Lewes, DE -- (ReleaseWire) -- 03/18/2014 -- The launch of premium-priced targeted therapies has changed the Non-Small Cell Lung Cancer (NSCLC) treatment paradigm and elevated the NSCLC market during the past decade. This growth is expected to continue at a moderate pace during the forecast period, culminating in growth from $1.8 billion in 2012 to $2.9 billion by 2019, in Asia-Pacific (APAC). In 2012, Japan and China had respective shares of 48.5% and 41.5% in the NSCLC market of APAC. India and Australia had much lower shares of 4.1% and 5.9% respectively.
An aging population and increasing number of NSCLC incident cases, especially in China and India, drive the growth in the market. The expected launches of premium-priced novel antibodies and immunotherapies in the first and second lines of therapies, targeting both Non-Squamous NSCLC (NOS NSCLC) and Squamous NSCLC (S NSCLC) patients, widen the eligible treatment population, maximize the patient share and ultimately drive market growth. In spite of many expected drug launches, without the risk of generic erosion of currently entrenched therapies, growth is expected to be marginal due to the dominant generic penetration of a few NSCLC drugs in India. A complex and lengthy regulatory pathway and limited reimbursement from national insurance programs, in China, as well as regular price cuts, in Japan, also limit growth in the APAC market.
A multitude of targeted agents have been explored in the treatment of advanced NSCLC in the last few years. The launch of targeted drugs has shifted the NSCLC treatment landscape away from cytotoxic chemotherapies towards targeted biomarker-driven therapies. Thus far, the broad classes of agents that have been implemented in clinical practice include antagonists of the Epidermal Growth Factor Receptor (EGFR) and Hepatocyte Growth Factor Receptor (HGFR), Vascular Endothelial Growth Factor (VEGF)-directed therapies, and inhibitors of Anaplastic Lymphoma Kinase (ALK).
In the last decade, five targeted therapies have been approved by the US Food and Drug Administration (FDA) for the treatment of NSCLC: Iressa (gefitinib) in 2002, Tarceva (erlotinib) in 2003, Avastin (bevacizumab) in 2006, Xalkori (crizotinib) in 2011 and Gilotrif (afatinib) in 2012. All of these drugs are also marketed in APAC regions, except Gilotrif, which is currently in the pre-registration phase in Japan. The launch of Iressa by AstraZeneca and Tarceva by F. Hoffmann-La Roche Ltd (Roche) has greatly increased the treatment options available to NSCLC patients that harbor specific EGFR mutations. The last entrant, Gilotrif (afatinib), has the potential to overcome the resistance developed to the first-generation EGFR inhibitors: Iressa and Tarceva. So far, Avastin is the only approved VEGF-targeted agent. Anti-angiogenic Avastin has shown landmark improvements in survival when added to standard doublet cytotoxic therapy. Pfizer’s Xalkori is the only approved targeted agent that addresses the treatment needs of the sub-set of NSCLC patients that harbor ALK mutations.
Advancement in the diagnostic patterns will also improve the treatment of NSCLC. New biomarkers include the recently approved companion diagnostics: Abbott’s Vysis ALK Break-Apart FISH Probe Kit and Pfizer’s Xalkori, for the detection of rearrangements involving the ALK gene; the cobras EGFR Mutation Test and Tarceva, for the detection of specific mutations of the EGFR gene; and Qiagen’s therascreen EGFR RGQ PCR Kit and Boehringer Ingelheim’s Gilotrif, for the diagnosis of specific substitutive mutations of EGFR.
However, all of the approved targeted therapies in the current therapeutic landscape are not approved for NSCLC patients with squamous histology. A significant unmet need exists for therapies that can extend overall survival, with an improved safety profile over gemcitabine, the current standard of care for this patient population.
Robust Pipeline with Promising Late-Stage Molecules to Cater to Unmet Need in Squamous Non-Small Cell Lung Cancer Patients
The pipeline for NSCLC is very strong, with a total of 290 active pipeline molecules in development, either as monotherapies or in combination with chemotherapy. The majority of pipeline candidates being investigated are for the treatment of stage IV advanced disease, either as first-line or second-line therapies. Only a few of these promising pipeline molecules are likely to grab part of the patient population of existing NSCLC therapeutics, and only a few have the potential to increase the treatment population.
Promising candidates in the late-stage clinical trials include second-generation Tyrosine-Kinase Inhibitors (TKIs) such as, Pfizer’s dacomitinib and Boehringer Ingelheim’s Gilotrif, which is currently a pre-registration drug in Japan, for EGFR-positive patients. In contrast to the currently marketed EGFR inhibitor Tarceva, these second-generation TKIs are effective against both mutant EGFR and wild-type EGFR. Novartis’s LDK378 is another promising second-generation TKI targeting ALK-positive patients. A necitumumab by Eli Lilly (Lilly) is in development as a first-line targeted therapy for NSCLC patients with squamous histology. In addition to this, Lilly is also evaluating a second-generation VEGF receptor antibody, ramucirumab, in the second-line setting for patients with squamous histology. Apart from these targeted therapies, the Phase III immunotherapy Yervoy of Bristol-Myers Squibb (BMS) also targets patients with squamous histology. These pipeline molecules targeting patients with squamous histology are expected to gain a rapid uptake due to the absence of marketed drugs that target patients with squamous histology.
Additional promising immunotherapies include BMS’s nivolumab, which indicated its improved efficacy for treatment of NSCLC regardless of EGFR mutational status and the MAGE-A3 vaccine therapy of GlaxoSmithKline (GSK) as an adjuvant treatment for EGFR-mutant patients. In addition to pipeline candidates for EGFR- and ALK-mutant patients, early-stage emerging targeted therapies are in development for patients with specific biomarkers or mutations, such as KRAS, ROS1, DDR2, and Fibroblast Growth Factor Receptor 1. Overall, the focus of the NSCLC development pipeline trends towards targeting niche patient populations defined by biomarkers or histology.
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