Oncology
Novocure's lung cancer study stirs debate
A medical device made by Novocure that creates electric fields in the lungs via wearable skin patches extended the survival of patients with lung cancer in a clinical trial, researchers reported Monday.
As STAT's Adam Feuerstein reports, the findings could lead to a new approval for the device, called Optune, beyond its current marketing clearance to treat a type of brain cancer. Delivering additional sales, however, could be a significant challenge.
Novocure's study achieved its primary goal and showed a survival benefit for patients with lung cancer that progressed following initial chemotherapy. But those data don't fit the current medical practice for patients with lung cancer because nearly 70% of study participants didn't receive initial treatment with an immune checkpoint inhibitor such as Merck's Keytruda, which has come to dominate current therapy.
"It's quite impressive that it's a positive trial. I thought it would be negative. But with that said, these patients don't exist in my practice in 2023," said Joshua Sabari, a medical oncologist and lung cancer specialist at NYU Langone Health.
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Oncology
Gilead's CAR-T posts pioneering data
Gilead Sciences' CAR-T cancer therapy prolonged the lives of patients with a type of lymphoma by 27% compared to standard treatment in the first study of its kind, a milestone for the technology and a boon to the company's efforts to expand its use.
As STAT's Adam Feuerstein reports, the study is the first randomized trial to show meaningful survival benefit in a long-running trial. Among patients with large B-cell lymphoma whose disease returned after initial treatment, 55% of patients given a single administration of Gilead's Yescarta were still alive four years after treatment, compared to 46% of the patients offered standard treatment.
"These results are consistent with curative therapy," said Jason Westin, an oncologist and blood cancer expert at the University of Texas MD Anderson Cancer Center. And the data make a "compelling case" for using Yescarta as soon as patients relapse after first-line treatment.
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Regulatory
The FDA's cancer chief isn't toeing the party line
Months after FDA Commissioner Robert Califf promised to do away with the yes-or-no votes that conclude the agency's many expert panels, Richard Pazdur, director of the FDA's Oncology Center of Excellence, said he intends to keep them.
"I think we need to vote," Pazdur said at STAT's event at the American Society of Clinical Oncology meeting. "We have to make a binary decision at FDA whether to or not to approve. If we are going in one direction, and we hear a unanimous vote against — we have to pause. You have to step back and say, were we wrong on this?"
Califf's problem with the vote is more a matter of perception. Agency advisers spend an entire day digging through the details of a given drug application, and the public focus on the final vote tends to pave over hours of nuanced conversation. Pazdur said Califf is aware of his views, and that as long as he's in charge of the agency's cancer division, voting questions aren't going anywhere.
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Washington
BIO's new chair has his work cut out
Ted Love, an accomplished biotech executive, is stepping into a new challenge as the incoming chair of BIO, a lobbying group facing unfriendly winds in Washington and some messy internal dynamics that have clouded its future.
As STAT's Rachel Cohrs reports, Love is taking the reins after the industry lost a bruising lobbying fight that resulted in Medicare getting the right to negotiate certain drug prices, and BIO is only months removed from the awkward separation from its former CEO last year.
Love said he plans to bring the personal stories of his experiences developing drugs that helped patients to Capitol Hill, hoping to reset lawmakers' perception of the biotech industry. And internally, BIO is mounting "a very transparent, inclusive search process" for its next CEO, Love said.
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