Monday, 14 January 2019

IMMUNO-ONCOLOGY (IO) THERAPIES: A NEW ERA OF PERSONALIZED CANCER MEDICINES

New York City, 14 Jan 2019: The Immuno-Oncology (IO) Market Therapies is estimated to be the more than USD ~30 billion by 2022. The market is projected to grow at a higher CAGR of ~30% with the launch of potential therapies and expansion of existing therapies during the forecast period from 2016-2022 in the niche segment of cancer therapy areas as reported by the Polaris Market Research Report "Immuno-Oncology (IO) -Competitive Analysis and Market Forecast- [2016-2022]”.



In the past decade, the oncology community has witnessed major advances in the understanding of cancer biology and major breakthroughs in several different therapeutic areas, from solid tumors to hematological malignancies; moreover, the advent of effective immunotherapy approaches, such as immune-checkpoint blockade has changed the current landscape and have provided personalized treatment solutions.

There are six immunotherapies in the market, Keytruda and Opdivo being the highest sales generating drugs. Currently Keytruda is challenging the Opdivo by rapidly taking its market share giving fresh momentum in the race to get hold on to the new patients. In 2016, Bristol-Myers had been the undisputed leader in immunotherapy after Opdivo was approved for all patients with “second line” lung cancer patients who are no longer responding to the chemotherapy treatment where Merck’s drug Keytruda had the less sales due to its restricted use in the lung cancer patients.

Immuno-Oncology as a Personalized Therapy?

Immuno-oncology represents an innovative approach to cancer research that seeks to harness the body’s own immune system to fight tumor cells. We are at the forefront of this science with several compounds in development that are being investigated for use in a variety of cancers, as well as an approved immuno-oncology medicine that continues to be studied for new uses.

The more precise targeting of patients for selected therapies is another important area of focus in oncology. Clinical biomarkers and pharmacogenomic studies are increasingly used to identify groups and sub-groups of patients most likely to benefit from an investigational agent in order to maximize its potential benefits.

Immune-Checkpoint Inhibitors: The first targets to reach the Immuno-Onco market!


Immune checkpoints refer to a plethora of inhibitory pathways hardwired into the immune system that are crucial for maintaining self-tolerance and modulating the duration and amplitude of physiological immune responses in peripheral tissues in order to minimize collateral tissue damage. Checkpoint inhibitor immuno-oncology (I-O)treatments, the new breed of immuno-oncology therapies, enable the immune system to identify and attack foreign cells, halting the spread of cancer without destroying healthy cells like traditional therapies. It is theorised that this targeted response will enable the use of I-O therapies in almost all cancer types.

Currently, six checkpoint inhibitors (Yervoy (ipilimumab), Keytruda (pembrolizumab), Opdivo (nivolumab), Tecentriq (atezolizumab)), Bavencio (Avelumab) and Imfinzi (Durvalumab) have gained  the US Food and Drug Administration (FDA) approval for the treatment of a wide range of cancers. Yervoy & Opdivo by BMS and Keytruda by Merck were the first immunotherapies to reach the market with the remarkable efficacy profile. Opdivo alone has regulatory approval to treat six tumour types: melanoma, Hodgkin’s lymphoma, non-small cell lung cancer (NSCLC), kidney cancer, bladder cancer, and head and neck cancer.

Challenges associated with Immuno-Oncology Therapies

Cancer immunotherapy has eliminated the terminal disease in some patients, but the clinical success is highly variable. While biomarkers, oncogenes and mutations have been classic maps for predicting therapy outcome, clinical success has reached a plateau. The current problem is that the mechanism by which a drug target is selected is dictated by our knowledge of the role of growth factor receptors or key immune checkpoint proteins, and not patient-specific biology.
 Cost presents another challenge to market access for checkpoint inhibitors. The live example is NSCLC treatment with Opdivo and Keytruda has been estimated at $150,000/year per patient, a potentially significant strain on the fixed budgets of health care systems. Cost-effectiveness is a key driver in decision making for agencies that conduct economic assessments.

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