During their quarterly conference call, Legend Biotech executives expressed little concern about new threats to the company’s only commercial product, the multiple myeloma CAR-T Carvykti.
Oddly enough, this competition is being conducted through Karvicti’s commercial partner, Johnson & Johnson.
Over the past three months, the pharmaceutical giant has announced data from two successful trials of its multiple myeloma bispecific Tecvayli. One in combination with J&J’s Darzalex and the other with BCMAxCD3 T-cell engager as a single agent. The results of the study show a competitive profile compared to Carvykti, and the combo quickly won FDA approval last week.
During Tuesday’s fourth-quarter earnings call, Legend emphasized that the size and growth of the market should allow each treatment option to grow.
“We and our partner J&J strongly believe that new drugs, including Carvykti and Tecvayli, should be the preferred option based on clinical data demonstrating the superiority of these regimens over the standard-of-care triplet,” said Legend CEO Dr. Ying Huang. “If we look at community medicine in secondary-to-quaternary care settings in the United States, all therapies targeting BCMA still only account for about 5% of the market share. This indicates that there is plenty of growth potential for these new regimens in community care settings.”
Noting that Legend has more than 100,000 patients receiving second-line therapy worldwide, “there is significant unmet need and significant opportunity for adoption of CAR-T in second- and third-line therapy,” said Alan Bash, Legend’s head of Carvykti.
Beyond the expanding market opportunity, Legend executives highlighted several factors that support the company’s confidence in Kalvikti’s competitiveness.
“We continue to hear very important feedback that Carvykti in these early-line settings has a very unique value proposition in delivering overall survival and five-year treatment-free remissions in late-line patients with a single infusion,” Basch added.
The professional treatment guidelines also highlight considerations for sequencing BCMA drugs that position Carvykti as a better initial treatment, as “foregrounding BCMA bispecificity may reduce the efficacy obtained from CAR-T.”
Three months ago, Imran Khan, MD, J&J’s medical vice president of hematology, told Fierce Pharma that some patients prefer to receive a single infusion of Calvikti and finish their treatment, while others, for a variety of reasons, may be treated locally in community settings where CAR-T therapy is not available.
“As a one-time, time-limited infusion, Carvykti offers a different clinical profile, has a different economic impact, and provides meaningful savings to payers compared to combination therapies that require ongoing treatment,” Legend also told Fierce in December.
Legend also noted Tuesday that its manufacturing success rate has increased from 97% to 99% and that it is “not constrained from a capacity standpoint,” Bash added.
“This is one of the many reasons why we and our partner Johnson & Johnson are moving full steam ahead with our capacity expansion plans,” he said. “Our partnership with Johnson & Johnson is built to expand Carvykti to its potential, which is expected to be more than $5 billion in peak annual sales.”
Legend reported 2025 sales of $1.03 billion (including $306 million in the fourth quarter), a 64% increase from the previous year. Originally approved for 2022, Carvykti’s total sales were $1.9 billion, including $555 million in the fourth quarter.
Jefferies analysts predict Carvicti’s sales will grow to $1.5 billion in 2026 and $2.4 billion by 2028.
The New Jersey-based biotech company started 2026 with $949 million in cash on hand. Legend added that Kalvikti will be profitable in 2025 and will be profitable this year as well as the company.
