is part of the Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

HLN00CPO-T-Cells-attacking-cancel-cell.jpg

Innovation driving expansion of the cancer therapy market

The pharmaceutical and biotech industries are honing in on better targeted, more effective treatments for cancer, an increasingly complex disease area. What are the latest inroads being made in oncology research and development?

The cancer market, shaped by decades of R&D investment and scientific advances, is a major focus for the pharmaceutical industry. While chemotherapy and radiotherapy continue to be the most commonly used forms of cancer therapy, in recent decades considerable efforts have been made to develop better targeted, more effective treatments, which are now starting to make an impact. Seven of the 28 drugs approved by the US Food and Drug Administration (FDA) this year treat cancer [1]. In 2019 [2], eight of the 48 drugs which the agency granted marketing approval for were cancer therapies.

There is little doubt that cancer drug development is a major focus for pharmaceutical developers – both in the small molecule industry and biologics sector. Partly this reflects the increased incidence of cancers worldwide – the World Health Organisation [3] says 18.1 million cancer and 9.6 million deaths were recorded in 2018, a significant increase on previous years.

Need for improved treatments

Pharma’s focus on oncology also reflects the need for improved treatments and growing scientific understanding of the genetics of cancers. According to US pharma industry group PhRMA [4], “rapid technological advances and an emerging understanding of the underlying drivers of disease are changing the face of cancer. We now know that cancer is not a singular condition but, rather, a collection of diseases, each with unique characteristics and features.”

According to EvaluatePharma, oncology attracts the largest proportion of clinical development spending with 40% of total pipeline expenditure. The organisation [5] predicts revenues generated by prescription cancer drugs will generate revenue of USD 237 billion by 2024, a CAGR of 6.9%.

And innovation will continue to drive expansion as pharma and biotech firms work to develop drugs for currently untreatable forms of the disease.

Adam Pearson, Senior Oncology and Haematology Analyst at GlobalData, says that on the whole, it is the pharma industry bringing drugs to market with new targets.

“However, there have been significant M&A of biotech by Big Pharma over recent years,” he says. “It could be argued that biotech is making bigger strides in innovation but it’s when collaborations occur that they can have a big impact.”

He cites Sanofi’s acquisition of Synthorx [6] and Merck & Co’s takeover of ArQule [7] as examples of billion-dollar cancer-focused investments.

Check point inhibitors

A significant proportion of cancer drug revenue growth will be driven by PD-1 inhibitors such as Merck’s & Co Keytruda (Pembrolizumab) and Bristol Myers Squibb’s Opdivo (Nivolumab).

PD-1 is a so-called “checkpoint inhibitor” found on the surface of immune T-cells. In normal functioning it binds a protein called PD-L1 on the surface of healthy cells preventing their destruction. The trouble is that some tumours also have PD-L1, which helps them evade the immune system. PD-1 inhibitors address this by preventing PD-1 binding PD-L1.

Keytruda – which has been cleared for 20 different cancer indications since it was first approved for skin cancer in 2014 – generated revenue of USD 7.1bn last year [8]. GlobalData predicts it will generate USD 22.2 billion a year by 2025 [9].

Likewise, Opdivo – which was also first approved for skin cancer before being cleared for other cancer indications – generated revenue of USD 7.204 billion in 2019, up 7% year-on-year despite a slight dip in revenue in the fourth quarter.

GlobalData predicts Opdivo will generate USD 12 billion a year by 2025. In March [10] the FDA approved Opdivo in combination with Yervoy (ilimumab) – a BM-S checkpoint inhibitor that targets the CTLA-4 receptor on T cells – for patients with a subgroup of lung cancer patients.

Other types of drug – like Pfizer’s breast cancer medicine Ibrance (Palbociclib) and AstraZeneca’s Tagrisso (Osimertinib) for lung cancers - are also expected to see revenue growth, further increasing market value.

Therapies to watch

Competition between newer products is also likely to spur growth in the cancer therapy market.

For example, Immunomedics’ drug Trodelvy (sacituzumab govitecan) is an antibody that targets the protein Trop-2 on tumours linked to chemotherapy Onivyde. It is designed to treat patients with triple negative breast cancer (TNBC). The FDA cleared it in April [11]. EvaluatePharma predicts the drug could generate USD 2.151 billion a year by 2026 [12].

Trodelvy will battle it out with Roche’s Tecentriq, which was approved to treat TNBC in March last year [13].

Daiichi Sankyo’s HER2-targeting antibody drug conjugate Enhertu (trastuzumab deruxtecan) – developed with AstraZeneca – is also worth keeping an eye on. The drug was approved by the FDA last December [14]. A month later the firm released data suggesting it could be used to treat gastric cancer, a potentially significant expansion [15].

“Sacituzumab govitecan was approved for TNBC recently, also Enhertu just had some positive data in NSCLC,” says GlobalData’s Adam Pearson. “Key opinion leaders are also excited about this drug opening up a new treatable sub-population in NSCLC.”

Bristol Myers Squibb’s candidate lymphoma CAR-T therapy Liso-cel (lisocabtagene maraleucel) has also attracted attention. The product – which BMS gained when it bought Celgene [16]– is currently under FDA review with the decision expected in November [17].

Luso-cel – which was previously known as JCAR017 and developed by Celgene acquisition Juno Therapeutics – is forecast to generate revenue of USD 3 billion a year [18].

