Legend Biotech stock reversed lower Monday after the company said its Johnson & Johnson-partnered cancer drug, Carvykti, lowered the risk of death by 45% in a roughly three-year study of multiple myeloma patients.
Carvykti works by targeting BCMA, a protein that shows up almost exclusively on multiple myeloma cells. It's the first drug aimed at BCMA to show an overall survival benefit, says Chief Executive Ying Huang. That could help vastly expand Carvykti's share of the market.
There are numerous methods of targeting BCMA. Carvykti is a CAR-T drug. This means physicians remove a patient's immune cells and train them to find and destroy BCMA before reinfusing the cells into the patient. Other drugs include bispecific antibodies, which can block two targets at one time, and targeted chemotherapy, known as antibody drug conjugates.
"In terms of recently approved new medications for multiple myeloma, there's a class of drugs that target BCMA," he told Investor's Business Daily. "In this whole class, Carvykti, right now is the only drug, the only BCMA-targeting medication for the treatment of multiple myeloma that can claim we actually prolong survival for patients."
Shares initially rose as much as 4.4%, but closed down 1.1% at 43.73. Legend Biotech stock has been under pressure for the last year, topping out in July 2023 and falling 37% in the months since.
Legend Biotech: Carvykti Outperforms
William Blair analyst Sami Corwin says the results are "incrementally positive" for Legend Biotech.
Notably, patients who received Carvykti didn't progress, while patients given the traditional regimen saw their cancer worsen after 11.79 months, she said in a note to clients. In addition, 77% of patients had complete responses — meaning their tumors shrank to imperceivable levels — vs. 73% in the last follow-up after a median of 23 months.
"However, we continue to believe the number of available commercial manufacturing slots will be the primary driver of revenue and the stock in the near term," she said.
Corwin has a market perform rating on Legend stock.
But Huang, Legend Biotech's CEO, says the company is already working to bolster its manufacturing capabilities. The company is hoping to roughly double its supply to the market this year compared to last. In 2025, he hopes to do so again.
"Our goal is to reach annualized capacity of 10,000 doses by the end of 2024," he said.
Carvykti's Benefit Over Standard Drugs
There are other benefits to Carvykti over traditional treatment. Typically, patients with multiple myeloma receive a cocktail of drugs. But that's cumbersome, says Huang. Carvykti, on the other hand, is a one-time treatment.
The Food and Drug Administration approved it in early 2022 for patients who previously worsened while undergoing one previous treatment. Carvykti was approved based on its ability to lengthen the amount of time patients live before their cancer worsens.
But overall survival is the "gold standard" in cancer treatment. That's how long patients live before dying of any cause. Carvykti lowered the risk of death by 45% compared with standard drugs over three years of treatment.
The study could extend Legend Biotech's share of the market for multiple myeloma treatment. Huang estimates the company has 87% share of the CAR-T market for treating multiple myeloma.
"If you look at multiple myeloma as a category, we have a lot of room to grow with this benefit," he said.
Replacing Stem Cell Transplants?
Legend Biotech and Johnson & Johnson are also testing Carvykti as a treatment for newly diagnosed multiple myeloma patients. The companies have two studies. One is in patients who aren't eligible for a stem cell transplant or defer that option. The other is in patients who are eligible for — but don't want — a stem cell transplant.
Stem cell transplants have long been the best treatment option for multiple myeloma patients who can undergo one. But it's a lengthy process and patients must first receive chemotherapy to wipe out their bone marrow. Not every patient is healthy enough for that process.
"We want to replace transplants with Carvykti," Huang said. "If we show superiority against stem cell transplants, then we will replace them."
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
