A recent analysis shows that lung cancer mortality rate among women are projected to increase by 43% from 2015 to 2030

According to a new report published by ReportsnReports, the Immunotherapy is expected to become the oncology treatment of choice by 2026 with an estimated 60% of previously treated cancer patients likely to adopt immunotherapy in this timeframe.

The authors of the report believe that multiple treatment lines, combination therapy and the opportunity for repeat treatment are likely to accelerate fast growth.

Cancer immunotherapy is also expected to expands into multiple indications and the analysis of the current market data seems to confirm, according to the authors of the report, that key immunotherapies including anti-PD-1 drugs, dendritic cell vaccines, T-cell therapies and cancer vaccines are all driving the market.

In addition, the authors write, that the rising incidence and prevalence of numerous cancers globally is a significant accelerator of growth. This is due to more sensitive early diagnostics, higher patient awareness and an aging population.

Furthermore, the Food and Drug Administration‘s (FDA) pro-science attitude is also expected to accelerate development and regulatory approval for these drugs. To that end, the cancer immunotherapy market is forecast to hit U.S. $ 115 billion by 2023. Overall strong growth rates are expected due to a significant unmet need and increasing trends of hematological cancers.

Prior to the launch of ipilimumab (Yervoy®; Bristol-Myers Squibb) a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that down-regulates the immune system, the five-year survival rate for patients with early stage melanoma was 98%; but the five-year survival rate for late-stage melanoma was just 16%.

Ipilimumab has been reported to have a survival rate of 25% when tested alone. However, a combination therapy with nivolumab (Opdivo®; Bristol‑Myers Squibb), demonstrates an increase in the two-year survival rates to up to 88% for patients with late-stage cancer.

Increase in patient survival rates brought about by cancer immunotherapy treatment is similar to that seen when bone marrow transplantation changed our conception on how blood cancer was treated. Other key therapeutics  include pembrolizumab (Keytruda®), atezolizumab (Tecentriq®), palbociclib, (Ibrance®) and the newly approved avelumab (Bavencio®) and durvalumab Imfinzi ®) as well as the first CAR-T therapies tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®).

Guiding the market
The authors believe that nivolumab, which is indicated for melanoma, lung cancer, kidney cancer, blood cancer, head and neck cancer, and bladder cancer, is one of the most exciting agents in the immunotherapy space. The drug was given a fast-track approval by the FDA on December 22, 2014. The majority of immune-oncology agents are anti-programmed death-1 (PD-1) monoclonal antibodies, which will certainly guide the market over the coming years.

They also look at ongoing developments projects currently attracting attention, including the combing immunotherapies and other targeted anti-cancer agents.

Noteworthy is, according to the reports authors, a study of a novel effector activating monoclonal antibody known as IMAB362 for the treatment of solid cancers. Other projects comparing CAR-T cell effectiveness against T-cells that target CD19 or mesothelin are interesting in a preclinical setting.

They note that Novartis gained the first FDA approved Chimeric Antigen Receptor T-cell therapy (CAR-T) for tisagenlecleucel (CTL019) in August 2017 for children and young adults with B-cell ALL which was followed, in October 2017, by the approval of Kite’s  axicabtagene ciloleucel for the treatment of adult patients large B-cell lymphoma. This is a major boost for the global immunotherapy markets.

CAR-T Therapies
CAR T-cell therapy is are engineered specificity using antibody fragments directed to the tumor cell, and also T-cell CD8/CD3 plasma membrane proteins that elicit specific activity towards the tumor cell, via intracellular signaling pathways. To date publications have revealed a number of effective intracellular molecules in the engineered T cell including CD28, 4-1BB (CD137) and CD3 zeta.

Challenges
To date, the main challenges associated with CAR T-cell therapy include manufacturing, regulations, pricing and toxicity in patients.

Currently there are over 100 recruiting CAR-T clinical trials globally, mainly in the US, China and Europe. To date a number of CAR T Cells (autologous/allogeneic) trials are demonstrating clinical benefit to patients, but others have demonstrated toxicity such as cytokine release syndrome.

In July 2017, an FDA advisory panel determined that the benefits of CAR T-cell outperform the risks. Novartis’ tisagenlecleucel showed encouraging results in the ELIANA trial. Based on these results, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended this agent for approval and became the first CAR-T cell therapy on the US market.

Unmet medical need
The CAR T-cell therapy is addressing unmet needs in specific relapsed or refracorty cancers, and trials have indicated that some patients show long term activity and high remission rates, but there is a large proportion of patients with toxicities such as cytokine release syndrome and neurotoxicity.

Today, the main players involved in the development of CAR T-cell tharpies include Novartis, Juno Therapeutics, Kite Pharma and Cellectis. However, the market is moving ahead, backed by years of R&D, from both academia and industry, investors capitol and small clinical studies.

Kelly Scientific forecasts that CAR T-cell therapy will become more streamlined, with faster manufacturing times as advances in technologies take hold and clinical trials provide more robust evidence that this immunotherapy is robust. These factors, plus strategies to reduce adverse reactions and toxicities and larger players like Novartis taking stage will push CAR T-cell therapy ahead.

Being highly targeted and specific, immunotherapeutic drugs are expected to play a major role in the total cancer therapeutics space.  Cancer immunotherapy is, according to the authors of the new report, estimated to capture 50% of the overall oncology drugs market, generating about $75 billion in 2019 alone.  The authors also believe that it is realistic to believe that the market forecast for immunotherapeutic drugs will surpass $115 billion in 2023.

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