A healthy pipeline feeds a changing treatment landscape

A record number of oncology drugs was launched in 2018 with a global report recording 15 new cancer drugs for 17 indications last year.

In fact, over the past five years oncology treatments appear to have taken centre stage for the pharmaceutical industry.

Some 57 oncology therapies for 89 indications were launched in that time, according to data from the IQVIA Institute for Human Data Science.

Oncology is the area with the largest clinical development spend, say the authors of another trend analysis. The Evaluate Pharma World Preview 2019 reveals oncology accounts for 40% of total pipeline and predicts that by 2024 nearly 20% of pharma sales ($237 billion) will be from oncology therapies alone.

Treatment is changing

Nearly a third of the approved indications over the past five years have been for haematologic cancers, says IQVIA. Lung cancer tops the solid tumour treatments with 12 indications, followed by breast cancer and melanoma.

But treatment paradigms continue to shift in oncology with the emergence of immunotherapies, biosimilars and next-generation biotherapeutics – defined as cell, gene and nucleotide therapies.

A key paradigm shift, according to IQVIA, is treating tumours based on genetic profile rather than site-of-origin in the body.

For example, in 2018, larotrectinib (Vitrakvi) became the second tissue-agnostic oncology therapy to be approved by the US FDA, following the first approval of pembrolizumab (Keytruda) in 2017.

Vitrakvi (not yet available in Australia) has been tested in patients with lung, colon, breast and thyroid cancer among others.

Keytruda is indicated in Australia for melanoma, non-small cell lung carcinoma, head and neck squamous cell carcinoma, Hodgkin lymphoma, primary mediastinal B-cell lymphoma and urothelial carcinoma.

Predicted top performer

According to Evaluate Pharma, Keytruda will be the top-selling drug worldwide in 2024 with sales forecasts of more than $17 billion.

The report predicts that oncology will be the top therapy area in 2024, with a 19.4% market share and sales reaching $237 billion. And it says sales will be driven mainly by immunotherapies.

Is Australia lagging behind?

The IQVIA report found that only 15 of the 54 new oncology therapies launched from 2013–2017 reached Australia within two years of their global launch.

This means Australia lags behind countries such as Italy, France, Canada, Spain and Japan in terms of access to therapies, while patients in the US, Germany and UK have access to more than 40 of the 54 oncology treatments launched between 2013 and 2017.

What’s next?

According to Evaluate Pharma, oncology will continue to be the main focus of R&D in the biopharma industry, despite the fact that oncology is one of the more expensive areas in which to develop new therapies.

And it’s not just big pharma that’s getting involved. IQVIA reports that 711 companies are active in late-stage R&D, working on 849 products as of 2018, with 88% of them coming from emerging biopharma companies.

This 19% growth in R&D from 2017 is due to the increasing number of targeted therapies in the oncology pipeline, says IQVIA – 91% of the late-stage oncology pipeline is focused on targeted small molecule and biologic therapies, rather than non-specific therapies like cytotoxic agents. 

“The combined immunotherapies and next-generation biotherapeutics are targeting almost all cancer tumour types with over 80 mechanisms of action,” the report says.

What can Australian patients expect?

Victoria’s Centre for Cancer Immunotherapy was announced last year, with the goal of granting Victorian patients with all types of advanced cancer access to a clinical trial with an appropriate immune-based therapy within five years.

It’s a partnership between the Victorian Comprehensive Cancer Centre (VCCC) alliance, Peter MacCallum Cancer Centre and the University of Melbourne.

VCCC executive director Professor Grant McArthur suggests the outlook for cancer patients is better than ever: “Immune-based therapies are revolutionising cancer outcomes, even in very advanced cases of diseases such as melanoma, lung cancer and childhood leukaemia.”