This year in the U.S., according to the National Cancer Institute (NCI), an estimated 1.65 million new cases of cancer will be diagnosed and almost 600,000 people will succumb to the disease. In addition, the economic burden for cancer care in the U.S. runs on the order of $130 billion – a staggering amount that continues to rise annually.
To reverse these statistics, the country will certainly be placing its hopes on biotech innovation to deliver more effective therapies in the not-too-distant future. Fortunately, the industry has already begun to deliver. In its Cancer Progress Report 2015 the American Association for Cancer Research (AACR) highlights that progress against cancer has continued at a spectacular pace during the past five years with number of FDA-approved therapeutics targeting specific molecules involved in cancer more than doubling to 52 medicines.
The future also looks bright with a full pipeline, with U.S. biopharmaceutical companies collectively having close to 850 medicines and vaccines in clinical development or awaiting review by the FDA, according to research conducted by the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA).
Commenting on the report, John Castellani, president and CEO of PhRMA, noted that while significant advances have been made in identifying new, more effective therapies "the battle is far from over."
With, according to NCI`s projections, breast, lung and prostate cancer, to be among the prevalently diagnosed cancers in 2015 the PhRMA found that there were 123 therapies in various stages of development for lung cancer, which remains the leading cause of cancer death in the U.S.
The progress of many of the candidate therapies were reported on at last month`s 16th World Conference on Lung Cancer in Denver. (See BioWorld Insight, Sept. 14, 2015.)
The meeting reinforced the excitement swirling around immuno-oncology and the technology is predicted to make a major impact going forward.
Bristol-Myers Squibb Co. (BMS) and Roche AG, for example, presented data for their immuno-oncology drugs that block the programmed death receptor-1 (PD-1) and its interaction with the receptor's ligand (PD-L1). While companies are testing immuno-oncology drugs as monotherapies, they may prove most useful as combination therapies, especially in the first-line setting.
In a phase Ib trial known as Checkmate-012, New York-based BMS presented data for new dosing regimens of Opdivo (nivolumab), a PD-1 blocking antibody, plus CTLA-4 inhibitor Yervoy (ipilimumab), showing that the combination of two immuno-oncology drugs can produce objective response rates of up to 39 percent in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC).
London-based Astrazeneca plc is also testing its PD-L1 antibody, durvalumab, with its CTLA-4 antibody, tremelimumab, in NSCLC. The phase III trial, dubbed ARCTIC, which is already under way, is testing the combination vs. standard of care in third-line metastatic NSCLC.
In addition to the IO approach there are a variety of other therapeutic strategies being employed that have advanced to late stage testing according to Cortellis Clinical Trials Intelligence, which identified more than 70 trials that have reached the phase III stage. (See Late-Stage Cancer Clinical Trials, below.)