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Execs Talk Hurdles As Immunotherapy Combos, CAR-T Launches Progress

Xconomy New York — 

With multiple products on the market and many more coming, it’s easy to think that cancer immunotherapy has arrived. In reality, however, we’ve only just begun to figure out how to coax the immune system into killing cancer. That’s why a mad dash is on to expand its reach, and a panel of experts invested in doing so pondered the major issues that lie ahead.

The five-member panel, speaking at the yearly BIO CEO & Investor Conference in New York on Monday, noted that the success of first wave of cancer immunotherapies approved over the past several years has led to a new, set of problems, from managing side effects and reimbursement issues to finding new ways to measure drug effects and new biomarkers to identify the best patients for a treatment.

“This is really the beginning of a 20-year campaign,” said Tito Serafani, the president and CEO of Redwood City, CA-based immunotherapy startup Atreca.

Cancer immunotherapies have gone from hype to drugs in recent years. Multiple checkpoint inhibitors, which help the immune system see tumors, are now approved for cancers of the skin, lung, bladder, and more, and several others are in clinical development.

Yet immunotherapy faces significant limitations. Only a fraction of patients respond to drugs like Merck’s pembrolizumab (Keytruda) and Bristol-Myers Squibb’s nivolumab (Opdivo), and researchers are still trying to figure out why. And these treatments bring on side effects like the onset of autoimmune diseases. The level of side effects was “probably not fully appreciated,” said Mustang Bio (NASDAQ: MBIO) vice president Sadik Kassim.

CAR-T treatments that alter immune cells to hunt down cancers are now on the market for certain leukemias and lymphomas, and are advancing for multiple myeloma and other cancers. Yet they are currently restricted to patients who have run out of other options. Much work has to be done for these treatments to become more than just niche products.

Companies are combining immunotherapy drugs with chemotherapy, other immunotherapies, or other experimental treatments, hoping that more patients will respond, and more cancers will be impacted, without adding more side effects. More than 1,000 combination trials are underway. Panel moderator and Bloomberg Intelligence analyst Asthika Goonewardene noted that this year, 21 Phase 3 clinical trials involving combinations of immunotherapies will produce data.

Here are a just a few issues pointed out by the panel as these treatments progress forward.

How should we measure the effect of an immunotherapy?

The immune system is constantly changing as it reacts to its environment, and its responses to cancer and immunotherapies are no exception. There are biological indicators that an immunotherapy might be working—but for the most part, we don’t … Next Page »

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