AACR Review: Biden Fired Up, Incyte Doubles Up, BMS Up And Down

Xconomy National — 

The American Association for Cancer Research held its annual meeting this week in Washington, DC, a convenient venue for former Vice President Joe Biden to deliver a broadside against the Trump administration’s proposed budget cuts in science funding.

For Biden, it’s personal. In the final year of the Obama administration, he championed a push for integrated cancer research with both public and private entities. The so-called cancer “moonshot” was supposed to get $1.8 billion in earmarked funds over seven years from the bipartisan 21st Century Cures Act, signed by Obama in December. (Congress honored Biden by naming part of the law after his son, Beau Biden, who died of brain cancer in 2015.)

While by no means guaranteed, the Trump administration’s 2018 budget request, with a 20 percent cut to the National Institutes of Health—plus a proposal to shift funds this year to start paying for a Mexico border wall— has put the moonshot funding and much more federally backed biomedical research on uncertain ground.

In his AACR speech, Biden called the Trump cuts “draconian.” “This is not the time to undercut progress, for God’s sake,” Biden said. “This is the time to double down.”

The AACR weighed in, as well, on the eve of the meeting, calling the Trump proposals “shocking,” and the association’s president-elect Elizabeth Jaffe testified at a friendly House committee hearing last week about the value of cancer research. In a shot across the administration’s bow, the Republican-led committee’s website highlighted how several conservative members talked up support for research funding.

Politics and policy are never far from anyone’s mind these days, but the meeting was mainly about cancer research and clinical data. Here is a notable selection:

—The relatively new field of cancer immunotherapy has produced remarkable short-term effects in a small percentage of patients, but it remains to be seen over time how long those effects last. Longer-term answers are starting to trickle in; a few durability studies are outlined here. One came from Bristol-Myers Squibb (NYSE: BMY), which said that a combination of its two marketed immunotherapy agents, nivolumab (Opdivo) and ipilimumab (Yervoy), helped extend the lives of melanoma patients more than when used alone. The Phase 3 study, called Checkmate 067, only showed a modest benefit over two years, however, and there were more side effects than with people taking nivolumab alone.

How the FDA reads those data is important: The agency approved the combo in 2015 on condition that later studies would show a survival benefit. The approval could be withdrawn with bad data. Barclays analyst Geoff Meacham noted that “the debate will move to the relative risk/reward profile” of combination immunotherapy—particularly given the higher price tag.

—AACR provided more ups and downs for Bristol, which has lost significant ground to Merck (NYSE: MRK) in the battle for leadership in cancer immunotherapy. BMS also disclosed that nivolumab failed a Phase 3 trial in glioblastoma, an aggressive brain cancer that immunotherapy hasn’t yet had much success with.

—Bristol has ceded ground to Merck in large part because, as reported last year, nivolumab failed to help newly diagnosed lung cancer patients, while Merck’s pembrolizumab (Keytruda) succeeded. Given the drugs’ similarities the results were perplexing; as Matthew Herper of Forbes explains here, researchers may have unearthed clues as to what happened.

—Merck and Bristol are also competing to combine their drugs with those of others to boost their effectiveness. The Delaware-based biotech Incyte (NASDAQ: INCY) is on the dance card of both companies. Both reported before and during AACR plans to test Incyte’s epacadostat with nivolumab and pembrolizumab in Phase 3 trials for various cancers.

Epacadostat blocks the tumor enzyme IDO; IDO inhibitors target the immune system differently than the first wave of immunotherapy drugs, checkpoint inhibitors, and thus might help more people respond to them.

—The epacadostat news and data overshadowed Phase 2 results for Newlink Genetics’s (NASDAQ: NLNK) rival IDO blocker, indoximod. Newlink has a partnership with Roche but saw its shares slide more than 20 percent this week. EPVantage has more on the emerging IDO drugs and more upcoming data.

—Another major target for cellular immunotherapy is the blood-borne cancer multiple myeloma. Bluebird Bio (NASDAQ: BLUE) and the University of Pennsylvania reported the first glimmer of results in human studies last year. At AACR, several firms in the chase— Kite Pharma (NASDAQ: KITE), Poseida Therapeutics, and partners Seattle Genetics (NASDAQ: SGEN) and Unum Therapeutics—all reported preclinical data, a sign that several of these so-called CAR-T cell therapies could be in human studies this year for multiple myeloma. Keep an eye on the American Society of Hematology meeting, in December, for data.

—Kite also noted that it has completed its FDA application for its CAR-T treatment axi-cel for non-Hodgkin lymphoma, or NHL. It is racing with Novartis to have the first CAR-T ever approved. The other CAR-T under FDA review is from Novartis, to treat children with leukemia. A second CAR-T program from Novartis, to treat the same NHL subtype as axi-cel, could be for review this year, too, but as The Street’s Adam Feuerstein wrote this week, Novartis is being tight-lipped about the timeline of the final push.

Ben Fidler contributed to this report.

Image of metastatic melanoma cells by the National Cancer Institute.