RIO DE JANEIRO - Johnson & Johnson (NYSE: JNJ) announced today that a Phase 1b study, TRIMM-2, has shown encouraging outcomes for patients with relapsed or refractory multiple myeloma. The combination treatment includes TALVEY® (talquetamab-tgvs), DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), and pomalidomide, demonstrating an overall response rate (ORR) of 82 percent.
Patients in the study had previously undergone at least three lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), or were double refractory to a PI and IMiD, and had not received anti-CD38 therapy within the prior 90 days. The weekly dosing arm reported a 100 percent ORR, with 56 percent achieving complete response (CR) or better. The biweekly dosing arm showed a 76 percent ORR, with a median duration of response (DOR) of 26.4 months and median progression-free survival (PFS) of 20.3 months.
Patients who had developed resistance to anti-CD38 therapy and those who had previously received chimeric antigen receptor T cell (CAR-T) therapy also responded well to the combination treatment, with high rates of CR.
The safety profile was consistent with the known profiles of the individual drugs. Despite high incidence of neutropenia, the rate of serious infections remained generally low. The majority of treatment-related adverse events were low-grade and did not lead to discontinuation of therapy.
According to Nizar Bahlis, M.D., from the University of Calgary, the results support the potential of TALVEY in combination with DARZALEX FASPRO and pomalidomide, which could offer significant disease control and improved survival for patients who have undergone multiple prior therapies.
Additional data from the RedirecTT-1 study, also presented at the International Myeloma Society Annual Meeting, further underscore the combinability of TALVEY. These findings follow previous presentations at the 2023 ASCO Annual Meeting.
TALVEY received FDA approval in August 2023 for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. DARZALEX FASPRO, approved in May 2020, is indicated for multiple myeloma treatments across various patient groups.
This news is based on a press release statement and reflects ongoing research in multiple myeloma treatment, aiming to provide more options for patients with limited treatments at advanced stages of the disease.
In other recent news, Johnson & Johnson's subsidiary, Red River Talc LLC, has filed for a prepackaged Chapter 11 bankruptcy as part of an $8 billion settlement strategy to resolve ongoing ovarian cancer claims related to cosmetic talc litigation in the U.S. This commitment to the settlement increased by $1.75 billion, bringing the total to an estimated $8 billion. The plan aims to resolve 99.75% of all pending talc lawsuits against Johnson & Johnson and its affiliates in the U.S.
In a separate legal development, an Oregon judge has ordered a new trial in a case involving a $260 million verdict against Johnson & Johnson concerning claims that its talc powder caused mesothelioma. Goldman Sachs reiterated its Buy rating on shares of CG Oncology, citing limited downside risk following new data presented by Johnson & Johnson.
Johnson & Johnson has also announced significant findings from their Phase 2 SKIPPirr study, indicating a substantial reduction in infusion-related reactions in patients with advanced non-small cell lung cancer treated with RYBREVANT®. Additionally, the company announced the retirement of D. S. Davis from its board of directors and the retirement of Executive Vice President and Chief Human Resources Officer, Dr. Peter M. Fasolo, with Kristen Mulholland named as his successor. These are some of the recent developments at Johnson & Johnson.
InvestingPro Insights
Johnson & Johnson's latest clinical trial results for its multiple myeloma treatments align with the company's strong position in the pharmaceutical industry. According to InvestingPro data, J&J boasts a substantial market capitalization of $388.51 billion, underscoring its significant presence in the healthcare sector.
The company's focus on innovative treatments like TALVEY and DARZALEX FASPRO is reflected in its solid financial performance. J&J reported a revenue of $86.58 billion over the last twelve months, with a healthy revenue growth of 5.13%. This growth is particularly noteworthy given the company's size and maturity in the market.
An InvestingPro Tip highlights that J&J is a "Prominent player in the Pharmaceuticals industry," which is evident from its continued investment in groundbreaking therapies like those mentioned in the article. This industry leadership is further supported by the company's strong profitability, with a gross profit margin of 69.43% over the last twelve months.
Investors may also find comfort in J&J's dividend performance. Another InvestingPro Tip notes that the company "Has raised its dividend for 53 consecutive years," demonstrating a long-term commitment to shareholder returns. The current dividend yield stands at 3.07%, which could be attractive to income-focused investors.
For those interested in a deeper analysis, InvestingPro offers 11 additional tips for Johnson & Johnson, providing a comprehensive view of the company's financial health and market position.
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