Pharma opens new front in war on cancer

Swiss drug maker Roche has developed its capacity to produce cancer drugs in recent years. It now makes an estimated $7 billion per year off of immunotherapy cancer treatments Keystone

It is the Holy Grail of medical science. Ever since Hippocrates, the Greek physician, first described the disease more than 2,000 years ago, generation after generation of doctors have searched in vain for a cure for cancer.

This history of failure instils oncologists with a natural sense of caution, which makes it all the more striking when some say their profession is on the cusp of the biggest breakthrough in cancer therapy for decades.

This history of failure instils oncologists with a natural sense of caution, which makes it all the more striking when some say their profession is on the cusp of the biggest breakthrough in cancer therapy for decades.

“I’ve been an oncologist for a long time and I’ve never experienced as much excitement,” says Edward Bradley, head of Oncology Innovative Medicines at Medimmune, part of AstraZeneca, the UK drugmaker. This excitement will come to a head in Chicago [May 30-June 3] as thousands of scientists gather for the annual meeting of the American Society of Clinical Oncology. Taking centre stage are a series of experimental drugs that promise to open a new front in the war on cancer.

Whereas traditional treatments such as chemotherapy and radiotherapy have been likened to “carpet bombing”, the new class of immunotherapy drugs are more akin to precision-guided missiles that hunt and destroy cancer cells. Their potential is stirring optimism not only among scientists and patients but also among investors eyeing a multibillion-dollar windfall for the four main companies behind the medicines: Merck & Co, Bristol-Myers Squibb, Roche and AstraZeneca.

Andrew Baum, an analyst at Citigroup, predicts that cancer immunotherapy will become the backbone of treatment for 60 per cent of cancers within 10 years, generating peak annual revenues of $35bn or more. This would exceed the value of past blockbuster drug categories such as cholesterol-busting statins and could go a long way towards reviving the fortunes of an industry struggling for growth.

Mr Baum has been championing the potential of immunotherapy since declaring in a report last year “the beginning of the end for cancer”. Twelve months later, he says he is feeling even more bullish as fresh trial data emerge to support his belief that the new drugs will transform cancer into “something akin to a chronic disease”.

Immunotherapy includes a range of techniques to harness the body’s immune system to attack cancer. Scientists have been experimenting with the concept since 1850, when German physicians noticed that tumours would sometimes shrink when they became infected – stimulating an immune response. “It is not a new idea but we are finally seeing that it is going to work,” says Paul Higham, chief executive of Immatics, a German biotech company that has an immunotherapy partnership with Roche. “The question now is what is the best way to do it.”

The leader so far has been US-based Bristol-Myers Squibb, whose Yervoy treatment for advanced melanoma – the most deadly form of skin cancer – was the first product of its kind to reach market, with sales of almost $1bn last year. Without the drug, a patient with advanced melanoma would typically die within a year. When treated with Yervoy, 22 per cent were still alive three years later and 17 per cent survived for seven years.

Some of the next wave of drugs look still more promising. The focus at Asco will be on a category known as anti-PD-1s and anti-PD-L1s, which aim to remove the “invisibility cloak” that cancer cells use to roam the body unchecked.

Programmed death receptor 1s (PD1s) are proteins that act as a brake on the immune system to stop healthy cells from being attacked – but they are exploited by cancer cells to avoid detection. When this process is blocked, cancer cells suddenly find themselves exposed to the body’s disease-busting killer T-cells.

“Tumours are damn smart,” Mr Baum says. “It’s like Whack a Mole. As soon as you block one pathway they find another. But, with a little help, the immune system is the one thing smart enough to keep up.”

Bristol-Myers Squibb is again at the forefront with nivolumab, a drug that has kept 43 per cent of advanced melanoma patients alive for two years in trials. But it is facing stiff competition from US rival Merck – which has jumped ahead in the race for regulatory approval – as well as Roche of Switzerland and AstraZeneca, which are scrambling to catch up. Analysts think all four could secure regulatory approval by the end of next year.

Having previously shown promise in treating lung cancer as well as melanoma, data released at Asco is expected to demonstrate the drugs’ potential to tackle several other forms of the disease, including cancers of the kidney, bladder, head and neck. Another focus will be on trials of combination therapies that twin the new drugs with other medicines in a bid to increase response rates.

“It is an oversimplification to see this as a horse race in which the winner is the first to market,” Mr Baum says. “Who ends up generating most economic value is going to be determined by a number of factors, including who has the right combinations.” This explains why Roche and AstraZeneca, which have broad portfolios of cancer drugs to mix and match, still feel they can be competitive even though they are currently trailing Bristol-Myers Squibb and Merck.

Novartis, another big oncology performer, is placing its bets on a different form of immunotherapy that involves removing patients’ T-cells from their bodies and re-engineering them to destroy cancer cells once reinjected. In early trials, 19 of 22 children suffering from acute lymphoblastic leukaemia went into complete remission after treatment.

Inevitably, scientists warn there will be setbacks. There had been high hopes, for example, that nivolumab and Yervoy would provide Bristol- Myers Squibb with a powerful combination therapy. However, trial results this month showed that nearly half the 46 participants suffered bad side effects and there were three “treatment-related” deaths – raising doubts over whether the benefits outweighed the risks.

Pricing is likely to be another challenge. Annual global spending on cancer drugs more than doubled in the past decade to $91bn in 2013. The figure looks certain to rise further given that the World Health Organisation expects a 57 per cent increase in worldwide incidence of cancer in the next 20 years as western populations age and those in developing countries adopt less healthy lifestyles.

These trends should ensure strong demand for new cancer drugs but also put pressure on pricing as countries from the US to China battle to contain rising healthcare costs. Mr Baum thinks society will reward industry for coming up with new ways to treat a disease responsible for a quarter of all developed-world deaths. He highlights Bristol-Myers Squibb’s success with Yervoy at a price of $120,000 a course. “These are not incremental drugs that add a couple of months’ of extra life,” Mr Baum says. “They are potentially transformational.”

Copyright The Financial Times Limited 2014