New drugs and novel drug combinations for cancer care hold the promise of improved outcomes and lower toxicity profiles. Bristol-Myers Squibb’s Opdivo generated $942 million in total sales in 2015.
Cancer cells are cunning and opportunistic, increasingly finding ways to play hide-and-seek with the immune system. That said, they’re proving no match for a wave of highly effective new anticancer drugs, including immunotherapies and pathway-targeted agents.
Immunotherapies are nestling into a spot in the cancer armamentarium. In fact, deep investments in immunologic and targeted therapies may strip cytotoxic drugs of their first-line treatment title.
“Many of these therapies are dramatically changing oncology care from short-term cytotoxic treatment to long-term ongoing care,” says Chris Weber, SVP and group account director at Sandbox.
Digitas Health LifeBrands’ VP and group director Lee Fraser refers to chemotherapy as the cornerstone of cancer care — most treatment regimens’ basis. New drugs and novel drug combinations, however, hold the promise of improved outcomes and lower toxicity profiles. According to IMS Health’s Global Oncology Trend Report 2015, a large number of immuno-oncology/targeted therapy combinations will launch during the next six years, with an inflection point near 2020–2021.
So what does this mean for pharma companies — and, by extension, their marketing teams? Companies are teaming up to investigate drug combinations, a strategy expected to advance the category.
“Partnering provides a solid foothold in the competitive market,” says Ipsos Healthcare’s head of oncology insight Savade Solanki. “The approach gives second- or third-to-market products an edge by providing physicians with a proven safety profile alongside a drug they already prescribe.” Roche is currently leading the pack of companies making combination investments, but Eli Lilly recently announced plans to match its cancer therapies with AstraZeneca’s PD-L1 program for durvalumab.
Personalized cancer care — specifically genomic testing — is on tap to transform cancer care in the next few years. All eyes are on the role of genomics and proteomics in identifying individualized, molecularly targeted therapies and the emergence of real-time data to inform patients’ treatment decisions.
According to Naxion’s senior VP Deborah Kossman, the strides made in cancer care in the last 35 years have been dramatic, and “many feel we’re on the threshold of similarly exciting discoveries,” she says.
Immunotherapies are achieving striking results in the oncology space. The immunotherapy moniker encompasses a vast array of newfangled cancer treatments that destroy cancer cells.
But while BMS has cornered the near-term immunotherapy market, Merck, AstraZeneca, and Roche are beginning to close the gap. AstraZeneca’s two lead assets, durvalumab (anti-PD-L1) and tremelimumab (anti-CTLA4), are in extensive Phase III trials. Indeed, Datamonitor Healthcare analysts expect PD-1/PD-L1 inhibitors to shoot to the top of the immunotherapy commercial success list during the next decade.
With consistent efficacy and low-toxicity profiles, anti-PD-1s pair well with other immunotherapy and targeted therapies. The layering of therapies combines the high response rates associated with small-molecule-targeted therapy with the durability of immunotherapy.
Opdivo and Merck’s Keytruda (pembrolizumab), fellow checkpoint inhibitors, joined in the treatment of melanoma in 2014. Targeted therapies, including Genentech’s Zelboraf (vemurafenib) and Novartis’ Tafinlar (dabrafenib) and Mekinist (trametinib), target common genetic mutations such as the BRAF V600 mutation found in a subset of melanoma patients.
Following the approval of Pfizer’s Ibrance (palbociclib) to treat a form of hormone-dependent breast cancer, clinical studies of CDK and other checkpoint inhibitors are popping up at a staggering rate. Eli Lilly’s abemaciclib and Novartis’ LEE011, CDK 4/6 inhibitors in development with the same mechanism of action as Ibrance, could send the market into a tailspin. Nonetheless, Leerink Partners and JP Morgan analysts agree that Ibrance will rake in $4 billion a year by 2020. The global breast-cancer therapeutics market is expected to reach $17.2 billion by 2021.
Early clinical results in CAR-T cell therapy hold promise in the treatment of cancer. Novartis, Juno, and Kite are developing CD19-targeted CAR-T treatments for patients with multiple relapsed or refractory acute lymphoblastic leukemia.
Novartis’ Sandoz launched Zarxio, the first biosimilar approved by the FDA , in the U.S. in September 2015.
As for the FDA’s decision to green-light Sandoz’s Zarxio, the first biosimilar drug, it reflects broader changes occurring in the practice of oncology. Now Amgen/Allergan’s ABP 215, an Avastin biosimilar in Phase III trials, is angling for a share of the cancer market, one that brought Roche $6.6 billion in 2014. Amgen believes ABP 215 will gain approval in all six cancers for which Avastin is already indicated.
Only time will tell if the biosimilar can position itself for an easy approval, but critics worry more about what happens once the biosimilar is approved. First, the price differential compared with its original antibody cannot parallel that of typical generic drugs. So with the smaller potential for discounts, oncologists will need an incentive to make the switch.
See also: Therapeutic Focus: Oncology
“The approach in oncology is to add layers [drugs] to increase the efficacy,” says Ipsos’ Solanki. “Oncologists are comfortable … and may not be open to using a biosimilar alongside another clinical treatment.”
The industry’s rising interest in oncology mirrors the fall of the blockbuster drug empire and a shift away from primary care indications serving large patient populations. As a result, drug developers have come face-to-face with an altered marketing pathway.
“Marketers have to manage expectations for a dramatically different treatment experience for patients, caregivers, and healthcare providers,” says Weber.
High prices attached to new cancer treatments further challenge oncology stakeholders. With prices that hover around $9,800 per treatment month, Ibrance is a frequent target for drug-pricing critics. FDA-approved oral medications, such as Genentech’s Alecensa for advanced lung cancer, are also creating a stir.
Cancer accounts for just 5% of total healthcare expenditures — yet analysts expect its costs to climb to $175 billion in 2020, a 40% increase over 2010 levels.
“Cost is the white elephant in the marketing mix and treatment room,” notes Gil Bashe, health managing partner at Finn Partners. “Payers, providers, and pharma innovators are coming to grips with how to define the value of these new cancer therapies.”