Population Growth and Inflation to Drive Market
Publisher has identified and analyzed 10 promising late-stage pipeline drugs (see section 5). However, of these 10, only Telik’s Telcyta has been shown to improve median patient Overall Survival (OS); however, questions raised over the validity of the data mean that the drug is not expected to be approved within the forecast period of 2013–2020. Further Phase III trials of the drug are required, for which Telcyta is currently seeking corporate partners. Most of the late-stage drugs provide no clinical benefit to patients, with the best responses being mild to moderate improvements in Progression-Free Survival (PFS) in comparison with standard-of care treatment. In the projected scenario, those drugs that have been shown to provide an improvement in PFS will be approved in the EU, Canada and Japan. These are Vynfinit, olaparib and Trebananib. This is in line with the most recent drug approvals in these markets: Avastin and Yondelis, which were approved on the basis of improved PFS. However, the expected high cost of these drugs and their minimal clinical benefit, are expected to create a negative opinion of them among healthcare professionals and regulatory bodies in these three geographies, limiting their prescription volumes.
In the US, the improvements in PFS observed with Yondelis and Avastin were not sufficient for either drug to be granted approval in the US. However, despite its refusal, Avastin is approved for other indications within oncology, with evidence that the drug is prescribed off-label for the treatment of Ovarian Cancer (OC) in the US, contributing significantly to the current market (Burger, 2007). The inflation of Avastin, which costs up to $100,000 for a course of treatment, is expected to be a major contributor to market growth in the US and globally. Given the similar lack of OS benefit with current late-stage pipeline drugs, it is unlikely the aforementioned late-stage pipeline drugs will be approved in the US within the forecast period.
Despite the lack of new approvals in this territory the growth of the global market is expected to be driven primarily by growth in the US market. As discussed, no new drugs are expected to be approved in this territory, in which there is a small increase in the prevalence population. Growth is expected to instead be driven by inflation on the cost of therapy, which currently averages $30,000. Inflationary pressure on Avastin, in particular is expected to drive growth. This high inflation rate, not observed across other territories, will result in the North American market becoming increasingly dominant in the global market, within the forecast period.
Lack of Targeted Therapies Being Addressed by Current Developmental Pipeline
There is currently a lack of targeted therapies indicated for the treatment of OC, certainly in comparison with other indications within oncology. Avastin is the only approved targeted therapy and was approved in the EU in 2011 on the basis of improved PFS. The current treatment of OC is dominated by the use of off-patent chemotherapeutic agents: primarily carboplatin, paclitaxel, pegylated liposomal doxorubicin, topotecan and gemcitabine. The current development pipeline appears to be focusing on this lack of targeted therapies, with a wide range of novel targets specific to ovarian tumor cell growth and progression, including growth factors, serine/threonine protein kinases and tumor-associated antigens/genes.
Improvements in Clinical Trial Design Necessary
Recent insights have highlighted that OC is a highly heterogeneous disease with mutations in a range of signaling pathways involved in the initiation and propagation of the disease. Furthermore associated mutations vary among the different histological subtypes and stages of the disease, adding further levels of complexity to the treatment of OC (Wang et al., 2005; Lawrenson et al., 2011). Clinical trials of marketed and current late-stage pipeline drugs have rarely taken this heterogeneity into account, and results across all patient cohorts are usually aggregated, regardless of patients’ disease histology and variations in genetic alterations. The poor results obtained, particularly with pipeline drugs, demonstrate that this ‘‘universal approach’’ is not efficient, and more efforts need to be made to explore the effects of drugs in different disease subtypes. However, it is recognized that further molecular studies are necessary to fully understand the etiology of each disease histotype and make these analyses by subtype fully applicable (Karst and Drapkin, 2010). There is evidence that the genetic and epigenetic characteristics of patients are beginning to be taken into account. Post-hoc analyses of the late-stage pipeline drug olaparib demonstrated that this drug had improved efficacy in patients with Breast Cancer (BRCA) mutation.
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