During the past decade, advances in personalized medicine and immuno-oncology have fueled a major shift in treatment of cancer, according to new research from the QuintilesIMS Institute. Since 2011, 68 novel therapies have been approved across 22 cancer indications globally. These developments have led to more options as well as greater access and improved outcomes for patients—especially for those individuals with metastatic disease.
In addition to the recent wave of newly launched therapies, the late-stage oncology pipeline is robust with 631 unique molecules in development. That marks a 7.7% increase from the 586 oncology molecules in advanced-stage clinical research just a year ago. During the past five years, clinical development has become more efficient with shortened research-cycle times—particularly within phase III trials for new cancer medicines. That efficiency, coupled with continuing efforts to compress investigational timelines, signal faster review periods and greater availability of superseding treatments than ever before, said QuintilesIMS.
The study, “Global Oncology Trends 2017: Advances, Complexity and Cost,” found that this innovation comes at a cost. Global spending of oncology therapeutics and supportive care drugs increased to $113 billion in 2016 from $107 billion in 2015. The total global cost of cancer medicines rose at a constant annual growth rate (CAGR) of 8.7% during the past five years. That marks a noticeable increase compared to the 4.9% growth recorded between 2006 and 2011. Total spending for oncologics and supportive care worldwide is expected to exceed $147 billion by 2021. With projected growth of 6 to 9% annually, spending across the oncology therapy area will likely outpace the 4 to 7% CAGR for total global spending on medicines during the same period.
“The launch of multiple novel agents, coupled with increasing awareness and focus on cancer prevention, and emphasis on early diagnosis, have contributed to improved outcomes and a reduction in mortality rates for many of the major cancers over the past decade,” said Murray Aitken, senior vice president and executive director of the QuintilesIMS Institute.
Additional highlights from the QuintilesIMS Institute report include:
The pipeline of oncology drugs in clinical development has expanded by 45% during the past ten years. Using predictive biomarkers has enabled researchers to identify sub-populations within cancer types. This capability has driven an increase in the number of personalized medicines targeted for specific cancer populations. Trials using biomarkers to predict patient response are gaining increasing significance with nearly 11% of current late-phase trials using biomarker-based segmentation. Eighty-seven percent of treatments in the late-stage pipeline use targeted therapies, which include small-molecule protein-kinase inhibitors and biologic monoclonal antibodies.
The two approved PD-1 inhibitors have spawned more than 135 clinical trials for additional indications across 30 tumor types. In tumors that overexpress PD-1, treatment with these agents stimulates a patient’s own immune system to fight the cancer. These agents are associated with durable response in multiple cancer types. Although most PD-1 and PDL-1 agents are in development for solid tumors, development for hematologic malignancies is increasing. In the case of advanced melanoma, several novel therapy classes, including PD-1 inhibitors, BRAF inhibitors, MEK inhibitors and anti-CTLA4 have launched in the past five years—tripling the number of treated patients. Until the relatively recent launch of these innovations, there was virtually no effective therapeutic option for melanoma patients.
Trial duration and average enrollment have declined highlighting shifts in trial design and target indication size. The number of patients enrolled in phase III trials has declined from a high of 671 in 1998 to 188 patients in 2016, with a corresponding decline in trial duration from 2000 days in 1997 to 1070 days in 2016. These declines could be the results of increasing focus on smaller patient segments with tumor types that require lower enrollment to demonstrate clinical benefit. In addition, trial sponsors are employing improved trial design technologies to accelerate development of cancer drugs.
In 2016, the median time from patent filing to approval was 9.8 years, down from 10.25 years in 2013. A favorable regulatory environment has helped drive this acceleration. Among the changes: the FDA Breakthrough Therapy Designation, introduced in 2012, as well as other expedited development and review methods adopted by the FDA. Those include accelerated approval, priority review and fast track designation. Nearly 70% of the drugs approved in 2015 were designated in one or more expedited categories.