Friday, Legend Biotech Corporation (NASDAQ:LEGN) and Johnson & Johnson (NYSE:JNJ) announced late-breaking three-year follow-up data from the Phase 3 CARTITUDE-4 study.

Data shows that a single infusion of Carvykti (ciltacabtagene autoleucel) significantly extended overall survival (OS) for relapsed or lenalidomide-refractory multiple myeloma patients who have received at least one prior line of therapy.

The company says Carvykti is now the first and only cell therapy to improve OS versus standard therapies for patients with lenalidomide-refractory multiple myeloma as early as the second line.

These results were presented at the 2024 International Myeloma Society Annual Meeting.

The Phase 3 CARTITUDE-4 study evaluated Carvykti compared to standard therapies of pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) for relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy.

• At a median follow-up of almost three years (34 months), median OS was not reached for patients in the Carvykti arm.
• At 30-month follow-up, OS rates were 76% in the Carvykti arm and 64% for patients treated with standard therapies.

In patients randomized to the Carvykti arm, Carvykti reduced the risk of death by 45% compared to standard therapies, demonstrating clinically meaningful responses for patients as early as after the first relapse.

• Median progression-free survival (PFS) was not reached in the Carvykti arm and 11.79 months in patients treated with standard therapies, demonstrating sustained deep and durable responses.
• Patients in the Carvykti arm had a 77% complete response or better and an 85% overall response rate.
• Patients in the Carvykti arm had 62% minimal residual disease (MRD)negativity at 10-5 and 57% MRD negativity at 10-6, compared to patients treated with standard therapies (18.5%, 9%), respectively.
• The Median duration of response was not reached in the Carvykti arm, but it was 18.69 months for patients treated with standard therapies.
• Median time to symptom worsening was not reached with Carvykti and 34.33 months with patients treated with standard therapies.

William Blair views this data as a positive step for the company, reinforcing the case for Carvykti's use in second-line treatment.

The analyst writes that the near-term revenue and stock performance will largely depend on the availability of commercial manufacturing slots. William Blair's outlook remains that Legend's valuation fairly reflects the approval of Carvykti in second-line-plus treatment, its anticipated peak revenue, and the current progress of its other pipeline programs.

Price Action: LEGN stock is up 2.29% at $50.40 during the premarket session at last check Monday.

Illustration of Phrama lab worker created with MidJourney

• Prime Medicine Inks Cell Therapy Pact With Bristol Myers Squibb Worth Over $3.5B, Streamlines Pipeline.