Johnson & Johnson (JNJ.US) launches dual pipeline for multiple myeloma. Morgan Stanley comments: Tec-Dara shows significant efficacy, new CAR-T therapy shows initial promise.

Morgan Stanley stated that Johnson & Johnson (JNJ.US) recently announced several groundbreaking clinical data at the American Society of Hematology (ASH) annual meeting. Among them, the Tecvayli and Darzalex combination therapy (Tec-Dara) showed outstanding performance in the Phase III clinical trial (MajesTEC-3) for relapsed/refractory multiple myeloma (RRMM) second line and above treatments, significantly outperforming current standard therapies, and has the potential to expand the use of this combination therapy to frontline treatments. Additionally, Johnson & Johnson's newly developed CAR-T therapy also demonstrated potential competitiveness. Currently, Morgan Stanley maintains a "hold" rating for Johnson & Johnson with a target price of $190. In a report, the firm noted that the MajesTEC-3 clinical trial involved 587 patients, and the results showed that the Tec-Dara combination significantly outperformed the control group (DPd/DVd regimen) in key efficacy indicators. Furthermore, this combination therapy reduced the risk of patient mortality and extended treatment duration. Even patients who had previously received anti-CD38 treatment showed benefits in progression-free survival. In terms of safety, the occurrence rates of grade 3/4 treatment-related adverse events in the Tec-Dara combination were similar to the control group, as were the occurrence rates of grade 5 events, with low treatment interruption rates for both groups. Although the combination had a higher infection rate and there were cases of infection-related deaths in the initial stages of treatment, the addition of an immunoglobulin prophylaxis regimen in February 2023 significantly reduced the rate of grade 3 and above infections six months later, with only one fatal infection reported, effectively managing safety. The incidence of cytokine release syndrome was 60.1%, and the incidence of immune effector cell-related neurotoxicity syndrome was only 1.0%. Morgan Stanley analysts believe that the excellent data of the Tec-Dara combination will drive its expansion from the current backline treatment to the frontline. As a blockbuster drug under Johnson & Johnson with an expected annual sales of $14 billion, Darzalex has already established a solid position in frontline treatments, with approximately 76% of US patients still sensitive to it after first relapse, laying the foundation for the advancement of the Tec-Dara combination. The firm predicts that global sales of Tecvayli will increase from $1 billion in 2026 to $9.3 billion in 2033, and its efficacy performance is competitive with Legend Biotech Corp Sponsored ADR (LEGN.US)/Johnson & Johnson's BCMA CAR-T therapy Carvykti (CARTITUDE-4 trial data). Additionally, the report also mentioned Johnson & Johnson's collaboration with Kelonia on the new CAR-T therapy KLN-1010, with preliminary Phase I clinical data. This therapy uses a lentiviral vector for delivery, does not require pre-treatment, and reduces treatment logistic burdens and production costs. Among the four patients who had received at least third-line treatments, all achieved minimal residual disease negativity responses, with one achieving complete remission, three achieving partial remission, and no instances of immune effector cell-related neurotoxicity syndrome or delayed neurotoxicity, demonstrating good safety performance. The firm believes that if subsequent trials are successful, KLN-1010 has the potential to become a new option for multiple myeloma treatment, further strengthening Johnson & Johnson's leading position in the field, while also posing long-term competitive pressure on existing BCMA CAR-T therapies.