-month period. Data culled from over 300 patients with different tumors showed robust clinical activity and minimal side effects.
AstraZeneca also had other treatments and combinations of treatments for NSCLC to highlight at ASCO, underscoring a multilateral strategy of developing drugs in different classes and testing them in different combinations. Pascal Soriot recently outlined his company’s winning approach on forbes.com. He explained that as the company continues to progress AZD9291 through clinical trials, the strategy is to develop additional indications beyond NSCLC, while positioning it as a first-line treatment option.
In addition, there are plans to consider this drug in the adjuvant setting and in combination with other drugs. Pondering that approach, Soriot characterized the combination of AZD9291 with the PD-L-1 antibody as a therapeutic combination that “could completely transform the treatment of lung cancer.”
AstraZeneca’s confidence in its development potential in oncology is encouraging -- which means ASCO 2015 could be a big event for the company.