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Risk of therapeutic crowding in cancer drives increase in genetic testing

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Risk of therapeutic crowding in cancer drives increase in genetic testing

Big Pharma's push into oncology has yielded advances in the ability to detect disease earlier, identify more genetic links and develop new ways to tackle tumors. It's also spurred a stampede into the field as cancer is set to be diagnosed in 23.6 million people a year by 2030, bringing the annual cost of care to over $1 trillion.

Oncology will be the main therapeutic focus for over half of large-cap pharmaceutical companies by 2022, and sales are forecast to jump by 50% to $128 billion, according to Jefferies analyst Peter Welford. But the risk of therapeutic crowding is growing at the expense of research into respiratory, cardiovascular and infectious disease, as more companies zero in on the same types of cancer treatments.

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"When you take a look at analysts' own estimates, oncology is forecast to be the fastest-growing therapeutic area over the course of the next 10 to 15 years," Dave Fredrickson, AstraZeneca PLC's head of oncology, said in an interview with S&P Global Market Intelligence. That is driving an influx of competition, he said, but the opportunities are more attractive for companies that are trying to break ground on new types of treatments.

The focus of innovation in the treatment of cancer has shifted momentarily from immunotherapies, which harness the body's own immune system to fight the disease, to two classes of drugs that disrupt cancer cells' growth.

One class, called PARP inhibitors, stops cancer cells from repairing themselves, while the other class, EGFR inhibitors, thwarts cancer cell division and survival. Both types of treatment have seen positive clinical trial results recently, in part due to diagnostics that help determine which patients will benefit.

A decade ago, Paris-based Sanofi was among the first of the big drug companies to embark on the PARP trail, buying California's BiPar Sciences for its experimental BSI-201 medicine. Also known as iniparib, the compound had shown a 60% increase in survival rates in women with triple-negative breast cancer compared with chemotherapy alone and analysts had penciled in valuations of up to $2 billion.

But, in spite of being fast-tracked by U.S. regulators for approval, that PARP inhibitor failed in late-stage trials in 2011 and was written off after Sanofi moved on to the $18.5 billion acquisition of U.S. biotech group Genzyme.

At the time, AstraZeneca's Lynparza was already in the early stages of development, but it took the arrival of CEO Pascal Soriot in late 2012 to reignite development of the compound, then known as olaparib, which had been shelved under previous management.

Now approved for the treatment of breast and ovarian cancer in people who have inherited the faulty BRCA1 or BRCA2 genes, recent clinical trials have shown Lynparza to be effective in a wider population than just the group with those particular mutations. The Profound study showed that the tablet cut the risk of prostate cancer progressing or of premature death by 66% in men with BRCA1/2 or ATM-mutated prostate cancer, a panel of 12 other genes.

"Beyond BRCA, that's been a recurring theme of this meeting," said Scot Ebbinghaus of Merck & Co. Inc., which co-develops Lynparza, in an interview on the sidelines of the European Society for Medical Oncology conference. The Profound and Paola studies, both presented at the conference, showcase the benefits of Lynparza for patients whose disease is not defined by faulty BRCA genes, he said.

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Beyond BRCA

Ebbinghaus, Merck's vice president of clinical research, expects that men with prostate cancer will now start to have genetic testing for 15 genes including BRCA1 or 2, collectively known as HRRM. Together, this group of genes accounts for some 25% of men diagnosed with prostate cancer, according to AstraZeneca's Fredrickson.

Deploying a companion diagnostic to limit the use of a drug to the appropriate patients can raise the median objective response rates from 23% for cancer patients whose treatment didn't involve such a diagnostic, to over 55% for those whose treatment was paired with a test, goetzpartners securities analyst Brigitte de Lima said.

"Molecular diagnostics are playing an increasingly important role in the personalization of cancer therapy," she said.

"There are currently over 30 companion diagnostics linked to the use of specifically targeted cancer therapies, and biomarkers were used in nearly 40% of oncology trials in 2018, up from 25% in 2010. A growing repertoire of additional genetic markers are increasingly used to guide treatment and determine individual prognosis," goetzpartners securities said in a recent report on oncology.

Still, that is a fraction of the investment being plowed into so-called second wave immuno-oncology investments in the PD1/L1 checkpoint inhibitor field where some six treatments are forecast to bring in $33 billion, or around a quarter of estimated oncology revenues, by 2022, according to Welford. Even with effective diagnostics to direct treatment, Jefferies' Welford says that the PARP space is crowded, with $4.7 billion of sales expected by 2022 from the four medicines that are on the market.

"What cancer R&D is proving as we go forward, is that patient populations are becoming more sophisticated," said an analyst who spoke on condition of anonymity. "We have BRCA now in breast and ovarian, KRAS in lung cancer ... As more and more cancer R&D gets done, there are more and more biomarkers that are coming out."

AstraZeneca, under CEO Soriot, has invested heavily in its cancer business and is likely to overtake Roche Holding AG to become the drugmaker most concentrated in oncology by 2025, according to Jefferies. New treatments, including Infinzi, Lynparza and Tagrisso, form the bedrock of the Cambridge, England-based company's pledge to attain sales of $45 billion by 2023.

Roche does both

Basel, Switzerland-based Roche and its U.S. business Genentech have long been recognized as the cancer heavyweight, with a stable of established blockbuster drugs including Herceptin and Avastin, with Kadcycla and Tecentriq approaching $1 billion in annual sales.

In addition, Roche has a diagnostics business and acquired Foundation Medicine, which makes genetic tests and uses data to match patients to treatments. Peers like Brentford, London-based GlaxoSmithKline PLC, whose research is led by ex-Genentech lead Hal Barron, have moved fast to catch up, and now have twice the number of experimental cancer assets compared with a year ago — as well as a PARP of its own, Zejula, gained through the $5.1 billion acquisition of Tesaro.

"Personalized healthcare [is] something that we're particularly proud of being involved with and something that we think about all the time, with all of our therapies," Alan Sandler, global head of product development oncology — solid tumors at Genentech, said in an interview. "And now with Foundation medicine, that put us in a very unique position to be able to try and identify those patients that do better with therapies, and ultimately, what group of patients don't benefit that's the hardest one, right?"

The impetus is now on oncologists to avail themselves of the increasing number of diagnostic tools they have to hand, in order to match the correct treatment to the type of disease, thus prolonging life and justifying the cost of such innovation in cancer to the payers.

"The explosion in genomic data and in deeper understanding of science is allowing us to make even greater progress into oncology, and to be able to really start putting things like cure on the table," said AstraZeneca's Fredrickson. "So I think that explains the reason why we're seeing so many players coming into this space.

"All of us have the same goal: right drug, right patient, right time."

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