Future innovation

Innovation is also going to determine how we treat cancer in the future. According to a 2018 [19] study, new strategies involving energy metabolism and extracellular vesicles as well as advances in immunotherapy and nanotechnology are driving the next generation of cancer treatments.

An obvious example is nanomedicine, in which particles with dimensions of less than 100 nm are used to treat disease. In theory, there are significant therapeutic advantages of such products according to the US National Cancer Institute [20], which cites enhanced tumour targeting and reduce side effects as examples.

To date, the FDA has approved just a handful of cancer nanomedicines [21] - examples include Abraxane (albumin–bound paclitaxel), Doxil (Doxorubicin), Daunoxome (daunorubicin citrate liposome injection), Oncaspar (pegaspargase) and Depocyt (cytarabine liposome injection).

But more are expected. According to a 2019 study in the Journal of the American Chemical Society [22], government support for nanomedicine developers continues.

Immuno-oncology

Immuno-oncology – the use of immunomodulation to optimise the immune system’s response -- is also likely to play a greater role in cancer treatment according to Pearson.

“The move from tissue specific to tumour agnostic approaches i.e. targeting a specific genetic mutation across multiple tumour types will accelerate,” he says. “In some cancers that are under-served with therapeutic options – the question is now how to personalize treatments and integrate IOs into the treatment paradigm?”

He cites PD-1 inhibitors as an example, explaining “it is about refining IO treatments and looking at the right biomarker, for example specific PD-L1 expression, a PD-1 vs PD-L1 inhibitor and stratifying populations on new biomarkers such as tumour mutation burden or micro-satellite instability, this is an area of research which is rapidly evolving.”

Combinations

Innovation will not be limited to drugs, according to Pearson. He predicts that future cancer treatments are likely to combine two or more therapies in a bid to prevent resistance developing.

“Another question for developers will be how best to cope with patients who develop resistance from targeted therapies or immunotherapies. They will need to develop and personalise a treatment sequence which can deal with the development of resistance.

“For example, one approach is how to best combine immunotherapy with another agent which will improve the chance of a sustainable response and overcome the development of resistance.”

Real world data

Cancer drug developers are also likely to make greater use of real world data (RWD). The US FDA [23] defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.”

These sources include electronic health records, healthcare claims, product and disease registries and patients themselves.

In cancer therapy, RWD has the potential to help drug companies expand their products’ potential market, according to Pearson.

“The leveraging of RWD has been used by Pfizer last year to gain a label expansion - Ibrance in Men with breast cancer [24]. He added that “Roche is also going in that direction, evidenced by the acquisition of Flatiron Health in 2018 [25].”

References:

  [1] https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020

  [2] https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019

  [3] https://www.who.int/cancer/PRGlobocanFinal.pdf

  [4] http://phrma-docs.phrma.org/sites/default/files/pdf/decade-of-innovation-cancer.pdf

  [5] https://info.evaluate.com/rs/607-YGS-364/images/EvaluatePharma_World_Preview_2019.pdf

[6] https://www.sanofi.com/en/media-room/press-releases/2019/2019-12-09-07-00-00

  [7] https://uk.reuters.com/article/us-arqule-m-a-merck-co/merck-pushes-deeper-into-targeted-cancer-therapy-with-2-7-billion-arqule-deal-idUKKBN1YD15Z

  [8] https://investors.merck.com/news/press-release-details/2020/Merck-Announces-Fourth-Quarter-and-Full-Year-2019-Financial-Results/default.aspx

  [9] https://www.pharmaceutical-technology.com/comment/keytruda-projections/#:~:text=Keytruda%20is%20forecast%20to%20take,forecast%20%2422.2bn%20by%202025.&text=Eliquis'%20strong%202018%20sales%20are,reaching%20%2418.7bn%20by%202025.

 [10] https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-opdivo-nivolumab-ye-1

  [11] https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-triple-negative-breast-cancer-has-spread-not-responded-other-treatments#:~:text=Today%2C%20the%20U.S.%20Food%20and,prior%20therapies%20before%20taking%20Trodelvy.

  [12] https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-april

  [13] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-atezolizumab-pd-l1-positive-unresectable-locally-advanced-or-metastatic-triple-negative

  [14] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer#:~:text=On%20December%2020%2C%202019%2C%20the,regimens%20in%20the%20metastatic%20setting.

  [15] https://www.evaluate.com/vantage/articles/news/trial-results/enhertu-succeeds-where-kadcyla-and-others-failed

  [16] https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-completes-acquisition-celgene-creating-le

  [17] https://www.businesswire.com/news/home/20200506005301/en/Bristol-Myers-Squibb-Update-Biologics-License-Application

 [18] https://www.sec.gov/Archives/edgar/data/816284/000114420418002935/tv483707_ex99-2.htm

 [19] https://www.mdpi.com/2072-6694/10/6/208/pdf

  [20] https://www.cancer.gov/nano/cancer-nanotechnology/benefits#:~:text=Nanotechnology%20can%20provide%20rapid%20and,and%20highly%20effective%20therapeutic%20agents.

  [21] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5720487/

  [22] https://pubs.acs.org/doi/abs/10.1021/acs.accounts.9b00228

  [23] https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

  [24] https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_ibrance_palbociclib_for_the_treatment_of_men_with_hr_her2_metastatic_breast_cancer

 [25] https://www.roche.com/media/releases/med-cor-2018-02-15.htm

 
Hide comments
account-default-image

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish